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

Sponsor

University of Arizona (Other)

Overall Status

Recruiting

CT.gov ID

NCT04760405

Collaborator

(none)

Enrollment

Location

Arm

27.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Stem Cell Transplant Complications	Other: Tai Chi Easy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 11, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tai Chi Easy Intervention 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.	Other: Tai Chi Easy 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.

Arm

Intervention/Treatment

Experimental: Tai Chi Easy Intervention

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.

Other: Tai Chi Easy

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.

Outcome Measures

Primary Outcome Measures

Determine natural killer cell phenotype [Baseline]
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype [Day 14]
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype [Day 30]
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype [Day 100]
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity [At baseline]
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity [Day 14]
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity [Day 30]
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity [Day 100]
Determine NK cell activity through peripheral blood analysis
Determine immune function [At baseline]
Determine immune function through peripheral blood analysis of immune factors
Determine immune function [Day 14]
Determine immune function through peripheral blood analysis of immune factors
Determine immune function [Day 30]
Determine immune function through peripheral blood analysis of immune factors
Determine immune function [Day 100]
Determine immune function through peripheral blood analysis of immune factors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant
18 years or older
English speaking
General proficiency to read/write in English
Able to attend TCE training session per study protocol
ECOG performance status 0-1

Exclusion Criteria:

Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more
Syncopal event in prior 60 days
Concurrent major depressive disorder or anxiety disorder (DSMIV)
Chronic dizziness or vestibular disorders
History of recurrent falls (>2 in the prior year)
Grade 3 or greater neuropathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724

Sponsors and Collaborators

University of Arizona

Investigators

Principal Investigator: Kristinna Gowin, DO, University of Arizona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arizona

ClinicalTrials.gov Identifier:

NCT04760405

Other Study ID Numbers:

2011190017

First Posted:

Feb 18, 2021

Last Update Posted:

May 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Arizona

Multiple Myeloma

Stem cell transplant

Autologous stem cell transplantation

ASCT

Tai Chi

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of May 3, 2022