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

Not Applicable

Recruiting

• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8
• Interventions: Other: Questionnaire Administration; Behavioral: Tonation Breathing Technique

• Registration Number: NCT05412953
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-02-22
• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2025-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

• Patients should not have significant underlying pulmonary disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (tonation breathing techniques, questionnaire)	Questionnaire Administration	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.
Supportive care (tonation breathing techniques, questionnaire)	Tonation Breathing Technique	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.

Primary Outcome Measures

Name	Time	Method
Change in aromatase inhibitor induced musculoskeletal pain symptoms	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States