Effect of L-alanyl L-glutamine dipeptide on diarrhea, treatment response, and patients’ survival in colon cancer patients receiving chemotherapy
Not Applicable
Completed
- Conditions
- Incidence of diarrhea in colon cancer patients receiving mFOLFOX-6 therapySigns and Symptoms
- Registration Number
- ISRCTN13489936
- Lead Sponsor
- Taif University
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35334570/ (added 08/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
1. Patients of both genders
2. Aged =18 years
3. Have histologically confirmed colon adenocarcinoma stage II, and III according to American Joint Committee on Cancer and the Union for International Cancer Control (AJCC-UICC); 7th Edition
4. Have adequate hematological parameters (evidenced by white blood cell count = 4000/µl and platelet count = 100,000/µl).
5. Have adequate renal (creatinine < 1.5 mg/dl) and hepatic functions (serum total bilirubin < 1.5 mg/dl).
Exclusion Criteria
1. Patients with stage IV colon cancer.
2. Patients with second primary colon cancer.
3. Patients with colon cancer with any other co-morbidity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At baseline (prior to chemotherapy) and after two, four, and six cycles of treatment:<br>1. Treatment response to chemotherapy will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)<br>2. Diarrhea will be graded according to the National cancer institute.
- Secondary Outcome Measures
Name Time Method Treatment-related toxicities will be estimated according to standard World Health Organization (WHO) criteria at the baseline and after two, four, and six cycles of treatment