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Yoga for Aromatase Inhibitor-associated Joint Pain

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
Yoga Classes
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast, carcinoma, stage 0-III breast cancer, post-menopausal, aromatase inhibitor (AI), joint pain, AI-associated joint pain

Eligibility Criteria

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

Inclusion Criteria:

  • Have been diagnosed with stage 0-III breast cancer
  • Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously
  • Are post-menopausal defined as defined as no menses in the past 12 months
  • Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician
  • Report joint pain that started or worsened after initiation of AI medication
  • Report worst pain score > 4 in the preceding week on an 11-point (0-10) numeric rating scale

Exclusion Criteria:

  • Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years
  • Have uncontrolled cardiac disease, pulmonary disease, or infectious disease
  • Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea)
  • Have a body mass index (BMI) > 40 kg/m^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses)
  • Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history
  • Had surgery within the past 3 months
  • Had injections of medication within the last 3 months to joint(s) currently painful
  • Are currently using corticosteroids or opioid medications
  • Are currently attending yoga classes
  • Do not speak or read standard English
  • Are scheduled or are planning to discontinue AI medication in the next 16 weeks
  • Do not have sufficient access to the Internet to complete study assessments

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Condition

Arm Description

Questionnaires and yoga classes. Group will attend a series of 90-minute yoga classes twice a week for 12 weeks.

Outcomes

Primary Outcome Measures

Rate of Study Enrollment
Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.
Rate of Study Completion
Feasibility of the proposed study assessment and intervention methods. The study methods will be considered feasible if 70% or more of consented participants complete both the baseline and follow-up assessments and attend an average of 70% or more of scheduled yoga classes.

Secondary Outcome Measures

Occurrence of Reduced Pain Severity
Potential efficacy of the intervention in relieving AI medication-associated joint pain. The intervention will be considered potentially efficacious in relieving AI medication-associated joint pain if comparisons of pre- and post-intervention means for one or more measures of pain severity yield an effect size >/= 0.3 consistent with pain reduction.
Occurrence of Relief from Other Side Effects
Potential efficacy of the intervention in relieving other reported side effects of AI medication (i.e., fatigue, hot flashes, sleep problems, and depressive symptoms). The intervention will be considered potentially efficacious in relieving other known side effects if comparisons of pre- and post-intervention means yield an effect size >/= 0.3 consistent with side effect reduction.

Full Information

First Posted
September 24, 2013
Last Updated
July 1, 2016
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01951976
Brief Title
Yoga for Aromatase Inhibitor-associated Joint Pain
Official Title
Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether it might be practical and useful to investigate the effectiveness of yoga classes in relieving joint pain associated with the use of a class of medications known as aromatase inhibitors.
Detailed Description
The study uses a single-arm design. All study participants will be assigned to an intervention condition in which they participate in group Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes). Study outcomes are assessed: 1) following recruitment but prior to the first yoga class; and 2) within two weeks post-intervention (follow-up). Additionally, a brief assessment of pain will be conducted four weeks and eight weeks after the start of yoga classes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, carcinoma, stage 0-III breast cancer, post-menopausal, aromatase inhibitor (AI), joint pain, AI-associated joint pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Condition
Arm Type
Experimental
Arm Description
Questionnaires and yoga classes. Group will attend a series of 90-minute yoga classes twice a week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Participants will be asked to complete a set of questionnaires about their health and well-being on two occasions (baseline and follow-up). Each set of questionnaires will take about 45 minutes to complete.
Intervention Type
Other
Intervention Name(s)
Yoga Classes
Other Intervention Name(s)
Iyengar yoga, yoga, exercise, Hatha yoga
Intervention Description
Iyengar yoga is a traditional form of Hatha yoga that has been used previously to address quality of life issues in women with breast cancer. Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes).
Primary Outcome Measure Information:
Title
Rate of Study Enrollment
Description
Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.
Time Frame
24 months
Title
Rate of Study Completion
Description
Feasibility of the proposed study assessment and intervention methods. The study methods will be considered feasible if 70% or more of consented participants complete both the baseline and follow-up assessments and attend an average of 70% or more of scheduled yoga classes.
Time Frame
Up to 24 weeks per participant
Secondary Outcome Measure Information:
Title
Occurrence of Reduced Pain Severity
Description
Potential efficacy of the intervention in relieving AI medication-associated joint pain. The intervention will be considered potentially efficacious in relieving AI medication-associated joint pain if comparisons of pre- and post-intervention means for one or more measures of pain severity yield an effect size >/= 0.3 consistent with pain reduction.
Time Frame
Up to 24 weeks per participant
Title
Occurrence of Relief from Other Side Effects
Description
Potential efficacy of the intervention in relieving other reported side effects of AI medication (i.e., fatigue, hot flashes, sleep problems, and depressive symptoms). The intervention will be considered potentially efficacious in relieving other known side effects if comparisons of pre- and post-intervention means yield an effect size >/= 0.3 consistent with side effect reduction.
Time Frame
Up to 24 weeks per participant

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with stage 0-III breast cancer Have completed local and/or adjuvant breast cancer therapy (with the exception of hormonal therapy) at least one month previously Are post-menopausal defined as defined as no menses in the past 12 months Are currently prescribed an aromatase inhibitor (AI) medication (anastrozole, letrozole, or exemestane) by a Moffitt-affiliated physician Report joint pain that started or worsened after initiation of AI medication Report worst pain score > 4 in the preceding week on an 11-point (0-10) numeric rating scale Exclusion Criteria: Have been diagnosed with another form of cancer (except nonmelanoma skin cancer) in the last five years Have uncontrolled cardiac disease, pulmonary disease, or infectious disease Have physical symptoms or conditions that could make yoga unsafe (i.e., neck injuries, dizziness, shortness of breath, chest pain, or severe nausea) Have a body mass index (BMI) > 40 kg/m^2 (based on difficulties severly obese individuals may have with engaging in Iyengar yoga poses) Have joint pain attributed to inflammatory arthritic conditions (i.e., rheumatoid arthritis, gout, pseudo-gout) per medical record or patient history Had surgery within the past 3 months Had injections of medication within the last 3 months to joint(s) currently painful Are currently using corticosteroids or opioid medications Are currently attending yoga classes Do not speak or read standard English Are scheduled or are planning to discontinue AI medication in the next 16 weeks Do not have sufficient access to the Internet to complete study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Jacobsen, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Yoga for Aromatase Inhibitor-associated Joint Pain

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