Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer (LGG)
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|ClinicalTrials.gov Identifier: NCT01790035|
Recruitment Status : Terminated (Low accrual)
First Posted : February 12, 2013
Last Update Posted : March 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Neoplasms||Drug: LGG Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
Other Name: Culturelle
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.
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.
- 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
- 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.
- 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.
- 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)
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Matthew Ciorba, M.D.||Washington University School of Medicine|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Washington University School of Medicine|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases