Exercise for Sarcoma

(ACTIVE-SARC Trial)

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GF
Overseen ByGrey Freylersythe, BS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercise can help kids and young adults with sarcoma better tolerate chemotherapy. It tests a special exercise program, the Multimodal Exercise Intervention, which includes aerobic, resistance, and balance exercises. Participants will exercise three times a week for 12 weeks. Eligible participants must have sarcoma, be starting specific cancer treatments for the first time, and not have been very active in the past three months. As an unphased trial, this study offers a unique opportunity to explore innovative exercise strategies that could enhance treatment outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It's best to discuss this with your doctor and the study team.

What prior data suggests that this exercise intervention is safe for pediatric, adolescent, and young adult sarcoma patients?

Research has shown that exercise programs combining various activities, such as aerobic exercises and strength training, are generally safe for individuals undergoing cancer treatment. These programs can enhance physical abilities and reduce cancer-related fatigue, with few negative effects reported. Specifically, strength training, included in these programs, can be safely used by those treated for sarcoma, although results may vary among individuals. Overall, exercise during cancer treatment is considered feasible and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about the multimodal exercise intervention for sarcoma because it approaches treatment through physical activity, focusing on aerobic, resistance, and balance exercises. Unlike typical treatments for sarcoma, which often involve chemotherapy or radiation, this method enhances patients' fitness and potentially improves their quality of life without the side effects typical of conventional therapies. By integrating this exercise regimen into care, researchers hope to discover new ways to support patient recovery and well-being beyond traditional medical interventions.

What evidence suggests that this exercise intervention is effective for sarcoma?

Research has shown that a mix of different exercises, such as aerobic (cardio), resistance (strength), and balance training, can benefit cancer patients. One study found that these exercise programs improved physical abilities in older cancer patients. Another study demonstrated that combining aerobic and resistance exercises helped reduce body fat in cancer patients. Additionally, supervised exercise programs have eased cancer-related tiredness, a common issue during treatment. Exercising during chemotherapy has also positively affected muscle mass and strength. In this trial, participants in the Exercise Intervention Group will follow a supervised multimodal exercise program, which may help sarcoma patients undergoing chemotherapy by improving their physical health and reducing treatment side effects.12346

Who Is on the Research Team?

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Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for pediatric and young adult patients aged 12-39 with a Sarcoma diagnosis, who speak English or Spanish. They must be starting first-line chemotherapy but not already doing moderate to vigorous exercise more than half the time in the past 3 months. A doctor's approval is required.

Inclusion Criteria

I haven't regularly done resistance training more than once a week for the last 3 months.
I am between 12 and 39 years old.
I can sign and understand the consent form.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised multimodal exercise intervention three times per week for 12 weeks

12 weeks
36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Multimodal Exercise Intervention

Trial Overview

The study tests how well an exercise program works alongside usual cancer care in improving how chemotherapy works in young Sarcoma patients. Participants will either follow this special exercise routine or receive standard care without additional exercise guidance.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Usual Care Control Group (UC)Experimental Treatment1 Intervention
Group II: Exercise Intervention Group (EXE)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Florida Department of Health

Collaborator

Trials
30
Recruited
13,000+

Citations

Effects of a 12-Week Multimodal Exercise Intervention Among ...

The results from this RCT showed that a 12-week multimodal exercise program was effective in improving physical function in older patients with advanced PC, BTC ...

Evaluating the Impact of Resistance Exercise in the...

Our findings indicate that, although resistance exercise can be safely implemented for individuals treated for sarcoma, the outcomes demonstrate a heterogeneous ...

Network meta-analysis of the intervention effects of different ...

Network meta-analysis results revealed that aerobic combined with resistance multimodal exercise could reduce fat mass in cancer patients (SUCRA ...

Effects of Supervised Multimodal Exercise Interventions ... - PMC

Multimodal interventions including aerobic exercise, resistance training, and stretching improved CRF symptoms (SMD = −0.23; 95% CI: −0.37 to −0.09; P = 0.001).

The effectiveness of exercise-based interventions on ...

The included studies indicate positive effects of exercise during chemotherapy on muscle mass, muscle strength, func- tional performance, ...

a systematic review of randomized controlled trials

Exercise interventions during treatment were found to be feasible with few adverse events reported. The included studies indicate positive ...