Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386887
• Other study ID #: CASE1824
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Mariam AlHilli, MD
• Phone: (216) 445-8090
• Email: ALHILLM[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and above

• Participants with confirmed diagnosis of epithelial ovarian cancer (EOC) by internal cytologic or histologic evaluation (including fallopian tube and primary peritoneal cancer)

• Participant who had undergone laparoscopic evaluation or laparotomy for diagnosis but did not proceed with surgical debulking

• Participants with stage III or IV EOC planned to undergo NACT or already receiving NACT (cycle 1)

• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Intermittent Fasting
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).

Drug:
• Neoadjuvant chemotherapy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermittent fasting compliance as measured by serum glucose laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.	Day 1 of cycle 1 (each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by ketone laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.	Day 1 of cycle 1 (each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by IGF-1 laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.	Day 1 of cycle 1 (each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by insulin laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.	Day 1 of cycle 1 (each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by serum glucose laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by ketone laboratory testing	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.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by IGF-1 laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by insulin laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by serum glucose laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (serum glucose) prior to each chemotherapy.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by ketone laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (ketone) prior to each chemotherapy.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by IGF-1 laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (IGF-1) prior to each chemotherapy.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by insulin laboratory testing	Participants will be assessed for intermittent fasting compliance which will be measured by metabolic laboratory tests (insulin) prior to each chemotherapy.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by self-reported assessment	Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by self-reported assessment	Participants will be assessed for intermittent fasting compliance which will be measured by a self-reported compliance checklist assessment.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by food diary	Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.	Week 3 (Day 1 of cycle 2; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by food diary	Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.	Week 6 (Day 1 of cycle 3; each cycle consisting of 21 days)
Primary	Intermittent fasting compliance as measured by food diary	Participants will be assessed for intermittent fasting compliance which will be measured a 3-food diary submitted during each dietitian in person visit.	Up to 12 weeks post intervention
Primary	Pre body composition	Pre- and post- treatment body composition will be assessed by Computed Tomography scans.	Baseline
Primary	Post body composition	Pre- and post- treatment body composition will be assessed by Computed Tomography scans.	Up to 12 weeks post intervention
Secondary	Chemotherapy related toxicity at Cycle 2	Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE version 5.0]).	Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Secondary	Chemotherapy related toxicity at Cycle 3	Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE version 5.0]).	Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
Secondary	Chemotherapy related toxicity at Cycle 4	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]).	Week 9 (At day 1 of cycle 4; each cycle consisting of 21 days)
Secondary	Chemotherapy related toxicity at post treatment	Participants will undergo evaluation of chemotherapy related toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE version 5.0]),	Up to 12 weeks post intervention
Secondary	ESAS Score at Enrollment	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.	At baseline
Secondary	ESAS Score at Cycle 2	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.	Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Secondary	ESAS Score at Cycle 3	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.	Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
Secondary	ESAS Score at Post Treatment	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.	Up to 12 weeks post intervention
Secondary	SF-125 Score 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.	At baseline
Secondary	SF-125 Score at Cycle 2	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.	Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Secondary	SF-125 Score at Cycle 3	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.	Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
Secondary	SF-125 Score at Post Treatment	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.	Up to 12 weeks post intervention
Secondary	Pre Quality of Life (QLQ-C30) Score 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.	At baseline
Secondary	Post Quality of Life (QLQ-C30) Score Post Treatment	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.	Up to 12 weeks post intervention
Secondary	Pre Functional Assessment (FACT-O) Score at Baseline	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.	Up to 12 weeks post intervention
Secondary	Post Functional Assessment (FACT-O) Score Post Treatment	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.	Up to 12 weeks post intervention
Secondary	AIM Survey Score at Cycle 2	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.	Week 3 (At day 1 of cycle 2; each cycle consisting of 21 days)
Secondary	AIM Survey Score at Cycle 3	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.	Week 6 (At day 1 of cycle 3; each cycle consisting of 21 days)
Secondary	AIM Survey Score at Post Treatment	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.	Up to 12 weeks post intervention