Multimodal Program for Cancer Related Cachexia Prevention

Sponsor

Cyprus University of Technology (Other)

Overall Status

Recruiting

CT.gov ID

NCT04627376

Collaborator

German Oncology Center, Cyprus (Other)

Enrollment

Location

Arms

14.2

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Cancer Cachexia Malnutrition Educational Problems	Other: Multimodal education and support program for cancer related cachexia prevention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

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

Other: Multimodal education and support program for cancer related cachexia prevention

Outcome Measures

Primary Outcome Measures

Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks [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.

Secondary Outcome Measures

Change from baseline in inflammation based on the CRP test at 12 weeks [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.
Change from baseline in edema according to albumin levels from baseline at 12 weeks [Baseline and week 4, week 8, week 12]
Blood test for Albumin Levels. normal ranges >35g/L
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks [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
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%