Can ear acupuncture reduce hot flashes in women with hormone-receptor-positive breast cancer who are undergoing adjuvant anti-hormone therapy?

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors, such as the patient’s general health, the stage of the disease, the tumor’s growth rate (Ki-67 index), the presence of detectable hormone receptors on the surface of the cancer cells (estrogen receptor-positive, progesterone receptor-positive), and the increased presence of HER2 receptors on the cells (HER2-positive). Cancer cells often have hormone receptors, making anti-hormone therapy a core component of treatment. This therapy aims to inhibit the growth of hormone-dependent tumor cells by inducing a drug-induced estrogen deficiency. However, the resulting estrogen deficiency not only affects the tumor but can also cause symptoms similar to the hormonal changes experienced during menopause. This can lead to various discomforts, such as hot flashes.

Acupuncture is a treatment method from traditional Chinese medicine that is used for a wide variety of conditions. Previous studies have shown that acupuncture can also have a beneficial effect on hot flashes. There are, in turn, various techniques used in acupuncture itself.

The goal of the OhrHit study is to investigate the effectiveness of ear acupuncture treatments in reducing hot flashes in patients receiving adjuvant anti-hormone therapy. As part of the study, patients are randomly assigned to three groups. Group 1 receives acupuncture treatments twice a week for a total of five weeks according to the so-called Balanced Ear Acupuncture (BEA) principle. Group 2 receives acupuncture treatments twice a week for a total of five weeks according to the so-called National Acupuncture Detoxification Association (NADA) protocol. For the final evaluation, patients in each group must have received at least eight treatments. Symptoms are assessed before treatment, 6 weeks after the start of therapy, and over a three-month follow-up period. Group 3, serving as the control group, initially receives no specific treatment. After the three-month observation period, ten acupuncture treatments are also administered to this group. Thus, every participant in the study receives acupuncture treatment. The study is not blinded; that is, both the medical staff and the patients know which treatment they are receiving. The primary endpoint of the study is the assessment of experienced hot flashes.

Women between the ages of 18 and 75 with hormone receptor-positive, non-metastatic breast cancer (stages 1–3) who are experiencing hot flashes while undergoing adjuvant anti-hormone therapy are eligible to participate in this study. Patients who are receiving chemotherapy, radiation therapy, or surgery—or for whom one of these treatments is planned—are not eligible to participate. Additionally, participants must not be currently undergoing acupuncture treatment.