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Breast Cancer | Yoga for Aromatase Inhibitor-associated Joint Pain

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:QuestionnairesParticipants 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.

Other:Yoga ClassesIyengar 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).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Completed

Start Date: September 2013

Completed Date: June 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Rate of Study Enrollment

Secondary Outcome: Occurrence of Reduced Pain Severity

Study sponsors, principal investigator, and references

Principal Investigator: Paul Jacobsen, Ph.D.

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01951976

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