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Completed

NCT Number: NCT02442635

Yoga During Chemotherapy Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Have a Karnofsky Performance Status Score of 60 or above
  • Diagnosed with any cancer except acute leukemia
  • Self-reported poor quality of sleep
  • Receiving Chemotherapy
  • Able to read, write, and understand English
  • Ability to give informed consent

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

Treatment and study plan

Yoga

Behavioral

Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.

Primary outcomes

  1. Sleep Disturbance as measured by the General Sleep Disturbance Scale

    Time frame: 6 weeks

Secondary outcomes

  1. Fatigue as measured by the Lee Fatigue Scale

    Time frame: 6 weeks

Other outcomes

  1. Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer

    Time frame: 6 weeks

  2. Depressive Symptoms as measured by the CES-D

    Time frame: 6 weeks

  3. Anxiety as measured by the Spielberger State Anxiety Inventory

    Time frame: 6 weeks

  4. Pain as measured by the modified Brief Pain Inventory

    Time frame: 6 weeks

  5. Hot Flashes as measured by the Hot Flash Related Daily Interference Scale

    Time frame: 6 weeks

  6. Mindfulness as measured by the Five Facet Mindfulness Questionnaire

    Time frame: 6 weeks

  7. Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness

    Time frame: 6 weeks

  8. Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale

    Time frame: 6 weeks

  9. Social Support as measured by single items on social support

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Developing a Yoga Intervention During Cancer Chemotherapy

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 13, 2015
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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