IRB Number:

06-005157

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have hot flashes and they
would like to have fewer and/or less severe hot flashes. Paced breathing is a kind of rhythmic and controlled breathing. Practicing paced breathing might be helpful in controlling the hot flashes participants experience.
This study is being done to:
- Look at what effects (good and bad) the paced breathing exercises will have on the patient and
their hot flashes.
- Look at what effects (good and bad) the paced breathing exercises will have on their mood, tiredness, sleep quality, and blood pressure.

Who is Eligible to Participate in the Study?

-Women age 18 or older
-History of breast cancer or patients preferring not to take hormones because of concern for breast cancer.
-Frequent hot flashes (HF) (greater than 14 per week) of sufficient severity to make the patient desire treatment.
-Presence of HF for greater than 1 month prior to study entry.

More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

-Patients will be put in one of 3 groups by chance (like pulling a number out of a hat). Group one will be taught to use a CD to practice paced breathing at a prescribed rate for 15 minutes once per day.
Group two will be taught to use a CD to practice paced breathing at a prescribed rate for 15 minutes twice per day.
Group three will be taught to use a CD to practice paced breathing at a different prescribed rate for 10 minutes once per day.

-Completion of questionnaires and forms
-Monitoring of blood pressure
-During this study, patients will not be permitted to take other drugs or natural products that may be effective in treating hot flashes. This is because the study is trying to determine how helpful paced breathing is in controlling hot flashes.

How long will the Study run?

Patients will be in the study for up to 10 weeks.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 03/08/2007

IRB Review and Approval Date: 12/05/2006

Study Type: Symptom Management

Projected Accrual: Up to 105 patients may be enrolled to participate

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Amit Sood, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/10/2008