Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT

NCT04685525 | Withdrawn

• 1 other identifier: CASE12Z20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autologous Transplant; Myeloma

Outcome Measures

Primary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

Study Arms (1)

Mycobiome Supporting Diet

EXPERIMENTAL

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

Behavioral: Mycobiome Supporting Diet

Interventions

Mycobiome Supporting Diet BEHAVIORAL

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.

Mycobiome Supporting Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ehsan Malek, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)