Status:
WITHDRAWN
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang Cancer Hospital
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Chemotherapy-related Diarrhea
Eligibility:
All Genders
18-65 years
Phase:
NA
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 supplementat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04447443
Start Date
June 30 2020
End Date
June 30 2021
Last Update
August 6 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009