Clinical trial · Interventional
Multimodal Program for Cancer Related Cachexia Prevention
Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
NCT04627376CI-TRIAL-00060679unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Educational Problems | — | UNRESOLVED | — |
| Malnutrition | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal education and support program for cancer related cachexia prevention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Other: Multimodal education and support program for cancer related cachexia prevention
Primary outcomes (1)
- measure
- Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.