跳至主要内容
临床试验/NCT03390569
NCT03390569已完成不适用

Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年8月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Progression-Free Survival

研究概览

简要总结

Patients with newly-diagnosed GBM will be given personalized exercise regimes during concurrent chemo-radiation and up to 3 months later. Study aims are to investigate the feasibility and preliminary efficacy of the exercise program on progression free survival. Secondary outcomes of interest include cognition, fatigue, and quality of life.

详细描述

Background: Glioblastoma (GBM) is the most common malignant glioma in adults, with a very poor prognosis, limited new treatment options, and neurological sequelae, including physical and cognitive decline that adversely affect quality of life (QOL). Physical activity may be an intervention that attenuates the cognitive and physical decline associated with GBM. However, few studies examine physical activity in brain tumor patients, perhaps due to challenges in trial design, measuring outcomes, and complexity of care. Aims of this work are to develop and implement an individualized exercise intervention for GBM patients to support functional independence, and to delay tumor progression and cognitive decline. Methods: GBM patients scheduled to be treated with concurrent radiation and chemotherapy will be recruited from the neuro-oncology clinic at the Princess Margaret Cancer Centre. Participants will receive an individualized, home-based exercise program that includes aerobic and resistance training, tailored to prior level of fitness, current physical status, and individual interests. They will undergo 1-hr standardized, validated assessments of physical and neurocognitive functions, mood, fatigue, and QOL, prior to radiation, and then 3, 6, 12, and 18 months later. Significance: Identifying interventions that preserve or improve mobility and cognitive function will enhance QOL and may lengthen progression-free survival in brain tumor patients. Moreover, finding ways to help patients maintain self-care will lessen the strain on the health care system (e.g., fewer hospitalizations, delayed utilization of palliative care hospice).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed glioblastoma
  • fluent in English
  • scheduled to be treated with concurrent chemoradiation (or within 2 weeks of starting treatment)

排除标准

  • brain metastases secondary to non-central nervous system cancer
  • less than 18 years old
  • receiving treatment at a location other than the Princess Margaret Cancer Centre
  • deemed unfit to exercise by a study oncologist
  • lack of fluency in English
  • psychiatric or neurological disorders that could interfere with participation

结局指标

主要结局

Progression-Free Survival

时间窗: 6 months

Time to tumor progression, based on Response Assessment in Neuro-Oncology (RANO) criteria

次要结局

  • Sleep Quality(3, 6, 12 and 18 months post-treatment)
  • Overall survival(Up to 18 months post-treatment)
  • Personality Changes(3, 6, 12 and 18 months post-treatment)
  • Mood(3, 6, 12 and 18 months post-treatment)
  • Cognitive Decline(3 months, 6 months, 12 months, 18 months post-treatment)
  • Cognitive Complaints(3 months, 6 months, 12 months, 18 months post-treatment)
  • Physical Function(3, 6, 12 and 18 months post-treatment)
  • Quality of Life(3, 6, 12 and 18 months post-treatment)
  • Interference with valued activities and interests(3, 6, 12 and 18 months post-treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验