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NCT02919670 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2023-03-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity

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outcome · POSTED

Maximum Daily Stool Frequency

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outcome · POSTED

Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency

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outcome · POSTED

Duration Of Hospitalization (Days) From Admission To Discharge

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outcome · POSTED

Percent Change in Weight From Baseline to Day 14

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outcome · POSTED

Median Amount Of Anti-Diarrheal Medications

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outcome · POSTED

the Tolerability of Enterade® as Measured by the Number of Compliant Patients

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outcome · POSTED

Calorie Consumption

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outcome · POSTED

Number of Participants With Fever or Neutropenia

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Participants must have histologically or cytologically confirmed Multiple Myeloma, or Non-Hodgkin Lymphoma and must be undergoing Melphalan conditioning for autologous HSCT. * Age equal or greater than 18 years old. * ECOG performance status ≤2 (Karnofsky ≥60%) * Participants must have adequate organ and marrow function to proceed to transplant. * Ability to tolerate thin liquids by mouth at the time of admission. * The effects of Enterade® on the developing human fetus are unknown. For this reason and other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) at the time of study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the trial. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to chemotherapy agents administered during this time period. * Participants who are receiving any other investigational agents. Participants who are receiving standard of care induction therapy on a clinical trial may be eligible after discussion with the overall principal investigator. * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Known allergy to Stevia. * Participants receiving any medications or antibiotics to treat Clostridium difficile infection prior to the initiation of the study will be ineligible for this study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active Clostridium difficile infection or history of Clostridium difficile infection. * Participants with evidence of diarrhea as defined by three or more loose or liquid stools per day or loose watery stool (greater volume of stool), that occurs more frequently than usual and lasting for more than three days prior to admission, history of inflammatory bowel disease, irritable bowel syndrome, colectomy or bariatric surgery, Celiac disease. * Participants with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and nursing women are excluded from this study because of teratogenicity and toxicity risks associated with the conditioning regimen for patients undergoing autologous HSCT.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    * Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice
    intervention Names
    1. Dietary Supplement: Enterade
    2. Other: Standard Supportive Care
    label
    Enterade and Standard Supportive Care
    type
    EXPERIMENTAL
  2. description
    * Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice
    intervention Names
    1. Dietary Supplement: Placebo
    2. Other: Standard Supportive Care
    label
    Placebo and Standard Supportive Care
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Enterade and Standard Supportive Care
    name
    Enterade
    type
    DIETARY_SUPPLEMENT
  2. arm Group Labels
    1. Placebo and Standard Supportive Care
    name
    Placebo
    type
    DIETARY_SUPPLEMENT
  3. arm Group Labels
    1. Enterade and Standard Supportive Care
    2. Placebo and Standard Supportive Care
    name
    Standard Supportive Care
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
114
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Evaluation will made using Fisher's exact test. Among 99 participants who received some intervention
    measure
    Number of Participants With Grade 3 or Higher Diarrhea GI Toxicity
    time Frame
    14 days
secondary Outcomes
  1. measure
    Maximum Daily Stool Frequency
    time Frame
    14 days
  2. measure
    Percentage of Participants With Diarrhea on the Day of Maximum Daily Stool Frequency
    time Frame
    14 days
  3. measure
    Duration Of Hospitalization (Days) From Admission To Discharge
    time Frame
    Up to 45 days
  4. measure
    Percent Change in Weight From Baseline to Day 14
    time Frame
    baseline and day 14
  5. measure
    Median Amount Of Anti-Diarrheal Medications
    time Frame
    14 days
  6. measure
    the Tolerability of Enterade® as Measured by the Number of Compliant Patients
    time Frame
    14 days
  7. measure
    Calorie Consumption
    time Frame
    14 days
  8. measure
    Number of Participants With Fever or Neutropenia
    time Frame
    14 days
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      id
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      occurrences
      1. context exact
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        exact text
        NCT02919670
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
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      source json pointer
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      source kind
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice