Chronic Radiation Proctitis
Conditions
Keywords
chronic radiation proctopathy, argon plasma coagulation, sucralfate
Brief summary
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.
Detailed description
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.
Interventions
DRUGSucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
DRUGPlacebo
Argon plasma coagulation treatment followed by placebo administration for four weeks
Sponsors
Medical Centre for Postgraduate Education
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* radiotherapy due to pelvic tumors completed at least three months prior to enrollment * presence of rectal bleeding * radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy * informed written consent to participate in the study
Exclusion criteria
* history of clinically significant rectal bleeding prior to radiotherapy * conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream * sucralfate treatment during the two weeks prior to enrollment * renal insufficiency (creatinine level ≥2 mg/dl) * concurrent chemotherapy * concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction) * concurrent therapy with oral anticoagulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in disease severity scores, as assessed using our three-item symptom scale | baseline vs. 16 week | Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 \>6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in endoscopic severity score | baseline vs. week 8 and week 16 | Endoscopic severity score of chronic radiation proctopathy: Normal, score 0 - Normal mucosa Mild, score 3 - Erythema and/or teleangiectasia, edema, thickening, pallor of mucosa Moderate, score 6 - Above plus friability Severe, score 9 - Ulceration and/or necrosis |
| change in disease severity score | baseline vs. week 52 | disease severity score as in primary outcome measure |
| complication rate | baseline to 16 weeks | — |
Countries
Poland
Outcome results
None listed