Colorectal cancer cachexia. Cachexia
Conditions
Interventions
Intervention 1: Intervention group: Participants in the intervention group will receive a Mediterranean diet menu. For this purpose, the energy required by the patients in the intervention group, acco
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Bagheri
Tehran University of Medical Sciences
Outcome results
None listed