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

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    80
  • sponsor
    Dana-Farber Cancer Institute
Updated on 1 April 2021
estrogen
endocrine therapy
hormone therapy
trastuzumab
tamoxifen
erbb2
estrogen receptor
adjuvant chemotherapy
immunostimulant

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.

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).

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Usual Care, Acupuncture
Clinical Study IdentifierNCT03783546
SponsorDana-Farber Cancer Institute
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast or Breast Cancer Diagnosis or breast carcinoma?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or breast carcinoma or Breast Cancer?
Do you have any of these conditions: cancer, breast or breast carcinoma or Breast Cancer Diagnosis or Breast Cancer?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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