The effect of the Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer cachexia: A randomized controlled clinical trial
- Conditions
- Colorectal cancer cachexia.Cachexia
- Registration Number
- IRCT20211027052884N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Patients with colorectal cancers in stages III-IV according to TNM UICC 2010 method (based on the oncologist diagnosis).
The patient has cachexia, which is defined according to the Global Leadership Initiative on Malnutrition (GLIM).
Patients' functional status is at least = 70% according to Karnofsky scale.
Individuals who have no contraindications for oral feeding and be able to be fed orally.
Patients without acute uncontrolled underlying diseases such as kidney and/or liver failure.
Patients who need supportive nutrition such as enteral or parenteral feeding.
Patients with a history of allergy to any components of the Mediterranean diet, such as olive oil or nuts.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method utritional status score. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: PG-SGA (Patient Generated-Subjective Global Assessment) questionnaire.;Muscle strength. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Handgrip strength dynamometer.;Muscle mass. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA).;Inflammatory markers (hs-CRP, IL-6, TNF-a). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: enzyme-linked immunosorbent assay (ELISA).
- Secondary Outcome Measures
Name Time Method Body weight. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA).;Fat mass. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Bio-Electrical Impedance Analysis (BIA).;Quality of life and treatment complications (diarrhea, nausea, constipation, vomiting and appetite). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire).;Albumin and Total Protein. Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: Autoanalyzer (spectrophotometric method).;Complete Blood Count (CBC). Timepoint: Before the intervention - 8 weeks after the intervention. Method of measurement: cell counter.