Clinical trial NCT01234805: Yoga Therapy in Treating Patients With Malignant Brain Tumors
Official title: Yoga and Brain Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Meningioma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Choroid Plexus Tumor
Adult Diffuse Astrocytoma
Adult Ependymoblastoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Grade II Meningioma
Adult Medulloblastoma
Adult Meningeal Hemangiopericytoma
Adult Mixed Glioma
Adult Oligodendroglioma
Adult Papillary Meningioma
Adult Pineal Gland Astrocytoma
Adult Pineoblastoma
Adult Pineocytoma
Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
Recurrent Adult Brain Tumor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies yoga therapy in treating patients with malignant brain tumors. Yoga therapy may improve the quality of life of patients with brain tumors

Detailed description: PRIMARY OBJECTIVES:

I. To estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors.

SECONDARY OBJECTIVES:

I. To obtain estimates of the variability of self-reported fatigue, distress (i.e., depression, anxiety), sleep disturbance, cognitive function, and health-related quality of life from baseline to the end of the intervention at 6 (post-onsite intervention) and 12 weeks (post-full intervention).

II. To obtain preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function.

III. To standardize the cancer-specific yoga protocol for use with brain tumor patients.

OUTLINE:

Patients participate in yoga classes comprising postures, deep relaxation, breathing practices, and meditation twice weekly for 75 minutes during weeks 1-6. Patients then practice yoga at home twice weekly for 45 minutes during weeks 7-12.

After completion of study treatment, patients are followed up periodically for 4-5 months.

Eligibility criteria: Inclusion Criteria:

Signed protocol specific informed consent Are diagnosed with a Malignant Brain Tumor (Grades II-IV) Able to start the on-site yoga intervention within 1 week of first radiation treatment Are physically able to attend the intervention classes (Eastern Cooperative Oncology Group \[ECOG\] performance status rating 0-2) Able to understand written and spoken English Have no medical contraindications reported by the attending physician

Exclusion Criteria:

Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks to recruit participants who are not already regularly practicing yoga; given that the benefits of yoga are likely more immediate than long-term, however, we will enroll participants who have previously had a yoga practice

Primary outcomes:
measure: Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Self-reported fatigue
timeFrame: Up to 12 weeks
measure: Depressive symptoms
timeFrame: Up to 12 weeks
measure: Distress
timeFrame: Up to 12 weeks
measure: Health-related quality of life
timeFrame: Up to 12 weeks
measure: Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function
timeFrame: Up to 12 weeks
measure: Standardize the cancer-specific yoga protocol for use with brain tumor patients
timeFrame: At the end of therapy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Danhauer
role: PRINCIPAL_INVESTIGATOR
References: