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Randomized Control Trial Comparing Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer


Phase 3
21 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Randomized Control Trial Comparing Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer


Inclusion Criteria:



- Patients with a history of rectal cancer treated with an anterior resection preformed
at MSKCC (tumor at or below 12cm from anal verge) with restoration of bowel
continuity ≥1 and ≤ 5 years. (Patients may also have had procedures to construct
neo-rectums including j-pouch, coloplasty, and end to side anastomosis).

- Patients ≥ 21 years of age.

- Presence of anterior resection symptoms by patients own assessment. These symptoms
may include any of the following: incomplete evacuation, clustering of bowel motions,
frequency of bowel motions, unformed stool, excessive flatus, or incontinence of
flatus and/or feces.

Exclusion Criteria:

- Local recurrence of rectal cancer.

- Antibiotic treatment within the last 4 weeks for any condition.

- Pregnancy or breast feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To compare the efficacy of rifaximin and placebo in the treatment of bowel dysfunction as measured by MSKCC Bowel Function Instrument (BFI score) in patients following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for rectal cancer.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Philip Paty, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-045

NCT ID:

NCT01345175

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Rectal Cancer
  • rectal
  • colon
  • PLACEBO
  • RIFAXIMIN
  • metronidazole
  • 11-045
  • Rectal Neoplasms
  • Intestinal Diseases

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center Commack Commack, New York  11725
Memorial Sloan-Kettering Cancer Center Sleepy Hollow Sleepy Hollow, New York  10591