FastingNCT04330339
Prolonged Nightly Fasting in Breast Cancer Survivors
A study testing Fasting in people with Fasting and Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fasting, Breast Cancer, Survivorship
- What is being tested?
- Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2020to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
- Being tested
- Fasting
- Keywords
- Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
- Medical subject headings
- Fasting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingBehavioural
Fasting
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | * 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. Receives: Behavioral: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (15)
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.
Measured: 12 weeks
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)
Measured: 6 and 12 weeks
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)
Measured: 6 and 12 weeks
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
Measured: 6 and 12 weeks
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)
Measured: 6 and 12 weeks
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).
Measured: 12 weeks
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%)
Measured: 12 weeks
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)
Measured: 12 weeks
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
Measured: 12 weeks
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
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start24 Jul 2020
- Primary completion31 Jan 2021
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kully Family Foundation
- Responsible party
- Principal investigator, Elizabeth O'Donnell, Massachusetts General Hospital
- Investigators
- Elizabeth K O'Donnell, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330339
- Sponsor's protocol ID
- 19-586
- Status last verified
- Jul 2022
- First submitted
- 25 Mar 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35441995
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04330339
- Acronym / sponsor ID
- 19-586
- Conditions
- Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
- Keywords
- Fasting, Breast Cancer, Survivorship, Breast Cancer Recurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Kully Family Foundation
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 1 Apr 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| FastingFasting | Behavioural | Fasting |
Primary outcome
Percentage of Participants adhere to 13 hours of fasting
Time frame: 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.
15 secondary outcomes
Change in body mass index (BMI) (kg/m^2)
Time frame: 12 weeks
Quality of life (QOL) Change using the Functional Assessment of Cancer Therapy General Scale (FACT-G)
Time frame: 6 and 12 weeks
Change in Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety and/or depression)
Time frame: 6 and 12 weeks
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue
Time frame: 6 and 12 weeks
Change in physical activity using the Godin Leisure-Time Exercise Questionnaire
Time frame: 6 and 12 weeks
Change in lipid profile
Time frame: 12 weeks
Change in hemoglobin A1c (%)
Time frame: 12 weeks
Change in c-reactive protein (mg/L)
Time frame: 12 weeks
Change in interleukin-6 (pg/mL)
Time frame: 12 weeks
Change in tumor necrosis factor alpha (pg/mL)
Time frame: 12 weeks
Change in insulin (mcU/mL)
Time frame: 12 weeks
Change in leptin (ng/mL)
Time frame: 12 weeks
Change in adiponectin level (microgram/mL)
Time frame: 12 weeks
Change in insulin-like growth factor (ng/mL)
Time frame: 12 weeks
Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Results publication: PubMed 35441995O'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.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Elizabeth K O'Donnell principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Fasting and Breast Cancer, run by Massachusetts General Hospital at 1 site 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants adhere to 13 hours of fasting (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330339, which also lists 1 linked publication.
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 21 Jul 2022.