search
Back to results

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

Primary Purpose

Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic exercise
Iyengar yoga
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin-Madison Natatorium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobic exercise

Yoga

Arm Description

44 minutes of moderate intensity walking on a treadmill.

44 minutes of Iyengar yoga.

Outcomes

Primary Outcome Measures

Change in Neuropathic Pain Sensations as determined by VAS
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
The minimum cold temperature needed to elicit a pain response.

Secondary Outcome Measures

Change in total mood disturbance (Profile of Mood States)
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)
Plasma concentration of 2-AG, one effector of the endocannabinoid system

Full Information

First Posted
August 28, 2019
Last Updated
March 18, 2020
Sponsor
University of Wisconsin, Madison
Collaborators
American College of Sports Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT04075097
Brief Title
Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Official Title
Pain, Psychological, and Endocannabinoid Responses to Yoga in Breast Cancer Survivors With Chemotherapy-induced Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
February 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
American College of Sports Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
44 minutes of moderate intensity walking on a treadmill.
Arm Title
Yoga
Arm Type
Experimental
Arm Description
44 minutes of Iyengar yoga.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
1 session
Intervention Type
Behavioral
Intervention Name(s)
Iyengar yoga
Intervention Description
1 session
Primary Outcome Measure Information:
Title
Change in Neuropathic Pain Sensations as determined by VAS
Description
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."
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.
Title
Change in cold pain threshold
Description
The minimum cold temperature needed to elicit a pain response.
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.
Secondary Outcome Measure Information:
Title
Change in total mood disturbance (Profile of Mood States)
Description
65-item self-reported mood questionnaire that measures mood "right now." Scores range from 0-200 with higher scores indicating higher mood disturbance.
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.
Title
Change in plasma concentration of 2-Arachidonoylglycerol (2-AG)
Description
Plasma concentration of 2-AG, one effector of the endocannabinoid system
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelli Koltyn, PhD
Organizational Affiliation
Professor of Kinesiology- Exercise Psychology, University of Wisconsin-Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison Natatorium
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs