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NCT04760405 Clinical Trial

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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04760405
Other study ID # 2011190017
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 11, 2021
Est. completion date December 31, 2024

Study information
Verified date May 2024
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida
United States University of Arizona Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

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