Chemotherapy-related Diarrhea
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic 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.
DIETARY_SUPPLEMENTMaltodextrin + 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.
Sponsors
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea | 2 weeks | Numbers of bowel movements per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changs in Karnofsky Performance Status | 2 weeks | — |
| onset time | 2 weeks | — |
| Adverse events | 2 weeks | 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 |
| Gut microbiota changes in response to intervention | Change from baseline in gut microbiota at 1 and 2 weeks ] | 16S rRNA sequencing |
Countries
China
Outcome results
None listed