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

4 giugno 2026 aggiornato da: Abbas Khokhar, King Edward Medical University

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

Panoramica dello studio

Descrizione dettagliata

BACKGROUND AND RATIONALE Cancer cachexia is a metabolic syndrome characterized by progressive involuntary weight loss, skeletal muscle depletion, systemic inflammation, and anorexia, affecting 50-80% of cancer patients and contributing to 30% of cancer-related deaths. International guidelines from ESPEN and ASCO recommend nutritional counselling as a cornerstone of multimodal cachexia management; however, high-quality randomized evidence remains limited, particularly in low-and-middle-income countries.

In Pakistan, 31-97% of cancer patients experience malnutrition, compounded by geographic barriers, critical shortage of trained clinical nutritionists, and catastrophic out-of-pocket healthcare expenditure. No randomized controlled trial has evaluated telemedicine-delivered nutritional counselling for cancer cachexia anywhere in South Asia, representing a critical evidence gap.

STUDY DESIGN Single-centre, parallel-group, pilot randomized controlled trial with 1:1 allocation. Randomization is computer-generated with variable block sizes (4-6), stratified by cancer type (gastrointestinal vs. non-gastrointestinal) using sequentially numbered sealed opaque envelopes. The trial uses a single-blind design: outcomes assessors, laboratory staff, and the statistician are blinded to group allocation; participants and dietitians cannot be blinded due to the nature of the intervention.

INTERVENTION RATIONALE Both arms receive identical nutritional counselling content from the same registered dietitians following standardized ESPEN-based protocols (energy ≥25 kcal/kg/day; protein ≥1.0 g/kg/day), with culturally adapted Pakistani meal plans. Sessions are delivered bi-weekly at equal frequency (7 sessions over 12 weeks) so that delivery modality - not counselling dose - is the sole variable under study. The telemedicine arm uses WhatsApp Video Call as the primary platform (given its widespread use and low-bandwidth requirements in Pakistan), with Zoom or Microsoft Teams as alternatives. Patients participate from home; dietitians conduct sessions from a dedicated workspace at the Department of Medical Oncology, KEMU.

NON-INFERIORITY RATIONALE Given that both groups receive equivalent counselling frequency and content, a non-inferiority design is appropriate. The non-inferiority margin of -1.0 kg for body weight change at 12 weeks was selected based on clinical judgment and published cachexia literature, representing the maximum weight difference that would still be considered clinically acceptable for telemedicine to be adopted as a delivery alternative. Telemedicine will be declared non-inferior if the lower limit of the 95% confidence interval for mean weight difference (telemedicine minus standard care) exceeds -1.0 kg.

SAMPLE SIZE Using G*Power for an independent samples t-test: Cohen's d = 0.75, α = 0.05 (two-sided), power = 85%, yields 29 participants per group. Adjusted for 20% anticipated dropout in cancer cachexia trials, the final sample is 40 per group (80 total), with an expected evaluable sample of 64 participants.

STATISTICAL ANALYSIS Primary analysis is intention-to-treat. The primary outcome (body weight change, baseline to Week 12) will be analysed using an independent samples t-test or Mann-Whitney U test as appropriate, with ANCOVA adjusting for baseline weight, cancer type, ECOG performance status, and treatment changes during the study. Missing data will be handled by multiple imputation using chained equations (20 imputations) for <20% missingness, with complete case analysis as a sensitivity check. Per-protocol analysis (participants completing ≥75% of sessions) will be conducted as a secondary analysis. Exploratory subgroup analyses are planned by cancer type, baseline cachexia severity, sex, and urban versus rural residence.

SIGNIFICANCE This is the first RCT of telemedicine nutritional counselling for cancer cachexia in South Asia. The design isolates the effect of delivery modality by equalizing counselling frequency across arms. Results will provide effect size estimates to power a larger multi-centre trial, cost-effectiveness data for health policy decisions, and a scalable evidence-based model for nutritional care delivery in resource-constrained settings.

Tipo di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Altri nomi:
  • Remote nutritional counseling
  • Video consultation nutrition therapy
  • Tele-nutrition
Comparatore attivo: 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.
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.
Altri nomi:
  • Conventional nutrition counseling
  • Hospital-based nutritional counseling
  • Traditional nutritional counseling

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight From Baseline to 12 Weeks
Lasso di tempo: Baseline (Week 0) and Week 12 (end of 12-week intervention period). Measurements also collected at Week 6 (mid-point) for trajectory analysis.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants Achieving Adequate Daily Energy Intake at 12 Weeks
Lasso di tempo: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
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
Lasso di tempo: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary comparison at Week 12.
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
Lasso di tempo: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
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
Lasso di tempo: Measured at baseline (Week 0), Week 6 (mid-point), and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
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
Lasso di tempo: Measured at baseline (Week 0) and Week 12 (end of intervention). Primary endpoint is change from baseline to Week 12.
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
Lasso di tempo: Assessed continuously throughout the 12-week intervention period. Final adherence rate calculated at Week 12 (end of intervention).
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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

19 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cachessia; Cancro; Sarcopenia

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