A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Number of participants with alleviated rectal bleeding (degraded by 1 or more)
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75 years
- •At least 3 months since the completion of pelvic radiotherapy
- •No evidence of tumor recurrence or metastasis
- •Rectal bleeding with grade 1-2 by LENT-SOMA scales
Exclusion Criteria
- •Acute or chronic infectious diseases
- •Serious systemic diseases
- •Known allergies to any components of the study medication
- •Colonoscopy indicating rectal ulceration (\>1cm2), fistula, stricture, or necrosis
- •Late complications related to pelvic radiation injury
- •Other hemorrhagic or coagulation disorders
- •Previous rectal resection
- •Bowel obstruction or perforation that require surgery
- •Cognitive or psychological disorder
Outcomes
Primary Outcomes
Number of participants with alleviated rectal bleeding (degraded by 1 or more)
Time Frame: At the time of 12 weeks since the start of treatment
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Secondary Outcomes
- Number of participants with mild rectal bleeding (grade 0-1)(At the time of 24 weeks since the start of treatment)