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Completed

NCT Number: NCT01951976

Yoga for Aromatase Inhibitor-associated Joint Pain

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.

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Key information

Conditions

Breast Cancer Arthralgia Breast Diseases Breast Neoplasms Carcinoma Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 27, 2013
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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