Yoga for Aromatase Inhibitor-associated Joint Pain

Breast Cancer Clinical Trial

Official title:

Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951976
• Other study ID #: MCC-17592
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: July 1, 2016
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months	No
Primary	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.	Up to 24 weeks per participant	No
Secondary	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.	Up to 24 weeks per participant	No
Secondary	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.	Up to 24 weeks per participant	No

External Links

•   Moffitt Cancer Center Clinical Trials website