Short-term fasting during chemotherapy – Investigation of tumor cells in the blood
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. Viola Heinzelmann-Schwarz
+41 61 265 25 25
viola.heinzelmann@clutterusb.chUniversitätsspital Basel, Frauenklinik / Gynäkologische Onkologie
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
29.05.2026
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Fasting and Circulating Tumor Cells (CTCs) in Metastatic Breast and Gynecologic Cancers: A Pilot Study on Short-Term Fasting and CTC Dynamics (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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non disponibile
Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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