Clinical trial NCT04760405: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Stem Cell Transplant Complications
Keywords: Multiple Myeloma
Stem cell transplant
Autologous stem cell transplantation
ASCT
Tai Chi
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine natural killer cell phenotype
timeFrame: Baseline
measure: Determine natural killer cell phenotype
timeFrame: Day 14
measure: Determine natural killer cell phenotype
timeFrame: Day 30
measure: Determine natural killer cell phenotype
timeFrame: Day 100
measure: Determine NK cell activity
timeFrame: At baseline
measure: Determine NK cell activity
timeFrame: Day 14
measure: Determine NK cell activity
timeFrame: Day 30
measure: Determine NK cell activity
timeFrame: Day 100
measure: Determine immune function
timeFrame: At baseline
measure: Determine immune function
timeFrame: Day 14
measure: Determine immune function
timeFrame: Day 30
measure: Determine immune function
timeFrame: Day 100
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: University of Arizona
name: Krisstina Gowin, DO
role: PRINCIPAL_INVESTIGATOR
References: