Clinical trial NCT04685525: Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
Official title: Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autologous Transplant
Myeloma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.

Detailed description: This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.

Eligibility criteria: Inclusion Criteria:

* Eligible for first autologous transplant for myeloma
* Willing to adhere to the allowed and disallowed foods of the diet plan.
* Able to get and prepare their own food items for all meals during the study

Exclusion Criteria:

* Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
* Pregnant women, planning to get pregnant or breastfeeding
* Prior bowel resection
* Inability to tolerate the study diet due to allergies/ intolerance/ preference
* Inability to consent to trial
* Patients with restrictions in diet including inability to have oral nutrition with regular consistency
* Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
* Patients with absolute neutrophil count (ANC) \< 1000 on long term antibacterial prophylaxis ongoing 3 days prior to enrollment
* Patients who received antifungal therapy in 3 days prior to enrollment
* Patients who received steroid therapy in 7 days prior to enrollment

Primary outcomes:
measure: Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
timeFrame: 21 days prior to Transplant (an average of 1 month from start of study)
measure: Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
timeFrame: 14 days prior to transplant (an average of 1 month from start of study)
measure: Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
timeFrame: 7 days prior to transplant (an average of 1 month from start of study)
measure: Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
timeFrame: After baseline (7 days post-transplant)
measure: PRO-CTCAE questionnaire scores
timeFrame: week 1 in the 1 month prior to transplant
measure: PRO-CTCAE questionnaire scores
timeFrame: week 2 in the 1 month prior to transplant
measure: PRO-CTCAE questionnaire scores
timeFrame: week 3 in the 1 month prior to transplant
measure: PRO-CTCAE questionnaire scores
timeFrame: week 4 in the 1 month prior to transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Ehsan Malek, MD
role: PRINCIPAL_INVESTIGATOR
References: