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Clinical Trial NCT06776016 for Radiotherapy, Radiation Proctitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Dietary Supplements to Treat Radiation-Induced Rectal Injury Phase 2 33 Non-Invasive Dietary

Recruiting
Clinical Trial NCT06776016 is designed to study Treatment for Radiotherapy, Radiation Proctitis. It is a Phase 2 interventional study that is recruiting, having started on January 15, 2025, with plans to enroll 33 participants. Led by Sixth Affiliated Hospital, Sun Yat-sen University, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on May 13, 2025.
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 sca...Show More
Official Title

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

Conditions
RadiotherapyRadiation Proctitis
Other Study IDs
  • CRP202402
NCT ID Number
NCT06776016
Start Date (Actual)
2025-01-15
Last Update Posted
2025-05-13
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
33
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
radiotherapy
radiation proctitis
tributyrin
rectal bleeding
butyrate
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalDietary supplements
Participants receive dietary supplements combined with supportive care.
Butyrate
Agent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 20 ml, 2-3 times daily, 12 weeks.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of participants with alleviated rectal bleeding (degraded by 1 or more)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
At the time of 12 weeks since the start of treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Number of participants with mild rectal bleeding (grade 0-1)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
At the time of 24 weeks since the start of treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
Sixth Affiliated Hospital, Sun Yat-sen University logoSixth Affiliated Hospital, Sun Yat-sen University
Study Central Contact
Contact: Lekun Fang, +86-13560226002, [email protected]
1 Study Locations in 1 Countries

Guangdong

Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Lekun Fang, M.D., Contact, +86-13560226002, [email protected]
Recruiting