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Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors

Primary Purpose

Chemotherapy-related Diarrhea

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prebiotic Fiber Supplement + loperamide hydrochloride capsule
Maltodextrin + loperamide hydrochloride capsule
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-related Diarrhea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65, be able to comply with the protocol
  • Life expectancy greater than 3 months
  • Patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers
  • Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments
  • Chemotherapy-related diarrhea grade 2-4
  • Not experience diarrhea before chemotherapy

Exclusion Criteria:

  • age<18 or >65
  • Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding
  • Other acute or chronic diarrhea or colostomy
  • Patients with other severe adverse effects of chemotherapy other than diarrhea
  • Patients with severe diseases of heart, kidney, liver and other major organs
  • Use of any other drug for promoting intestine movement
  • Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide
  • Allergic to the components of the intervention dietary supplements;
  • Pregnancy (positive serum pregnancy test) and lactation
  • Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial

Sites / Locations

  • Second Affiliated Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prebiotic Fiber

Maltodextrin

Arm Description

Outcomes

Primary Outcome Measures

Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Numbers of bowel movements per day

Secondary Outcome Measures

onset time
Adverse events
Incidence of mild (e.g. self-resolving), moderate (e.g. those that warrant medical evaluation and treatment) and serious (e.g. those that cannot be resolved by medical treatment) adverse events based on criteria adopted by the National Institute of Health common terminology criteria for adverse events (NIH severity) will be evaluated
Changs in Karnofsky Performance Status
Gut microbiota changes in response to intervention
16S rRNA sequencing

Full Information

First Posted
June 17, 2020
Last Updated
August 1, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04447443
Brief Title
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
Official Title
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
discontinued prematurely by sponsor for strategic reasons
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Zhejiang Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates longitudinal data associating changes in gut microbiota composition and diversity, defecation, performance status and adverse reactions in response to prebiotic fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea. 120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide hydrochloride capsule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-related Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic Fiber
Arm Type
Experimental
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic Fiber Supplement + loperamide hydrochloride capsule
Intervention Description
2-week sequential supplementation with prebiotic fiber supplement (3.5g, twice a day). The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin + loperamide hydrochloride capsule
Intervention Description
2-week sequential supplementation with placebo of of maltodextrin (3.5g, twice a day). The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.
Primary Outcome Measure Information:
Title
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Description
Numbers of bowel movements per day
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
onset time
Time Frame
2 weeks
Title
Adverse events
Description
Incidence of mild (e.g. self-resolving), moderate (e.g. those that warrant medical evaluation and treatment) and serious (e.g. those that cannot be resolved by medical treatment) adverse events based on criteria adopted by the National Institute of Health common terminology criteria for adverse events (NIH severity) will be evaluated
Time Frame
2 weeks
Title
Changs in Karnofsky Performance Status
Time Frame
2 weeks
Title
Gut microbiota changes in response to intervention
Description
16S rRNA sequencing
Time Frame
Change from baseline in gut microbiota at 1 and 2 weeks ]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65, be able to comply with the protocol Life expectancy greater than 3 months Patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments Chemotherapy-related diarrhea grade 2-4 Not experience diarrhea before chemotherapy Exclusion Criteria: age<18 or >65 Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding Other acute or chronic diarrhea or colostomy Patients with other severe adverse effects of chemotherapy other than diarrhea Patients with severe diseases of heart, kidney, liver and other major organs Use of any other drug for promoting intestine movement Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide Allergic to the components of the intervention dietary supplements; Pregnancy (positive serum pregnancy test) and lactation Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pianhong Zhang
Organizational Affiliation
Second Affiliated Hospital, Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors

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