Trials / Completed
CompletedNCT02919670
A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma
A Randomized Double-Blinded Phase 2 Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Enterade | |
| DIETARY_SUPPLEMENT | Placebo | |
| OTHER | Standard Supportive Care |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2019-05-01
- Completion
- 2020-07-01
- First posted
- 2016-09-29
- Last updated
- 2023-03-16
- Results posted
- 2023-03-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02919670. Inclusion in this directory is not an endorsement.