Yoga During Chemotherapy Study



Status:Recruiting
Conditions:Cancer, Cancer, Insomnia Sleep Studies, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 65
Updated:3/16/2019
Start Date:May 2015
End Date:June 2019
Contact:Trilce Santana
Email:trilce.santana@ucsf.edu
Phone:415-514-8608

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Developing a Yoga Intervention During Cancer Chemotherapy

This proposal aims to expand non-pharmacologic options for the control of symptoms during
chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a
secondary focus on fatigue.

Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in
up to 80% of patients during chemotherapy, and results in serious impairments in quality of
life. Although pharmacologic therapies improve sleep disturbance, they have numerous side
effects, problems with tolerance and dependence, and are not well studied in oncology
patients. While non-pharmacologic therapies may decrease sleep disturbance, the current level
of evidence on their efficacy is insufficient. Fatigue occurs in up to 95% of those receiving
chemotherapy, and results in major impairments in functioning and quality of life. Despite
its significance, few effective treatments currently exist for fatigue. Prior studies suggest
that yoga may be helpful for sleep disturbance and fatigue, but these studies have
limitations. An important challenge in yoga research is that it is typically a multi-modality
practice that can include physical postures, breathing practices, and/or meditation
components. Prior studies have not adequately addressed the effects of individual components.
Therefore, key questions remain unanswered about the most effective elements of yoga; how to
best combine them for particular problems such as chemotherapy symptoms; and optimal dosing.
The current study will address these gaps in the literature and perform key developmental
steps to prepare for a large randomized, controlled trial (RCT). It builds on preliminary
work in which yoga breathing practices during chemotherapy were found to improve sleep
disturbance, showed trends toward improvements in fatigue, and were feasible to implement in
patients undergoing chemotherapy. Using a mixed-methods approach to evaluate each
intervention component, the investigators will pursue three closely interlinked steps in
cancer patients receiving chemotherapy. In Aim 1 (n=10), the investigators will manualize an
individualized approach to the yoga breathing intervention and iteratively refine it to
insure feasibility and acceptability. In Aim 2 (n=20), the investigators will manualize a
yoga posture intervention, evaluating both restorative/static poses and flowing poses, and
perform iterative refinement to test feasibility and acceptability. In Aim 3 (n=70), the
investigators will assess the final multi-modality yoga intervention to select final
intervention elements and delivery methods for testing in a planned future RCT. This proposal
will help to improve the treatment of debilitating cancer associated symptoms and advance
approaches to developing therapeutic yoga intervention trials.

Inclusion Criteria:

- 18-65 years of age

- Have a Karnofsky Performance Status Score of 60 or above

- Diagnosed with ovarian, colon, or breast cancer

- Self-reported poor quality of sleep

- Receiving Chemotherapy

Exclusion Criteria:

- Diagnosed with brain metastasis

- Diagnosed with severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema

- Have New York Heart Association class II or greater congestive heart failure

- Requiring chronic home oxygen therapy

- Diagnosed with a sleep disorder (e.g., sleep apnea or narcolepsy)

- Have received more than 3 prior chemotherapy regimens

- Receiving radiation therapy

- Has a less than 6 month life expectancy

- Regular yoga practice within the last 2 months
We found this trial at
1
site
1635 Divisadero Street
San Francisco, California 94143
Phone: 415-353-7700
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mi
from
San Francisco, CA
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