Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
Primary Purpose
Autologous Transplant, Myeloma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mycobiome Supporting Diet
Sponsored by
About this trial
This is an interventional supportive care trial for Autologous Transplant
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
Sites / Locations
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mycobiome Supporting Diet
Arm Description
Participants will be able to abide by the allowed and disallowed foods in MSD diet for at least four consecutive weeks prior to conditioning and up to 10 days after transplant. Participants will maintain a diary of foods they consume and any adverse effects they are experiencing and will self- collect fecal samples 28 days before transplant, 2 days before transplant and 10 days after transplant
Outcomes
Primary Outcome Measures
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
PRO-CTCAE questionnaire scores
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Secondary Outcome Measures
Full Information
NCT ID
NCT04685525
First Posted
December 22, 2020
Last Updated
August 16, 2023
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT04685525
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autologous Transplant, Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mycobiome Supporting Diet
Arm Type
Experimental
Arm Description
Participants will be able to abide by the allowed and disallowed foods in MSD diet for at least four consecutive weeks prior to conditioning and up to 10 days after transplant. Participants will maintain a diary of foods they consume and any adverse effects they are experiencing and will self- collect fecal samples 28 days before transplant, 2 days before transplant and 10 days after transplant
Intervention Type
Behavioral
Intervention Name(s)
Mycobiome Supporting Diet
Intervention Description
MSD takes combines elements from several diets (e.g., Paleo, low-carbohydrate, vegetarian, and Mediterranean) and excludes elements of these diets that have been specifically proven to increase pathogenic fungi in the human gut.
Primary Outcome Measure Information:
Title
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Description
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Time Frame
21 days prior to Transplant (an average of 1 month from start of study)
Title
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Description
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Time Frame
14 days prior to transplant (an average of 1 month from start of study)
Title
Percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire
Description
MSD adherence feasibility measured by percent of participants with at least 2 out of 3 assessments marked "more than half the time" on compliance questionnaire. The questionnaire includes a multiple choice questions about adherence to diet (4 levels, from 'not at all' to 'the whole time'), a multiple choice question identifying barriers to adherence, and 8 yes/no questions about medication use and symptom experience. The MSD diet will deem feasible if at least 80 percent of participants showed adherence defined by 2 out of 3 assessment marked "more than half the time".
Time Frame
7 days prior to transplant (an average of 1 month from start of study)
Title
Patient-reported outcome (PRO)-Common Terminology Criteria for Adverse Even CTCAE questionnaire
Description
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Time Frame
After baseline (7 days post-transplant)
Title
PRO-CTCAE questionnaire scores
Description
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Time Frame
week 1 in the 1 month prior to transplant
Title
PRO-CTCAE questionnaire scores
Description
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Time Frame
week 2 in the 1 month prior to transplant
Title
PRO-CTCAE questionnaire scores
Description
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Time Frame
week 3 in the 1 month prior to transplant
Title
PRO-CTCAE questionnaire scores
Description
Patient perception of symptoms measured using PRO-CTCAE questionnaire, consisting of 15 questions with frequency and severity scores, questions ranging 1 to 5, 5 is worse and 1 is less
Time Frame
week 4 in the 1 month prior to transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehsan Malek, MD
Phone
1-800-641-2422
Email
CTUReferral@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehsan Malek, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehsan Malek, MD
First Name & Middle Initial & Last Name & Degree
Ehsan Malek, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared due to the small sample size of the study participants in order to protect their identities.
Learn more about this trial
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT
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