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

Chemotherapy-related Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04447443
• Other study ID #: 2019-111
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-related Diarrhea
• Diarrhea
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Dietary Supplement:
• Prebiotic Fiber Supplement + loperamide hydrochloride capsule
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.
• Maltodextrin + loperamide hydrochloride capsule
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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (6)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital Medical Group, Quzhou Kecheng People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea	Numbers of bowel movements per day	2 weeks
Secondary	onset time		2 weeks
Secondary	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	2 weeks
Secondary	Changs in Karnofsky Performance Status		2 weeks
Secondary	Gut microbiota changes in response to intervention	16S rRNA sequencing	Change from baseline in gut microbiota at 1 and 2 weeks ]