Clinical Trial: Combined Therapy in Radiation Proctopathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial

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 Summary: 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.
Sponsor: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Current Primary Outcome: change in disease severity scores, as assessed using our three-item symptom scale [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • change in endoscopic severity score [ Time Frame: 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 [ Time Frame: baseline vs. week 52 ]
    disease severity score as in primary outcome measure
  • complication rate [ Time Frame: baseline to 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Dates:
Date Received: June 5, 2012
Date Started: June 2003
Date Completion:
Last Updated: June 5, 2012
Last Verified: June 2012