Abstract P4-16-12: CARE: A pilot study of the effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in breast cancer patients

Background: Preclinical evidence shows that short-term fasting (STS) protects normal cells and makes cancer cells more vulnerable to chemotherapy. This pilot study examines the feasibility and the effects of STS on tolerance to chemotherapy in patients with breast cancer. Patients and methods: Eligible patients had histologically confirmed, HER2-negative, early stage breast cancer and adequate bone marrow, liver and renal function. Women receiving (neo) adjuvant TAC courses (docetaxel/adriamycin/cyclophosphamide; day 1, q 3 weeks with G-CSF support at day 2) were randomized to fast 24 hours before and 24 hours after start of chemotherapy or to eat according to the guideline for healthy nutrition. The primary endpoint of the study was to compare neutrophil count after therapy. Secondary endpoints were side effects of chemotherapy, other hematologic counts and chemotherapy-induced DNA damage in leukocytes. Results: A total of 13 patients were included of which 7 patients fasted for 48 hours around the chemotherapy infusion (arm A) and 6 patients had a normal diet according to healthy nutrition guidelines (arm B). The median age was 52 years versus 53 years, BMI was 25.5 kg/m 2 versus 22.9 kg/m 2 and stage III was 43% versus 17% of patients in arms A and B, respectively. Patients were generally motivated to fast and the fasting was well tolerated. Plasma glucose levels were significant lower in fasting patients compared to controls. However, other metabolic parameters showed no significant difference. Fasting did not result in significant differences in neutrophil count or side effects of chemotherapy. Hemoglobin levels and erythrocyte counts after therapy were significantly higher in patients who fasted. Leukocytes of the patients which were isolated at various time points during therapy will soon be analysed for chemotherapy-induced DNA damage and presented at San Antonio. Conclusion: This is the first study evaluating the feasibility of 48 hours STS and its impact on side effects of chemotherapy in a homogeneous group of cancer patients. STS was well tolerated and had a beneficial effect on hemoglobin level, but not on experienced side effects. DNA analysis will follow. Larger studies are required to produce more insight into the possible benefits of STS during chemotherapy. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-16-12.