Back to resultsProlonged Nightly Fasting in Breast Cancer Survivors
Primary Purpose
Fasting, Breast Cancer, Survivorship
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting
Sponsored by
About this trial
This is an interventional supportive care trial for Fasting focused on measuring Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
Eligibility Criteria
Inclusion Criteria:
- Participants must have a documented history of histologically confirmed invasive breast cancer.
- Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease.
- A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides.
- No evidence of distant metastatic disease or unresectable locally recurrent disease
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.
- Participant must be female.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fasting
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants adhere to 13 hours of fasting
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
Change in body mass index (BMI) (kg/m^2)
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.
Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)
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 Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)
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 fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
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 physical activity using the Godin Leisure-Time Exercise Questionnaire
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 lipid profile
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 hemoglobin A1c (%)
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 c-reactive protein (mg/L)
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 interleukin-6 (pg/mL)
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 tumor necrosis factor alpha (pg/mL)
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 insulin (mcU/mL)
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 leptin (ng/mL)
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 adiponectin level (microgram/mL)
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)
Change in insulin-like growth factor (ng/mL)
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 homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
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)
Full Information
NCT ID
NCT04330339
First Posted
March 25, 2020
Last Updated
July 18, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Kully Family Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04330339
Brief Title
Prolonged Nightly Fasting in Breast Cancer Survivors
Official Title
Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
July 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Kully Family Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
Keywords
Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasting
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fasting
Intervention Description
Fasting
Primary Outcome Measure Information:
Title
Percentage of Participants adhere to 13 hours of fasting
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in body mass index (BMI) (kg/m^2)
Description
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.
Time Frame
12 weeks
Title
Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)
Description
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)
Time Frame
6 and 12 weeks
Title
Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)
Description
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)
Time Frame
6 and 12 weeks
Title
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
Description
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
Time Frame
6 and 12 weeks
Title
Change in physical activity using the Godin Leisure-Time Exercise Questionnaire
Description
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)
Time Frame
6 and 12 weeks
Title
Change in lipid profile
Description
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).
Time Frame
12 weeks
Title
Change in hemoglobin A1c (%)
Description
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%)
Time Frame
12 weeks
Title
Change in c-reactive protein (mg/L)
Description
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)
Time Frame
12 weeks
Title
Change in interleukin-6 (pg/mL)
Description
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
Time Frame
12 weeks
Title
Change in tumor necrosis factor alpha (pg/mL)
Description
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
Time Frame
12 weeks
Title
Change in insulin (mcU/mL)
Description
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)
Time Frame
12 weeks
Title
Change in leptin (ng/mL)
Description
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)
Time Frame
12 weeks
Title
Change in adiponectin level (microgram/mL)
Description
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)
Time Frame
12 weeks
Title
Change in insulin-like growth factor (ng/mL)
Description
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)
Time Frame
12 weeks
Title
Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
Description
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)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must have a documented history of histologically confirmed invasive breast cancer.
Participants with a history of stage I to III invasive breast cancer, and no current evidence of disease.
A history of bilateral breast cancer is allowed provided the patient is currently disease free, with stage I to III disease on both sides.
No evidence of distant metastatic disease or unresectable locally recurrent disease
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.
Participant must be female.
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth K O'Donnell
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Citations:
PubMed Identifier
35441995
Citation
O'Donnell E, Shapiro Y, Comander A, Isakoff S, Moy B, Spring L, Wander S, Kuter I, Shin J, Specht M, Kournioti C, Hu B, Sullivan C, Winters L, Horick N, Peppercorn J. Pilot study to assess prolonged overnight fasting in breast cancer survivors (longfast). Breast Cancer Res Treat. 2022 Jun;193(3):579-587. doi: 10.1007/s10549-022-06594-4. Epub 2022 Apr 20.
Results Reference
result
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Prolonged Nightly Fasting in Breast Cancer Survivors
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