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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075097
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
American College of Sports Medicine
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy-induced Peripheral Neuropathy Neuropathic Pain Behavioral: Aerobic exercise Behavioral: Iyengar yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The proposed study is an acute, single group, crossover pilot study where participants will complete two different experimental conditions: aerobic exercise and yoga.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic exercise
44 minutes of moderate intensity walking on a treadmill.
Behavioral: Aerobic exercise
1 session

Experimental: Yoga
44 minutes of Iyengar yoga.
Behavioral: Iyengar yoga
1 session




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075097


Locations
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United States, Wisconsin
University of Wisconsin-Madison Natatorium
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
American College of Sports Medicine
Investigators
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Principal Investigator: Kelli Koltyn, PhD Professor of Kinesiology- Exercise Psychology, University of Wisconsin-Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04075097    
Other Study ID Numbers: 2018-1518
A176000 ( Other Identifier: UW Madison )
EDUC/KINESIOLOGY/KINESIOLOG ( Other Identifier: UW Madison )
UW18057 ( Other Identifier: UWCCC )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neuralgia
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms