Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer

NCT01345175 | Completed Phase 3 Results

• 1 other identifier: 11-045
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief Summary

The most common long-term problems after rectal surgery are bowel problems. These problems can include needing to pass bowel movements a lot, loose or mushy stools, inability to fully clear your bowels, and/or poor control of gas and stool. The investigators believe that a major cause of these problems is too much bacteria in the bowel and treatment with antibiotic tablets will hopefully help improve these bowel problems. In order to test this idea, the Colorectal Surgery Service of Memorial Sloan Kettering Cancer Center is sponsoring a clinical trial. This trial will compare the antibiotic rifaximin and a placebo (a harmless tablet that has no effect) in the treatment of these bowel problems. Following this we will attempt to see if another antibiotic metronidazole also helps to treat these bowel problems. Both Metronidazole and rifaximin are well established drugs that have minimal side effects.

Conditions

Rectal Cancer

Keywords

rectal; colon; PLACEBO; RIFAXIMIN; metronidazole; 11-045

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed MSKCC Bowel Function Instrument (BFI Score) in Patients Following Anterior Resection (AR) or Sphincter Preserving Surgery (SPS) for Rectal Cancer.

  1 year

Secondary Outcomes (4)

• To Determine if Reduction in Intestinal Bacterial Quantity Correlates With Improvement in Bowel Symptoms (BFI Score).

  1 year

• To Explore the Bacterial Composition of Stool Before and After Antibiotic Treatment.

  1 year

• To Identify Dynamic Changes in Bowel Function During and After Antibiotic Treatment Using a Bowel Function Log.

  1 year

• Efficacy of Metronidazole

  1 year

Study Arms (2)

Pts receiving Rifaximin

EXPERIMENTAL

This group will receive rifaximin 400mg bid for 4 weeks. At 1 - 24 months after completion of the phase III portion of the trial, patients will be contacted by phone and given the option of receiving metronidazole in a followup, single arm study in which all patients receive the antibiotic. Patients who wish to participate will be mailed a drug prescription for a 3 week course of metronidazole 500mgs tid as well as the BFI forms and stool diary. Pretreatment and post treatment BFI scores will be collected and analyzed for change in bowel function as was done in the initial Phase III study.

Drug: Rifaximin

Pts receiving placebo

PLACEBO COMPARATOR

This group will receive a placebo bid for 4 weeks. At 1 - 24 months after completion of the phase III portion of the trial, patients will be contacted by phone and given the option of receiving metronidazole in a followup, single arm study in which all patients receive the antibiotic. Patients who wish to participate will be mailed a drug prescription for a 3 week course of metronidazole 500mgs tid as well as the BFI forms and stool diary. Pretreatment and post treatment BFI scores will be collected and analyzed for change in bowel function as was done in the initial Phase III study.

Drug: Placebo

Interventions

Rifaximin DRUG

Pt will receive rifaximin 400mg bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.

Also known as: At 1 - 24 months after completion of the phase III portion of the trial, patients will be contacted by phone and given the option of receiving, metronidazole in a followup, single arm study in which all patients receive the antibiotic., Patients who wish to participate will be mailed a drug prescription for a 3 week course of, metronidazole 500mgs tid as well as the BFI forms and stool diary. Pretreatment and, posttreatment BFI scores will be collected and analyzed for change in bowel function as, was done in the initial Phase III study.

Pts receiving Rifaximin

Placebo DRUG

Pt will receive placebo bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.

Also known as: At 1 - 24 months after completion of the phase III portion of the trial,, patients will be contacted by phone and given the option of receiving, metronidazole in a followup, single arm study in which all patients receive, the antibiotic. Patients who wish to participate will be mailed a drug, prescription for a 3 week course of metronidazole 500mgs tid as well as the, BFI forms and stool diary. Pretreatment and post treatment BFI scores will be, collected and analyzed for change in bowel function as was done in the initial, Phase III study.

Pts receiving placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Local recurrence of rectal cancer.
• Antibiotic treatment within the last 4 weeks for any condition.
• Pregnancy or breast feeding.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center at Basking Ridge

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Cancer Center Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Rifaximin; Metronidazole; Defecation; Prescriptions; Clinical Trials, Phase III as Topic

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Philip Paty, MD
• Organization: Memorial Sloan Kettering Cancer Center

patyp@MSKCC.ORG

212-639-6703

Study Officials

• Philip Paty, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: April 26, 2011
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2023-03

Locations

US (3)