Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Participants will receive 16 hours of fasting, 8 hour regular feeding for 5 days a week starting 2 days prior to chemotherapy.

Participants will receive standard of care dietary recommendations and will provide a 3-day diet diary at study enrollment and during cycles 2 and 3.

Intermittent fasting (IF) also known as time restricted eating regimen consisting of 16 hours of fasting and 8 hours of ad libitum feeding for 5 days followed by ad libitum feeding for 2 days has been proposed. With this type of intervention, there are no dietary restrictions to the type or quality of food and it decreased daily energy intake by 20%. Participants will be asked to follow an IF schedule consisting of 16 hour of continuous fasting per day for 5 days a week. This will be started 2 days prior to chemotherapy (cycle 2).

Intermittent Fasting

Chemotherapy will be given as standard treatment every 3 weeks (21 days) and continue for 3 to 4 cycles per routine care. As chemotherapy is not part of this research study, participants will begin standard chemotherapy as decided by their physician.

Neoadjuvant chemotherapy

Mariam AlHilli, MD

Jackie Ludwig

The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are:

* Is it feasible to use intermittent fasting during neoadjuvant chemotherapy?
* Is it safe to use intermittent fasting during neoadjuvant chemotherapy?
* Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy?

Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes.

Participants will:

* Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy.
* All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing.
* Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week.

The quality of diet can affect the biology of cancer. For example, evidence implies a high fat/ Western diet may impose adverse events on ovarian cancer outcomes, and the potential that the gut microbiome alterations secondary to dietary changes may impact tumor responsiveness to treatment and outcomes. This study seeks to clarify the effect of dietary intervention on the tumor and gut microbiome and ovarian cancer biology. The objectives of this study include:

* Primary: To test the feasibility and safety of IF during neoadjuvant chemotherapy (including effects on body composition)
* Secondary: To measure the effects of IF on participant reported outcomes, chemotherapy toxicity and quality of life.
* Exploratory: To test the effect of IF on pathologic response, systemic inflammatory and immune responses, microbial diversity and metabolic pathway alterations.

Participants' cross-sectional skeletal muscle areas will be measured. Measurements will be performed on CT scans obtained within 4-6 weeks of treatment initiation (with a 7-day screening window) by a fellowship-trained, experienced radiologist and imaging specialist in consensus who will be blinded to participant clinical variables and treatment.

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

The Feasibility, Safety, and Clinical Outcomes of Fasting During Neoadjuvant Chemotherapy in Patients With Epithelial Ovarian Cancer

All collected participant data will be shared through publication including clinical data, laboratory results, CT data, qualitative data (questionnaire's) in additional, molecular data, histologic data, treatment response after statistical analysis. All data will be shared without participant identifiers.

Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.

Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.

Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.

Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.

Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy. which will be measured by metabolic laboratory tests (serum glucose, ketone, IGF-1, and insulin) prior to each chemotherapy.

Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.

Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.

Pre- and post- treatment body composition will be assessed by Computed Tomography scans.

Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).

Participants that undergo an additional cycle of chemotherapy will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]).

Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]),

Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS) at enrollment. The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Participants will complete Edmonton Symptom Assessment Questionnaires (ESAS). The ESAS assesses pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Participants will complete Study Short Form-12 Health Survey (SF-125) at enrollment. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Participants will complete Study Short Form-12 Health Survey (SF-125) day 1 cycle 2. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Participants will complete Study Short Form-12 Health Survey (SF-125) day 1 cycle 3. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Participants will complete Study Short Form-12 Health Survey (SF-125) post treatment. The SF-12 measures physical and mental health status. Responses are scored to produce a physical component summary and a mental component summary on a scale from 0 to 100, with higher scores indicative of better functional status.

Quality of life questionnaires will be distributed at enrollment and will be compared between IF and control groups. Quality of life will be measured by Quality of life will be measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30). EORTC QLQ-C30 is a 30 item questionnaire. Higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

Functional Assessment of Cancer Therapy- Ovarian (FACT-O) will be administered post treatment and will be compared between IF and control groups. FACT-O is a 39 item questionnaire with a 5 point Likert-type scale. Scores range from 0-156. The higher the score, the better the quality of life.

Functional Assessment of Cancer Therapy- Ovarian (FACT-O) will be administered at enrollment and will be compared between IF and control groups. FACT-O is a 39 item questionnaire with a 5 point Likert-type scale. Scores range from 0-156. The higher the score, the better the quality of life.

Acceptability of intervention Measure (AIM) questionnaire will be administered IF participants. AIM has 4 item psychometric assessment times measuring acceptability of intervention. Scale values range from 1 to 5. Overall scores that are lower indicating lower acceptability, and higher scores indicating greater acceptability, appropriateness, and feasibility.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer	NCT06386887	Epithelial Ovar...	Intermittent Fa... Neoadjuvant che...	18 Years -	Case Comprehensive Cancer Center
Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer	NCT06386887	Epithelial Ovar...	Intermittent Fa... Neoadjuvant che...	18 Years -	Case Comprehensive Cancer Center

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