Multimodal Program for Cancer Related Cachexia Prevention

September 1, 2022 updated by: Dr. Andreas Charalambous, Cyprus University of Technology

Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver

The aim of the study is to evaluate the effectiveness of a multifactorial education and support program for the prevention of cancer-related cachexia syndrome, for patients and their family caregivers during anti-cancer treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and the need to nominate a family caregiver, all patients and their family caregiver giving written informed consent, they will undergo a 12-weeks multimodal program. Randomly they will divided into two groups (intervention and control). This 12-weeks multimodal program includes 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Cyprus
      • Limassol, Cyprus, 4065
        • Recruiting
        • German Oncology Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years old or older
  2. Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
  3. Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
  4. Participants must be normal or pre cachectic as defined by the guidelines
  5. Read and understand Greek or English

Exclusion Criteria:

  1. Haematologic tumors
  2. Parenteral Nutrition
  3. ECOG Performance status >2 or Karnofsky Performance Status <60%
  4. Participant who can not introduce a family caregiver

  5. Participants in cachexia or refractory cachexia stage as defined by the guidelines below:

    • >5% weight loss over the past 6 months (in absence of simple starvation); OR
    • BMI <20 and any degree of weight loss >2%; OR
    • Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men <14.6 kg/m²; women <11.4 kg/m²) and weight loss >2%
  6. Patients who use complementary therapies (ex-acupuncture)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires.
Experimental: Intervention
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.
Other: Multimodal education and support program for cancer related cachexia prevention
12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
Time Frame: Baseline and week 4, week 8, week 12
To assess the patient's baseline cancer cachexia stage with weight (weight loss <5% in previous three months, kg), height (cm) and BMI (BMI > 20) measurements.
Baseline and week 4, week 8, week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in inflammation based on the CRP test at 12 weeks
Time Frame: Baseline and week 4, week 8, week 12
Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation.
Baseline and week 4, week 8, week 12
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Time Frame: Baseline and week 4, week 8, week 12
Blood test for Albumin Levels. normal ranges >35g/L
Baseline and week 4, week 8, week 12
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
Time Frame: Baseline and week 12

Participants will fill the questionnaire at baseline and at week 12 to compare the score of FAACT.

The FAACT questionnaire is validated, self-reported instrument (28-item) assessing the quality of life of cancer patients with any tumour type. Possible scores range from 0 (lower quality of life) to 112 (better quality of life).

Change = Week 12 - Baseline
Baseline and week 12
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
Time Frame: Week 4 and week 12

Participants will fill the questionnaire at week 4 and at week 12 to compare the score of CarGOQoL.

The CarGOQoL questionnaire is validated, self-reported instrument (29 items investigating 10 domains) assessing the quality of life of family caregivers. Possible scores range from 0 (lower quality of life) to 100 (better quality of life).

Change = Week 12 - Week 4
Week 4 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Collaborators

German Oncology Center, Cyprus

Investigators

  • Study Director: Andreas Charalambous, PhD, Cyprus University of Technology Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 7, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-SPCC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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