Using dietary supplements to treat rectal injury from radiation
A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury
PHASE2 · Sixth Affiliated Hospital, Sun Yat-sen University · NCT06776016
This study is testing whether a dietary supplement called tributyrin can help people with chronic rectal injury from radiation feel better and improve their quality of life.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06776016 on ClinicalTrials.gov |
What this trial studies
This clinical study is a prospective, single-arm trial that evaluates the safety and efficacy of tributyrin as a dietary supplement for patients suffering from chronic radiation-induced rectal injury. The study aims to improve symptoms of rectal bleeding and enhance the quality of life by administering tributyrin and monitoring its effects through blood tests and non-invasive methods. Participants will be closely monitored to ensure their safety and comfort throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced rectal bleeding after pelvic radiotherapy and have no evidence of tumor recurrence.
Not a fit: Patients with serious systemic diseases, rectal ulcerations, or other significant gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce rectal bleeding and improve the quality of life for patients with radiation-induced rectal injury.
How similar studies have performed: While this approach is novel in the context of radiation-induced rectal injury, other studies have explored the use of butyrate for gastrointestinal health with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Lekun Fang
- Email: fanglk3@mail.sysu.edu.cn
- Phone: +86-13560226002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Radiotherapy, Radiation Proctitis, radiotherapy, radiation proctitis, tributyrin, rectal bleeding, butyrate