Multiple MyelomaNCT04760405
The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
A study testing Tai Chi Easy in people with Multiple Myeloma and Stem Cell Transplant Complications, run by University of Arizona at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Stem Cell Transplant Complications
- What is being tested?
- Tai Chi Easy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Mar 2021to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Jacksonville, Florida, 32224
University of Arizona
Tucson, Arizona, 85724
About this study
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).
Read the 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.
- Being tested
- Tai Chi Easy
- Keywords
- Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi EasyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Easy Intervention | Experimental | 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. Receives: Other: Tai Chi Easy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Measured: Baseline
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Measured: Day 14
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Measured: Day 30
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Measured: Day 100
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Measured: At baseline
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Measured: Day 14
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Measured: Day 30
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Measured: Day 100
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Measured: At baseline
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Measured: Day 14
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Measured: Day 30
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start11 Mar 2021
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krisstina Gowin, DO, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760405
- Sponsor's protocol ID
- 2011190017
- Status last verified
- Aug 2024
- First submitted
- 15 Jan 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04760405
- Acronym / sponsor ID
- 2011190017
- Keywords
- Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Easy Intervention | Experimental | Other: Tai Chi EasyTai 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi EasyPatients 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 Intervention |
Primary outcome
Determine natural killer cell phenotype
Time frame: Baseline
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Time frame: Day 14
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Time frame: Day 30
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
Time frame: Day 100
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity
Time frame: At baseline
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Time frame: Day 14
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Time frame: Day 30
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
Time frame: Day 100
Determine NK cell activity through peripheral blood analysis
Determine immune function
Time frame: At baseline
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Time frame: Day 14
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Time frame: Day 30
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
Time frame: Day 100
Determine immune function through peripheral blood analysis of immune factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krisstina Gowin, DO principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Easy in people with Multiple Myeloma and Stem Cell Transplant Complications, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine natural killer cell phenotype (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.