Chronic Radiation-induced Proctitis
Conditions
Keywords
Radiotherapy complications, Chronic radiation-induced proctitis
Brief summary
This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are: 1. Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment? 2. Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)? 3. What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location. Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis: 1. Change in LENT-SOMA rectal injury score (baseline vs. 3 months). 2. Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores. 3. Symptom improvement rate and time to complete remission. Participant will: 1. Undergo baseline and 3-month endoscopic evaluations. 2. Complete symptom diaries and quality-of-life questionnaires. 3. Attend regular clinic visits for safety monitoring.
Detailed description
Baseline Assessments All enrolled patients must complete the following evaluations: 1. Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose) 2. Physical examination 3. ECOG performance status 4. Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers 5. Pelvic scans to exclude tumor recurrence/progression 6. Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally 7. Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria Treatment protocol Kangfupen (liquid dressing) retention enema * Dosage: 50 mL once daily for 3-6 months * Administration depth: Determined by colonoscopy findings Enema preparation & administration 1. Reconstitution: 1. Transfer liquid from plastic to brown glass vial 2. Shake vigorously to dissolve lyophilized powder 3. Return solution to plastic bottle and shake again 2. Delivery: <!-- --> 1. Position: Left lateral decubitus with waste basin 2. Slowly instill 50 mL into rectum 3. Retain for ≥30 minutes, rotating positions every 15 minutes (left/right lateral, supine, knee-chest) Concomitant therapies Permitted: probiotics, smectite, antibiotics, stool softeners Prohibited: 5-ASA drugs (mesalazine/sulfasalazine), endoscopic hemostasis (e.g., argon plasma coagulation), formaldehyde/HBO/surgery/fecal microbiota transplant, other enema therapies. Toxicity monitoring Potential adverse events include allergic reactions and mechanical injury (bleeding/perforation). Required Actions include immediately discontinuing treatment and reporting to the principal investigating site within 24 hours. All adverse events will be assessed using CTCAE v5.0 criteria. Follow-up schedule Month 1-2: LENT-SOMA, RTOG/CTCAE grades, IBDQ, symptom improvement evaluation Month 3: Above + sigmoidoscopy with Vienna scoring Every 6 months after month 6: sigmoidoscopy + all scales + physician's global assessment of treatment efficacy
Interventions
DRUGKangfupen (liquid dressing) retention enema administration
Dosage: 50 mL per administration, once daily Duration: 3-6 months of continuous therapy Procedure: Enema depth determined by colonoscopy-identified lesion location Administered as retention enema (minimum 30-minute retention time)
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Peking University First Hospital
Tianjin Medical University Cancer Institute and Hospital
Beijing Rectum Hospital
Jilin City Hospital of Chemical Industry
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The efficacy assessment employs a repeated-measures design with intra-individual comparisons between baseline and post-treatment timepoints.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Fully voluntary with decision-making capacity * 18-80 years old * Completed pelvic radiotherapy for malignancy ≥3 months prior * Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2) * Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1) * No prior surgery * ECOG score 0-2 * Estimated survival ≥1 year
Exclusion criteria
* Primary rectal tumours or pelvic malignancies with rectal involvement * Uncontrolled, recurrent, or metastatic tumours * Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties * Patients with intestinal fistula, perforation, or obstruction * History of electrocautery treatment within 1 month * Recent medication use (within 2 weeks): traditional Chinese medicine enemas, mesalazine (oral or rectal) and other anti-inflammatory bowel medications * History of superoxide dismutase allergy * Pre-existing chronic colitis, ulcerative colitis, or nonspecific proctitis * Connective tissue diseases requiring long-term corticosteroid therapy * Pregnant or lactating women * Active infection or fever * Other severe comorbidities potentially affecting trial compliance: unstable cardiac disease requiring treatment, renal disorders, chronic hepatitis, poorly controlled diabetes and psychiatric illnesses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment | From enrolment to 3 months post-treatment | Treatment response is defined as: 1. Effective: Decrease in LENT-SOMA score compared to baseline 2. Ineffective: No change or increase in LENT-SOMA score versus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vienna endoscopic scores from baseline to post-treatment | From enrolment to 3 months post-treatment | Treatment response is defined as: 1. Effective: Any decrease in Vienna endoscopic score at 3 months post-treatment compared to baseline 2. Ineffective: Stable or increased score compared to baseline |
| Changes in RTOG and CTCAE grading from baseline to post-treatment assessments | From enrolment to 3 months post-treatment | Treatment response is defined as: 1. Efficient: Any decrease in either RTOG radiation toxicity grade or CTCAE adverse event grade from baseline 2. Inefficient: No improvement or worsening in both grading systems |
| Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Function and Bleeding Scores from baseline to post-treatment | From enrolment to 3 months post-treatment | Treatment response is defined as: 1. Efficient: Any decrease in IBDQ bowel function and bleeding scores post-treatment compared to baseline 2. Inefficient: No change or increase in IBDQ bowel function and bleeding scores versus baseline |
| Post-treatment symptom improvement rate | From enrolment to 3 months post-treatment | Symptoms are categorized into: Complete remission: Complete resolution of clinical symptoms (e.g., rectal bleeding, diarrhea, tenesmus) Partial remission: Significant improvement in symptoms, but not complete resolution Stable disease: No significant change in symptoms (no improvement or worsening) Progression: Worsening of clinical symptoms Treatment response is defined as: 1. Effective: Complete remission or partial remission 2. Ineffective: Stable disease or progression |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic response (Vienna Score) | From enrolment to 6, 12, 24, 36 months post-treatment | Assessment: Change from baseline at each timepoint Response Criteria: Effective: Decreased Vienna score Ineffective: Stable/increased score |
| Toxicity improvement (RTOG/CTCAE) | From enrolment to 6, 12, 24, 36 months post-treatment | Assessment: Grading change from baseline Response Criteria: Effective: Reduced RTOG/CTCAE grade Ineffective: Unchanged/worsened grade |
| Quality of life (IBDQ Bowel Function/Bleeding) | From enrolment to 6, 12, 24, 36 months post-treatment | Assessment: Subscore change from baseline Response Criteria: Effective: Score reduction (symptom improvement) Ineffective: Stable/elevated score |
| Symptom improvement rate | From enrolment to 6, 12, 24, 36 months post-treatment | Categories: Complete Response (CR): Total symptom resolution (RTOG Grade 0) Partial Response (PR): ≥50% symptom reduction Stable Disease (SD): No significant change Progression (PD): Symptom worsening Clinical Benefit: CR + PR Note: For discordant symptoms, the primary symptom (investigator-designated) determines classification. |
| Time to complete symptom resolution | From enrolment to sustained (≥7 days) CR | — |
Countries
China
Contacts
Primary ContactKe Hu, Doctor
Outcome results
None listed