Breast cancer is the most common cancer in women and one of the most important causes of death in women. In Switzerland, breast cancer represents 31.7% of all cancers in women and 17.9% of cancer-related deaths.
The majority of women diagnosed with breast cancer are over 50 years of age, but 10% are under 40 years of age.
Breast cancer is considered a heterogeneous disease with a spectrum of many different types and subtypes that result in different therapeutic responses and disease-specific outcomes.
Numerous studies have now demonstrated the importance of cancer stem cells (CSCs) in cancer development and progression. They represent 7-10 % of tumor cells and are known to be responsible for breast cancer tumorigenesis, tumor progression, proliferation, metastasis, drug resistance and tumor recurrence. These cells have a strong capacity for self-renewal and differentiation into all cell types, leading to tumor growth and development, including distant metastasis.
The presence of CSCs makes treatment more complex and complicated. It seems obvious that CSCs should be a target for treatment, and, in this sense, melatonin seems to be a suitable candidate for a clinical trial. Indeed, recent studies have demonstrated the oncostatic potential of melatonin.
We have therefore set up a clinical trial involving about 40 participants over 2 years. The trial will take place only at the CHUV site, at the breast center.
Participants who meet all our selection criteria and who do not present any exclusion criteria will be able to take part in the study. The participants must then take 20mg of melatonin every day for 15 days before their operation.
Thus, we hope to be able to demonstrate the impact of melatonin on cancer stem cells. For this clinical trial, we have defined the following objectives:
- The main objective is to determine the effect of the test substance (Melatonin) on the proportion of patients with an ALDH1 positive tumor (CSC marker).
- The secondary objective is to observe the effect of the test substance (Melatonin) on the following tumour biomarkers of each tumour: ER (oestrogen receptor), PR (progesterone receptor), HER2 (Human Epidermal Growth Factor Receptor) and Ki67 (MIB-1) (proliferation markers).
- We also defined safety objectives to assess the safety of the drug (melatonin) and its tolerability in terms of the incidence of the most common side effects: drowsiness, irritability, mood swings, headaches and other study-related side or adverse effects.
In the following document, we present part of the study protocol.