Prolonged Nightly Fasting in Breast Cancer Survivors
- Conditions
- FastingBreast Cancer RecurrentBreast CancerSurvivorship
- Interventions
- Behavioral: Fasting
- Registration Number
- NCT04330339
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
This study is being done to examine whether fasting for 13 hours every night is feasible and if it can help breast cancer survivors lose weight and improve their health.
* Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring. Recent research suggests that prolonged nighttime fasting (\>13 hours) may improve the risk of recurrence for breast cancer.
* This study will examine if fasting for 13 hours per night is doable for participants and will also study what the effect of fasting is on quality of life, mood, fatigue, body size, and markers of health in the blood.
- Detailed Description
This research study involves fasting (not eating any food or drinking fluids that contain calories) for 13 hours nightly for 12 weeks.
* It is expected that about 40 people will take part in this research study.
* Eligible participants will undergo baseline assessments prior to starting the intervention.
* Baseline assessments include measurements of weight, height, quality of life, fatigue, mood, levels of physical activity, and blood markers.
* Assessments will be repeated at the completion of the 12-weeks
This is a a Feasibility Study, which means this is the first time that investigators are examining prolonged nightly fasting and its effect on breast cancer survivors body size, blood markers, quality of life, emotional regulation, fatigue and level of physical activity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
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Participants must have a documented history of histologically confirmed invasive breast cancer.
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Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease.
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A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides.
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No evidence of distant metastatic disease or unresectable locally recurrent disease
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All adjuvant or neoadjuvant cytotoxic chemotherapy, radiation, and surgery for breast cancer must have been completed at least 6 month prior to registration. Except:
- Adjuvant hormonal therapy is permitted. Must have been on for a minimum of 1 month.
- Adjuvant trastuzumab, pertuzumab, TDM1, or neratinib for Her2 positive breast cancer is permitted Age ≥18 years.
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Participant must be female.
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Ability to understand and the willingness to sign a written informed consent document
- Distant metastatic breast cancer (Stage IV breast cancer) or unresectable locally recurrent disease
- Participants with diabetes mellitus.
- Participants with a pre-existing eating disorder (anorexia nervosa, bulimia)
- Participants with a BMI< 19kg/m2 or a weight loss of 5% in the last month or 10% in the last 3 months.
- Participants using weight loss medications at the time of study enrollment.
- Participants using oral steroids at the time of enrollment.
- Participants who are receiving any other investigational agents. Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because the effects of prolonged fasting on the fetus are not known.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fasting Fasting * Eligible participants will undergo baseline assessments prior to starting the intervention. * Baseline assessments include measurements of weight, height, quality of life, fatigue, mood, levels of physical activity, and blood markers. * Participants will fast for 13 hours nightly for 12 weeks. * Assessments will be repeated at the completion of the 12-week intervention.
- Primary Outcome Measures
Name Time Method Percentage of Participants adhere to 13 hours of fasting 12 weeks Feasibility will be demonstrated if ≥60% of participants adhere to 13 hours of fasting nightly at least 70% of the nights during the intervention.
Adherence will be assessed through patient-reported fasting logs.
- Secondary Outcome Measures
Name Time Method Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression) 6 and 12 weeks Effects of prolonged nightly fasting on psychological well-being using The Hospital Anxiety and Depression Scale (HADS). Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)
Change in hemoglobin A1c (%) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%)
Change in body mass index (BMI) (kg/m^2) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (kg/m\^2). Body mass index calculated using patient height (meters) and weight (kilograms) measured at baseline and at the completion of the study intervention. BMI = weight in kilograms divided by the square of height in meters.
Change in physical activity using the Godin Leisure-Time Exercise Questionnaire 6 and 12 weeks Calculated score where patient-reported weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula:
Weekly leisure activity score = (9 x Strenuous) + (5 x Moderate) + (3 x Light)Change in interleukin-6 (pg/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL
Change in adiponectin level (microgram/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL)
Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G) 6 and 12 weeks FACT-G is a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences)
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue 6 and 12 weeks 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Higher scores represent better functioning or less fatigue.Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences
Change in lipid profile 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL).
Change in tumor necrosis factor alpha (pg/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL
Change in leptin (ng/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)
Change in c-reactive protein (mg/L) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD)
Change in insulin (mcU/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL)
Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL)
Change in insulin-like growth factor (ng/mL) 12 weeks Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL)
Trial Locations
- Locations (1)
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States