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

August 14, 2024 updated by: University of Arizona
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine natural killer cell phenotype
Time Frame: Baseline
Determine natural killer (NK) phenotype through peripheral blood analysis
Baseline
Determine natural killer cell phenotype
Time Frame: Day 14
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 14
Determine natural killer cell phenotype
Time Frame: Day 30
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 30
Determine natural killer cell phenotype
Time Frame: Day 100
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 100
Determine NK cell activity
Time Frame: At baseline
Determine NK cell activity through peripheral blood analysis
At baseline
Determine NK cell activity
Time Frame: Day 14
Determine NK cell activity through peripheral blood analysis
Day 14
Determine NK cell activity
Time Frame: Day 30
Determine NK cell activity through peripheral blood analysis
Day 30
Determine NK cell activity
Time Frame: Day 100
Determine NK cell activity through peripheral blood analysis
Day 100
Determine immune function
Time Frame: At baseline
Determine immune function through peripheral blood analysis of immune factors
At baseline
Determine immune function
Time Frame: Day 14
Determine immune function through peripheral blood analysis of immune factors
Day 14
Determine immune function
Time Frame: Day 30
Determine immune function through peripheral blood analysis of immune factors
Day 30
Determine immune function
Time Frame: Day 100
Determine immune function through peripheral blood analysis of immune factors
Day 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Krisstina Gowin, DO, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011190017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Tai Chi Easy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe