Multimodal Program for Cancer Related Cachexia Prevention

Not Applicable

Recruiting

• Conditions: Cachexia; Neoplasms; Malnutrition; Educational Problems; Cancer
• Interventions: Other: Multimodal education and support program for cancer related cachexia prevention

• Registration Number: NCT04627376
• Lead Sponsor: Cyprus University of Technology

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.

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 Timeline

• Study Start: 2020-09-24
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-07
• Study First Posted: 2020-11-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02
• Primary Completion: 2023-02
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

German Oncology Centre; 🇨🇾 Limassol, Cyprus