Yoga for Aromatase Inhibitor-associated Joint Pain

NCT01951976 | Completed

• 1 other identifier: MCC-17592
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of Study Enrollment

  Acceptability of the proposed study to potential participants. The study will be considered acceptable if 50% or more of eligible participants agree to participate.

  24 months

• Rate of Study Completion

  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.

  Up to 24 weeks per participant

Secondary Outcomes (2)

• Occurrence of Reduced Pain Severity

  Up to 24 weeks per participant

• Occurrence of Relief from Other Side Effects

  Up to 24 weeks per participant

Study Arms (1)

Intervention Condition

EXPERIMENTAL

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

Other: Questionnaires; Other: Yoga Classes

Interventions

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.

Intervention Condition

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).

Also known as: Iyengar yoga, yoga, exercise, Hatha yoga

Intervention Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma; Arthralgia

Interventions

Surveys and Questionnaires; Yoga; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paul Jacobsen, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 27, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

US (1)