Efficacy of Oral Administration of Cystine and Theanine in Colorectal Cancer Patients Undergoing Capecitabine based Adjuvant Chemotherapy after Surgery: Randomized, Double-blind, Placebo controlled, Phase-II Study

Not Applicable

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000024784
• Lead Sponsor: on-Profit Organization JORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-10
• Study Completion: 2018-11-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. Past history of chemotherapy 2. Past history of radiotherapy 3. Administration of amino acid supplement (including protein supplement) 4. Prior administration of Cystine and Theanine 5. Administration of supplements derived from herbs (St. John's wort, etc.), not including multivitamins 6. Pregnant or lactating patient 7. Immunodeficiency 8. Phenylketonuria 9. Registered in other clinical trials 10. Cognitive disorder (dementia, deliria, and decreased level of consciousness, etc.) 11. Psychiatric/neurological disorder 12. Aphasia, aphonia, and dysarthria 13. Oral intake difficulty 14. Malabsorption syndrome 15. Past history of gastrectomy 16. Active gastrointestinal bleeding 17. Inappropriate for the study at the physician's assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of Grade 1 or more diarrhea (CTCAE v4.0)

Secondary Outcome Measures

Name	Time	Method
1) Score of EORTC QLQ-C30 and QLQ-CR29 2) Incidence rate of Grade 1 or more hand-foot syndrome (Classification of Blum) 3) Incidence rate of Grade 2 or more diarrhea (CTCAE v4.0) 4) Incidence rate of Grade 1 or more and Grade 2 or more adverse events (white blood cell count, neutrophill count, hemoglobin, platelet count, total bilirubin, ALP, AST, ALT, gamma-GTP, creatinine, and adverse events other than diarrhea) 5) Adherence to medication (Cystine and Theanine or placebo) 6) Completion rate of four cycles of capecitabine without interruption or reduction 7) Duration of capecitabine therapy (four cycles) 8) Total dose of capecitabine