The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma

Not Applicable

Completed

• Conditions: Multiple Myeloma; Stem Cell Transplant Complications
• Interventions: Other: Tai Chi Easy

• Registration Number: NCT04760405
• Lead Sponsor: University of Arizona

Brief Summary

The current proposal aims to test the feasibility of immune function analysis for Tai Chi Easy (TCE) intervention in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT) with concurrent exploration of health related quality of life (HRQOL).

Detailed Description

The current proposal aims to test the feasibility of immune function analysis for TCE intervention in MM patients undergoing ASCT with concurrent exploration of HRQOL. The data obtained from this trial will provide supporting data for a future randomized clinical trial evaluating the impact of TCE on immune function (incidence of ASCT related infectious complications, natural killer cell phenotype and activity, and myeloma remission rate (clonal plasma cell % at day 100, minimal residual disease (MRD)), with the evaluation of efficacy on improving HRQOL during ASCT. Successful completion of this CROC project will provide necessary data to support future grant applications, in particular the feasibility of immunoassay evaluation of MM patients undergoing ASCT.

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-03-11
• Primary Completion: 2023-11-28
• Study Completion: 2023-11-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant
2. 18 years or older
3. English speaking
4. General proficiency to read/write in English
5. Able to attend TCE training session per study protocol
6. ECOG performance status 0-1
7. Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)

Exclusion Criteria

1. Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more
2. Syncopal event in prior 60 days
3. Concurrent major depressive disorder or anxiety disorder (DSMIV) as determined by treating provider
4. Chronic dizziness or vestibular disorders
5. History of recurrent falls (>2 in the prior year)
6. Grade 3 or greater neuropathy
7. Grade 3 or greater spinal fracture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tai Chi Easy Intervention	Tai Chi Easy	Tai Chi Easy: TCE is a standardized protocol used in several prior studies. TCE has been manualized and has a formal training program for instructors. The protocol is taught as a series of repeated and simple-to-learn movements. Patients will receive two 30-minute small group training sessions (Via Zoom) within 7 days of their scheduled transplant. After the training has been completed the participant will be provided with written (via manual) and electronic (DVD, MP3 file download) materials to continue with self-direct practice throughout the duration of the study.

Primary Outcome Measures

Name	Time	Method
Determine natural killer cell phenotype	Day 100	Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity	Day 100	Determine NK cell activity through peripheral blood analysis
Determine immune function	Day 100	Determine immune function through peripheral blood analysis of immune factors

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States