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

NCT05412953 | Completed

• 2 other identifiers: 21-012300NCI-2022-01372
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Supportive care (tonation breathing techniques, questionnaire)

EXPERIMENTAL

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.

Other: Questionnaire Administration; Behavioral: Tonation Breathing Technique

Interventions

Questionnaire Administration OTHER

Complete questionnaire

Supportive care (tonation breathing techniques, questionnaire)

Tonation Breathing Technique BEHAVIORAL

Participate in tonation breathing techniques

Also known as: Breathing and Tonation Technique, TBT

Supportive care (tonation breathing techniques, questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients should not have significant underlying pulmonary disease

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Respiration

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Prema P Peethambaram, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 9, 2022
• Study Start: February 22, 2022
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

US (1)