Clinical trial NCT01951976: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast
carcinoma
stage 0-III breast cancer
post-menopausal
aromatase inhibitor (AI)
joint pain
AI-associated joint pain
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-09-27
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of Study Enrollment
timeFrame: 24 months
measure: Rate of Study Completion
timeFrame: Up to 24 weeks per participant
Secondary outcomes:
measure: Occurrence of Reduced Pain Severity
timeFrame: Up to 24 weeks per participant
measure: Occurrence of Relief from Other Side Effects
timeFrame: Up to 24 weeks per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Paul Jacobsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: