Intermittent Fasting/Time Restricted Feeding during Chemotherapy in Patients with Stage III or IV Ovarian Cancer

PRIMARY OBJECTIVE:

I. To test the feasibility and safety of intermittent fasting (IF) during chemotherapy (including effects on body composition).

SECONDARY OBJECTIVE:

I. To measure the effects of IF on patient reported outcomes, chemotherapy toxicity and quality of life.

EXPLORATORY OBJECTIVE:

I. To test the effect of IF on pathologic response, systemic inflammatory and immune responses, microbial diversity and metabolic pathway alterations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients participate in IF continuously for 16 hours per day followed by normal eating for 8 hours for 5 consecutive days with 2 days of regular eating per week starting 2 days prior to cycle 1 of standard of care (SOC) chemotherapy treatment continuing through cycle 3 and until planned surgery, for at least 9 weeks. Patients who are receiving neoadjuvant chemotherapy start the IF intervention with cycle 2. Patients also meet with a dietician during each treatment cycle and post-treatment, as well as receive weekly virtual or phone visits between treatment cycles on study. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive SOC dietary recommendations starting 2 days prior to SOC chemotherapy treatment through cycle 3 and until planned surgery, for at least 9 weeks, and meet with a dietician during each treatment cycle on study. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Additionally, patients undergo blood, stool, vaginal and rectal sample collection, as well as computed tomography (CT) scan during screening and on study. Patients also undergo tissue collection on study.

After completion of study intervention, patients are followed up at 6-8 weeks and then at 6 months and 1 year.