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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire Administration
Tonation Breathing Technique
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (tonation breathing techniques, questionnaire)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2022
Last Updated
September 28, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05412953
Brief Title
Tonation Breathing Technique Method to Ease Aromatase Inhibitor-induced Joint and/or Muscle Pain
Official Title
Tonation Breathing Technique, a Non-Pharmacogenic Method to Ease Aromatase Inhibitor-Induced Musculoskeletal Symptoms - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (tonation breathing techniques, questionnaire)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaire
Intervention Type
Behavioral
Intervention Name(s)
Tonation Breathing Technique
Other Intervention Name(s)
Breathing and Tonation Technique, TBT
Intervention Description
Participate in tonation breathing techniques
Primary Outcome Measure Information:
Title
Change in aromatase inhibitor induced musculoskeletal pain symptoms
Description
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.
Time Frame
Baseline to 2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prema P Peethambaram
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Prema P. Peethambaram, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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