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Completed

NCT Number: NCT05412953

Tonation Breathing Technique Method to Ease Aromatase Inhibitor-induced Joint and/or Muscle Pain

This clinical trial evaluates how well tonation breathing techniques (use of a breathing and tonation [creating sounds]) works to ease pain joint and/or muscle pain in patients with stage I-III breast cancer and currently take an aromatase inhibitor. Tonation breathing techniques may help relieve pain in patients with stage I-III breast cancer who are receiving aromatase inhibitor.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

PRIMARY OBJECTIVE:

I. To study impact of active participation of patients in producing tones in combination with breathing technique, i.e., tonation breathing techniques (TBT) to reduce aromatase inhibitor induced musculoskeletal symptoms.

OUTLINE:

Patients participate in tonation breathing techniques twice daily (or more if pain occurs) for 2 weeks. Patients also complete questionnaire at baseline and at 2 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females with stage I-III breast cancer taking adjuvant aromatase inhibitor (AI) (either standard dose of anastrozole 1 mg daily or letrozole 2.5 mg daily or exemestane 25 mg daily) for greater than 30 days experiencing AI induced musculoskeletal pain scores of 5 or higher on a Likert scale will be enrolled
  • Subjects should have completed any planned surgery for breast cancer, chemotherapy and radiation therapy at least 30 days prior to enrollment
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
  • Patients should be at least 18 years old with no maximum age limit

Exclusion criteria

  • Patients should not have significant underlying pulmonary disease

Treatment and study plan

Questionnaire Administration

Other

Complete questionnaire

Tonation Breathing Technique

Behavioral

Participate in tonation breathing techniques

Other names: Breathing and Tonation Technique, TBT

Primary outcomes

  1. Change in aromatase inhibitor induced musculoskeletal pain symptoms

    Time frame: Baseline to 2 weeks

    Patients will be asked to complete a validated brief pain inventory- SF ( BPI-SF) at baseline and after 2 weeks which would be end of study. The BPI- SF measures pain intensity at its worse in the last week, at its least in the last week in addition to average pain and location of pain. It also measures relief of pain from pain treatments or medications and percentage of relief.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Tonation Breathing Technique, a Non-Pharmacogenic Method to Ease Aromatase Inhibitor-Induced Musculoskeletal Symptoms - A Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Sep 3, 2024

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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