Yoga Therapy in Treating Patients With Malignant Brain Tumors

Adult Glioblastoma Clinical Trial

Official title:

Yoga and Brain Cancer: A Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01234805
• Other study ID #: IRB00015038
• Secondary ID: NCI-2010-02044CC
• Status: Terminated
• Phase: N/A
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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)
• Astrocytoma
• Brain Neoplasms
• Choroid Plexus Neoplasms
• Ependymoma
• Glioblastoma
• Glioma
• Gliosarcoma
• Hemangiopericytoma
• Medulloblastoma
• Meningioma
• Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Oligodendroglioma
• Pinealoma
• Recurrent Adult Brain Tumor

Intervention

Procedure:
• yoga therapy
Participates in yoga classes and yoga at home

Other:
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the participation rate, accrual, adherence, and retention to a yoga trial in patients with malignant brain tumors	Track barriers to recruitment. Participation rate calculated as proportion of eligible patients who agree to participate. Study retention estimated as proportion of participating patients who complete questionnaires at Week 6. Further retention data obtained by tracking # of dropouts, when dropout occurs, & reasons for dropout. Intervention adherence estimated as mean % of yoga classes attended. Summary statistics for patient characteristics, participation rates, adherence & retention. 95% confidence intervals calculated for each feasibility measure.	Up to 12 weeks
Secondary	Self-reported fatigue		Up to 12 weeks
Secondary	Depressive symptoms		Up to 12 weeks
Secondary	Distress		Up to 12 weeks
Secondary	Health-related quality of life		Up to 12 weeks
Secondary	Preliminary estimates of the efficacy of a yoga intervention in patients with malignant brain tumors on the outcomes of fatigue, distress, and cognitive function		Up to 12 weeks
Secondary	Standardize the cancer-specific yoga protocol for use with brain tumor patients		At the end of therapy