Prehabilitation Program for Multiple Myeloma

Overseen By Noha Sharafeldin, MBBS PhD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Noha Mohamed Sharafeldin

Disqualifiers: High fracture risk

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special diet and exercise program can help older adults with multiple myeloma, a type of blood cancer, who are about to undergo a stem cell transplant. Participants will either join a guided exercise program via telehealth or receive weekly phone check-ins without exercise. The trial aims to determine if the program is feasible and if it improves physical function before and after the transplant. People with multiple myeloma scheduled for a transplant at UAB in the next ten weeks might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance pre- and post-transplant care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prehabilitation program is safe for older adults undergoing stem cell transplantation?

Research has shown that exercise programs for people with multiple myeloma are safe and manageable. Past studies found that exercise did not cause serious side effects and was both safe and beneficial. This trial includes a variety of exercises delivered through online sessions. Participants in other studies have completed similar exercise programs without major issues.

For those in the nutrition-focused group, following dietary guidelines is generally safe. While these guidelines are not detailed here, they typically promote balanced eating, which most people can manage well.

Overall, existing research supports the safety of both exercise and dietary plans for multiple myeloma patients. Participants can feel confident about the safety of these treatments based on this evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a holistic approach to support people with multiple myeloma through a prehabilitation program. Unlike standard treatments that focus solely on medication like chemotherapy, this trial emphasizes lifestyle changes, specifically through dietary guidelines and a multi-modal exercise regimen. The teleprehab arm of the trial is particularly innovative because it delivers the exercise program remotely via telehealth, making it accessible and convenient for participants, especially those who may have mobility issues or live far from medical facilities. This approach aims to improve overall physical health and well-being, potentially enhancing the effectiveness of traditional treatments and improving the quality of life for patients.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that exercise benefits people with multiple myeloma. Studies have found that exercise programs can reduce tiredness, improve daily activity performance, enhance quality of life, and boost mental well-being. Although some results vary, many studies support the idea that exercise positively impacts health for these patients. In this trial, participants in the Teleprehab arm will follow a varied exercise plan, which is expected to improve overall health and muscle strength. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 60 or older who have been diagnosed with Multiple Myeloma and are scheduled to undergo Autologous Stem Cell Transplantation (ASCT) at UAB within the next 10 weeks. Those at high risk for imminent bone fractures as determined by Mirels score cannot participate.

Inclusion Criteria

I am scheduled for a stem cell transplant at UAB within 10 weeks of joining the study.

I have been diagnosed with Multiple Myeloma.

I am 60 years old or older and have had a stem cell transplant.

Exclusion Criteria

You have a high risk of breaking a bone based on a Mirels score.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation/Attention Control

Participants undergo an 8-week prehabilitation exercise program or receive nutrition counseling as an attention control

8 weeks

16 telehealth sessions (prehabilitation) or weekly phone calls (attention control)

Transplantation

Participants undergo Autologous Stem Cell Transplant

1 week

Follow-up

Participants are monitored for changes in physical function and other outcomes post-transplant

12 weeks

Assessments at baseline, post-intervention, and 12 weeks post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Guidelines
• Multi-modal Exercise Regimen

Trial Overview

The study is testing a prehabilitation program consisting of a multi-modal exercise regimen and dietary guidelines against an attention control group, to see if it's feasible and how it affects physical function before transplant and after 12 weeks.

How Is the Trial Designed?

Group I: Teleprehab Experimental Treatment 2 Interventions

The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions.

Group II: Attention Control Experimental Treatment 1 Intervention

The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week..

Who Is Running the Clinical Trial?

Noha Mohamed Sharafeldin

Lead Sponsor

Trials

1

Recruited

30+

Smith Giri

Lead Sponsor

Trials

1

Recruited

30+

O'Neal Comprehensive Cancer Center at UAB

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

A rehabilitation program combining medication and physical exercise successfully helped two patients with myeloma regain independence and return to work.

This case study highlights the potential effectiveness of integrated treatment approaches for improving mobility and quality of life in patients with significant locomotive system dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation of patients with myeloma and marked locomotor disfunction]. Zyzek, G., Zdiarska, B., Dolińska, D., et al.[2008]

A precision-based exercise program (PEP) for myeloma patients was found to be safe and effective, with no reported injuries, and it significantly increased the number of patients engaging in resistance training (up to 55%).

The PEP helped 75% of patients report relief from musculoskeletal pain, and those who exercised regularly were able to reduce their pain medication, indicating improved self-efficacy in managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A precision-based exercise program for patients with multiple myeloma. Dapunt, U., Ehret, P., Paratte, JL., et al.[2023]

The individualized, high-intensity exercise program for people with multiple myeloma (MM) was found to be safe, with no adverse events reported during the 12-week trial involving 60 participants.

The program showed high acceptability among participants (82% enjoyment), although adherence to the exercise protocols was limited, indicating a need for strategies to enhance participation, especially in unsupervised sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Acceptability of a Multisite Individualized Exercise Intervention for People with Multiple Myeloma. Nicol, JL., Cunningham, BJ., Woodrow, C., et al.[2023]

This study aims to assess the feasibility of conducting a randomized controlled trial on prehabilitation exercise for patients with multiple myeloma awaiting autologous stem-cell transplantation, focusing on recruitment, adherence, and safety.

The intervention involves six weeks of individualized, supervised exercise, with outcomes measured through walking distance and quality of life, highlighting the potential benefits of exercise in improving recovery for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study. Keen, C., Skilbeck, J., Ross, H., et al.[2021]

The PrISMS clinic, a multidisciplinary team approach for myeloma patients, significantly improved exercise levels and patient confidence in self-management, with 61 patients participating in 210 consultations.

The clinic was found to be safe and well-accepted by patients, indicating its potential to enhance quality of life and manage fatigue, warranting further research through randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High patient satisfaction and increased physical activity following a remote multidisciplinary team multiple myeloma clinic. Lecat, CSY., Fisher, A., Atta, M., et al.[2023]

Exercise prehabilitation is crucial for preparing cancer patients for treatments like surgery, with evidence supporting its role in improving fitness and strength, particularly through supervised moderate-intensity aerobic and resistance exercises.

Multimodal prehabilitation programs that include exercise, nutritional support, and psychological interventions are becoming standard practice, enhancing patient outcomes and adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Exercise Before Cancer Treatment. Denehy, L., Edbrooke, L.[2022]

A home-based exercise program for patients with multiple myeloma showed a high adherence rate of 75% over six months, indicating that such programs can be feasible even during intensive treatments like chemotherapy.

Patients who participated in the exercise program demonstrated improvements in physical performance, while those in the usual-care group experienced declines, highlighting the potential benefits of exercise for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating exercise adherence for patients with multiple myeloma. Coleman, EA., Hall-Barrow, J., Coon, S., et al.[2008]

A virtually supported exercise program for people with multiple myeloma was found to be acceptable, with positive feedback from 20 participants regarding its tailored and supportive nature.

Participants appreciated the diversity of exercise options and the user-friendly design of the accompanying eHealth app, although some components could be improved for better usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participant perceptions of a virtually supported home exercise program for people with multiple myeloma using a novel eHealth application: a qualitative study. Purdy, GM., Sobierajski, FM., Al Onazi, MM., et al.[2023]

A randomized trial involving 187 patients with newly diagnosed multiple myeloma found that a home-based individualized exercise program (HBIEP) did not significantly reduce fatigue, improve sleep, or enhance aerobic performance compared to usual care over a 15-week period.

Despite the minimal impact on fatigue and performance, the study suggests that exercise is safe for patients undergoing treatment for multiple myeloma and may provide physiological benefits, particularly in alleviating anemia when combined with epoetin alfa therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. Coleman, EA., Goodwin, JA., Kennedy, R., et al.[2021]

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