Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

Not Applicable

Recruiting

• Conditions: Advanced Breast Cancer; HER2-positive Breast Cancer

• Registration Number: NCT06123988
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to test if four different programs (prolonged overnighting fasting alone, exercise alone, a combination of prolonged overnight fasting and exercise, or general health education sessions alone) can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a cyclin-dependent kinases-4 and 6 (CDK4/6) inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without HER2-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a PI3K inhibitor, within the past 90 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Study Start: 2024-09-09
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-02
• Last Update Posted: 2025-08-06
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

1. Women

2. Able to provide written informed consent

3. Able to speak, read, and understand English or Spanish

4. Postmenopausal (including concurrent use of ovarian suppression)

5. Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer

6. Initiation of first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, or abemaciclib), with or without hormone estrogen receptor-2 (HER2)-directed therapy (e.g., trastuzumab ± pertuzumab), or in combination with both a CDK4/6 inhibitor and a Phosphoinositide 3-kinase (PI3K) inhibitor, within the past 90 days.

   1. Prior use of a CDK4/6 inhibitor in the adjuvant setting is permitted; participants must be enrolled within 90 days of starting a CDK4/6 inhibitor for the first or second time in the metastatic or locally advanced setting.
   2. Participants who switch from one CDK4/6 inhibitor to another due to toxicity or insurance constraints remain eligible, provided enrollment occurs within 90 days of initiating the first or second-line CDK4/6 inhibitor in the metastatic or locally advanced setting.

7. Having not consistently (not equal to or more than 50% of the time) engaged in more than 90 minutes of moderate or 45 minutes of vigorous physical activity per week over the past 3 months

8. Having not consistently engaged in resistance training 2 or more days per week over the past 3 months

9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months

10. Approval from a medical oncology provider to participate.

Exclusion Criteria

1. Unable to provide consent
2. Unable to read or understand English or Spanish
3. Oxygen dependent
4. Unstable cardiac disease
5. Insulin-dependent diabetes
6. Unable to walk 2 blocks without assistance (excluding canes)
7. Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
8. History of a clinical eating disorder
9. Unstable bone metastases
10. More than 90 days since initiation of first- or second-line endocrine therapy in combination with 1) a CDK4/6 inhibitor, with or without HER2-directed therapy, or 2) a CDK 4/6 inhibitor in combination with a PI3K inhibitor, in the metastatic or locally advanced.
11. Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores	Baseline, 12 weeks	Change in self-reported cancer-related fatigue as measured by participant scores on the European Organisation For Research And Treatment Of Cancer (EORTC) core quality of life questionnaire (QLQ) (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-administered, 30-item questionnaire used to measure cancer patients' health-related quality of life. The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For the raw score, less points are considered to have a better outcome.; For the questions 29 and 30, the EORTC-QLQ-30 uses a 7-points scale. The scale scores from 1 to 7: 1 ("Very poor") to 7 ("Excellent"). More points are considered to have a better outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Levels of Tumor necrosis factor alpha (TNF-α) levels	Baseline, 12 weeks, 6 months and 12 months	Change in levels of Tumor necrosis factor alpha (TNF-α) among participants across study arms will be measured in picograms per milliliter (pg/ml) via analyses of blood samples collected at designated study timepoints over a period of 12 months.
Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores	Baseline, 12 weeks, 6 months, and 12 months	Change in sleep quality among participants across study arms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-administered questionnaire for evaluating subjective sleep quality. PSQI global scores range from 0 to 21, with higher scores indicating worse sleep quality.
Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores	Baseline, 12 weeks, 6 months, and 12 months	Change in patient-reported outcomes among participants across study arms as measured by scores on the Patient Health Questionnaire (PHQ-4). The PHQ-4 is a self-administered, 4-item valid screening instrument for detecting psychological distress due to anxiety and/or depression in participants. Scores range from 0 to 12, with higher scores indicating greater psychological distress.
Change in Levels of C-reactive protein (CRP)	Baseline, 12 weeks, 6 months and 12 months	Change in levels of C-reactive protein (CRP) among participants across study arms will be measured in milligrams per liter (mg/L) via analyses of blood samples collected at designated study timepoints over a period of 12 months.
Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores	Baseline, 12 weeks, 6 months, and 12 months	Change in incidence of toxicity among study participants across all study arms as measured by scores on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire. The PRO-CTCAE was developed by the National Cancer Institute (NCI) to assess symptomatic adverse events (AEs) in adult patients receiving cancer therapy. The PRO-CTCAE is a self-administered questionnaire. The investigators will measure incidence of mouth/throat sores, taste changes, decreased appetite, nausea, vomiting, heartburn, constipation, diarrhea, abdominal pain, shortness of breath, neuropathy, concentration, memory, pain, insomnia, hot flashes, joint pain, and fatigue.
Change in Quality of Life as Measured by EORTC QLQ-C30 Scores	Baseline, 12 weeks, 6 months, and 12 months	Change in physical function and quality of life among study participants across all study arms will be measured by scores on the European Organisation For Research And Treatment Of Cancer (EORTC) core quality of life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a self-administered, 30-item questionnaire used to measure cancer patients' health-related quality of life. The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). For the raw score, less points are considered to have a better outcome.; For the questions 29 and 30, the EORTC-QLQ-30 uses a 7-points scale. The scale scores from 1 to 7: 1 ("Very poor") to 7 ("Excellent"). More points are considered to have a better outcome.
Change in Body Composition as measured in Hounsfield using PET Scan	Baseline, 12 weeks, 6 months, and 12 months	Body composition analysis is defined as the quantification of skeletal muscle versus subcutaneous, visceral, and intermuscular adipose tissue, measured using Hounsfield units based on attenuation and anatomic information. A positron emission tomography (PET) will be used to obtain this measure.
Change in Levels of Interleukin-6 (IL-6)	Baseline, 12 weeks, 6 months and 12 months	Change in levels of Interleukin-6 (IL-6) among participants across study arms will be measured in picograms per milliliter (pg/ml) via analyses of blood samples collected at designated study timepoints over a period of 12 months.
Change in Physical Function as Measured by Short Physical Performance Battery (SPPB) Test	Baseline, 12 weeks, 6 months, and 12 months	Change in physical function among participants across study arms as assessed by the Short Physical Performance Battery (SPPB). The SPPB is assessment tool for evaluation of lower extremity functioning, and will be administered at designated study timepoints over a period of 12 months. The SPPB score ranges from 1 to 12, with higher scores indicating better physical performance.
Change in Body Composition measured in Hounsfield using CT Scan	Baseline, 12 weeks, 6 months, and 12 months	Body composition analysis is defined as the quantification of skeletal muscle versus subcutaneous, visceral, and intermuscular adipose tissue, measured using Hounsfield units based on attenuation and anatomic information. A computerized tomography (CT) scan will be used to obtain this measure.

Trial Locations

Locations (3)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States