HER2-positive Breast CancerFastERNCT06123988
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
A study testing Prolonged Overnight Fasting, Moderate-Intensity Exercise and General Health Education Sessions in people with HER2-positive Breast Cancer and Advanced Breast Cancer, run by University of Miami at 3 sites in United States.
Trial summary
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Prolonged Overnight Fasting, Moderate-Intensity Exercise and General Health Education Sessions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Sep 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Postmenopausal (including concurrent use of ovarian suppression)
- Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
- Initiation of 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) or Protein kinase B (AKT) inhibitor, within the past 90 days.
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- 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 subsequent CDK4/6 inhibitor in the metastatic or locally advanced setting.
- 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
- Having not consistently engaged in resistance training 2 or more days per week over the past 3 months
- 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
- Approval from a medical oncology provider to participate.
Who cannot join
- Unable to provide consent
- Unable to read or understand English or Spanish
- Dependent on supplemental oxygen
- Unstable cardiac disease
- Insulin-dependent diabetes
- Unable to walk 2 blocks without assistance (excluding canes)
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- Regularly maintaining a shiftwork schedule, i.e. working evening shifts, night shifts, or rotating shifts in the last 3 months
- History of a clinical eating disorder
- Unstable bone metastases
- More than 90 days since initiation of 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/AKT inhibitor, in the metastatic or locally advanced.
- Presence of a severe medical condition or psychiatric condition or medications that would preclude participation of the study intervention.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPI, (617) 632-6405, christinam_dieliconwright@dfci.harvard.edu
Jennifer Ligibel, MD, MPI, 617-632-5702, jennifer_ligibel@dfci.harvard.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Grey Freylersythe, BS, (305) 243-9832, g.freylersythe@med.miami.edu
Tracy E Crane, PhD, RDN, (305) 243-8255, tecrane@med.miami.edu
- Not yet recruiting
Arizona State University
Phoenix, Arizona, 85004
Dorothy Sears, PhD, (602) 496-3351, dorothy.sears@asu.edu
Dorothy Sears, PhD
About this study
Official title: Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer (FastER)
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.
- Being tested
- Prolonged Overnight Fasting, Moderate-Intensity Exercise, General Health Education Sessions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Overnight FastingBehavioural
Also called Intermittent fasting
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.
Moderate-Intensity ExerciseBehavioural
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.
General Health Education SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Overnighting Fasting Alone (POF Alone) Group | Experimental | 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 receive a Fitbit (activity monitor). 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. Receives: Behavioral: Prolonged Overnight Fasting |
| Exercise Alone (EXE Alone) Group | Active comparator | 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. 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. Receives: Behavioral: Moderate-Intensity Exercise |
| Prolonged Overnight Fasting and Exercise (POF+EXE) Group | Active comparator | 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. Participants will complete health-related quality of life questionnaires, and undergo blood sample collection at designated study timepoints.
Total participation is about 12 months. Receives: Behavioral: Prolonged Overnight Fasting; Behavioral: Moderate-Intensity Exercise |
| Attention Control (AC) Group | Other | 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 receive a Fitbit (activity monitor). Participants will also complete health-related quality of life questionnaires at designated study timepoints.
Total participation is about 12 months. Receives: Behavioral: General Health Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores
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.
Measured: Baseline, 12 weeks
Secondary outcomes (10)
Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Quality of Life as Measured by EORTC QLQ-C30 Scores
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Physical Function as Measured by Short Physical Performance Battery (SPPB) Test
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Body Composition measured in Hounsfield using CT Scan
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Body Composition as measured in Hounsfield using PET Scan
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.
Measured: Baseline, 12 weeks, 6 months, and 12 months
Change in Levels of Interleukin-6 (IL-6)
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.
Measured: Baseline, 12 weeks, 6 months and 12 months
Change in Levels of Tumor necrosis factor alpha (TNF-α) levels
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.
Measured: Baseline, 12 weeks, 6 months and 12 months
Change in Levels of C-reactive protein (CRP)
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.
Measured: Baseline, 12 weeks, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start9 Sep 2024
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Tracy E Crane, PhD, RDN, University of Miami
- Investigators
- Tracy E Crane, PhD, RDN, Principal investigator, University of MiamiCarmen Calfa, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123988
- Sponsor's protocol ID
- 20230599
- Other IDs
- R01CA281861, NCI-2024-08363
- Acronym
- FastER
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer (FastER)
- ClinicalTrials.gov ID
- NCT06123988
- Acronym / sponsor ID
- FastER / 20230599
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) alongwith endocrine therapy with or without a PI3K or AKT inhibitor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prolonged Overnighting Fasting Alone (POF Alone) Group | Experimental | Behavioral: Prolonged Overnight FastingParticipants 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 receive a Fitbit (activity monitor). 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 | Active comparator | Behavioral: Moderate-Intensity ExerciseParticipants 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. 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 | Active comparator | Behavioral: Prolonged Overnight Fasting, Behavioral: Moderate-Intensity ExerciseParticipants 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 receive a Fitbit (activity monitor). Participants will receive exercise equipment (resistance bands, adjustable dumbbells, and a stationary aerobic bike) free of charge and may keep it after the study's completion. 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 | Other | Behavioral: General Health Education SessionsParticipants 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 receive a Fitbit (activity monitor). Participants will also complete health-related quality of life questionnaires at designated study timepoints. Total participation is about 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women
- Able to provide written informed consent
- Able to speak, read, and understand English or Spanish
- Postmenopausal (including concurrent use of ovarian suppression)
- Diagnosis of ER+ and/or PR+, hormone estrogen receptor-2 (HER-2)- or HER-2+ metastatic or locally advanced unresectable breast cancer
Key exclusion criteria (11 listed)
- Unable to provide consent
- Unable to read or understand English or Spanish
- Dependent on supplemental oxygen
- Unstable cardiac disease
- Insulin-dependent diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Overnight FastingAlso: Intermittent fastingParticipants 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. | Behavioural | Prolonged Overnight Fasting and Exercise (POF+EXE) Group, Prolonged Overnighting Fasting Alone (POF Alone) Group |
| Moderate-Intensity ExerciseParticipants 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. | Behavioural | Exercise Alone (EXE Alone) Group, Prolonged Overnight Fasting and Exercise (POF+EXE) Group |
| General Health Education SessionsParticipants 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. | Behavioural | Attention Control (AC) Group |
Primary outcome
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores
Time frame: 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.
10 secondary outcomes
Change in Sleep Quality as Measured by Pittsburgh Sleep Quality Index (PSQI) Scores
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Incidence of Toxicity as Measured by PRO-CTCAE Scores
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Levels of Psychological Distress as Measured by Patient Health Questionnaire (PHQ-4) Scores
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Quality of Life as Measured by EORTC QLQ-C30 Scores
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Physical Function as Measured by Short Physical Performance Battery (SPPB) Test
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Body Composition measured in Hounsfield using CT Scan
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Body Composition as measured in Hounsfield using PET Scan
Time frame: Baseline, 12 weeks, 6 months, and 12 months
Change in Levels of Interleukin-6 (IL-6)
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in Levels of Tumor necrosis factor alpha (TNF-α) levels
Time frame: Baseline, 12 weeks, 6 months and 12 months
Change in Levels of C-reactive protein (CRP)
Time frame: Baseline, 12 weeks, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy E Crane, PhD, RDN principal investigator
University of Miami
Carmen Calfa, MD principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Overnight Fasting, Moderate-Intensity Exercise and General Health Education Sessions in people with HER2-positive Breast Cancer and Advanced Breast Cancer, run by University of Miami at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grey Freylersythe, BS ((305) 243-9832, g.freylersythe@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer-Related Fatigue as Measured by EORTC QLQ-C30 Scores (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.