search
Back to results

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

Primary Purpose

Multiple Myeloma, Stem Cell Transplant Complications

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi Easy
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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)
  4. Chronic dizziness or vestibular disorders
  5. History of recurrent falls (>2 in the prior year)
  6. Grade 3 or greater neuropathy

Sites / Locations

  • University of ArizonaRecruiting
  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tai Chi Easy Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Determine immune function through peripheral blood analysis of immune factors

Secondary Outcome Measures

Full Information

First Posted
January 15, 2021
Last Updated
July 25, 2023
Sponsor
University of Arizona
search

1. Study Identification

Unique Protocol Identification Number
NCT04760405
Brief Title
The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
Official Title
The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Stem Cell Transplant Complications
Keywords
Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi Easy Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tai Chi Easy
Intervention Description
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 Measure Information:
Title
Determine natural killer cell phenotype
Description
Determine natural killer (NK) phenotype through peripheral blood analysis
Time Frame
Baseline
Title
Determine natural killer cell phenotype
Description
Determine natural killer (NK) phenotype through peripheral blood analysis
Time Frame
Day 14
Title
Determine natural killer cell phenotype
Description
Determine natural killer (NK) phenotype through peripheral blood analysis
Time Frame
Day 30
Title
Determine natural killer cell phenotype
Description
Determine natural killer (NK) phenotype through peripheral blood analysis
Time Frame
Day 100
Title
Determine NK cell activity
Description
Determine NK cell activity through peripheral blood analysis
Time Frame
At baseline
Title
Determine NK cell activity
Description
Determine NK cell activity through peripheral blood analysis
Time Frame
Day 14
Title
Determine NK cell activity
Description
Determine NK cell activity through peripheral blood analysis
Time Frame
Day 30
Title
Determine NK cell activity
Description
Determine NK cell activity through peripheral blood analysis
Time Frame
Day 100
Title
Determine immune function
Description
Determine immune function through peripheral blood analysis of immune factors
Time Frame
At baseline
Title
Determine immune function
Description
Determine immune function through peripheral blood analysis of immune factors
Time Frame
Day 14
Title
Determine immune function
Description
Determine immune function through peripheral blood analysis of immune factors
Time Frame
Day 30
Title
Determine immune function
Description
Determine immune function through peripheral blood analysis of immune factors
Time Frame
Day 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Larsen, MS
Phone
(520) 626-7761
Email
golmana@email.arizona.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristinna Gowin, DO
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UACC IIT
Email
UACC-IIT@uacc.arizona.edu
First Name & Middle Initial & Last Name & Degree
Krisstina Gowin, DO
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Perlman, MD
Email
Perlman.Adam@mayo.edu
First Name & Middle Initial & Last Name & Degree
Adam Perlman, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs