Resistance Exercise for Glioblastoma

(RESIST Trial)

Overseen By Jodi Langley, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Cardiac, Pulmonary, Cognitive, Seizures, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a personalized exercise routine for brain cancer patients to help them build muscle and improve their ability to do daily activities. The goal is to counteract muscle weakness caused by long-term steroid use during cancer treatment.

Do I need to stop my current medications to join the trial?

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 data supports the effectiveness of the treatment Circuit-based resistance exercise (CRT) for glioblastoma?

Exercise, including resistance training, has been shown to improve quality of life and mental health in cancer patients, including those with brain cancer. Studies suggest that exercise can be safe and beneficial, potentially reducing depression and anxiety while enhancing physical function. ^{1 2 3 4 5}

Is resistance exercise safe for people with glioblastoma?

Research on exercise for people with brain cancer, including glioblastoma, suggests that exercise is generally safe. Studies have shown that exercise can improve quality of life and does not cause harmful changes in the body, even in animal models with brain tumors. ^{1 2 3 6 7}

How does the treatment Circuit-based resistance exercise (CRT) differ from other treatments for glioblastoma?

Circuit-based resistance exercise (CRT) is unique because it focuses on physical exercise to potentially improve quality of life and treatment outcomes for glioblastoma patients, unlike traditional treatments that primarily involve surgery, radiation, and chemotherapy. Exercise interventions have shown benefits in reducing cancer-related symptoms and improving functional performance, which are not typically addressed by standard medical treatments. ^{1 6 7 8 9}

Research Team

Mary MacNeil, MD

Principal Investigator

Nova Scotia Health Authority

Scott Grandy, PhD

Principal Investigator

Dahousie University and Nova Scotia Health Authority

Eligibility Criteria

This trial is for English-speaking glioblastoma patients who can travel to Halifax, have a doctor's approval, and are physically able to do daily tasks (KPS >70). They must have started steroid treatment. It's not for those with unstable heart/lung disease, exercise-limiting injuries or diseases, uncontrolled seizures affecting awareness, or major cognitive issues.

Inclusion Criteria

I have taken DEX medication.

My diagnosis is glioblastoma (GBM).

Physician approval

Exclusion Criteria

I do not have heart or lung conditions that prevent me from safely exercising.

I experience seizures that I cannot control and make me lose awareness.

I have significant difficulties with thinking or memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week circuit-based resistance training program or maintain an active lifestyle

12 weeks

3-4 supervised sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Circuit-based resistance exercise (CRT)

Trial Overview The study tests how well a tailored circuit-based resistance exercise program helps glioblastoma survivors with their functional fitness and overall quality of life while they're receiving active treatment for their condition.

Participant Groups

Group I: Exercise Intervention Experimental Treatment 1 Intervention

12-week circuit-based resistance exercise

Group II: Wait-list Control Active Control 1 Intervention

Standard of care wait-list control group

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Findings from Research

An 18-week exercise intervention for adults with primary brain cancer was found to be safe, with no serious adverse events reported, and feasible, achieving high recruitment (80%) and retention (92%) rates.

Participants showed significant improvements in quality of life, functional well-being, and various physical fitness measures, indicating that exercise can be beneficial for individuals recovering from brain cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety, feasibility, and efficacy of an 18-week exercise intervention for adults with primary brain cancer - the BRACE study. Sandler, CX., Gildea, GC., Spence, RR., et al.[2023]

A 12-week structured exercise program was well tolerated by two female brain cancer patients, with no adverse effects reported, indicating that exercise can be safely integrated into their treatment plans.

Both participants showed significant improvements in physical strength, cardiovascular fitness, and psychological well-being, including reduced anxiety and depression, suggesting that exercise may enhance quality of life for brain cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. Levin, GT., Greenwood, KM., Singh, F., et al.[2018]

A submaximal exercise program for glioma patients, consisting of individualized sessions of bicycle ergometry and resistance training, was found to be safe and feasible, with only two minor epileptic events reported during 1828 training sessions.

Patients participating in the program achieved significant cardiorespiratory fitness, with a median survival of 24.1 months for glioblastoma patients, suggesting that exercise may positively impact their overall health and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. Jost, J., Müther, M., Brandt, R., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation Exercises Supported by Monitor-Augmented Reality for Patients with High-Grade Glioma Undergoing Radiotherapy: Results of a Randomized Clinical Trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patients and carers' perspectives of participating in a pilot tailored exercise program during chemoradiotherapy for high grade glioma: A qualitative study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The safety, feasibility, and efficacy of an 18-week exercise intervention for adults with primary brain cancer - the BRACE study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Physical fitness and its association with fatigue in patients with low-grade glioma. [2023]

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

Exercise Improves Physical Function and Mental Health of Brain Cancer Survivors: Two Exploratory Case Studies. [2018]

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

Physical Training Protects Against Brain Toxicity in Mice Exposed to an Experimental Model of Glioblastoma. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Voluntary Physical Exercise Reduces Motor Dysfunction and Hampers Tumor Cell Proliferation in a Mouse Model of Glioma. [2020]

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

Development of an exercise intervention as part of rehabilitation in a glioblastoma multiforme survivor during irradiation treatment: a case report. [2020]

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

Conceptual development of an intensive exercise program for glioma patients (ActiNO): summary of clinical experience. [2023]