Enterade in Reducing Side Effects from High-Dose Melphalan in Patients with Non-Hodgkin Lymphoma Undergoing Stem Cell Transplant
This randomized phase II trial studies how well amino acid/electrolyte mixture-based dietary supplement (Enterade) works in reducing side effects from high-dose melphalan in patients with non-Hodgkin lymphoma undergoing stem cell transplant. Dietary supplements, such as Enterade, may rehydrate intestinal cells and help restore normal bowel function.
Inclusion Criteria
- Participants must have histologically or cytologically confirmed non-Hodgkin lymphoma and must be undergoing melphalan conditioning for autologous HSCT
- Age equal or greater than 18 years old
- Eastern Cooperative Oncology Group (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
- 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 gastrointestinal (GI) adverse events due to induction therapy; patients who have had localized radiation which would not result in any GI effects are allowed on study
- 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
- 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02919670.
PRIMARY OBJECTIVES:
I. To compare the incidence of National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) 4.03, grade 3 or higher gastrointestinal toxicity in the fourteen days following autologous hematopoietic stem cell transplant (HSCT) between the medical food product, Enterade, with standard of care versus placebo with standard of care, following melphalan conditioning.
SECONDARY OBJECTIVES:
I. To compare average total daily stool volume between patients receiving Enterade and placebo.
II. To compare average daily stool frequency between the Enterade and placebo groups.
III. To compare duration of hospitalization (days) from admission to discharge.
IV. To compare change in weight, as a percent of initial weight, between patients receiving Enterade and placebo from admission and/or the first day of conditioning to day +14.
V. To compare daily calorie counts from the day of admission, day +7 and day +14 following HSCT between patients receiving Enterade or placebo.
VI. To compare total use of anti-diarrheal medications (number of medications, mean number of daily doses) from randomization to discharge from the inpatient setting.
VII. To compare use of antibiotic medications from randomization until discharge from the inpatient setting.
VIII. To compare the incidence of fever and neutropenia between the Enterade and placebo groups.
IX. To compare duration (days) of neutropenia between the Enterade and placebo groups.
X. To characterize the tolerability of Enterade as measured by the number of total 8-oz Enterade bottles consumed throughout the trial, and average drinks per day.
XI. To assess patient reported health-related quality of life in patients receiving melphalan conditioning and the intervention Enterade or placebo using the Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain, and the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) and Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) symptom inventory at day +14 following HSCT.
XII. To assess stool inflammation with fecal lactoferrin on admission, and day +7 following HSCT.
XIII. To assess markers of systemic inflammation and nutrition, including CRP and pre-albumin on admission, and day +7 and day +14 following HSCT.
XIV. To assess plasma endotoxin and cytokine levels of IL-1 beta, TNF-alpha, in all patients receiving melphalan with serum samples collected at day +7 after transplantation.
XV. To estimate compliance rate.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive Enterade orally (PO) twice daily (BID) from admission and/or the day of conditioning to day 14 after HSCT or until discharge. Patients also receive standard supportive care.
ARM B: Patients receive placebo PO BID from admission and/or the day of conditioning to day 14 after HSCT or until discharge. Patients also receive standard supportive care.
After completion of study, patients are followed up for 14 days or until discharge.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMahasweta Gooptu
- Primary ID16-329
- Secondary IDsNCI-2016-01562
- ClinicalTrials.gov IDNCT02919670