Yoga for Aromatase Inhibitor-associated Joint Pain

• ClinicalTrials.gov Identifier: NCT01951976
• Recruitment Status: Completed
• First Posted: September 27, 2013
• Last Update Posted: July 4, 2016
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: Pfizer
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: Questionnaires; Other: Yoga Classes	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluating Yoga for Aromatase Inhibitor-associated Joint Pain in Women With Breast Cancer: A Pilot Study
• Study Start Date: September 2013
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: Intervention Condition; Questionnaires and yoga classes. Group will attend a series of 90-minute yoga classes twice a week for 12 weeks.

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.; 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).; Other Names: Iyengar yoga; yoga; exercise; Hatha yoga

Outcome Measures

Primary Outcome Measures :

1. Rate of Study Enrollment [ Time Frame: 24 months ]
   Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.
2. Rate of Study Completion [ Time Frame: Up to 24 weeks per participant ]
   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 :

1. Occurrence of Reduced Pain Severity [ Time Frame: Up to 24 weeks per participant ]
   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.
2. Occurrence of Relief from Other Side Effects [ Time Frame: Up to 24 weeks per participant ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Pfizer

Investigators

• Principal Investigator: Paul Jacobsen, Ph.D.; H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Moffitt Cancer Center Clinical Trials website 

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT01951976
• Other Study ID Numbers: MCC-17592
• First Posted: September 27, 2013
• Last Update Posted: July 4, 2016
• Last Verified: July 2016

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

breast; carcinoma; stage 0-III breast cancer; post-menopausal; aromatase inhibitor (AI); joint pain; AI-associated joint pain

Additional relevant MeSH terms:

Breast Neoplasms; Arthralgia; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs