Prehabilitation for Multiple Myeloma

(MOTIVATE Trial)

Overseen By Margaret L McNeely, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Disease status, Comorbidities, Internet access, others

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

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 focuses on exercise during chemotherapy, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Prehabilitation Exercise for Multiple Myeloma?

Research shows that exercise is safe and beneficial for patients with multiple myeloma, helping to improve quality of life by reducing fatigue and pain. Exercise programs tailored to individual needs can enhance adherence and effectiveness, making them a valuable part of prehabilitation for cancer treatment. ^{1 2 3 4 5}

Is prehabilitation exercise safe for multiple myeloma patients?

Exercise is considered safe and beneficial for multiple myeloma patients, with studies showing no serious adverse events during prehabilitation programs. ^{1 3 4 6 7}

How is the Supported Exercise treatment for Multiple Myeloma different from other treatments?

Supported Exercise, as part of prehabilitation, is unique because it focuses on preparing patients for cancer treatment by improving their physical fitness and overall health before starting standard care. This approach is different from typical treatments that focus solely on addressing the disease, as it aims to enhance patients' quality of life and treatment outcomes through tailored exercise programs. ^{1 3 4 5 8}

What is the purpose of this trial?

The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.

Research Team

Chris Sellar, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for individuals with Multiple Myeloma who are about to undergo chemotherapy and a stem cell transplant. Participants should be interested in following a tailored exercise program, which can be done both in-person and virtually.

Inclusion Criteria

Be an Alberta resident

Be transplant eligible

I have been diagnosed with Multiple Myeloma.

Exclusion Criteria

Do not have regular access to the internet and/or an electronic device in the home

My health conditions prevent me from doing exercise tests or activities.

I cannot commit to a 10-week exercise program at the University of Alberta.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Study

Determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone

10 weeks

Minimum of 1 supervised session (in-person or virtual), 1 independent exercise workout per week

Qualitative Study

Evaluate the acceptability of the HEAL-ME app design, program delivery/design, and perceived effectiveness of the intervention

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Standard Care
• Supported Exercise

Trial Overview The study is testing whether a customized exercise regimen before stem cell transplantation can help maintain or improve physical fitness, muscle mass, strength, and quality of life during chemotherapy for Multiple Myeloma patients.

Participant Groups

Group I: Supported Exercise Group Experimental Treatment 1 Intervention

Participants assigned to the exercise group will take part in a 10-week exercise program delivered in-person and through the HEAL-ME app. The program comprises (1) a minimum of one supervised session (in-person or virtual through a Zoom platform embedded in HEAL-ME), (2) a minimum of one independent exercise workout within the HEAL-ME app, and (3) exercise specific education content as per standard care.

Group II: Standard Care Active Control 1 Intervention

Participants in this group will receive exercise counseling as per standard care for 10-weeks. This will include: (1) counseling on remaining active during chemotherapy; (2) handouts on the benefits of exercise during chemotherapy, exercise behavior change strategies, and how to exercise safely. Participants will be encouraged to remain as physical active as possible. As per American College of Sports Medicine 2019 guidelines, participants will be advised to take part in moderate intensity exercise for a total of 90 minutes per week.

Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Varenicline for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

A study involving 50 patients undergoing preoperative treatment for pancreatic cancer found that social support and neighborhood walkability positively influenced their physical activity levels during treatment.

Patients reported that encouragement from healthcare providers and their motivation to complete treatment were key factors in adhering to home-based exercise prescriptions, highlighting the importance of interpersonal and environmental support in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. Parker, NH., Lee, RE., O'Connor, DP., 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]

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]

In a study of 41 multiple myeloma patients undergoing chemotherapy, 71% complied with exercise recommendations, leading to significant increases in exercise levels and decreases in fatigue severity.

Patients with a history of pathological fractures, spinal cord compression, or those who received radiation therapy were more likely to be noncompliant with exercise, indicating they may need extra support to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise compliance among patients with multiple myeloma undergoing chemotherapy: a retrospective study. Shallwani, S., Dalzell, MA., Sateren, W., et al.[2018]

A study involving 30 multiple myeloma patients showed that exercise therapy is safe and feasible, with no adverse events reported during the program.

Among those who adhered to the exercise regimen, significant improvements in physical functioning and a trend towards reduced fatigue were observed, suggesting that exercise may enhance quality of life for MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. Wefelnberg, MM., Niels, T., Holtick, U., et al.[2023]

A prehabilitation exercise program for myeloma patients before autologous stem-cell transplantation (ASCT) was feasible, with 23 patients participating and a mean attendance of 75% for scheduled sessions, although only 62% completed the program.

Participants who completed the program showed significant improvements in their 6-minute walking distance, increasing from an average of 346 to 451 meters, and reported enhanced physical fitness and mental well-being, with no serious adverse events noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and benefits of a structured prehabilitation programme prior to autologous stem cell transplantation (ASCT) in patients with myeloma; a prospective feasibility study. Mawson, S., Keen, C., Skilbeck, J., et al.[2022]

A 12-week study involving breast and colon cancer patients showed that while exercise interventions were safe and had good adherence among breast cancer patients (67% attendance), the overall cardio-respiratory fitness (VO2-peak) declined by an average of 12% during chemotherapy, raising questions about the effectiveness of aerobic exercise in this context.

The hospital-based exercise intervention showed some benefits in sustaining performance and reducing fat mass compared to the home-based pedometer intervention, but attendance was significantly lower for colon cancer patients (33%), indicating challenges in engaging this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study. Møller, T., Lillelund, C., Andersen, C., et al.[2022]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Exercise Before Cancer Treatment. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Exercise compliance among patients with multiple myeloma undergoing chemotherapy: a retrospective study. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility and benefits of a structured prehabilitation programme prior to autologous stem cell transplantation (ASCT) in patients with myeloma; a prospective feasibility study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. [2023]