Clinical trial NCT04447443: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Chemotherapy-related Diarrhea
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: Jinhua Municipal Central Hospital
name: Quzhou Kecheng People's Hospital
First posted: 2020-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
timeFrame: 2 weeks
Secondary outcomes:
measure: onset time
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
measure: Changs in Karnofsky Performance Status
timeFrame: 2 weeks
measure: Gut microbiota changes in response to intervention
timeFrame: Change from baseline in gut microbiota at 1 and 2 weeks ]
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University School of Medicine
name: Pianhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: