Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This research study is evaluating acupuncture, a medical therapy in which hair-thin, stainless steel needles are shallowly inserted into specific points to help the body's natural healing process, as a possible treatment to reduce hot flashes.

Detailed Description
-----------------
Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot flashes are common side effects of breast cancer treatments and can affect mood and daily life. Medications can help ease hot flashes, but many patients continue to experience symptoms despite these treatments. Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on the skin, with the goal of affecting body's natural healing system. Acupuncture has been tested in clinical trials in cancer patients and has been shown to be helpful in treating a number of side effects of cancer treatment, such as nausea and vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to lessen hot flashes, but more information is needed about the benefits of acupuncture in breast cancer patients. This study is being done to test whether acupuncture can help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with mediations such as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara).

Official Title
-----------------
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Acupuncture
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor; Premenopausal or postmenopausal status; Completed all primary chemotherapy and surgery; Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed; Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry; Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Signed informed consent Exclusion Criteria: Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period; Unstable cardiac disease or myocardial infarction within 6 months prior to study entry; Uncontrolled seizure disorder or history of seizure; Active clinically significant uncontrolled infection; Use of acupuncture for hot flashes within 6 months prior to the study entry; Uncontrolled major psychiatric disorders, such as major depression or psychosis; Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Acupuncture<br>Will receive a standardized acupuncture protocol for a 10-week period 20 sessions: twice a week for 10 weeks After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks. | Device: Acupuncture<br>* Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system<br>|
| Active Comparator: Delayed acupuncture<br>Will receive standard usual care without acupuncture for 10 weeks Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study | Other: Usual Care<br>* the current standard of care with non-hormonal pharmacotherapy of western medicine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10 |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 10 weeks | 
| Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer |  | 2 years | 
| Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale |  | 2 years | 
| Pittsburgh Sleep Quality Index |  | 2 years | 
| Changes in plasma proinflammatory cytokines |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer