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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01790035
Recruitment Status : Terminated (Low accrual)
First Posted : February 12, 2013
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Drug: LGG Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I and Randomized Controlled Phase II Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Actual Study Start Date : August 19, 2014
Actual Primary Completion Date : January 12, 2017
Actual Study Completion Date : December 12, 2021

Arm Intervention/treatment
Experimental: LGG
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.
Drug: LGG
Other Name: Culturelle

Experimental: Placebo
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.
Drug: Placebo
No Intervention: No intervention
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.



Primary Outcome Measures :
  1. Efficacy (randomized phase II trial) [ Time Frame: Up to 6 months following the last dose of LGG or placebo ]
    Compare the proportion of patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine being treated with the probiotic LGG who develop CTCAE grade 2 or greater diarrhea to the proportion of patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine being treated with placebo who develop CTCAE grade 2 or greater diarrhea

  2. Safety (phase I safety lead-in) [ Time Frame: Up to 30 days following completion of treatment ]

    Determine the safety and tolerability of LGG in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine

    The DSMC will review the data as part of an interim analysis when the last patient has had 30 days of follow-up. The DSMC will ensure that at least 18 patients have had follow-up at 30 days (with expected 10% drop-out). Accrual to the randomized portion of the trial will occur only if there are no episodes of lactobacillus associated septicemia. Additionally, if two or more serious adverse events of a similar nature occur and a causal relationship to the investigational product cannot be excluded, accrual to the randomized portion will not occur.



Secondary Outcome Measures :
  1. Diarrhea subscale score [ Time Frame: Up to 5 years after completion of treatment. ]

    The average AUC of the FACIT-D diarrhea subscale scores will be compared between the two treatment groups using a two-sample t-test.

    The FACIT-D will be completed at baseline, weekly during radiation treatment, for the two weeks following completion of radiation treatment, 12 months following the end of radiation treatment, and years 2-5 following the completion of radiation treatment.


  2. Need for antidiarrhea medication [ Time Frame: Up to 2 weeks after completion of treatment ]
    Need for use of an antidiarrheal medication (Loperamide) will be evaluated at a binary endpoint (Use or No Use). Comparison will be made using Fisher's exact test as previously described (Chitapanarux 2010)

  3. Grade 3 or greater diarrhea [ Time Frame: Up to 6 months following the last dose of LGG or placebo ]
    In patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine, compare the proportion of patients who develop diarrhea of grade 3 or greater (by CTCAE version 4.0) in those treated with the probiotic LGG to the proportion in those receiving placebo

  4. Fecal calprotectin [ Time Frame: Up to 2 weeks following the completion of treatment ]
    Determine whether fecal calprotectin correlates with onset, duration, and/or severity of diarrhea during chemoradiation

  5. Serum citrulline [ Time Frame: Up to 2 weeks following the completion of treatment ]
    Determine whether serum citrulline correlates with onset, duration, and/or severity of diarrhea during chemoradiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01790035


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Matthew Ciorba, M.D. Washington University School of Medicine
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01790035    
Other Study ID Numbers: 201404101
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases