Multimodal Program for Cancer Related Cachexia Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer, Cachexia, Neoplasms, Malnutrition, Educational Problems

Intervention / Treatment
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* Other: Multimodal education and support program for cancer related cachexia prevention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung) Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy Participants must be normal or pre cachectic as defined by the guidelines Read and understand Greek or English Exclusion Criteria: Haematologic tumors Parenteral Nutrition ECOG Performance status >2 or Karnofsky Performance Status <60% Participant who can not introduce a family caregiver 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% Patients who use complementary therapies (ex-acupuncture)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cachexia, prevention, management, malnutrition