This research study is evaluating Enterade, a supplement, as a possible treatment for the side effects caused by Stem Cell Transplant. The following interventions will be involved in this study: * Enterade plus standard supportive care * Placebo plus standard supportive care. The placebo will be a mixture of water, electrolytes, and sweetener.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease, or in this case, the side effects from a standard treatment for Stem Cell Transplant side effect. "Investigational" means that the intervention is being studied. In this research study, the investigators are evaluating Enterade/Placebo plus standard supportive care for the treatment of the side effects caused by transplant. Enterade works by rehydrating the intestinal cells, thereby helping to restore normal bowel function. The ingredients in Enterade are generally recognized as safe by the Food and Drug Administration. This research study is hoping to learn if adding Enterade to the standard supportive care regimen for the participant transplant will help reduce the side effects from the transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
Time frame: 14 days
Maximum Daily Stool Frequency
Time frame: 14 days
Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
Time frame: 14 days
Duration Of Hospitalization (Days) From Admission To Discharge
Time frame: Up to 45 days
Percent Change in Weight From Baseline to Day 14
Time frame: baseline and day 14
Median Amount Of Anti-Diarrheal Medications
Time frame: 14 days
the Tolerability of Enterade® as Measured by the Number of Compliant Patients
Time frame: 14 days
Calorie Consumption
Time frame: 14 days
Number of Participants With Fever or Neutropenia
Time frame: 14 days
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