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Completed

NCT Number: NCT04760405

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

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).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Stem Cell Transplant Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)

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) as determined by treating provider
  • Chronic dizziness or vestibular disorders
  • History of recurrent falls (>2 in the prior year)
  • Grade 3 or greater neuropathy
  • Grade 3 or greater spinal fracture

Treatment and study plan

Tai Chi Easy

Other

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 outcomes

  1. Determine natural killer cell phenotype

    Time frame: Baseline

    Determine natural killer (NK) phenotype through peripheral blood analysis

  2. Determine natural killer cell phenotype

    Time frame: Day 14

    Determine natural killer (NK) phenotype through peripheral blood analysis

  3. Determine natural killer cell phenotype

    Time frame: Day 30

    Determine natural killer (NK) phenotype through peripheral blood analysis

  4. Determine natural killer cell phenotype

    Time frame: Day 100

    Determine natural killer (NK) phenotype through peripheral blood analysis

  5. Determine NK cell activity

    Time frame: At baseline

    Determine NK cell activity through peripheral blood analysis

  6. Determine NK cell activity

    Time frame: Day 14

    Determine NK cell activity through peripheral blood analysis

  7. Determine NK cell activity

    Time frame: Day 30

    Determine NK cell activity through peripheral blood analysis

  8. Determine NK cell activity

    Time frame: Day 100

    Determine NK cell activity through peripheral blood analysis

  9. Determine immune function

    Time frame: At baseline

    Determine immune function through peripheral blood analysis of immune factors

  10. Determine immune function

    Time frame: Day 14

    Determine immune function through peripheral blood analysis of immune factors

  11. Determine immune function

    Time frame: Day 30

    Determine immune function through peripheral blood analysis of immune factors

  12. Determine immune function

    Time frame: Day 100

    Determine immune function through peripheral blood analysis of immune factors

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2021
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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