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A Randomized Controlled Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Neoplasms

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Trial Information

A Randomized Controlled Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer


Inclusion Criteria:



- Current diagnosis of cancer that supports the use of continuous definitive or
adjuvant external-beam RT to the abdomen or pelvis to a minimum dose of 4500 cGy.

- Scheduled to receive concurrent administration of fluoropyrimidine chemotherapy (5-FU
or capecitabine) during radiation therapy.

- Age ≥ 18 years.

- Life expectancy ≥ 6 months.

- Negative pregnancy test done ≤7 days prior to registration (for women of childbearing
potential only).

- The following laboratory values obtained ≤ 28 days prior to registration:

- Hemoglobin ≥ 10.0 g/dL

- WBC ≥ 3,500

- Absolute neutrophil count ≥ 1,500

- Platelets ≥ 100,000

- ECOG Performance Status (PS) of 0, 1, or 2.

- Willingness to abstain from ingestion of yogurt products and/or any product
containing probiotics during study drug treatment.

- Ability to complete questionnaire(s) alone or with assistance.

- Ability to understand and willingness to sign informed consent.

Exclusion Criteria:

- Previous significant bowel resection.

- Known allergy to a probiotic preparation.

- Any history of inflammatory bowel disease.

- Grade 3 or 4 diarrhea, rectal bleeding, abdominal cramping, or incontinence of stool
≤7 days prior to registration.

- Any medical condition that may interfere with ability to receive protocol treatment.

- Prior abdominal or pelvic RT.

7-Use of probiotics ≤ 2 weeks prior to registration.

- Use of antibiotics ≤ 3 days prior to registration.

- Planned continuous antibiotic treatment during RT.

- History of gastrointestinal or genitourinary obstruction or porphyria.

History of irritable bowel syndrome (IBS).

Inclusion of Women and Minorities

-Both men and women and members of all races and ethnic groups are eligible for this
trial.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Outcome Description:

Compare the frequency of diarrheal events grade 2 or greater by CTCAE version 4.0 in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine who are treated with the probiotic LGG to the frequency of these events in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine who receive placebo

Outcome Time Frame:

14 months

Safety Issue:

No

Principal Investigator

Matthew Ciorba, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

12-X387

NCT ID:

NCT01790035

Start Date:

April 2013

Completion Date:

August 2015

Related Keywords:

  • Gastrointestinal Neoplasms
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110