Clinical Trials Logo

Clinical Trial Summary

Glioblastoma patients are confronted with a debilitating disease associated with a low survival rate and poor quality of life. The goal of this study will be to reach a largely underrepresented population in the exercise literature and explore the role of a tailored circuit-based resistance training program on functional fitness (i.e., ability to carry out tasks of daily living) and associated health outcomes (e.g., quality of life) for GBM patients on active treatment.

Clinical Trial Description

PROBLEM: Glioblastoma multiforme (GBM) is the most common brain malignancy accounting for approximately 48% of all brain tumors. GBMs are highly vascular and can cause vasogenic brain edema and mass effect, which can worsen the neurologic symptoms associated with the disease. Corticosteroids (i.e., Dexamethasone; DEX) are the treatment of choice to reduce vasogenic edema and intercranial pressure associated with GBM. However, the use of steroids comes at a cost. High dose steroid therapy and/or long-term use results in muscle myopathy (i.e., muscle weakness) in 10-60% of GBM patients, significantly reducing functional ability as well as quality of life (QOL). Thus, adjuvant therapies are needed to help patients maintain their functional ability and QOL. There is a wealth of evidence to support the use of exercise as an adjuvant therapy to improve functional ability as well as help manage treatment-related symptoms. Resistance training (RT) has been shown to increase muscle mass, strength, and functional ability in aging adults and several cancer populations. While limited, studies in GBM have shown that exercise is safe and feasible for this population and that it can improve functional performance. However, no specific research has been performed to determine whether RT can be successfully used in GBM to prevent or reduce steroid induced muscle myopathy. Therefore, the primary purpose of this study is to establish whether an individualized circuit-based RT program will improve functional fitness for patients on active treatment and receiving steroids. METHODS: This is a two-armed randomized control trial with repeated measures. Thirty-eight adult (18+ years) patients diagnosed with either primary or secondary GBM who are scheduled to receive standard radiation and concurrent adjuvant Temozolomide chemotherapy post-surgical debulking as well as received any dose of DEX will be recruited through the neuro-oncology clinic and the QEII Cancer Center. Patients will be randomly allocated to a standard of care group (SOC) or SOC+RT group (EX). Those in the SOC group will be advised to maintain an active lifestyle for the 12-week intervention whereas those in the EX group will receive a personalized 12-week circuit-based RT program. This program will consist of 3-4 supervised RT sessions/wk. During each session participants will perform a RT program that is comprised of 3 circuits. Each circuit will include 3 sets of 3 different exercises. Each exercise set will be 1 minute in duration (20 seconds/exercise) with 1 minute of rest between sets. Initial exercise intensity will be light and will increase throughout the program based on the participant's progress. All exercise programs will be designed and supervised by a Clinical Exercise Physiologist (CEP). The primary outcome measure for the study is functional performance which will be assessed using the Short Physical Performance Battery and hand grip strength. Secondary outcome measures will include body composition, aerobic fitness, physical activity levels, general health, QOL, fatigue, and cognitive function. All measures will be assessed pre/post-intervention. Safety and exercise adherence will be assessed throughout the study. ANALYSIS: Descriptive statistics will be used to describe the population, accrual, program adherence and safety. Outcome data will be analyzed using an intention to treat approach. All participants will be entered into a mixed effects model with participant group assignment (EX, SOC) at randomization and timepoint (pre- and post-test) as fixed factors and participant entered as a random factor. Due to feasibility in recruiting participants in the allotted time, the study will not be fully powered to detect sex-based differences; however, effect sizes associated with the intervention will be calculated and presented separately for each sex. SIGNIFICANCE: This study will demonstrate the not only is RT safe and feasible for those with GBM, but that it also significantly improves functional status by protecting against myopathy. This will help GBM patients maintain their independence which could lead to marked improvements in QOL. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05116137
Study type Interventional
Source Nova Scotia Health Authority
Contact Melanie Keats, PhD
Phone 902-494-7173
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05023434 - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Recruiting NCT04114786 - 3D Printed Mask for GBM and Brain Mets N/A
Recruiting NCT04367779 - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Completed NCT02911155 - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Completed NCT02852655 - A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma Phase 1
Completed NCT00329589 - A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients Phase 1
Completed NCT01650922 - Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples N/A
Completed NCT00505141 - Urban Environmental Exposures and Childhood Cancer N/A
Completed NCT00504660 - 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients Phase 2
Completed NCT00979810 - Image-Guided Stereotactic Biopsy of High Grade Gliomas N/A
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Not yet recruiting NCT04745156 - A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas N/A
Recruiting NCT02851706 - Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
Completed NCT02798406 - Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects Phase 2
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT03149575 - VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM Phase 3
Withdrawn NCT01320787 - 18-F-Fluoroacetate as PET Imaging Agent Phase 1
Active, not recruiting NCT01974804 - Assessment of Early Treatment Response by Diffusion and Perfusion MRI in Patients With Brain Metastasis
Completed NCT01478178 - Safety Study of VAL-083 in Patients With Recurrent Malignant Glioma Phase 1/Phase 2