Trial Title:
Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer
NCT ID:
NCT06123988
Condition:
HER2-positive Breast Cancer
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Prolonged Overnight Fasting
Description:
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.
Arm group label:
Prolonged Overnight Fasting and Exercise (POF+EXE) Group
Arm group label:
Prolonged Overnighting Fasting Alone (POF Alone) Group
Other name:
Intermittent fasting
Intervention type:
Behavioral
Intervention name:
Moderate-Intensity Exercise
Description:
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.
Arm group label:
Exercise Alone (EXE Alone) Group
Arm group label:
Prolonged Overnight Fasting and Exercise (POF+EXE) Group
Intervention type:
Behavioral
Intervention name:
General Health Education Sessions
Description:
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.
Arm group label:
Attention Control (AC) Group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona State University
Address:
City:
Phoenix
Zip:
85004
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Dorothy Sears, PhD
Phone:
(602) 496-3351
Email:
dorothy.sears@asu.edu
Contact backup:
Last name:
Dorothy Sears, PhD
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grey Freylersythe, BS
Phone:
(305) 243-9832
Email:
g.freylersythe@med.miami.edu
Contact backup:
Last name:
Tracy E Crane, PhD, RDN
Phone:
(305) 243-8255
Email:
tecrane@med.miami.edu
Contact backup:
Last name:
Tracy E Crane, PhD, RDN
Contact backup:
Last name:
Carmen Calfa, MD
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Dieli-Conwright, PhD, MPI
Phone:
(617) 632-6405
Email:
christinam_dieliconwright@dfci.harvard.edu
Contact backup:
Last name:
Jennifer Ligibel, MD, MPI
Phone:
617-632-5702
Email:
jennifer_ligibel@dfci.harvard.edu
Contact backup:
Last name:
Christina Dieli-Conwright, PhD, MPI
Contact backup:
Last name:
Jennifer Ligibel, MD, MPI
Contact backup:
Last name:
Michael Rosenthal, MD
Start date:
September 9, 2024
Completion date:
September 30, 2029
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123988
