NCT01613534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

4 years

First QC Date

June 5, 2012

Last Update Submit

June 5, 2012

Conditions

Chronic Radiation Proctitis

Keywords

chronic radiation proctopathyargon plasma coagulationsucralfate

Outcome Measures

Primary Outcomes (1)

  • change in disease severity scores, as assessed using our three-item symptom scale

    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.

    baseline vs. 16 week

Secondary Outcomes (3)

  • change in endoscopic severity score

    baseline vs. week 8 and week 16

  • change in disease severity score

    baseline vs. week 52

  • complication rate

    baseline to 16 weeks

Study Arms (2)

APC plus oral sucralfate

EXPERIMENTAL

Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.

Drug: Sucralfate

APC plus placebo

PLACEBO COMPARATOR

Argon plasma coagulation treatment followed by placebo administration for four weeks.

Drug: Placebo

Interventions

SucralfateDRUG

Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks

Also known as: Carafate, Ulgastran
APC plus oral sucralfate
PlaceboDRUG

Argon plasma coagulation treatment followed by placebo administration for four weeks

APC plus placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, Masovian Voivodeship, 02-781, Poland

Location

Related Publications (1)

  • Chruscielewska-Kiliszek MR, Regula J, Polkowski M, Rupinski M, Kraszewska E, Pachlewski J, Czaczkowska-Kurek E, Butruk E. Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial. Colorectal Dis. 2013 Jan;15(1):e48-55. doi: 10.1111/codi.12035.

    PMID: 23006660DERIVED

MeSH Terms

Interventions

Sucralfate

Intervention Hierarchy (Ancestors)

ThioglycosidesSulfur CompoundsOrganic ChemicalsSucroseDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Magdalena R Chruscielewska-Kiliszek, MD, PhD

    Medical Centre for Postgraduate Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

June 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 7, 2012

Record last verified: 2012-06

Locations

PL(1)