Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer

The Washington University

Status and phase: Terminated; Phase 1

Conditions: Gastrointestinal Neoplasms

Treatments: Drug: Placebo; Drug: LGG

Study type: Interventional

Funder types: Other

Identifiers

NCT01790035

201404101

Details and patient eligibility

About

Phase 3 placebo-controlled trial to determine efficacy of the probiotic LGG for reducing acute treatment related GI toxicity in patients with GI malignancy with phase 1 safety lead-in.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current diagnosis of a gastrointestinal, abdominal, or pelvic cancer for which the use of continuous definitive or adjuvant external-beam RT to the abdomen or pelvis to a minimum dose of 4500 cGy is planned.

• 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 ≥ 9.0 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 bowel resection which, in the opinion of the investigator, would decrease the benefit of the probiotic. Patients who have undergone recent bowel surgeries which would not decrease the benefit of the probiotic are eligible provided they are more than 30 days from surgery with no serious complications.
• 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.
• 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).
• History of hypersensitivity to all of the following antibiotics: penicillin, erythromycin, clindamycin, and any fluoroquinolone.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 3 patient groups

LGG

Experimental group

Description:

LGG (containing 10^10 viable bacteria) taken by mouth twice daily beginning at baseline (but starting at least 3 days prior to the start of radiation) and continue during RT and for the 2 weeks following RT.

Treatment:

Drug: LGG

Placebo

Experimental group

Description:

Placebo taken by mouth twice daily beginning at baseline (but starting at least 3 days prior to the start of radiation) and continue during RT and for the 2 weeks following RT.

Treatment:

Drug: Placebo

No intervention

No Intervention group

Description:

Patients who prefer not to receive LGG will not be randomized and will receive standard of care RT. These patients will serve as a non-intervention comparator cohort to the first 20 patients and will have specimens collected but will not receive the placebo.