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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412953
• Other study ID #: 21-012300
• Secondary ID: NCI-2022-01372
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2022
• Est. completion date: March 15, 2026

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 15, 2026
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Questionnaire Administration
Complete questionnaire

Behavioral:
• Tonation Breathing Technique
Participate in tonation breathing techniques

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aromatase inhibitor induced musculoskeletal pain symptoms	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.	Baseline to 2 weeks

External Links

•   Mayo Clinic Clinical Trials