Effects of Short-term Fasting on Tolerance to Chemotherapy
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ClinicalTrials.gov Identifier: NCT01304251 |
Recruitment Status :
Completed
First Posted : February 25, 2011
Last Update Posted : January 12, 2016
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Condition or disease | Intervention/treatment | Phase |
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Breast Cancer | Other: Short-term fasting Other: Healthy nutrition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Effects of Short-term Fasting on Tolerance to Adjuvant Chemotherapy in Breast Cancer Patients |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Short-term fasting
short term fasting (i.e. 24 hours before and 24 hours after administration of chemotherapy) in 20 breast cancer patients
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Other: Short-term fasting
Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy |
Placebo Comparator: Healthy nutrition
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.
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Other: Healthy nutrition
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 [ Time Frame: approximately 126 days ]Neutrophil count after 6 cycles of chemotherapy (6x 21 days)
- chemotherapy-induced DNA damage in leukocytes [ Time Frame: 21 days ]chemotherapy-induced DNA damage in leukocytes will be determined after each cycle of chemotherapy (i.e. every 21 days)
- perceived side effects of chemotherapy [ Time Frame: 21 days ]To determine the effect of short-term fasting on perceived side effects after each cycle of chemotherapy (i.e. every 21 days)
- effect of short-term fasting on the body's inflammatory response to chemotherapy [ Time Frame: 21 days ]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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female breast cancer patients, receiving adjuvant TAC-chemotherapy
- Age ≥ 18 years old
- WHO performance status 0-2
- Adequate bone marrow function: white blood cells (WBCs) ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l
- Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤ 2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
- Adequate renal function: the calculated creatinine clearance should be ≥ 50 mL/min
- Survival expectation > 3 months
- Patients must be accessible for treatment and follow-up
- Written informed consent according to the local Ethics Committee requirements
Exclusion Criteria:
- Serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- Diabetes Mellitus
- body mass index (BMI) < 19 kg/m2
- Pregnancy or lactating
- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304251
Netherlands | |
Leiden University Medical Center | |
Leiden, Netherlands |
Principal Investigator: | Hanno Pijl, MD PhD | Leiden University Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hanno Pijl, Prof. dr. H. Pijl, Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT01304251 |
Other Study ID Numbers: |
P10.247 |
First Posted: | February 25, 2011 Key Record Dates |
Last Update Posted: | January 12, 2016 |
Last Verified: | January 2016 |
short-term fasting adjuvant chemotherapy toxicity side-effects |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |