Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Fatigue

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

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.

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.

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.

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.

Participants will undergo a 12-week program of prolonged overnight fasting (POF) during which they will abstain from consuming food or drink after 8pm, and wait 12 to 14 hours before resuming eating the next day. Participants will fast overnight for six nights each week, with one night off, and log their fasting start and stop times and timing of food intake daily via text messaging, or via study-provided app accessible by web browser or smart phone, or via paper journal returned by mail at the end of each month.

Participants will also complete one weekly session with a health coach to review their fasting log and any barriers to and/or facilitators of meeting the POF goals. Sessions may be delivered in-person, by telephone, or by video call based on participant preference. Sessions will last 15 to 30 minutes each, for a total of 12 sessions.

Participants will be provided with a notebook with information and support to encourage meeting the POF goals.

Prolonged Overnight Fasting

Participants will undergo a 12-week program consisting of three weekly sessions of moderate-to-vigorous aerobic and resistance exercises, under the supervision of a health coach. Sessions may be delivered either in-person or virtually via telehealth. Sessions will be tailored to the individual participant based on fitness level and symptoms at study entry, and limited to daylight hours as much as possible. Each session will last 30 to 50 minutes, as tolerated by the participant, for a total of 36 sessions.

Participants will receive a Fitbit device to track their activity, and to provide heart rate monitoring during each session. Participants without access to wi-fi will be loaned cellular-enabled tablets to allow them to participate in telehealth sessions. Participants will also receive a notebook with information and support to encourage exercise.

Moderate-Intensity Exercise

Participants will receive a general health education resource manual at study entry, followed by six bi-weekly sessions with a health coach to review the information. Six topics, one topic for each session, will be selected based on topics of potential interest to a population living with advanced breast cancer, focusing on general nutrition, healthy lifestyle, and quality of life, with no discussion of prolonged overnight fasting or exercise. Each session, administered via telephone or video call, will last about 15 to 30 minutes, and have a specific topic and call script for the health coach to follow to minimize any intervention drift and/or contamination. Participants will receive a Fitbit activity monitoring device and additional study materials at the end of their participation in the study.

General Health Education Sessions

Grey Freylersythe, BS

Tracy E Crane, PhD, RDN

Dorothy Sears, PhD

Carmen Calfa, MD

Christina Dieli-Conwright, PhD, MPI

Jennifer Ligibel, MD, MPI

Michael Rosenthal, MD

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.

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

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

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.

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 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 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 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 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.

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.

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) 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 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 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.

National Cancer Institute (NCI)

University of Miami

Pending Rank at Research Associate Professor

Participants randomized to the fasting arm will be instructed on how to use the SMS texting app to indicate the beginning and end of the nightly fast. In the first 2-4 weeks following the first overnight fast, intervention participants will complete three phone calls with study staff trained in motivational interviewing. These calls will be used to reinforce the prolonged overnight fasting instructions, identify barriers to prolonged overnight fasting, and support successes where they have occurred.

Participants randomized to the usual care arm will be instructed to eat a heart-healthy diet and exercise for at least 30 minutes five days a week, which is usual counseling in our clinics.

Three phone calls using motivational interviewing, support via SMS text.

prolonged overnight fasting

Eat a heart-healthy diet and exercise for at least 30 minutes five days a week

usual care

Danielle Friedman, MD, MS

Chaya Moskowitz, PhD

The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.

The OnFACT study is a pilot randomized controlled trial of prolonged overnight fasting among adult survivors of childhood cancer.

Overnight Fasting After Completion of Therapy: The OnFACT Study

Proportion of registered participants who successfully complete the 6-month intervention

Assess the effect of prolonged overnight fasting on glucose metabolism, measured by glycosylated hemoglobin (HbA1c).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer	NCT06123988	HER2-positive B... Advanced Breast...	Prolonged Overn... Moderate-Intens... General Health ...	18 Years -	University of Miami
Overnight Fasting After Completion of Therapy: The OnFACT Study	NCT03523377	Childhood Cance...	prolonged overn... usual care	18 Years -	Memorial Sloan Kettering Cancer Center

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