Breast CancerEFFECT-BCNCT04691999
The Effect of Intermittent Fasting on Body Composition in Women With Breast Cancer
A study testing Intermittent Fasting in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to Aug 2023
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III
- completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted)
- BMI > 25 kg/m2 or body fat% greater or equal to 31%
- have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist
- have access to the internet and email with capability to join Zoom calls
Who cannot join
- Metastatic breast cancer
- Currently receiving chemotherapy
- Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.9.
- Diabetic condition requiring the usage of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Intermittent Fasting
- Keywords
- intermittent fasting
- Medical subject headings
- Breast Neoplasms, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
16-18 hour fasting period four times per week
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Receives: Behavioral: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intermittent fasting program
as determined by the proportion of fasting days met divided by the total fasting days planned for each participant
Measured: 6 months
Change in body fat
as measured by mean change in percent body fat between baseline and 6 months
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start2 Dec 2021 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: The PI is leaving Duke for a position in another state.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Champ, MD CSCS, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691999
- Sponsor's protocol ID
- Pro00107216
- Acronym
- EFFECT-BC
- Status last verified
- Nov 2021
- First submitted
- 29 Dec 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT-BC: The EFFECT of Intermittent Fasting on Body Composition in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04691999
- Acronym / sponsor ID
- EFFECT-BC / Pro00107216
- Conditions
- Breast Cancer
- Keywords
- intermittent fasting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is leaving Duke for a position in another state.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 31 Dec 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.
The objective of this study is to evaluate intermittent fasting after the treatment of breast cancer with surgery and radiation therapy. All participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. Over six months, the innovative protocol will 1) assess adherence, and is expected to 2) improve body composition, quality of life and inflammatory and metabolic variables linked with outcomes after breast cancer treatment. The long-term goal of this project is to incorporate this dietary strategy as a standard component of care for breast cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Behavioral: Intermittent FastingAll participants will either delay their first meal of the day or advance their last meal to achieve an approximate 16-18 hour fasting period four times per week. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast stage I-III
- completed any chemotherapy prior to initiation of the trial (adjuvant endocrine therapy is permitted)
- BMI > 25 kg/m2 or body fat% greater or equal to 31%
- have a schedule amenable to nutrition and dietitian counseling described within the study protocol as determined by the treating radiation oncologist
- have access to the internet and email with capability to join Zoom calls
Key exclusion criteria (4 listed)
- Metastatic breast cancer
- Currently receiving chemotherapy
- Uncontrolled hypertension or diabetes, defined as systolic blood pressure over 149, diastolic blood pressure over 99, or hemoglobin A1c greater than 8.9.
- Diabetic condition requiring the usage of insulin
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 |
|---|---|---|
| Intermittent Fasting16-18 hour fasting period four times per week | Behavioural | Intermittent Fasting |
Primary outcome
Adherence to the intermittent fasting program
Time frame: 6 months
as determined by the proportion of fasting days met divided by the total fasting days planned for each participant
Change in body fat
Time frame: baseline, 6 months
as measured by mean change in percent body fat between baseline and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Colin Champ, MD CSCS principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Breast Cancer, run by Duke University 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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 23 Nov 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Adherence to the intermittent fasting program (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2021.