Cachexia, Cancer, Educational Problems, Malnutrition, Neoplasms
Conditions
Keywords
cachexia, prevention, management, malnutrition
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.
Interventions
OTHERMultimodal 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.
Sponsors
German Oncology Center, Cyprus
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks | Baseline and week 4, week 8, week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in inflammation based on the CRP test at 12 weeks | Baseline and week 4, week 8, week 12 | Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation. |
| Change from baseline in edema according to albumin levels from baseline at 12 weeks | Baseline and week 4, week 8, week 12 | Blood test for Albumin Levels. normal ranges \>35g/L |
| Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks | Baseline and week 12 | 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 |
| Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks | Week 4 and week 12 | 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 |
Countries
Cyprus
Contacts
Primary ContactAndreas Charalambous, PhD
Backup ContactConstantina Cloconi, MSc
Outcome results
None listed