Telemedicine Nutritional Counseling for Cancer Cachexia in Pakistan (TELE-CACHE)

Telemedicine-Delivered Nutritional Counseling Versus Standard Care for Cancer Cachexia in Pakistani Cancer Patients: A Pilot Randomized Controlled Trial

What is this study about? Cancer often causes unwanted weight loss and loss of appetite, a condition called "cancer cachexia." This affects patients' strength, quality of life, and ability to tolerate cancer treatment. Proper nutrition is very important to help maintain weight and strength during cancer treatment. Currently, cancer patients receive nutritional counseling during hospital visits, which requires travel time and expense. With telemedicine (video calls on mobile phones), nutritional counseling can be provided from patients' homes.

What is the purpose of this study?

This study compares two ways of providing nutritional counseling to cancer patients who have experienced weight loss:

Telemedicine group: Counseling through video calls (WhatsApp, Zoom, or Microsoft Teams) from home Standard care group: Counseling during in-person hospital visits Both groups receive the same nutritional advice every 2 weeks for 12 weeks. The only difference is how the counseling is delivered (video call vs. in-person).

Who can participate? Adults (18 years or older) with cancer who have lost weight in recent months and have access to a smartphone with internet connection.

What will participants do?

Telemedicine group:

Receive counseling through 20-30 minute video calls every 2 weeks (7 sessions total) Come to hospital only twice: at the beginning and end (Week 0 and Week 12)

Standard care group:

Come to hospital every 2 weeks for 30-45 minute counseling sessions (7 visits total)

Both groups receive:

Personalized dietary advice from registered dietitians Help with eating problems (poor appetite, nausea, taste changes) Pakistani meal plans that fit their preferences Free nutritional counseling throughout the study Reimbursement for travel or mobile data costs

What will be measured? Body weight change over 12 weeks Food and protein intake Arm muscle measurements Nutritional status and quality of life Patient satisfaction with counseling method Costs of each method

Why is this study important? This will be the first study in Pakistan and South Asia to test whether telemedicine nutritional counseling works as well as hospital visits for cancer patients. Results will help make nutritional care more accessible, especially for patients living far from hospitals.

Study Location: King Edward Medical University/Mayo Hospital, Lahore, Pakistan Duration: 12 weeks per participant Total Participants Needed: 80 patients

Study Overview

• Status: Active, not recruiting
• Conditions: Cachexia; Cancer; Sarcopenia
• Intervention / Treatment: Behavioral: Telemedicine-Delivered Nutritional Counseling; Behavioral: Standard In-Person Nutritional Counseling

Detailed Description

BACKGROUND AND RATIONALE Cancer cachexia is a devastating metabolic syndrome characterized by progressive involuntary weight loss, skeletal muscle depletion, systemic inflammation, and anorexia. It affects 50-80% of cancer patients and contributes to 30% of cancer-related deaths. Cachexia profoundly impairs quality of life, reduces tolerance to anti-cancer treatments (chemotherapy, radiation, surgery), increases treatment-related toxicity and complications, and significantly worsens survival outcomes across all cancer types.

International clinical practice guidelines from the European Society for Clinical Nutrition and Metabolism (ESPEN) and American Society of Clinical Oncology (ASCO) recommend nutritional counseling as a cornerstone of multimodal cachexia management. However, evidence supporting the effectiveness of specific nutritional interventions remains limited, particularly in resource-constrained settings. The ASCO 2020 guideline acknowledges that dietary counseling may increase body weight in some cancer patients but emphasizes the urgent need for more high-quality evidence from randomized controlled trials.

The Pakistani Context:

Pakistan faces an escalating cancer burden with 178,388 new cancer cases and 117,149 cancer deaths reported over five years (GLOBOCAN 2020 data). Pakistani cancer patients face multiple unique challenges:

• High malnutrition prevalence: 31-97% of cancer patients suffer from malnutrition
• Micronutrient deficiencies: Widespread vitamin D, vitamin A, zinc, and iron deficiencies documented in national nutrition surveys
• Late-stage diagnosis: 89% of patients in rural areas present with advanced-stage disease
• Financial catastrophe: 50-90% of lower-income cancer patients are pushed into poverty by out-of-pocket healthcare expenditure
• Geographic barriers: Traditional in-person nutritional counseling is limited by transportation costs, long travel distances, and critical shortage of trained clinical nutritionists

Telemedicine as a Solution:

Telemedicine (healthcare delivery via telecommunications technology) offers a promising strategy to overcome access barriers to nutritional care. Recent evidence demonstrates that telemedicine-delivered nutritional interventions improve dietary adherence, nutritional status, body weight, and quality of life in cancer patients. A 2025 systematic review found that mobile health interventions for cancer nutrition significantly improve body weight, energy intake, protein intake, and patient-reported outcomes.

However, no randomized controlled trials have evaluated telemedicine-based nutritional counseling specifically for cancer cachexia management in Pakistan or anywhere in South Asia. This represents a critical evidence gap, as telemedicine interventions must be evaluated in the local context considering technology literacy, internet infrastructure, cultural dietary practices, and healthcare system characteristics.

STUDY DESIGN AND METHODOLOGY Study Type: Single-center, parallel-group, pilot randomized controlled trial with 1:1 allocation ratio Study Setting: Department of Radiotherapy and Medical Oncology, King Edward Medical University/Mayo Hospital, Lahore, Pakistan (tertiary care academic medical center) Study Duration: 12 months total (February 2026 - January 2027)

• Preparation: 4 weeks
• Enrollment: 16 weeks (February - May 2026)
• Intervention: 28 weeks with overlapping enrollments (February - August 2026)
• Data collection: Through October 2026
• Analysis and dissemination: November 2026 - January 2027 Intervention Duration per Participant: 12 weeks (3 months)

SAMPLE SIZE AND POWER Total Sample: 80 participants (40 per group)

Power Calculation: Using G*Power software for independent samples t-test:

• Effect size (Cohen's d): 0.75 (medium-large effect based on published telemedicine nutrition literature showing 1.5-2.5 kg weight differences)
• Alpha: 0.05 (two-sided)
• Power: 85%
• Calculated sample per group: 29 participants
• Dropout adjustment: 20% anticipated dropout (realistic for cancer cachexia trials)
• Final sample: 40 per group (80 total)
• Expected evaluable sample: 64 participants (32 per group) Recruitment Feasibility: Approximately 50-60 new cancer patients are seen monthly at the Medical Oncology Department. With 50-60% cachexia prevalence and 60-70% anticipated consent rate, enrollment of 15-25 patients per month is feasible, allowing completion of recruitment in 4 months.

RANDOMIZATION AND ALLOCATION

Randomization Method:

• Computer-generated randomization sequence using block randomization
• Variable block sizes (4-6 participants per block) to prevent prediction of allocation
• Stratification by cancer type: gastrointestinal cancers vs. non-gastrointestinal cancers (due to different cachexia severity and nutritional needs)
• Allocation ratio: 1:1 (equal numbers in each group)

Allocation Concealment:

• Sequentially numbered, sealed, opaque envelopes prepared by statistician
• Envelopes opened only after participant provides informed consent and completes baseline assessment
• Allocation conducted by study coordinator not involved in outcome assessments

Blinding:

• Single-blind design (outcomes assessor blinded)
• Participants and dietitians cannot be blinded due to the nature of the intervention (obvious whether receiving video calls or in-person visits)
• Laboratory technicians blinded to group allocation
• Statistician blinded during analysis (data coded as Group A and Group B)
• Objective primary outcome (body weight on calibrated scale) minimizes detection bias

INTERVENTIONS - DETAILED DESCRIPTION Both groups receive identical nutritional counseling content delivered by the same registered dietitians following standardized protocols. The ONLY difference is delivery modality (telemedicine vs. in-person).

INTERVENTION GROUP: Telemedicine Nutritional Counseling Platform: WhatsApp Video Call (primary, most accessible in Pakistan), with Zoom or Microsoft Teams as alternatives based on patient preference

Delivery:

• Dietitian conducts sessions from dedicated workspace at Department of Medical Oncology, KEMU
• Patient participates from home or any convenient private location with internet access (mobile data or Wi-Fi)
• Session duration: 20-30 minutes per session
• Frequency: Bi-weekly (every 2 weeks)
• Total sessions: 7 sessions over 12 weeks (Weeks 0, 2, 4, 6, 8, 10, 12) In-Person Visits: Only 2 required (Week 0 for baseline assessments and Week 12 for final assessments)

Platform Training: 15-minute training session at Week 0 visit covers:

• How to join video calls on WhatsApp/Zoom/Teams
• Ensuring good lighting and quiet environment
• Troubleshooting common technical issues
• Privacy considerations

Technical Support:

• Study coordinator phone number provided for technical issues
• Backup contact via WhatsApp messaging
• Sessions rescheduled if technical difficulties prevent completion Session Recording: Sessions may be recorded (with separate consent) for quality assurance and protocol adherence monitoring only. Recordings destroyed after analysis.

CONTROL GROUP: Standard In-Person Nutritional Counseling Setting: Hospital nutrition clinic, Department of Medical Oncology, KEMU/Mayo Hospital

Delivery:

• Face-to-face consultation with registered dietitian
• Session duration: 30-45 minutes per session
• Frequency: Bi-weekly (every 2 weeks)
• Total visits: 7 in-person hospital visits over 12 weeks (Weeks 0, 2, 4, 6, 8, 10, 12)

COUNSELING CONTENT (IDENTICAL FOR BOTH GROUPS):

Each session includes:

1. Dietary Assessment:

   • 24-hour dietary recall using USDA 5-step multiple-pass method
   • Review of eating patterns since last session
   • Food frequency patterns
   • Barriers to adequate intake identified

2. Symptom Assessment and Management:

   • Appetite loss (early satiety, food aversions)
   • Nausea and vomiting
   • Taste and smell changes (metallic taste, foods taste bland)
   • Difficulty swallowing (dysphagia, odynophagia)
   • Dry mouth (xerostomia)
   • Diarrhea or constipation
   • Fatigue affecting meal preparation and eating
   • Practical strategies provided for each symptom

3. Personalized Meal Planning:

   • Culturally-adapted Pakistani food recommendations
   • High-protein foods: daal (lentils), chana (chickpeas), eggs, chicken, beef, fish, yogurt, milk, paneer (cottage cheese), nuts (almonds, walnuts, peanuts)
   • High-energy foods: ghee, cooking oils, full-fat dairy, nuts, dried fruits, honey, traditional sweets (in moderation)
   • Traditional meal patterns: breakfast (paratha, eggs, tea), lunch (roti, daal, vegetable, meat), dinner (rice, curry, salad), snacks
   • Small, frequent meals (5-6 times daily) if early satiety
   • Food safety during chemotherapy

4. Nutritional Targets:

   • Energy: ≥25 kilocalories per kilogram body weight per day (ESPEN guideline)
   • Protein: ≥1.0 gram per kilogram body weight per day (ESPEN guideline)
   • Individualized based on current intake and tolerance

5. Micronutrient Supplementation:

   • Vitamin D supplementation (high prevalence of deficiency in Pakistan)
   • Vitamin A (if deficient)
   • Iron supplementation (if anemic)
   • Zinc supplementation (if deficient)
   • Multivitamin/mineral recommended for most patients

6. Oral Nutritional Supplements (ONS):

   • Recommended if patient unable to meet >75% of energy/protein needs through regular food
   • Locally available commercial supplements discussed
   • Homemade high-protein, high-calorie supplements (e.g., milk-based drinks with eggs, banana, nuts, honey)

7. Goal Setting:

   • Specific, measurable, achievable goals for next 2 weeks
   • Examples: "Eat 2 eggs daily," "Drink 500ml milk daily," "Add 2 tablespoons ghee to meals"
   • Written goals provided to patient

8. Family/Caregiver Education:

   • Importance of nutrition during cancer treatment
   • How family can support patient (meal preparation, eating together, encouragement)
   • Addressing family concerns and myths about cancer diet

9. Progress Monitoring and Motivation:

   • Review progress toward previous goals
   • Celebrate successes
   • Problem-solve barriers
   • Encouragement and support

Standardization Measures:

• Same dietitians counsel both groups
• Standardized counseling checklists ensure all topics covered
• Monthly dietitian meetings to review protocols
• Random session audits for quality assurance

ASSESSMENTS AND DATA COLLECTION

BASELINE ASSESSMENT (Week 0 - Both Groups):

Demographic Data:

• Age, gender, marital status, education level, occupation
• Residence (urban vs. rural), distance from hospital
• Monthly household income, number of household members
• Primary caregiver

Clinical Data:

• Cancer diagnosis (type, site, stage)
• Date of diagnosis
• Current anti-cancer treatment (chemotherapy regimen, radiation, targeted therapy, immunotherapy)
• Treatment start date
• ECOG performance status (0-2)
• Comorbidities (diabetes, hypertension, heart disease, COPD, chronic kidney disease)
• Current medications

Anthropometric Measurements:

• Body weight: Calibrated digital scale (±0.1 kg), light clothing, no shoes, empty bladder
• Height: Stadiometer, no shoes
• Body Mass Index (BMI): Calculated as weight (kg) / height (m)²
• Mid-upper arm circumference (MUAC): Non-dominant arm, midpoint between acromion and olecranon, non-stretchable tape, nearest 0.1 cm

Weight History:

• Weight 1 month ago, 3 months ago, 6 months ago
• Usual adult weight
• Weight loss calculated (kg and percentage)

Nutritional Assessment:

1. Patient-Generated Subjective Global Assessment (PG-SGA):

   • Gold standard validated tool for cancer patients
   • Patient-completed section: Weight history, food intake, symptoms, activities/function
   • Professional-completed section: Disease, metabolic stress, physical examination
   • Score 0-35: Higher scores = greater malnutrition risk
   • Categories: Well-nourished (0-1), Moderate malnutrition (2-8), Severe malnutrition (≥9)

2. 24-Hour Dietary Recalls (Two Non-Consecutive Days):

   • One weekday and one weekend day
   • USDA 5-step multiple-pass method
   • All foods, beverages, amounts, preparation methods documented
   • Analyzed using Pakistani Food Composition Database (National Institute of Health, Islamabad)
   • Calculate: Total energy (kcal/day, kcal/kg/day), protein (g/day, g/kg/day), carbohydrate, fat, fiber, micronutrients

3. Food Frequency Questionnaire:

   • Usual intake patterns over past month
   • Major food groups and key nutrient sources

   Laboratory Investigations:

   • Serum albumin (g/dL) - nutritional status marker
   • Hemoglobin (g/dL) - anemia assessment
   • C-reactive protein (CRP) (mg/L) - systemic inflammation marker
   • HbA1c (if diabetic)
   • Serum creatinine

   Quality of Life:

   • EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
   • Validated cancer-specific questionnaire, Urdu version
   • 30 items covering global health status/QoL, functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties)
   • Scores transformed to 0-100 scale
   • Higher scores = better functioning (functional scales) or worse symptoms (symptom scales)

   Technology Literacy Assessment (Intervention Group Only):

   • Smartphone ownership and type
   • Internet access (home Wi-Fi, mobile data, both)
   • Prior video call experience
   • Apps previously used
   • Confidence in using video calls
   • Language preference

   MID-POINT ASSESSMENT (Week 6 - Both Groups):

   • Body weight
   • MUAC
   • Two 24-hour dietary recalls
   • PG-SGA score
   • Brief symptom assessment
   • Treatment changes since baseline
   • Session adherence to date
   • Any adverse events

   FINAL ASSESSMENT (Week 12 - Both Groups):

   All baseline measures repeated:

   • Anthropometrics (weight, height, BMI, MUAC)
   • Two 24-hour dietary recalls
   • Food frequency questionnaire
   • PG-SGA score
   • Laboratory tests (albumin, hemoglobin, CRP)
   • EORTC QLQ-C30 quality of life questionnaire
   • Treatment changes during study period
   • Complete session adherence record
   • Adverse events

   Patient Satisfaction Survey (Week 12):

   • Adapted Client Satisfaction Questionnaire-8 (CSQ-8)
   • 8 items, 4-point Likert scale, score 8-32
   • Additional questions for telemedicine group: Convenience, technical difficulties, preference for continuing telemedicine

   Cost Data:

   • Healthcare system costs: Dietitian time, platform costs, equipment
   • Patient costs: Transportation, time off work, caregiver time, internet/data charges
   • All costs tracked throughout study

   STATISTICAL ANALYSIS PLAN

   Analysis Populations:

   • Intention-to-treat (primary): All randomized participants analyzed in allocated groups
   • Per-protocol (sensitivity): Participants with ≥75% adherence, no major protocol violations
   • Modified ITT: Participants with at least one post-baseline assessment

   Primary Outcome Analysis:

   • Independent samples t-test (if normally distributed) or Mann-Whitney U test (if non-normally distributed) for mean weight change
   • Non-inferiority analysis: Non-inferiority margin -1.0 kg; telemedicine declared non-inferior if lower limit of 95% CI > -1.0 kg
   • ANCOVA adjusting for baseline weight, cancer type, ECOG status, treatment changes
   • Effect size: Cohen's d with 95% CI

   Secondary Outcomes:

   • Continuous outcomes: t-test or Mann-Whitney U, ANCOVA with baseline adjustment
   • Categorical outcomes (adequate intake proportions): Chi-square or Fisher's exact test
   • Repeated measures ANOVA for trajectory over time (Weeks 0, 6, 12)
   • Session adherence: t-test for mean, chi-square for proportion ≥70%
   • Patient satisfaction: Mann-Whitney U test
   • Cost analysis: t-test, bootstrap methods if skewed

   Missing Data:

   • Multiple imputation using chained equations (20 imputations) if <20% missing
   • Complete case analysis as sensitivity
   • ITT maintained regardless of missing data

   Subgroup Analyses (Exploratory):

   • Cancer type (GI vs. non-GI)

   • Baseline cachexia severity (3-5% vs. >5% weight loss)
   • Gender, residence (urban vs. rural), age (<60 vs. ≥60 years), baseline ECOG Software: IBM SPSS Statistics version 26.0 Significance Level: p<0.05 (two-tailed), 95% confidence intervals

   SAFETY MONITORING

   Adverse Event Monitoring:

   • Dietitians assess for new symptoms, hospitalizations, treatment changes at each session
   • All adverse events documented
   • Serious adverse events (death, life-threatening, hospitalization) reported to PI within 24 hours and IRB within 7 days

   Expected Events NOT Reported as AEs:

   • Cancer progression (natural disease course)

   • Expected chemotherapy/radiation side effects
   • Minor technical difficulties with video calls

   Interim Safety Review:

   • At 50% enrollment (40 participants)
   • Conducted by PI and independent oncologist
   • Review of adverse events, adherence, dropout reasons
   • Assess whether study should continue as planned

   Stopping Rules:

   • No specific stopping rules (minimal risk intervention)
   • Study may be stopped for unexpected serious adverse events attributed to intervention, major ethical concerns, or futility ________________________________________ SIGNIFICANCE AND EXPECTED IMPACT This will be the first randomized controlled trial evaluating telemedicine-delivered nutritional counseling for cancer cachexia in Pakistan and South Asia. The rigorous non-inferiority design with equal counseling frequency in both groups isolates the effect of delivery modality from frequency effect.

   Expected Outcomes:

   • Telemedicine will be non-inferior to in-person counseling for weight outcomes

   • Telemedicine will show superior adherence, patient satisfaction, and cost-effectiveness

   • Reduced travel burden and out-of-pocket costs for patients

   • Improved access to specialized nutritional care for rural patients

   Clinical Impact:

   • Evidence to support telemedicine nutrition services in Pakistani cancer centers

   • Scalable model for overcoming geographic and financial barriers to nutritional care

   • Reduced healthcare disparities for underserved cancer patients

   • Template for telemedicine interventions in other chronic diseases

   Research Impact:

   • First South Asian data on telemedicine for cancer cachexia

   • Robust effect size estimates to justify larger multi-center trial
   • Cost-effectiveness data to inform health policy
   • Methodology applicable to other low-and-middle-income countries

   Policy Impact:

   • Evidence for health ministry to invest in telemedicine infrastructure
   • Support for training dietitians in telemedicine service delivery
   • Framework for reimbursement policies for telemedicine nutrition services This pilot RCT addresses a critical evidence gap and will inform scalable, equitable models of nutritional care delivery in resource-constrained settings.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Department of Radiotherapy and Medical Oncology, Mayo Hospital Lahore, 54000, Lahore, Pakistan.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Age and Consent Capacity

  • Age ≥18 years (adults of either biological sex or gender identity)
  • Able to understand study procedures and provide written informed consent independently or with assistance from legally authorized representative 2. Cancer Diagnosis

  • Histologically or cytologically confirmed solid tumor malignancy of any type, including but not limited to:

    • Lung cancer (non-small cell or small cell)
    • Breast cancer
    • Gastrointestinal cancers: gastric (stomach), colorectal, pancreatic, esophageal, hepatobiliary (liver, gallbladder, bile duct)
    • Head and neck cancers (oral cavity, pharynx, larynx, nasal cavity, salivary glands)
    • Gynecological cancers: cervical, ovarian, endometrial, vulvar, vaginal
    • Genitourinary cancers: prostate, bladder, renal (kidney), testicular
    • Other solid tumors: sarcomas, melanoma, thyroid, brain tumors
  • Any cancer stage eligible (Stage I, II, III, or IV) 3. Cancer Cachexia

  • Documented unintentional weight loss meeting at least one of the following criteria:

    • Weight loss ≥3% of body weight within the past 3 months, OR
    • Weight loss ≥5% of body weight within the past 6 months
  • Weight loss must be documented by medical records, patient self-report, or measurement at screening visit compared to documented previous weight 4. Active Cancer Treatment
  • Currently receiving active anti-cancer treatment, OR
  • Scheduled to begin active anti-cancer treatment within 2 weeks of enrollment

  • Eligible anti-cancer treatments include:

    • Chemotherapy (cytotoxic agents, any regimen)
    • Radiation therapy (external beam or brachytherapy)
    • Targeted molecular therapy (tyrosine kinase inhibitors, monoclonal antibodies)
    • Immunotherapy (checkpoint inhibitors, CAR-T cell therapy)
    • Hormonal therapy for hormone-sensitive cancers
    • Combination therapies
  • Patients receiving palliative/supportive care only (without active anti-cancer treatment) are excluded 5. Performance Status

  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2:

    • Grade 0: Fully active; able to carry on all pre-disease activities without restriction
    • Grade 1: Restricted in physically strenuous activity but ambulatory; able to carry out light or sedentary work (e.g., light housework, office work)
    • Grade 2: Ambulatory and capable of all self-care activities but unable to carry out any work activities; up and about >50% of waking hours 6. Technology Access and Literacy
  • Access to a smartphone or tablet device with video calling capability (personal device or family member's device that participant can use)

  • Reliable internet connectivity available via at least one of:

    • Home Wi-Fi network
    • Mobile cellular data plan (3G, 4G, or 5G)
    • Access to public/community Wi-Fi
  • For telemedicine group: willingness and ability to participate in video consultations 7. Language
  • Able to communicate verbally in Urdu (national language of Pakistan) or English
  • Able to understand spoken instructions and questions
  • Literacy not required; illiterate participants eligible with assistance from family/witness for consent and questionnaires 8. Geography
  • Able to attend in-person assessments at King Edward Medical University/Mayo Hospital, Lahore, Pakistan at baseline (Week 0) and Week 12
  • For telemedicine group: only 2 hospital visits required (Weeks 0 and 12)
  • For standard care group: able to attend 7 hospital visits (Weeks 0, 2, 4, 6, 8, 10, 12) 9. Commitment
  • Willing to participate in the study for the full 12-week duration
  • Willing to comply with study procedures including dietary assessments, questionnaires, blood tests, and nutritional counseling sessions

Exclusion Criteria:

• Inability to Eat Orally

  • Severe dysphagia (difficulty swallowing) requiring enteral nutrition support via:

    • Nasogastric tube feeding
    • Percutaneous endoscopic gastrostomy (PEG) tube
    • Jejunostomy tube
  • Complete bowel obstruction preventing oral intake
  • Total parenteral nutrition (TPN) as sole nutritional support
  • Note: Partial oral intake supplemented with enteral nutrition is eligible if patient can consume at least some food by mouth 2. Refractory Cachexia

  • ECOG Performance Status 3 or 4:

    • Grade 3: Capable of only limited self-care; confined to bed or chair >50% of waking hours
    • Grade 4: Completely disabled; cannot carry out any self-care; totally confined to bed or chair
  • Active cachexia management deemed not clinically appropriate or futile by treating oncologist
  • Estimated life expectancy <3 months per treating oncologist's assessment
  • Imminent end-of-life care or transition to hospice care 3. Uncontrolled Comorbid Conditions

  • Uncontrolled diabetes mellitus defined as:

    • Glycated hemoglobin (HbA1c) >9% within past 3 months, OR
    • Frequent hypoglycemic or hyperglycemic episodes requiring emergency care
    • Rationale: Uncontrolled diabetes affects nutritional metabolism and requires specialized dietary management beyond scope of this intervention

  • End-stage renal disease requiring dialysis (hemodialysis or peritoneal dialysis)

    o Rationale: Dialysis patients require specialized renal diet with protein, fluid, potassium, and phosphorus restrictions that differ substantially from cancer cachexia nutritional recommendations

  • Severe heart failure, New York Heart Association (NYHA) Functional Class IV:

    • Symptoms at rest; any physical activity causes discomfort
    • Rationale: Severe cardiac cachexia has different pathophysiology and requires cardiology-directed nutritional management 4. Psychiatric or Cognitive Impairment

  • Active psychiatric illness that would preclude meaningful participation or informed consent, including:

    • Severe major depressive disorder with active suicidal ideation
    • Acute psychotic episode (schizophrenia, bipolar disorder with psychosis)
    • Severe anxiety disorder preventing participation in counseling sessions

  • Cognitive impairment preventing informed consent or ability to participate, including:

    • Advanced dementia (moderate to severe; unable to follow simple instructions)
    • Severe delirium (acute confusional state)
    • Significant brain metastases causing cognitive dysfunction
  • Note: Mild cognitive impairment or controlled psychiatric conditions with stable treatment are not exclusionary 5. Concurrent Study Participation
  • Currently enrolled in another interventional clinical trial testing nutritional interventions, dietary supplements, or appetite stimulants
  • Rationale: Concurrent nutritional interventions would confound outcome assessment
  • Note: Participation in observational studies, cancer treatment trials (chemotherapy, radiation), or non-nutritional supportive care trials is permitted 6. Pregnancy or Lactation
  • Pregnant women (confirmed by urine or serum pregnancy test if reproductive potential)
  • Breastfeeding/lactating women
  • Rationale: Pregnancy and lactation have substantially different and increased nutritional requirements that require specialized prenatal/postnatal nutritional counseling beyond the scope of cancer cachexia management in this protocol 7. Severe Food Allergies or Intolerances
  • Known severe allergy or intolerance to recommended nutritional supplements (oral nutrition supplements, protein powders, vitamins/minerals) for which no suitable alternatives are available in Pakistan
  • Note: Common food allergies (dairy, eggs, nuts) are not exclusionary as alternative food sources can be recommended 8. Logistical Barriers
  • Unable to attend baseline assessment visit (Week 0) at King Edward Medical University/Mayo Hospital, Lahore
  • Unable to attend final assessment visit (Week 12) at the hospital
  • For telemedicine group: Complete inability to access internet or use smartphone/tablet even with family assistance
  • No reliable means of contact (no phone number, no address) 9. Other
  • Enrolled in this study previously (re-enrollment not permitted)

  • Non-cancer-related causes of weight loss that would confound cachexia assessment:

    • Active eating disorder (anorexia nervosa, bulimia nervosa) requiring psychiatric treatment
    • Intentional weight loss through dieting for weight management
    • Hyperthyroidism causing unintentional weight loss (must be controlled before enrollment)
    • Active gastrointestinal infection (parasites, chronic diarrhea from infectious cause)
  • Any condition that, in the opinion of the principal investigator, would compromise patient safety, study integrity, or ability to complete study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine Nutritional Counseling; Participants receive bi-weekly nutritional counseling via video consultations using WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams for 12 weeks. Registered dietitians conduct sessions from the Department of Medical Oncology, King Edward Medical University, while patients participate from home or any convenient private location with internet access.	Behavioral: Telemedicine-Delivered Nutritional Counseling; Bi-weekly video consultation-based nutritional counseling delivered remotely via WhatsApp Video Call (primary platform), Zoom, or Microsoft Teams. Individual one-on-one sessions lasting 20-30 minutes conducted by registered dietitians from the hospital while patients participate from their homes.; Other Names: Remote nutritional counseling; Video consultation nutrition therapy; Tele-nutrition
Active Comparator: Standard In-Person Nutritional Counseling; Participants receive bi-weekly nutritional counseling via traditional face-to-face hospital visits for 12 weeks. Registered dietitians conduct sessions at the hospital nutrition clinic, Department of Medical Oncology, King Edward Medical University/Mayo Hospital, Lahore.	Behavioral: Standard In-Person Nutritional Counseling; Bi-weekly in-person hospital-based nutritional counseling delivered at the hospital nutrition clinic. Individual face-to-face sessions lasting 30-45 minutes conducted by registered dietitians at the Department of Medical Oncology, King Edward Medical University/Mayo Hospital.; Other Names: Conventional nutrition counseling; Hospital-based nutritional counseling; Traditional nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight From Baseline to 12 Weeks	Mean change in body weight (measured in kilograms) from baseline (Week 0) to end of intervention (Week 12). Body weight is measured using a calibrated digital scale (±0.1 kg precision) with standardized protocol: patient wearing light clothing without shoes, with empty bladder, measured at consistent time of day. Higher positive values indicate weight gain; negative values indicate weight loss. The primary objective is to assess non-inferiority of telemedicine-delivered nutritional counseling compared to standard in-person counseling, with a non-inferiority margin of -1.0 kg. Body weight is a validated, objective, clinically meaningful outcome for cancer cachexia interventions and recommended by international guidelines (ESPEN, ASCO) as a key endpoint for nutritional intervention trials in oncology.	Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Adequate Daily Energy Intake at 12 Weeks	Proportion (percentage) of participants achieving adequate daily energy intake, operationally defined as ≥25 kilocalories per kilogram of actual or adjusted body weight per day, consistent with European Society for Clinical Nutrition and Metabolism (ESPEN) clinical practice guidelines for cancer patients. Energy intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted by trained dietitians using the validated USDA 5-step multiple-pass method. Dietary data analyzed using the Pakistani Food Composition Database from the National Institute of Health, Islamabad. Higher proportions indicate better nutritional adequacy. This outcome reflects the effectiveness of nutritional counseling interventions in improving actual dietary intake behaviors.	Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
Proportion of Participants Achieving Adequate Daily Protein Intake at 12 Weeks	Proportion (percentage) of participants achieving adequate daily protein intake, operationally defined as ≥1.0 gram per kilogram of actual or adjusted body weight per day, consistent with ESPEN clinical practice guidelines for cancer patients. Protein intake assessed via two non-consecutive 24-hour dietary recalls (one weekday and one weekend day) conducted using the validated USDA 5-step multiple-pass method and analyzed using the Pakistani Food Composition Database. Higher proportions indicate better protein adequacy. Adequate protein intake is critical for preventing muscle wasting and supporting immune function during cancer treatment. This outcome measures the effectiveness of counseling in achieving evidence-based protein intake targets.	Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
Change in Mid-Upper Arm Circumference (MUAC) From Baseline to 12 Weeks	Mean change in mid-upper arm circumference (MUAC) measured in centimeters as a proxy anthropometric measure for skeletal muscle mass. MUAC is measured on the non-dominant arm at the midpoint between the acromion process (shoulder) and olecranon process (elbow) using a non-stretchable measuring tape with the arm relaxed at the side, recorded to the nearest 0.1 cm by trained personnel following standardized protocol. MUAC <23 cm indicates malnutrition; decreases indicate muscle wasting (sarcopenia); increases indicate muscle gain. Higher positive change scores indicate muscle mass preservation or gain. MUAC is a validated, simple, low-cost anthropometric assessment tool recommended by WHO and FAO for nutritional surveillance in clinical populations and has been validated as a muscle mass surrogate in cancer cachexia research.	Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Change in Patient-Generated Subjective Global Assessment (PG-SGA) Score From Baseline to 12 Weeks	Mean change in Patient-Generated Subjective Global Assessment (PG-SGA) total score from baseline to Week 12. The PG-SGA is the gold standard validated nutritional assessment instrument specifically developed and validated for cancer patients. The tool comprises a patient-completed section (weight history, food intake, nutrition impact symptoms, activities and function) and a professional-completed section (disease and metabolic stress, physical examination). Total score ranges from 0 to 35 points, with higher scores indicating greater malnutrition risk and severity. Score categories: well-nourished (0-1), moderately malnourished (2-8), severely malnourished (≥9). Negative change scores indicate nutritional improvement; positive change scores indicate deterioration. The PG-SGA has demonstrated reliability, validity, and sensitivity to change in multiple international studies and is recommended by the Oncology Nutrition Dietetic Practice Group of the Academy of Nutrition and Dietetics.	Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Change in Global Health Status/Quality of Life Score (EORTC QLQ-C30) From Baseline to 12 Weeks	Mean change in the Global Health Status/Quality of Life (QoL) scale from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) from baseline to Week 12. The EORTC QLQ-C30 is a validated, cancer-specific, multidimensional health-related quality of life instrument comprising 30 items organized into functional scales (physical, role, emotional, cognitive, social functioning), symptom scales (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties), and a global health status/QoL scale. The global health status/QoL scale (items 29-30) is scored and linearly transformed to a 0-100 scale, where higher scores represent better quality of life. The validated Urdu version will be used. Positive change scores indicate QoL improvement. The EORTC QLQ-C30 has been extensively validated internationally including in Pakistani cancer populations and is recommended by EORTC for cancer	Measured at baseline (Week 0) and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
Nutritional Counseling Session Adherence Rate Over 12 Weeks	Session adherence rate calculated as the percentage of scheduled nutritional counseling sessions actually completed by the participant over the 12-week intervention period. Calculated as: (number of sessions attended ÷ number of sessions scheduled) × 100%. Total of 7 sessions are scheduled per participant at Weeks 0, 2, 4, 6, 8, 10, and 12. For the telemedicine group, a session is considered "attended" if the participant successfully joins the video call and completes the counseling session. For the standard care group, a session is considered "attended" if the participant presents for the in-person hospital visit and completes the session. Adherence ≥70% (completing ≥5 out of 7 sessions) is defined as good adherence based on behavioral intervention literature. Higher adherence rates indicate better intervention engagement and may predict better outcomes. Adherence is a key implementation outcome for assessing intervention feasibility and acceptability.	Assessed continuously throughout the 12-week intervention period. Final adherence rate calculated at Week 12 (end of intervention).

Collaborators and Investigators

• Sponsor: King Edward Medical University

Publications and helpful links

General Publications

• Muscaritoli M, Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Oldervoll L, Ravasco P, Solheim TS, Strasser F, de van der Schueren M, Preiser JC, Bischoff SC. ESPEN practical guideline: Clinical Nutrition in cancer. Clin Nutr. 2021 May;40(5):2898-2913. doi: 10.1016/j.clnu.2021.02.005. Epub 2021 Mar 15.
• Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.
• Ng KLS, Munisamy M, Lim JBY, Alshagga M. The Effect of Nutritional Mobile Apps on Populations With Cancer: Systematic Review. JMIR Cancer. 2025 Feb 5;11:e50662. doi: 10.2196/50662.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: telemedicine; cachexia; nutritional counselling
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight; Body Weight Changes; Muscular Atrophy; Atrophy; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Sarcopenia; Cachexia
• Other Study ID Numbers: KEMU-IRB-337-RC-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared publicly to protect patient confidentiality and comply with institutional ethics requirements. The study involves vulnerable cancer patients with sensitive health information that could potentially identify individuals given the single-center setting.De-identified aggregate data may be shared upon reasonable request to the principal investigator after publication of primary results. Requests require: data sharing agreement, ethics approval, and compliance with Pakistani data protection regulations.This approach balances participant privacy protection with scientific transparency and enables future meta-analyses advancing cancer cachexia research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No