Breast CancerNCT04708860
Feasibility of Fasting & Exercise in Pts With HR+ MBC
A study testing Prolonged Nightly Fasting and Exercise in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Prolonged Nightly Fasting and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to 31 Jul 2024
- 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
- Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
- Postmenopausal (including concurrent use of ovarian suppression)
- Initiating endocrine therapy in combination with:
- Cohort 1: alpelisib
- Cohort 2: palbociclib
- Self-reported ability to walk two blocks
Show all 9Show fewer
- > 18 years of age
- Approval from treating oncologist, confirmed via email or in writing
- Ability to read and understand English
Who cannot join
- Diagnosis of diabetes requiring medication
- Engaging in >90 minutes of moderate or vigorous physical activity per week
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients With Advanced, Hormone Receptor Positive Breast Cancer
This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
Read the detailed description
This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 kinase inhibitors in women with metastatic breast cancer (MBC).
Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.
The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.
Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.
It is expected that about 30 people will take part in this research study
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Prolonged Nightly Fasting, Exercise
- Keywords
- Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Nightly FastingBehavioural
Restriction of consumption of calorie-containing food/drinks after 8pm
ExerciseBehavioural
Personalized moderate-intensity, aerobic exercise and strength training
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Nightly Fasting Plus Exercise | Experimental | Participants will be grouped into two cohorts determined by whether they receive palbociclib or alpelisib as part of their breast cancer treatment and then receive a 12 week prolonged nightly fasting plus exercise program consisting of:
* Prolonged overnight fasting: Not consume any calorie-containing food/drinks after 8pm, waiting a minimum of 13 hours after their last meal of the day before eating the next day, target goal of fasting at least 6 days a week, daily record of first and last meals
* Exercise Program: Coach provided at-home, personalized exercise regimen with target goal of 120 minutes of moderate-intensity aerobic activity each week as well as two 30-45-minute virtual strength training classes per week, receive fitbit for exercise and heart rate monitoring, weekly telephone-based support sessions with coach. Receives: Behavioral: Prolonged Nightly Fasting; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of enrollment
The primary objective is to evaluate the feasibility of the intervention. Feasibility will be defined by the rate of enrollment and the intervention will be considered feasible if at least 80% of planned participants are enrolled within 12 months of study activation.
Measured: 12 months
Rate of adherence to prolonged overnight fasting (POF) intervention goals
Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.
Measured: 12 weeks
Rate of adherence to exercise intervention goals
Feasibility will also be defined by at least 70% of participants achieving 120 minutes of aerobic exercise plus 2 strength training classes per week by week 12.
Measured: 12 weeks
Secondary outcomes (3)
Changes in metabolic biomarkers between baseline and week 12
We will evaluate changes in fasting glucose, insulin, insulin resistance, hemoglobin A1c and other metabolic biomarkers in study participants between the baseline and end-of-intervention blood draws.
Measured: 12 weeks
Change in quality of life and patient-reported outcome measures between baseline and week 12
Quality of life will be evaluated for participants at baseline and at the end of the intervention using the EORTC QLQ C-30, sleep quality will be assessed via the Pittsburgh Sleep Quality Index (PSQI). Additional patient reported outcomes include the PRO-CTCAE, the 7-Day Physical Activity Recall and the 24-Hour Dietary Recall. We will assess changes in these measures between baseline and week 12 for study participants.
Measured: 12 weeks
Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)
We will explore potential differences in changes in metabolic markers over the course of the 12-week POF and exercise intervention by treatment group (alpelisib vs palbociclib).
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 posted14 Jan 2021
- Study start15 Jan 2021
- Primary completion30 Aug 2022
- Study completion31 Jul 2024
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 Dana-Farber Cancer InstituteThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer Ligibel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708860
- Sponsor's protocol ID
- 20-503
- Status last verified
- Aug 2024
- First submitted
- 4 Jan 2021
- Last updated
- 16 Aug 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients With Advanced, Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04708860
- Acronym / sponsor ID
- 20-503
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- Breast Cancer, Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Jan 2021 (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 research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.
Detailed description
This is single-arm feasibility pilot study exploring whether a combined prolonged nightly fasting (POF) and exercise program could impact hyperglycemia and other adverse metabolic consequences of PI3 kinase inhibitors in women with metastatic breast cancer (MBC).
Women who exercise regularly and who have lower levels of blood sugar and metabolic hormones like insulin have a lower risk of developing breast cancer. Some evidence also suggests that exercise and metabolism are related to cancer recurrence in women who are diagnosed with breast cancers that can be removed with surgery, but less is known about how exercise and metabolic factors are related to cancer progression in women whose cancer has advanced beyond the breast and underarm lymph nodes. This study is designed to look at the effects of exercise combined with prolonged nightly fasting (having a longer time between dinner and breakfast the next day), on blood sugar and hormones that control metabolism. This study looks to provide important information about whether making these kinds of changes is possible for women living with advanced breast cancer and will explore how making these changes effects blood sugar and hormone levels in women taking different kinds of treatments for advanced breast cancer.
The research study procedures include screening for eligibility, a baseline visit to collect information about diet and exercise habits, a baseline blood draw, participation in a 12-week diet and exercise program, and a follow up visit and blood collection at the end of the diet and exercise program.
Participants will be in this research study for up to 14-weeks, including the baseline and end of study visits to collect study measures.
It is expected that about 30 people will take part in this research study
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged Nightly Fasting Plus Exercise | Experimental | Behavioral: Prolonged Nightly Fasting, Behavioral: ExerciseParticipants will be grouped into two cohorts determined by whether they receive palbociclib or alpelisib as part of their breast cancer treatment and then receive a 12 week prolonged nightly fasting plus exercise program consisting of: * Prolonged overnight fasting: Not consume any calorie-containing food/drinks after 8pm, waiting a minimum of 13 hours after their last meal of the day before eating the next day, target goal of fasting at least 6 days a week, daily record of first and last meals * Exercise Program: Coach provided at-home, personalized exercise regimen with target goal of 120 minutes of moderate-intensity aerobic activity each week as well as two 30-45-minute virtual strength training classes per week, receive fitbit for exercise and heart rate monitoring, weekly telephone-based support sessions with coach. |
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)
- Diagnosis of ER and/or PR+ metastatic or locally unresectable breast cancer
- Postmenopausal (including concurrent use of ovarian suppression)
- Initiating endocrine therapy in combination with:
- Self-reported ability to walk two blocks
- > 18 years of age
Key exclusion criteria (2 listed)
- Diagnosis of diabetes requiring medication
- Engaging in >90 minutes of moderate or vigorous physical activity per week
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 |
|---|---|---|
| Prolonged Nightly FastingRestriction of consumption of calorie-containing food/drinks after 8pm | Behavioural | Prolonged Nightly Fasting Plus Exercise |
| ExercisePersonalized moderate-intensity, aerobic exercise and strength training | Behavioural | Prolonged Nightly Fasting Plus Exercise |
Primary outcome
Rate of enrollment
Time frame: 12 months
The primary objective is to evaluate the feasibility of the intervention. Feasibility will be defined by the rate of enrollment and the intervention will be considered feasible if at least 80% of planned participants are enrolled within 12 months of study activation.
Rate of adherence to prolonged overnight fasting (POF) intervention goals
Time frame: 12 weeks
Feasibility will additionally be defined by participants achieving POF intervention goals on 70% of days by week 12.
Rate of adherence to exercise intervention goals
Time frame: 12 weeks
Feasibility will also be defined by at least 70% of participants achieving 120 minutes of aerobic exercise plus 2 strength training classes per week by week 12.
3 secondary outcomes
Changes in metabolic biomarkers between baseline and week 12
Time frame: 12 weeks
Change in quality of life and patient-reported outcome measures between baseline and week 12
Time frame: 12 weeks
Differences in changes in metabolic biomarkers by treatment group (palbociclib vs palbocilib)
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 16 Aug 2024.
- 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.
Jennifer Ligibel, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Nightly Fasting and Exercise in people with Breast Cancer and Metastatic Breast Cancer, run by Dana-Farber Cancer Institute 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 2 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 16 Aug 2024. 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?
Rate of enrollment (time frame: 12 months). The study lists 3 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 16 Aug 2024.