Multimodal Program for Cancer Related Cachexia Prevention

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627376
• Other study ID #: CC-SPCC-1
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2020
• Est. completion date: June 2026

Study information

• Verified date: September 2022
• Source: Cyprus University of Technology
• Contact: Andreas Charalambous, PhD
• Phone: 00357-25002011
• Email: andreas.charalambous[@]cut.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2026
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cachexia
• Cancer
• Educational Problems
• Malnutrition
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Cyprus	German Oncology Centre	Limassol

Sponsors (2)

Lead Sponsor	Collaborator
Cyprus University of Technology	German Oncology Center, Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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