Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT

Myeloma Clinical Trial

Official title:

Mycobiome Supporting Diet (MSD) to Reduce Gastrointestinal (GI) Toxicity Associated With Autologous Stem Cell Transplant (ASCT) For Patients With Multiple Myeloma (MM)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04685525
• Other study ID #: CASE12Z20
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autologous Transplant
• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Behavioral:
• Mycobiome Supporting Diet
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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	21 days prior to Transplant (an average of 1 month from start of study)
Primary	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".	14 days prior to transplant (an average of 1 month from start of study)
Primary	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".	7 days prior to transplant (an average of 1 month from start of study)
Primary	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	After baseline (7 days post-transplant)
Primary	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	week 1 in the 1 month prior to transplant
Primary	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	week 2 in the 1 month prior to transplant
Primary	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	week 3 in the 1 month prior to transplant
Primary	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	week 4 in the 1 month prior to transplant