Combined Therapy in Radiation Proctopathy

This study has been completed.
Sponsor:
Collaborator:
Medical Centre for Postgraduate Education
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01613534
First received: June 5, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Radiation Proctitis
Drug: Sucralfate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • change in disease severity scores, as assessed using our three-item symptom scale [ Time Frame: baseline vs. 16 week ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • change in endoscopic severity score [ Time Frame: baseline vs. week 8 and week 16 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    disease severity score as in primary outcome measure

  • complication rate [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: June 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APC plus oral sucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.
Drug: Sucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
Other Names:
  • Carafate
  • Ulgastran
Placebo Comparator: APC plus placebo
Argon plasma coagulation treatment followed by placebo administration for four weeks.
Drug: Placebo
Argon plasma coagulation treatment followed by placebo administration for four weeks

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613534

Locations
Poland
Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Mazowieckie, Poland, 02-781
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Medical Centre for Postgraduate Education
Investigators
Principal Investigator: Magdalena R Chruscielewska-Kiliszek, MD, PhD Medical Centre for Postgraduate Education
  More Information

No publications provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01613534     History of Changes
Other Study ID Numbers: 501-2-1-09-14/03
Study First Received: June 5, 2012
Last Updated: June 5, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:
chronic radiation proctopathy
argon plasma coagulation
sucralfate

Additional relevant MeSH terms:
Sucralfate
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014