RECRUITING

Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer

Conditions

Breast Cancer intermittent fasting obesity overweight hormone receptor positive HER2-negative human epidermal growth factor receptor 2-negative HR-positive HR+/HER2-early breast cancer adjuvant endocrine therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).

Official Title

Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer

Quick Facts

Study Start:2024-07-24

Study Completion:2027-07-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06106477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period. 2. Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III). 1. Progesterone receptor positive or negative patients are allowed. 2. Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negative breast cancer is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization fluorescence in situ hybridisation (FISH), chromogenic in situ hybridization (CISH), or silver-enhanced in situ hybridization (SISH) test is required. 3. Body mass index (BMI) ≥ 25. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 5. Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment. 6. Subjects who received neoadjuvant or adjuvant chemotherapy must have recovered completely from chemotherapy-related side effects such as nausea/emesis as determined by the treating providers. 7. Subjects who received neoadjuvant endocrine therapy are eligible only after completion of their definitive surgery (i.e., when ready to start adjuvant endocrine therapy) and treating provider ensures complete closure and healing of surgical incisions. 8. Subjects who had adjuvant systemic chemotherapy within two to four weeks prior to starting the IF intervention are eligible if they have recovered from acute effects of prior therapy to near baseline as determined by the treating physician. 9. Subjects on a targeted therapy, such as cyclin-dependent kinase (CDK) 4/6 inhibitor, or selective estrogen receptor degrader (SERD), or other clinical trial participants in the adjuvant setting are eligible at the discretion of the treating physician. 10. Subject co-administered with any prescriptions that may cause dizziness, hypoglycemia, or hypotension need to be evaluated and deemed eligible by the treating physician. 11. Adequate hepatic, renal function and adequate bone marrow reserve as determined by the treating physician: 1. aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit. 2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with Gilbert's syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN. 3. alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit with exception that ALP of \< 5 × ULN is acceptable in patients with elevated with ALP due to bone metastases (in the absence of liver metastases). 4. Serum creatinine \<1.5 × ULN. 5. Absolute neutrophil count (ANC) ≥1000/µL. 6. Subjects with lymphopenia are eligible at the discretion of the treating provider. 12. Premenopausal woman: 1. Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status. 2. Subjects must agree not to conceive throughout the study and must use accepted methods of contraception. 3. Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment. 13. Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting. 14. Ability to understand a written informed consent document, and the willingness to sign it.	1. Subject who works late night shifts. 2. Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year. 3. Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa). 4. Presence of diabetes. 5. Presence of chronic dizziness or vertigo. 6. Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia). 7. Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes). 8. Poorly controlled co-existing cardiac disease as determined by the treating physician, such as chronic hypotension, symptomatic congestive heart failure (New York Heart Association III-IV), unstable angina, arrythmia (e.g., atrial fibrillation, bradycardia, tachycardia). 9. History of heavy alcohol use as determined by the treating physician. 10. History of liver disease (cirrhosis, active hepatitis) or chronic renal disease. 11. Untreated or active infections such as hepatitis, human immunodeficiency virus (HIV), chronic unhealed infections. 12. Clinically significant illness or systemic disease as determined by the treating physician. 13. Recent hospitalization for a major illness, as determined by the treating physicians, within one month of enrollment. 14. Subject who is pregnant or breastfeeding. Subjects who become pregnant while on the study will be excluded.

Inclusion Criteria

Exclusion Criteria

1. Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period.
2. Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III).
1. Progesterone receptor positive or negative patients are allowed.
2. Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negative breast cancer is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization fluorescence in situ hybridisation (FISH), chromogenic in situ hybridization (CISH), or silver-enhanced in situ hybridization (SISH) test is required.
3. Body mass index (BMI) ≥ 25.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
5. Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment.
6. Subjects who received neoadjuvant or adjuvant chemotherapy must have recovered completely from chemotherapy-related side effects such as nausea/emesis as determined by the treating providers.
7. Subjects who received neoadjuvant endocrine therapy are eligible only after completion of their definitive surgery (i.e., when ready to start adjuvant endocrine therapy) and treating provider ensures complete closure and healing of surgical incisions.
8. Subjects who had adjuvant systemic chemotherapy within two to four weeks prior to starting the IF intervention are eligible if they have recovered from acute effects of prior therapy to near baseline as determined by the treating physician.
9. Subjects on a targeted therapy, such as cyclin-dependent kinase (CDK) 4/6 inhibitor, or selective estrogen receptor degrader (SERD), or other clinical trial participants in the adjuvant setting are eligible at the discretion of the treating physician.
10. Subject co-administered with any prescriptions that may cause dizziness, hypoglycemia, or hypotension need to be evaluated and deemed eligible by the treating physician.
11. Adequate hepatic, renal function and adequate bone marrow reserve as determined by the treating physician:
1. aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit.
2. Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with Gilbert's syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN.
3. alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit with exception that ALP of \< 5 × ULN is acceptable in patients with elevated with ALP due to bone metastases (in the absence of liver metastases).
4. Serum creatinine \<1.5 × ULN.
5. Absolute neutrophil count (ANC) ≥1000/µL.
6. Subjects with lymphopenia are eligible at the discretion of the treating provider.
12. Premenopausal woman:
1. Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status.
2. Subjects must agree not to conceive throughout the study and must use accepted methods of contraception.
3. Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment.
13. Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting.
14. Ability to understand a written informed consent document, and the willingness to sign it.

1. Subject who works late night shifts.
2. Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year.
3. Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).
4. Presence of diabetes.
5. Presence of chronic dizziness or vertigo.
6. Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia).
7. Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes).
8. Poorly controlled co-existing cardiac disease as determined by the treating physician, such as chronic hypotension, symptomatic congestive heart failure (New York Heart Association III-IV), unstable angina, arrythmia (e.g., atrial fibrillation, bradycardia, tachycardia).
9. History of heavy alcohol use as determined by the treating physician.
10. History of liver disease (cirrhosis, active hepatitis) or chronic renal disease.
11. Untreated or active infections such as hepatitis, human immunodeficiency virus (HIV), chronic unhealed infections.
12. Clinically significant illness or systemic disease as determined by the treating physician.
13. Recent hospitalization for a major illness, as determined by the treating physicians, within one month of enrollment.
14. Subject who is pregnant or breastfeeding. Subjects who become pregnant while on the study will be excluded.

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505

cccto@mcw.edu

Principal Investigator

Sailaja Kamaraju, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Sailaja Kamaraju, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-24

Study Completion Date2027-07-15

Study Record Updates

Study Start Date2024-07-24

Study Completion Date2027-07-15

Terms related to this study

Keywords Provided by Researchers

intermittent fasting
obesity
overweight
breast cancer
hormone receptor positive
HER2-negative
human epidermal growth factor receptor 2-negative
HR-positive
HR+/HER2-
early breast cancer
adjuvant endocrine therapy

Additional Relevant MeSH Terms

Breast Cancer