Multimodal Program for Cancer Related Cachexia Prevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCyprus University of Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old or older
Participants must be diagnosed with solid tumour (stomach, colorectal, pancreas, breast, lung)
Participants needing chemotherapy/immunotherapy/hormone therapy/target therapy
Participants must be normal or pre cachectic as defined by the guidelines
Disqualifiers
Haematologic tumors
Parenteral Nutrition
ECOG Performance status >2 or Karnofsky Performance Status <60%
Participant who can not introduce a family caregiver
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal education and support program for cancer related cachexia prevention
Other intervention12-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in pre-cachexia stage against cachexia criteria at 12 weeks
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.
Time frame
Baseline and week 4, week 8, week 12Secondary outcomes
1
Change from baseline in inflammation based on the CRP test at 12 weeks
Blood test for C-reactive protein (mg/L). CRP level greater than 10 mg/L is a sign of active inflammation.
Time frame
Baseline and week 4, week 8, week 122
Change from baseline in edema according to albumin levels from baseline at 12 weeks
Blood test for Albumin Levels. normal ranges \>35g/L
Time frame
Baseline and week 4, week 8, week 123
Change from baseline of patient's Quality of life on the FAACT questionnaire (score) at 12 weeks
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
Time frame
Baseline and week 124
Change from baseline (week 4) of family caregiver's Quality of life on the CarGOQoL questionnaire (score) at 12 weeks
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
Time frame
Week 4 and week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cyprus University of Technology
Lead sponsor
German Oncology Center, Cyprus
Collaborator
Source ClinicalTrials.gov