Trial Title:
4:3 Intermittent Fasting Intervention in Adults with Breast Cancer and Overweight or Obesity
NCT ID:
NCT06399276
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Overweight
Conditions: Keywords:
Overweight
Obese
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Weight Loss
Description:
Participants are instructed to perform a modified fast (~500 kcal) on 3 days/week with ad
libitum intake the other 4 days/week. Group-based behavioral support sessions will be
held by an experienced Registered Dietician. Participants will attend BfitBwell exercise
sessions in person and virtually to receive individualized support to progress to 150
min/wk of moderate-intensity physical activity
Arm group label:
Behavioral Weight Loss Focused on Intermittent Fasting
Summary:
This is a 3 month single arm pilot and feasibility study designed to examine the impact
of an intermittent fasting lifestyle weight loss intervention on pre-specified clinical
milestones (change in body weight, adherence to the fasting program, and moderate-to
vigorous physical activity, MVPA) in adults with overweight and obesity and breast cancer
after they have completed their cancer treatment. The investigators will also evaluate
feasibility of recruitment and retention of study participants, safety of the
intervention, and obtain feedback from participants to improve the program. Participants
will receive a 3 month lifestyle weight loss program focusing on a 4:3 intermittent
fasting paradigm (3 modified fast days per week) and support to increase physical
activity to 150 minutes per week. Outcome measures will be assessed at the end of the 3
month intervention (primary endpoint) and after a 3 month weight maintenance follow up
phase.
Criteria for eligibility:
Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
- Age 18-65 years
- Body Mass Index 25-45 kg/m2
- Diagnosis of stage 1-3 breast cancer within the past 10 years with completion of
standard of care definitive surgery, adjuvant chemotherapy, radiation, immunotherapy
and/or targeted therapy as appropriate prior to the intervention start date.
Completion of definitive surgery must be ≥ 3 months prior to the intervention start
date, other therapies must be completed ≥ 1 month prior to the intervention start
date (however exceptions to this 1-month timeframe for completion of other therapies
can be made on a case-by-case basis by the PI if patients are tolerating therapy
without adverse effects and will have completed treatment prior to the intervention
start date). Current/ongoing use of anti-endocrine directed therapy for breast
cancer (including ovarian suppression, tamoxifen, aromatase inhibitors, selective
estrogen degraders) is acceptable as long as participants have been on therapy for
≥3 months prior to the intervention start date.
- Live or work within 30 miles of the AHWC (exceptions may be made at the discretion
of the Study PI on a case-by-case basis for highly motivated subjects).
- Capable and willing to give informed consent and understand exclusion criteria,
willing to attend weekly small group sessions held by a registered dietitian, and
attend one in person BfitBwell exercise sessions per week.
- Have a primary care provider (PCP) (or are willing to establish care with a PCP
prior to study enrollment) to address medical issues which may arise during
screening or study procedures/interventions.
- Obtain a signed medical clearance from their medical provider for participation in
the 4:3 IMF dietary intervention and BfitBwell clinical exercise oncology program.
- Own or willing to purchase a smart phone or computer to join Zoom meetings, complete
questionnaires, and access/download the True Coach virtual exercise coaching
sessions.
All interested individuals will complete a brief online eligibility screener through
REDCap to confirm initial eligibility.
Exclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher.
- Actively undergoing chemotherapy, radiation, immunotherapy and/or targeted therapy
(other than anti-endocrine therapy) or are within 1 month of completion of
chemotherapy, radiation, immunotherapy and/or targeted therapy (other than
anti-endocrine therapy) as of the target intervention start date. Exceptions to this
1-month timeframe can be made on a case-by-case basis at the discretion of the PI if
patients are tolerating therapy without adverse effects and will have completed
treatment prior to the intervention start date.
- Plans to relocate within the next 12 months.
- Plans for extended travel (>2 weeks) within the next 12 months.
- Major surgery within the past 3 months (including mastectomy or breast
reconstruction but not including lumpectomy or other minor surgeries) or planned
major surgery (including mastectomy or breast reconstruction) during the timeframe
of the 6 month study intervention and follow-up phases.
- For Females:
- Currently pregnant or lactating.
- Pregnant within the past 6 months.
- Planning to become pregnant in the next 12 months; sexually active women of
childbearing potential may be enrolled if they have had a tubal ligation or use
a reliable means of contraception.
- Recent (past 6 months) acute coronary event, unstable angina, coronary
revascularization, stroke, pulmonary embolism, or hospitalization for heart failure
or cardiac arrythmia.
- Symptoms suggestive of cardiovascular disease or unstable angina (e.g., chest pain,
shortness of breath at rest or with mild exertion, lightheadedness, syncope).
- Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic
blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate on
the screening visit after 5 minutes of rest in a seated position.
- Diabetes (history of type 1 or type 2 diabetes or fasting glucose ≥126 mg/dL or
Hemoglobin A1C ≥6.5% as measured on screening labs) unless on metformin or on
dipeptidyl peptidase IV (DPP-IV) inhibitor monotherapy and well-controlled with
Hemoglobin A1C <8%.
- Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured
on screening labs) or history of uncontrolled thyroid disorder. History of thyroid
disease or current thyroid disease treated with a stable medication regimen is
acceptable.
- Stage 4 or 5 chronic kidney disease as assessed by estimated glomerular filtration
rate <30 as measured on screening labs.
- Triglycerides >500 mg/dL or LDL cholesterol >200 mg/dL as measured on screening
labs.
- Serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or
more per min), ventricular tachycardia (defined as runs of 3 or more successive
PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, known QTc
interval > 480 msec or other significant conduction defects.
- Clinically significant abnormalities in hematocrit/hemoglobin, white blood cell
count, platelets, serum sodium, potassium, or bicarbonate as measured on screening
labs or presence or history of other metabolic or chronic health problems which
would impact ability to safely participate in a weight loss intervention involving
an intermittent energy restricted diet and exercise including significant cardiac
valvular disease or heart failure, significant gastrointestinal, pulmonary, renal,
musculoskeletal, neurologic, hematologic, orthopedic, or psychiatric disease.
- Sustained use of prescription or over-the-counter medications known to significantly
impact appetite, weight, or energy metabolism (e.g., anti-obesity pharmacotherapy,
appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic
antidepressants) with the exception of anti-endocrine directed treatment for breast
cancer and standard of care anti-emetic or anti-diarrheal agents.
- Sustained use of systemic glucocorticoids (current or in the past 6 months) unless
physiologic replacement therapy for adrenal insufficiency.
- Previous obesity treatment with metabolic bariatric surgery or weight loss device,
except: (1) liposuction and/or abdominoplasty if performed > 1 year before
screening, (2) lap banding if the band has been removed > 1 year before screening,
(3) intragastric balloon if the balloon has been removed > 1 year before screening
(4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before
screening or 5) AspireAssist or other endoscopically placed weight loss device if
the device has been removed > 1 year before screening.
- Nicotine use (current or past 6 months)
- Current alcohol or substance abuse.
- History of clinically diagnosed eating disorders including anorexia nervosa,
bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or
pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5)
suggestive of possible binge eating disorder or bulimia will require further
assessment by the Study MD to determine if it is appropriate for the subject to
participate in the study.
- Current severe depression or history of severe depression within the previous year,
based on DSM-IV-TR criteria for Major Depressive Episode or history of other
significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar
disorder) which in the opinion of the Study PI would interfere with ability to
participate in the diet and exercise interventions and provide feedback on the
interventions via questionnaires and focus groups.
- Currently participating in or planning to participate in any formal weight loss or
physical activity programs or clinical trials over the next 12 months.
- Previous participation (within the past 3 years) in the Anschutz Health and Wellness
Center (AHWC) BfitBwell Oncology Exercise Program (exceptions may be made at the
discretion of the study PI).
- Previous participation (within the past 3 years) in a weight loss, exercise, or
nutrition research study (exceptions may be made at the discretion of the study PI).
Children (individuals under the age of 18 years per NIH guidelines) will not be recruited
for the current studies because breast cancer is rare in children and because the
lifestyle weight management curriculum used in the study was not designed for children or
adolescents.
We have elected to exclude adults over the age of 65 years as weight loss may not be
advisable in older patients undergoing treatment for breast cancer or in routine
follow-up for breast cancer due to issues with loss of lean mass and decreases in
functional capacity that can occur with weight loss in older individuals. A separate
study on the impact of a lifestyle weight loss intervention in older patients with breast
cancer is warranted.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anschutz Health and Wellness
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Liza Wayland
Phone:
303-724-9096
Email:
liza.wayland@cuanschutz.edu
Contact backup:
Last name:
Victoria Catenacci, MD
Facility:
Name:
University of Colorado Anschutz Medical Campus
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Liza Wayland
Phone:
303-724-9096
Email:
liza.wayland@cuanschutz.edu
Contact backup:
Last name:
Bing
Contact backup:
Last name:
Victoria Catenacci, MD
Start date:
May 28, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06399276
