Multimodal Program for Cancer Related Cachexia Prevention
NCT ID: NCT04627376
Last Updated: 2022-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2020-09-24
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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German Oncology Center, Cyprus
OTHER
Cyprus University of Technology
OTHER
Responsible Party
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Dr. Andreas Charalambous
Associate Professor Oncology and Palliative Care
Principal Investigators
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Andreas Charalambous, PhD
Role: STUDY_DIRECTOR
Cyprus University of Technology Department of Nursing
Locations
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German Oncology Centre
Limassol, , Cyprus
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CC-SPCC-1
Identifier Type: -
Identifier Source: org_study_id
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