Clinical trial NCT04627376: Multimodal Program for Cancer Related Cachexia Prevention
Official title: Effectiveness of a Multimodal Education and Support Program for the Prevention of Cancer Related Cachexia for Patients and Their Family Caregiver
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms
Cancer
Cachexia
Malnutrition
Educational Problems
Keywords: cachexia
prevention
management
malnutrition
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: German Oncology Center, Cyprus
First posted: 2020-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
timeFrame: Baseline and week 4, week 8, week 12
Secondary outcomes:
measure: Change from baseline in inflammation based on the CRP test at 12 weeks
timeFrame: Baseline and week 4, week 8, week 12
measure: Change from baseline in edema according to albumin levels from baseline at 12 weeks
timeFrame: Baseline and week 4, week 8, week 12
measure: Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
timeFrame: Baseline and week 12
measure: Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
timeFrame: Week 4 and week 12
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: German Oncology Centre
Study officials:
affiliation: Cyprus University of Technology Department of Nursing
name: Andreas Charalambous, PhD
role: STUDY_DIRECTOR
References: