Dietary Supplements to Treat Radiation-Induced Rectal Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Butyrate
Dietary supplementAgent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 1650 mg, 2-3 times daily, 12 weeks.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Dietary supplementsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with alleviated rectal bleeding (degraded by 1 or more)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Time frame
At the time of 12 weeks since the start of treatmentSecondary outcomes
1
Number of participants with mild rectal bleeding (grade 0-1)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Time frame
At the time of 24 weeks since the start of treatmentSponsors and contacts
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Source ClinicalTrials.gov