What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as chemotherapy, stem cell transplantation, and immunomodulatory drugs, often have significant side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infections. Stem cell transplantation may lead to complications like graft-versus-host disease, infections, and organ damage. Immunomodulatory drugs can result in blood clots, neuropathy, and gastrointestinal issues. In contrast, complementary therapies like Tai Chi Easy, which focus on stress reduction and physical activity, are generally associated with fewer side effects and may improve overall quality of life and immune function.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, including immunomodulatory drugs like lenalidomide (Revlimid) and pomalidomide (Pomalyst), proteasome inhibitors such as bortezomib (Velcade) and carfilzomib (Kyprolis), and monoclonal antibodies like daratumumab (Darzalex). These treatments primarily focus on targeting cancer cells and modulating the immune system. While Tai Chi Easy is not a pharmacological treatment, it shares the goal of improving immune function and quality of life, similar to the holistic benefits sought through supportive care measures in Multiple Myeloma management.

What other types of research exist?

Promising alternatives to Tai Chi Easy for Multiple Myeloma patients include progressive muscle relaxation, guided imagery, and acupuncture. These therapies have shown effectiveness in reducing stress, managing chemotherapy-induced side effects, and improving overall quality of life in cancer patients.

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Tai Chi for Multiple Myeloma

N/A

Waitlist Available

Led By Krisstina Gowin, DO

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant

18 years or older

Must not have

Grade 3 or greater neuropathy

Concurrent major depressive disorder or anxiety disorder (DSMIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100

Awards & highlights

Summary

This trial aims to see if Tai Chi Easy can help improve immune function and quality of life in multiple myeloma patients who are undergoing stem cell transplants.

Who is the study for?

This trial is for English-speaking adults over 18 with Multiple Myeloma who are about to have a bone marrow transplant and can do basic physical activities (ECOG status 0-1). They must be able to attend Tai Chi sessions. People with recent fainting, severe depression or anxiety, regular Tai Chi/Qi Gong/Yoga practice, chronic dizziness, frequent falls, or serious neuropathy cannot join.

What is being tested?

The TOTOM Trial is testing whether practicing Tai Chi Easy can improve immune function and quality of life in patients undergoing stem cell transplants for Multiple Myeloma. Participants will attend designated Tai Chi training sessions as part of the study.

What are the potential side effects?

Tai Chi Easy is generally considered safe but may include risks like muscle soreness or strain. Since it's a gentle form of exercise, serious side effects are not common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Multiple Myeloma and am planning to have a bone marrow transplant.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nerve pain or damage.

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I have been diagnosed with major depression or an anxiety disorder.

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I have fainted in the last 60 days.

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I suffer from long-term dizziness or balance problems.

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I have fallen more than twice in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine NK cell activity

Determine immune function

Determine natural killer cell phenotype

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tai Chi Easy InterventionExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Myeloma include chemotherapy, immunotherapy, targeted therapy, and stem cell transplantation. Chemotherapy works by killing rapidly dividing cancer cells, while immunotherapy boosts the body's immune system to better recognize and attack cancer cells. Targeted therapies specifically inhibit the growth and survival pathways of myeloma cells. Stem cell transplantation replaces diseased bone marrow with healthy stem cells to restore normal blood cell production. These treatments are crucial for managing Multiple Myeloma as they help control disease progression, alleviate symptoms, and improve survival rates. Additionally, interventions like Tai Chi Easy, which focus on stress reduction and physical activity, may enhance immune function and health-related quality of life, providing a complementary approach to traditional treatments.

Feasibility of Aerobic Exercise and Tai-Chi Interventions in Advanced Lung Cancer Patients: A Randomized Controlled Trial.People With Hematological Malignancies Treated With Bone Marrow Transplantation Have Improved Function, Quality of Life, and Fatigue Following Exercise Intervention: A Systematic Review and Meta-Analysis.Exercise for physical fitness, fatigue and quality of life of patients undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials.