Condition 1: Colorectal cancer. Condition 2: Rectosigmoid cancer. Condition 3: Rectal cancer. Malignant neoplasm of colon Malignant neoplasm of rectosigmoid junction Malignant neoplasm of rectum
Conditions
Interventions
Intervention 1: Fish oil /intervention. 1200mg (providing omega-3 420 mg EPA and 280 mg DHA) 5 times daily for 8 weeks after starting chemotherapy. Intervention 2: Probiotics/ intervention. 3 gr Gran
Treatment - Drugs
Placebo
Fish oil /intervention. 1200mg (providing omega-3 420 mg EPA and 280 mg DHA) 5 times daily for 8 weeks after starting chemotherapy
Probiotics/ intervention. 3 gr Granule contains the following probiotic strains: L.acidophilus, L. lactis, L. casei subsp, L. longum, L. bifidum, L. infantis twice a day for 4 weeks after starting
Sunflower oil /control 1200mg 5 times daily for 8 weeks after starting chemotherapy
Lactose / control 3 gr Granule contains: Lactose, Maltodextrin, Citric Acid, Ascorbic Acid, Skim Milk Powder, and Sugar twice a day for 4 weeks after starting chemotherapy
Sponsors
B-CROBES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Patients must have histological confirmed colorectal cancer; Patients must be recruited prior to chemotherapy after surgery; Patients must have sufficient organ and marrow function so that chemotherapy treatment can be administered; Ability to understand and the willingness to sign a written informed consent document. Exclusion criteria Patients may be receiving any other investigational agents; There are known allergies associated with supplements; Uncontrolled intercurrent illness that render the patient ineligible to receive chemotherapy; Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with supplements. Breastfeeding should also be discontinued if the mother is treated with supplements; Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with supplements; Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study; Chemotherapy initiation before supplements intervention; Patients with radiotherapy treatment; Patients suffer from anxiety and depression. This will be given to the patient as part of the recruitment process.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Before starting chemotherapy and supplementationa nd after completion of supplementation and chemotherapy. Method of measurement: EORTC QLQ C-30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of IL-6, TNF-a, and CRP. Timepoint: before and after supplementation. Method of measurement: ELISA.;Chemotherapy induced toxicity. Timepoint: before and after supplementation. Method of measurement: Questionnaire (CTCAE). | — |
Countries
Malaysia
Contacts
Public ContactDr. Babak. Golkhalkhali
University Malaya Medical Centre
Outcome results
None listed