We performed this phase 2 randomized trial in which we randomized patients to receive either short-term fasting or a free diet. Short-term was defined as fasting starting 36 hours before until 24 hours from the end of chemotherapy cycle. And patients with advanced ovarian cancer receiving neoadjuvant chemotherapy were enrolled. And so our findings suggest, first of all, that there was a higher level of insulin in the free diet arm compared with the short-term fasting arm, in which we have a reduction of the insulin...
We performed this phase 2 randomized trial in which we randomized patients to receive either short-term fasting or a free diet. Short-term was defined as fasting starting 36 hours before until 24 hours from the end of chemotherapy cycle. And patients with advanced ovarian cancer receiving neoadjuvant chemotherapy were enrolled. And so our findings suggest, first of all, that there was a higher level of insulin in the free diet arm compared with the short-term fasting arm, in which we have a reduction of the insulin. And this was the primary endpoint. So the primary endpoint was a metabolic one. And also we had several other endpoints. So about toxicity, we didn’t find significant differences in terms of hematological or non-hematological toxicity between the two groups. Also, we performed the same rate of interval cytoreductive surgery after an adjuvant chemotherapy in both groups. But from the response perspective, we found that roughly 60% of patients under the short-term fasting arm achieved a chemotherapy response score of 3, which means complete or near complete pathological response in ovarian cancer compared with only 17.6% of the patients. And accordingly, we also found a significantly longer median progression-free survival in the short-term fasting arm of 24 months compared with 13 months of the free diet arm. And also from the immunological perspective, we performed some preliminary analysis, and there was a reduction of the suppressive granulocytes and monocytes in the short-term fasting arm compared with the free diet. So overall, the primary endpoint was reached, and also other endpoints, especially survival and surgical outcomes, were in favor of the short-term fasting arm. And it was the first randomized trial addressing this issue in ovarian cancer patients.
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