Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNorthwestern University
About this trial
Endometrial cancer is the most common gynecologic cancer and ovarian cancer is the most lethal. The management of both advanced cancers is a combination of chemotherapy and surgery. Standard of care chemotherapeutic treatment for uterine and ovarian cancers is toxic and severely disruptive to the patient's quality of life with the potential for devastating short and long-term side effects. The role of fasting and ketogenic diets has been evaluated in a mixed cancer population and previously shown to be safe. There is no data specifically addressing the impact of a fasting diet regimen on side effects of chemotherapy during treatment for ovarian and endometrial cancers in the front-line setting. The information gathered from this study will inform future trials about the role of time-restricted eating and its impact on side-effects associated with chemotherapy as well as its role in improvement of quality of life for women afflicted with these debilitating diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female; ≥ 18 years of age
Confirmed or high suspicion for endometrial, ovarian, fallopian tube or primary peritoneal cancer, and are able and expecting to undergo adjuvant chemotherapy following hysterectomy for treatment of disease, as determined by their treating physician
Fluent in spoken and written English
Own a smart phone
Disqualifiers
Patients who are not planning to undergo chemotherapy at Northwestern Medicine
Patients engaged in shift work (i.e., those who work nights, 3rd shift)
BMI of 50+ or those with a diagnosed eating disorder. Patients who take medications for blood glucose regulation (e.g. insulin), and/or require treatment with therapeutic doses of anticoagulants will be excluded.
Patients who have been diagnosed with medication-dependent diabetes, recent myocardial infarction, stroke, pulmonary embolus, renal failure, or any condition that may preclude ability to tolerate a short-term fast will be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
FAST Intervention
BehavioralParticipants will alternate fasting days (FAST) with unrestricted eating (OFF, or "Feast") days, for one week surrounding the start of each chemotherapy cycle. The participants will fast for two consecutive days in the middle of the ADF week - the day prior to chemotherapy start date, and chemotherapy day 1 for each cycle. Participants will consume regular diet (OFF/Feast) during other days 5-18 of each cycle.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: FAST GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assessment Compliance
Assessment compliance will be defined as missing no more than 75% of indicated Biosense measurement (i.e. no more than number of cycles × 7 measurements), which roughly corresponds to no more than 1 missed measurement per day of fasting period. The study will be considered feasible in terms of assessment compliance if at least 80% of all patients are compliant.
Time frame
18 weeks2
Treatment Compliance
Treatment compliance will be defined among patients on FAST as the proportion of measurements on fasting days when the patient is in ketosis (i.e., ACE score \> 5, or ketone levels of 0.5+ mmol/L). FAST treatment will be considered feasible in this patient population if \>80% of patients in the FAST arm are compliant with treatment.
Time frame
18 weeks3
Fasting non-compliance
Fasting non-compliance will be defined as anyone who began fasting but was not compliant with completing the 48-hour fast. Anyone who started ADF by following low caloric (equal or less than 400 cal) fast within 24 hours of C1D1 chemo regimen will be considered fasting compliant. Patients randomized to the intervention arm will be considered evaluable if they start their fasting diet regimen within 24 hours prior to starting day 1 of their first chemotherapy cycle (C1D1) and if they fast for three out of the four 24-hour long fasting windows within each of the six chemotherapy cycles. Patients randomized to the control arm will be considered evaluable if they started chemotherapy. Fasting non-compliance will be measured by number of participants meeting the above definition.
Time frame
18 weeksSecondary outcomes
1
Adverse events and toxicity
Assess differences in expected toxicities associated with chemotherapy administration using Common Terminology Criteria for Adverse Events (CTCAE) Safety definition: we expect toxicity profile to be similar between the two arms, although formally testing the Adverse Event (AE) rates will be underpowered. After every 6 patients have been randomized (4+2 in the two arms), the PI will review cumulative toxicity data by arm. If a high proportion of patients in the AFT arm has a particular type of AE which has substantially lower prevalence or is not observed in the non-AFT arm, enrollment may be paused to further evaluate the reasons and supportive care of these unexpected AE's. Patients will be considered evaluable for safety if they started any of the study treatments (ADF and chemotherapy).
Time frame
18 weeks2
Neuropathic Pain
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for neuropathic pain
Time frame
18 weeks3
Physical Function
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for physical function
Time frame
18 weeksOther outcomes
1
Cancer Related Fatigue
Assess differences in Patient Reported Outcomes (PROs) utilizing Patient Reported Outcomes Measurement Information System (PROMIS) surveys for cancer related fatigue
Time frame
18 weeks2
Molecular biomarker: Insulin
Insulin concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame
18 weeks3
Molecular biomarker: insulin-like growth factor-1
Insulin-like growth factor-1 concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame
18 weeks4
Molecular biomarker: Insulin-like growth factor Binding Protein-1
Insulin-like growth factor Binding Protein-1 concentration from human serum will be measured and reported as pg/ml using enzyme-linked immunosorbent assay (ELISA) performed by the Comprehensive Metabolic Core Facility at Northwestern University's Feinberg School of Medicine
Time frame
18 weeksSponsors and contacts
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Source ClinicalTrials.gov