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Yoga for Aromatase Inhibitor-associated Joint Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951976
Recruitment Status : Completed
First Posted : September 27, 2013
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

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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

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951976


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

Additional Information:
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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    Key Record Dates
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:
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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