Short-term fasting during chemotherapy – Investigation of tumor cells in the blood
Summary description of the study
This study investigates how short fasting around the first chemotherapy affects cancer cells that can be detected in the blood. These cells are called circulating tumor cells. They can enter the bloodstream from the tumor and may be related to the course of the disease. Adult female patients with breast cancer or a gynecological cancer who receive chemotherapy as standard treatment can participate. The chemotherapy itself will not be altered by participation in the study. Some participants will fast under medical supervision for about 36–40 hours around the first chemotherapy. Other participants will not fast and will receive chemotherapy as usual. This allows for comparison of whether circulating tumor cells change differently in patients with and without fasting. During the study, blood samples will be taken at specified times. This will allow for the examination of circulating tumor cells and additional measurements related to metabolism. Some blood samples will be taken at specific times of the day to account for natural daily fluctuations. No additional examinations such as CT or MRI will be conducted. Participation lasts only a few days around the first chemotherapy. Fasting will be medically supervised and can be stopped at any time if a participant feels unwell. No direct personal benefit is expected. The results are intended to help better understand the relationship between fasting, metabolism, and circulating tumor cells during chemotherapy, thereby creating a foundation for further research. Participation is voluntary; non-participation or withdrawal will not have disadvantages for further treatment.
(BASEC)
Intervention under investigation
Short-term, medically supervised fasting around the first chemotherapy.
The intervention consists of a time-limited abstention from calorie intake for about 36–40 hours in the peri-chemotherapeutic period. No medication or medical product is used. Chemotherapy is carried out independently of the study according to medical standards and is not altered by the intervention.
(BASEC)
Disease under investigation
Metastatic breast cancer and metastatic gynecological cancers
(BASEC)
1. Adult female patients (≥ 18 years) with histologically confirmed metastatic breast cancer or metastatic gynecological cancers. 2. Planned systemic chemotherapy according to medical standards at the University Hospital Basel. 3. Ability to understand the study procedures and provide written consent to participate in the study. (BASEC)
Exclusion criteria
1. Medical conditions that contraindicate short-term fasting, particularly uncontrolled diabetes mellitus, eating disorders, or clinically relevant malnutrition. 2. Severe comorbidities that, in the opinion of the investigator, do not allow for safe participation in the study. 3. Pregnancy or breastfeeding. (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. Viola Heinzelmann-Schwarz
+41 61 265 25 25
viola.heinzelmann@clutterusb.chUniversitätsspital Basel, Frauenklinik / Gynäkologische Onkologie
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
29.05.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Fasting and Circulating Tumor Cells (CTCs) in Metastatic Breast and Gynecologic Cancers: A Pilot Study on Short-Term Fasting and CTC Dynamics (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available