An interventional study of Short-term fasting and Healthy nutrition in Breast Cancer, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Supportive care
The purpose of this study is to determine the effect of short-term fasting on tolerance to adjuvant chemotherapy in breast cancer patients
Evidence from experimental animals provides strong support for the concept that caloric restriction (CR) increases resistance to multiple forms of stress. CR decreases plasma levels of growth factors, e.g. insulin-like growth factor-I (IGF-I), thereby diverting energy from growth to maintenance. Accordingly, the currently available information suggests that short-term fasting protects normal cells against the perils of (high dose) chemotherapy. In contrast, cancer cells are not (or less) protected as a result of their self-sufficiency in growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR reduces the severity of side-effects caused by the toxicity of chemotherapy, without interfering with its effect on reduction of tumour volume or tumour markers. A recent report, sketching a case series of 10 cancer patients, suggests that short term fasting protects against the side effects of chemotherapy in humans. Indeed, the majority of patients preferred fasting over feeding in preparation of their therapy. This study aims to further evaluate the impact of fasting on tolerance to chemotherapy in humans.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 13 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients
Other: Short-term fasting
20 breast cancer patients eat according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy.
Other: Healthy nutrition
Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
Eating according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy. Dietary instructions will be given by a dietician and actual food intake will be recorded in a journal.
chemotherapy-induced neutropenia
Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
Time frame: approximately 126 days
chemotherapy-induced DNA damage in leukocytes
chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)
Time frame: 21 days
perceived side effects of chemotherapy
To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)
Time frame: 21 days
effect of short-term fasting on the body's inflammatory response to chemotherapy
To determine the effect of short-term fasting on the body's inflammatory response to chemotherapy, inflammation parameters will be measured after each cycle of chemotherapy
Time frame: 21 days
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center