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NCT Number: NCT06386887

Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

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.

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Key information

Conditions

Epithelial Ovarian Cancer Adnexal Diseases Behavior Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intermittent Fasting Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Subspecialty Care for Women's Health Women's Health; Division of Gynecologic Oncology, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Mariam AlHilli, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and above
  • Participants with confirmed diagnosis of primary epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer)
  • Participants receiving platinum-based chemotherapy for ovarian cancer including
  • Participants with stage III or IV EOC planned to undergo neoadjuvant chemotherapy (including participants who had a diagnostic laparoscopy or aborted debulking) OR
  • Participants with stage III or IV EOC following primary debulking surgery
  • Participants with recurrent epithelial ovarian cancer who will receive platinum-based chemotherapy OR
  • Participants who had undergone neoadjuvant chemotherapy and interval debulking surgery who will be receiving adjuvant (postoperative) chemotherapy
  • Any invasive ovarian cancer histology
  • Normal cognitive function

Exclusion criteria

  • Age <18 years
  • Malignant complete or partial bowel obstruction confirmed on imaging.
  • Participants unable to provide informed consent.
  • BMI <18
  • Participants diagnosed with severe malnutrition as assessed by study dietitian
  • Type I diabetes on insulin
  • Absence of pretreatment CT abdomen and pelvis imaging or >4-6 weeks between imaging and cycle 1 of chemotherapy.

Treatment and study plan

Intermittent fasting

Behavioral

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).

Other names: Time restricted eating

Neoadjuvant chemotherapy

Drug

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.

Primary outcomes

  1. Intermittent fasting compliance as measured by serum glucose laboratory testing

    Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)

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

  2. Intermittent fasting compliance as measured by ketone laboratory testing

    Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)

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

  3. Intermittent fasting compliance as measured by IGF-1 laboratory testing

    Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)

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

  4. Intermittent fasting compliance as measured by insulin laboratory testing

    Time frame: Day 1 of cycle 1 (each cycle consisting of 21 days)

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

  5. Intermittent fasting compliance as measured by serum glucose laboratory testing

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

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

  6. Intermittent fasting compliance as measured by ketone laboratory testing

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

    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.

  7. Intermittent fasting compliance as measured by IGF-1 laboratory testing

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

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

  8. Intermittent fasting compliance as measured by insulin laboratory testing

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

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

  9. Intermittent fasting compliance as measured by serum glucose laboratory testing

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  10. Intermittent fasting compliance as measured by ketone laboratory testing

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  11. Intermittent fasting compliance as measured by IGF-1 laboratory testing

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  12. Intermittent fasting compliance as measured by insulin laboratory testing

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  13. Intermittent fasting compliance as measured by self-reported assessment

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

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

  14. Intermittent fasting compliance as measured by self-reported assessment

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  15. Intermittent fasting compliance as measured by food diary

    Time frame: Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)

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

  16. Intermittent fasting compliance as measured by food diary

    Time frame: Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)

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

  17. Intermittent fasting compliance as measured by food diary

    Time frame: Up to 12 weeks post intervention

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

  18. Pre body composition

    Time frame: Baseline

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

  19. Post body composition

    Time frame: Up to 12 weeks post intervention

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

Secondary outcomes

  1. Chemotherapy related toxicity at Cycle 2

    Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)

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

  2. Chemotherapy related toxicity at Cycle 3

    Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)

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

  3. Chemotherapy related toxicity at Cycle 4

    Time frame: Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)

    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]).

  4. Chemotherapy related toxicity at post treatment

    Time frame: Up to 12 weeks post intervention

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

  5. ESAS Score at Enrollment

    Time frame: At baseline

    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.

  6. ESAS Score at Cycle 2

    Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)

    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.

  7. ESAS Score at Cycle 3

    Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)

    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.

  8. ESAS Score at Post Treatment

    Time frame: Up to 12 weeks post intervention

    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.

  9. SF-125 Score at Baseline

    Time frame: At baseline

    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.

  10. SF-125 Score at Cycle 2

    Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)

    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.

  11. SF-125 Score at Cycle 3

    Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)

    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.

  12. SF-125 Score at Post Treatment

    Time frame: Up to 12 weeks post intervention

    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.

  13. Pre Quality of Life (QLQ-C30) Score at Baseline

    Time frame: At baseline

    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.

  14. Post Quality of Life (QLQ-C30) Score Post Treatment

    Time frame: Up to 12 weeks post intervention

    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.

  15. Pre Functional Assessment (FACT-O) Score at Baseline

    Time frame: Up to 12 weeks post intervention

    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.

  16. Post Functional Assessment (FACT-O) Score Post Treatment

    Time frame: Up to 12 weeks post intervention

    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.

  17. AIM Survey Score at Cycle 2

    Time frame: Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)

    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.

  18. AIM Survey Score at Cycle 3

    Time frame: Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)

    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.

  19. AIM Survey Score at Post Treatment

    Time frame: Up to 12 weeks post intervention

    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 contacts

Contact information is provided by the study sponsor or research team.

Jackie Ludwig

CONTACT

[email protected]

216 390-2492

Michelle Kuznicki, MD

CONTACT

[email protected]

(216) 444-8811

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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