A Randomized Controlled Study on Cognitive Effects of Anti-cancer Therapy in Patients with Breast Cancer Treated with Rehabilitation Exercises, Diet and Add-on Homeopathy and Acupuncture/Auriculotherapy

Background and Aims: Chemotherapy-related cognitive impairment (CRCI) – ‘chemobrain’ – includes mental fatigue, and impairment in attention, processing speed and short-term memory.

Aims: This study evaluates the efficacy of complementary integrative medicine (CIM), acupuncture and homeopathy, compared to standard care in relieving CRCI.

Material and Methods: Inclusion criteria: females aged 18 to 70 years, with a primary diagnosis of early breast cancer (stage I-IIIA), treated with adjuvant chemotherapy regimens and/or endocrine therapy; written informed consent; educational level sufficient to understand the neurocognitive tests. Stratification: menopausal status; chemotherapy regimens; endocrine therapy.

Treatment: Acupuncture: basic acupuncture formulas Baihui (GB20), ExYintang1, Taixi (KI3). Sessions will be scheduled once a week for 4 weeks, followed by one month of auriculotherapy; at the end another 4 weekly sessions of acupuncture. Homeopathy: a magistral preparation including Helleborus niger 15 CH, Plumbum metallicum 6 CH, Phosphorus 15 CH, Cerebral cortex 5 CH and Nerves 5 CH, three granules three times a day for 3 months.

All the patients will receive dietary advice to reduce body inflammatory state and at the end of chemotherapy they will undergo a neuropsychological visit performed by a psychologist properly trained for cognitive function assessment. During the study, blood samples for plasma/serum analysis of BDNF (brain-derived neurotrophic factor), IL-6 and TNF (at baseline and 12 months) will also be collected.

The number of patients recruited will be 300, divided in three groups: 1) 100 with rehabilitation exercises and dietary advice, plus homeopathy; 2) 100 with rehabilitation exercises and dietary advice, plus acupuncture and auriculotherapy; 3) 100 with rehabilitation exercises and dietary advice as control group.

Results: The study is currently in its early stages, so there are no results at the time of writing. We expect to present the first preliminary results during HRI Congress.

Keywords: Breast cancer patients, anticancer therapy, cognitive impairments, homeopathy, complementary medicine

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