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出境医 / 临床实验 / Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)

Study Description
Brief Summary:
In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.

Condition or disease Intervention/treatment Phase
Radiotherapy Toxicity Diarrhea Probiotics Drug: Bacillus Licheniformis Drug: Placebo Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Probiotics
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
 Drug: Bacillus Licheniformis
Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
Other Name: Biscanen cap.
Placebo Comparator: Placebo
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
 Drug: Placebo
Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
Other Name: Placebo oral tablet
Outcome Measures
Primary Outcome Measures :
  1. Number of participants with grade 2 or more acute intestinal toxicities [ Time Frame: Adverse effect evaluated at 3 months after radiation therapy ]
    Evaluation using CTCAE version 4.0


Secondary Outcome Measures :
  1. Number of participants with grade 2 or more chronic intestinal toxicities [ Time Frame: Adverse effect occured after 3 months since end of radiation therapy ]
    Evaluation using CTCAE version 4.0


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
  • Over 20 years of age
  • Eastern Cooperative Oncology Group (ECOG) score 0-2
  • Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
  • Appropriate values of kidney function within 6 months after enrollment Creatinin < 2.0 ng/dL
  • Appropriate values of liver function within 6 months after enrollment Total bilirubin < 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase < 2.5 times upper limit normal range.
  • Willing to provide informed written consent

Exclusion Criteria:

  • History of pelvic irradiation
  • Double primary cancer other than skin/thyroid cancer
  • Combined serious morbidity
  • Experience of other clinical trial within 1 month.
Contacts and Locations

Contacts
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Contact: Young Seok Kim, M.D., PhD. 82 2 3010 5614 ext 5614 ysk@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young Seok Kim, M.D., Ph.D.    82 2 3010 5614 ext 5614    ysk@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Young Seok Kim, M.D., Ph.D. Asan Medical Center
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date January 19, 2021
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Number of participants with grade 2 or more acute intestinal toxicities [ Time Frame: Adverse effect evaluated at 3 months after radiation therapy ]
Evaluation using CTCAE version 4.0
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Number of participants with grade 2 or more chronic intestinal toxicities [ Time Frame: Adverse effect occured after 3 months since end of radiation therapy ]
Evaluation using CTCAE version 4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP)
Official Title  ICMJE Prevention of Radiotherapy Induced Enteropathy by Probiotics (PREP Trial): a Prospective, Randomized Controlled, Double Blinded, Single Center, Superiority Study
Brief Summary In recent studies, a radiation-induced enteropathy is being reported over 50%. In clinics, probiotics are actively prescribed as a treatment for radiation-induced enteropathy. If probiotics can be used during radiation therapy to prevent or reduce radiation-induced enteropathy, the investigators can 1) reduce the inconvenience which is caused from intestinal toxicity, 2) reduce the unnecessary interruption of radiation therapy, and 3) expect to improve the quality of life.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Radiotherapy
  • Toxicity
  • Diarrhea
  • Probiotics
Intervention  ICMJE
  • Drug: Bacillus Licheniformis
    Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
    Other Name: Biscanen cap.
  • Drug: Placebo
    Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
    Other Name: Placebo oral tablet
Study Arms  ICMJE
  • Experimental: Probiotics
    Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
    Intervention: Drug: Bacillus Licheniformis
  • Placebo Comparator: Placebo
    Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		248
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, ureter cancer, kidney cancer, urethral cancer, and prostate cancer
  • Over 20 years of age
  • Eastern Cooperative Oncology Group (ECOG) score 0-2
  • Appropriate values of blood test within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets≥50000cells/mm3
  • Appropriate values of kidney function within 6 months after enrollment Creatinin < 2.0 ng/dL
  • Appropriate values of liver function within 6 months after enrollment Total bilirubin < 1.5 times upper limit normal range, alanine aminotransferase or aspartate aminotransferase < 2.5 times upper limit normal range.
  • Willing to provide informed written consent

Exclusion Criteria:

  • History of pelvic irradiation
  • Double primary cancer other than skin/thyroid cancer
  • Combined serious morbidity
  • Experience of other clinical trial within 1 month.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Young Seok Kim, M.D., PhD. 82 2 3010 5614 ext 5614 ysk@amc.seoul.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978949
Other Study ID Numbers  ICMJE S2019-0657-0003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young Seok Kim, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Seok Kim, M.D., Ph.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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