Patients diagnosed with malignant gliomas suffer from a diverse range of neurologic symptoms largely arising from tumor mass effect and vasogenic edema. The mass effect can be reduced by surgical resection, loco-regional radiation, and corticosteroid medication. Unfortunately, radiotherapy and chronic corticosteroid usage is associated with a broad range of deleterious side-effects including peripheral edema, fatigue, hyperglycemia, thromboembolism, and severe skeletal muscle atrophy and weakness. In particular, the onset of corticosteroid-induced skeletal myopathy is clinically devastating and a major contributor to morbidity, mortality, and decreased quality of life (QoL) in this population. Clearly, interventions that can counteract or attenuate the adverse symptoms of conventional malignant glioma therapy stand to have substantial clinical benefit. One supportive care intervention that may compliment existing conventional therapies and address a multitude of therapy-induced toxicities in malignant glioma patients is exercise. In recent years, research conducted by our group and that of others have demonstrated that exercise training is a safe, feasible, and beneficial supportive therapy across a broad range of malignancies differing in pathology, prognosis, and therapy. Despite this rationale, no study to date has investigated this question. Given the preliminary nature of this field of investigation, prior to launching a large-scale RCT or even a small feasibility intervention study, it is first of crucial importance to quantify and profile the changes in patient's functional status across standard glioma cancer therapy using objective, gold-standard methodology. To this end, we propose a prospective, single-group pilot study among 25 newly diagnosed post surgical primary glioma patients with the following specific aims: (1) determine the safety, feasibility, and acceptability of endurance capacity and skeletal muscle function testing in glioma patients by assessing eligibility rate, acceptance rate, adverse events as well as patient capability to achieve acceptable standard endurance and strength function assessment criteria, (2) prospectively assess changes in endurance capacity and skeletal muscle function across standard therapy in this population, and (3) examine whether changes in functional outcomes are associated with changes in patient QoL. Overall, this study is extremely relevant to malignant glioma management and could provide a new non-pharmacologic approach to improving patient's functional status and QoL which may hold great promise for lowering morbidity and prolonging survival in this underserved population. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Research Grants (R03)
Project #
5R03CA126432-02
Application #
7289210
Study Section
Special Emphasis Panel (ZCA1-SRRB-D (O1))
Program Officer
O'Mara, Ann M
Project Start
2006-09-21
Project End
2009-08-31
Budget Start
2007-09-01
Budget End
2009-08-31
Support Year
2
Fiscal Year
2007
Total Cost
$75,738
Indirect Cost
Name
Duke University
Department
Surgery
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705