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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

Tracking Information
First Submitted Date  ICMJE August 28, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE July 31, 2019
Actual Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • 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."
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Official Title  ICMJE Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Breast Cancer
  • Chemotherapy-induced Peripheral Neuropathy
  • Neuropathic Pain
Intervention  ICMJE
  • Behavioral: Aerobic exercise
    1 session
  • Behavioral: Iyengar yoga
    1 session
Study Arms  ICMJE
  • Experimental: Aerobic exercise
    44 minutes of moderate intensity walking on a treadmill.
    Intervention: Behavioral: Aerobic exercise
  • Experimental: Yoga
    44 minutes of Iyengar yoga.
    Intervention: Behavioral: Iyengar yoga
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2020)
6
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
12
Actual Study Completion Date  ICMJE February 3, 2020
Actual Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075097
Other Study ID Numbers  ICMJE 2018-1518
A176000 ( Other Identifier: UW Madison )
EDUC/KINESIOLOGY/KINESIOLOG ( Other Identifier: UW Madison )
UW18057 ( Other Identifier: UWCCC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE American College of Sports Medicine
Investigators  ICMJE
Principal Investigator: Kelli Koltyn, PhD Professor of Kinesiology- Exercise Psychology, University of Wisconsin-Madison
PRS Account University of Wisconsin, Madison
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP