Program to prevent cancer-related weight loss
Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
This study is testing a 12-week program to see if it can help cancer patients and their caregivers prevent weight loss and improve their health during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cyprus University of Technology Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Limassol) |
| Trial ID | NCT04627376 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a multifactorial education and support program aimed at preventing cancer-related cachexia syndrome in patients undergoing anti-cancer treatment. Participants, along with their family caregivers, will engage in a 12-week program that includes educational meetings with healthcare professionals, blood tests, body composition measurements, and symptom management strategies. Patients will be randomly assigned to either an intervention group receiving the program or a control group. The goal is to improve nutritional status and overall well-being during cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with solid tumors who are undergoing chemotherapy, immunotherapy, hormone therapy, or targeted therapy.
Not a fit: Patients with hematologic tumors, those already in cachexia, or individuals unable to involve a family caregiver may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and nutritional status of cancer patients, potentially enhancing treatment outcomes.
How similar studies have performed: Other studies have shown promise in using educational and support programs to manage cancer-related cachexia, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Limassol
- German Oncology Centre — Limassol, Cyprus (Recruiting)
Study contacts
- Study coordinator: Andreas Charalambous, PhD
- Email: andreas.charalambous@cut.ac.cy
- Phone: 00357-25002011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.