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

NCT ID: NCT05412953

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2024-06-27

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (tonation breathing techniques, questionnaire)

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.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Complete questionnaire

Tonation Breathing Technique

Intervention Type BEHAVIORAL

Participate in tonation breathing techniques

Interventions

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Questionnaire Administration

Complete questionnaire

Intervention Type OTHER

Tonation Breathing Technique

Participate in tonation breathing techniques

Intervention Type BEHAVIORAL

Other Intervention Names

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Breathing and Tonation Technique TBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prema P Peethambaram, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2022-01372

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-012300

Identifier Type: -

Identifier Source: org_study_id

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