Yoga for Aromatase Inhibitor-associated Joint Pain

NCT ID: NCT01951976

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Condition

Questionnaires and yoga classes.

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

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: OTHER

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.

Yoga Classes

Intervention Type: OTHER

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).

Interventions

Questionnaires

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

Yoga Classes

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).

Intervention Type: OTHER

Other Intervention Names

Iyengar yoga; yoga; exercise; Hatha yoga

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Jacobsen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-17592

Identifier Type: -

Identifier Source: org_study_id