Skip to content

Effect of L-alanyl L-glutamine dipeptide on diarrhea, treatment response, and patients’ survival in colon cancer patients receiving chemotherapy

The ameliorative potential of L-alanyl L-glutamine dipeptide in colon cancer patients receiving modified FOLFOX-6 regarding the incidence of diarrhea, the treatment response, and patients’ survival: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13489936
Enrollment
100
Registered
2022-03-04
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of diarrhea in colon cancer patients receiving mFOLFOX-6 therapy Signs and Symptoms

Interventions

Treatment Plan (Chemotherapy) All patients will be treated with the standard mFOLFOX-6 consisting of 2-hour intravenous (IV) infusion of oxaliplatin (85 mg/m²) on day 1, and 2-hour IV drip infusion of

Sponsors

Taif University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
At baseline (prior to chemotherapy) and after two, four, and six cycles of treatment: 1. Treatment response to chemotherapy will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) 2. Diarrhea will be graded according to the National cancer institute.

Secondary

MeasureTime frame
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

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026