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
• Interventions: Behavioral: Prolonged Overnight Fasting; Behavioral: Moderate-Intensity Exercise; Behavioral: General Health Education Sessions

• 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.

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: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• 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 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)- metastatic or locally advanced unresectable breast cancer
6. Initiating first-line or second-line endocrine therapy in combination with a CDK4/6 inhibitor (e.g. palbociclib, ribociclib or abemaciclib). Participants can be enrolled up to 2 weeks after starting CDK4/6 inhibitor
7. Having not consistently 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 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. Unstable bone metastases
8. More than 15 days from initiation of first- or second-line endocrine therapy in combination with a CDK4/6 inhibitor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Prolonged Overnight Fasting and Exercise (POF+EXE) Group	Prolonged Overnight Fasting	Participants in this group will undergo a 12-week combined program of the prolonged overnight fasting and exercise interventions as described in the POF Alone and EXE Alone arm descriptions respectively. Participants will complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints. Total participation is about 12 months.
Prolonged Overnighting Fasting Alone (POF Alone) Group	Prolonged Overnight Fasting	Participants in this group will undergo a 12-week program of prolonged overnight fasting (POF), and weekly session with a trained health coach. Sessions may be delivered in-person, by telephone or by video call. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints. Total participant duration is about 12 months.
Exercise Alone (EXE Alone) Group	Moderate-Intensity Exercise	Participants in this group will undergo a 12-week exercise program during three weekly sessions supervised by a trained health coach. Sessions may be delivered in-person, or virtually via telehealth. Participants will also complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints. Total participant duration is about 12 months.
Prolonged Overnight Fasting and Exercise (POF+EXE) Group	Moderate-Intensity Exercise	Participants in this group will undergo a 12-week combined program of the prolonged overnight fasting and exercise interventions as described in the POF Alone and EXE Alone arm descriptions respectively. Participants will complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints. Total participation is about 12 months.
Attention Control (AC) Group	General Health Education Sessions	Participants in this group will receive other supportive care in the form of general health education sessions with a trained health coach. These bi-weekly sessions will be administered via telephone or video call in six (6) sessions over approximately 12 weeks. Participants will also complete health-related quality of life questionnaires at designated study timepoints. Total participation is about 12 months.

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