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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05412953
Enrollment
15
Registered
2022-06-09
Start date
2022-02-22
Completion date
2024-06-27
Last updated
2024-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERQuestionnaire Administration

Complete questionnaire

BEHAVIORALTonation Breathing Technique

Participate in tonation breathing techniques

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in aromatase inhibitor induced musculoskeletal pain symptomsBaseline to 2 weeksPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026