A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Lekun Fang
fanglk3@mail.sysu.edu.cn
+86-13560226002
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 33
Treatments
Experimental: Dietary supplements
Participants receive dietary supplements combined with supportive care.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University

This content was sourced from clinicaltrials.gov