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NCT Number: NCT04075097

Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain

This study evaluates the acute effect of aerobic exercise and yoga on pain, plasma levels of endocannabinoids, and mood (i.e., mood disturbance and anxiety). Participants will complete three separate sessions on different days. The first session is a familiarization session in which participants complete questionnaires and are familiarized with the experimental protocols. During the second and third sessions, outcomes are measured before and after the participants complete either 44 minutes of moderate aerobic exercise (i.e., walking on a treadmill) or 44 minutes of yoga.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy-induced Peripheral Neuropathy Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison Natatorium

Madison, Wisconsin, 53706, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A diagnosis of breast cancer (stage 0-III),
  • no evidence of active disease (i.e., recurrence, bone metastases, etc),
  • presence of painful polyneuropathy, with onset coinciding or developing after receiving chemotherapy agents that in the opinion of the research team is likely to have caused such symptoms,
  • at least six months since last active cancer treatment, with no further planned treatment (Note. active treatment is defined as surgery, chemotherapy, or radiation),
  • the participant agrees to use the safety stop feature on the treadmill if needed,
  • at least 18 years of age,
  • and their physicians has provided consent for them to participate in yoga and aerobic exercise sessions.

Exclusion criteria

  • Undergoing current chemotherapy or radiation treatment for cancer,
  • taking anticoagulant therapy,
  • uncontrolled medical conditions (i.e., uncontrolled hypertension, heart disease, stage 4 liver disease, end-stage renal disease, end-stage pulmonary disease, etc),
  • stroke or myocardial infarction in the past 6 months,
  • being pregnant or planning to become pregnant,
  • severe mobility constraints (e.g., confined to a wheelchair),
  • having a history of light headedness or fainting during blood draws or physical activity.

Treatment and study plan

Aerobic Exercise

Behavioral

1 session

Iyengar Yoga

Behavioral

1 session

Primary outcomes

  1. Change in Neuropathic Pain Sensations as determined by VAS

    Time frame: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.

    Visual analog scales (VAS) will be used to assess the intensity of the following sensations specific to neuropathic pain: pins and needles, tingles, stinging, and electrical pain sensations. The VAS is measured on a 100mm scale ranging from "No Pain" to "Worst Imaginable Pain."

  2. Change in cold pain threshold

    Time frame: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.

    The minimum cold temperature needed to elicit a pain response.

Secondary outcomes

  1. Change in total mood disturbance (Profile of Mood States)

    Time frame: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.

    65-item self-reported mood questionnaire that measures mood "right now." Scores range from 0-200 with higher scores indicating higher mood disturbance.

  2. Change in plasma concentration of 2-Arachidonoylglycerol (2-AG)

    Time frame: This will be measured 2 times during each experimental session- once before the assigned exercise task (i.e., baseline) and once upon task completion (i.e., approx. 50 mins later), approximately week 1 and week 2 on study.

    Plasma concentration of 2-AG, one effector of the endocannabinoid system

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • American College of Sports Medicine

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
Mar 20, 2020

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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