Breast CancerEXCAP-hEATNCT07529353
Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .
A study testing EXCAP Exercise Program and 10-Hour Healthy Eating Timeframe (hEAT) in people with Breast Cancer and Cancer Related Fatigue, run by University of Rochester at 1 site in United States.
Trial summary
This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer Related Fatigue
- What is being tested?
- EXCAP Exercise Program and 10-Hour Healthy Eating Timeframe (hEAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be aged 18 years or older
- Must have a confirmed diagnosis of breast cancer (stage I-IIIC)
- Must have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 2 - 120 months prior to enrolling,
- Must be prescribed adjuvant endocrine therapy,
- Must have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Symptom Inventory
- Must have a body mass index greater than or equal to 25 kg per meter squared
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- Must have the ability to ambulate independently
- Must be willing and able to participate in home-based exercise and eating timeframe intervention
- Must have the ability to read and understand the English language,
Who cannot join
- Must not have metastatic or recurrent breast cancer
- Must not be currently receiving chemotherapy or radiation therapy
- Must not have a medical condition that would preclude safe participation in intervention or study procedures
- Must not be pregnant, or planning to become pregnant during the study period
- Must not be in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form,
- Must not have any condition that in the opinion of the investigator would interfere with participation or safety
- Must not be currently using, or plan to initiate use of prescription or over-the-counter weight-loss medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wilmot Cancer Institute
Rochester, New York, 14642
Lindsey Mattick, PhD MS, 5852740473, Lindsey_Mattick@urmc.rochester
About this study
Official title: Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.
This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.
- Conditions
- Breast Cancer, Cancer Related Fatigue
- Being tested
- EXCAP Exercise Program, 10-Hour Healthy Eating Timeframe (hEAT)
- Keywords
- Breast Cancer Survivorship, Home Based Exercise, Fatigue Management
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCAP Exercise ProgramBehavioural
Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.
10-Hour Healthy Eating Timeframe (hEAT)Behavioural
Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily.
| Study group | Role | What they receive |
|---|---|---|
| EXCAP-hEAT Intervention | Experimental | Participants will complete a 6-week home-based combined lifestyle intervention consisting of a structured exercise program (EXCAP) and a self-selected 10-hour daily healthy eating timeframe. The intervention includes aerobic walking, progressive resistance band training, and daily tracking of eating timeframes and physical activity. Receives: Behavioral: EXCAP Exercise Program; Behavioral: 10-Hour Healthy Eating Timeframe (hEAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Meeting Pre-Specified Adherence Criteria
Percentage of participants who meet all three adherence criteria during the 6-week intervention:
Maintain a ≤10-hour eating timeframe on at least 50 percent of intervention days (21 of 42 days)
Complete resistance band exercises at least 12 total sessions during the 6-week period
Increase average weekly step count by at least 20 percent from baseline to Week 6
Measured: Baseline to Day 42
Secondary outcomes (6)
Mean Change in Brief Fatigue Inventory Total Score
Mean difference in total BFI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue.
Measured: Baseline to Day 42
Mean Change in Multidimensional Fatigue Symptom Inventory Total Score
Mean difference in total MFSI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue burden.
Measured: Baseline to Day 42
Mean Change in Body Mass Index
Mean difference in BMI (kg/m²) measured at baseline and at Day 42.
Measured: Baseline to Day 42
Mean Change in 30-Second Bicep Curl Test Repetitions
Mean difference in total number of completed bicep curl repetitions within 30 seconds from baseline to Day 42.
Measured: Baseline to Day 42
Mean Change in 30-Second Chair Stand Test Repetitions
Mean difference in total number of completed chair stands within 30 seconds from baseline to Day 42.
Measured: Baseline to Day 42
Mean Change in Estimated Submaximal VO2
Mean difference in estimated VO2submax (mL/kg/min) obtained from treadmill testing at baseline and Day 42.
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
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 University of RochesterThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lindsey Mattick, University of Rochester
- Investigators
- Lindsey Mattick, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529353
- Sponsor's protocol ID
- STUDY00010857
- Acronym
- EXCAP-hEAT
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.
- ClinicalTrials.gov ID
- NCT07529353
- Acronym / sponsor ID
- EXCAP-hEAT / STUDY00010857
- Conditions
- Breast Cancer, Cancer Related Fatigue
- Keywords
- Breast Cancer Survivorship, Home Based Exercise, Fatigue Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Apr 2026 (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 evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXCAP-hEAT Intervention | Experimental | Behavioral: EXCAP Exercise Program, Behavioral: 10-Hour Healthy Eating Timeframe (hEAT)Participants will complete a 6-week home-based combined lifestyle intervention consisting of a structured exercise program (EXCAP) and a self-selected 10-hour daily healthy eating timeframe. The intervention includes aerobic walking, progressive resistance band training, and daily tracking of eating timeframes and physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be aged 18 years or older
- Must have a confirmed diagnosis of breast cancer (stage I-IIIC)
- Must have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 2 - 120 months prior to enrolling,
- Must be prescribed adjuvant endocrine therapy,
- Must have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Symptom Inventory
Key exclusion criteria (7 listed)
- Must not have metastatic or recurrent breast cancer
- Must not be currently receiving chemotherapy or radiation therapy
- Must not have a medical condition that would preclude safe participation in intervention or study procedures
- Must not be pregnant, or planning to become pregnant during the study period
- Must not be in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form,
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 |
|---|---|---|
| EXCAP Exercise ProgramHome-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks. | Behavioural | EXCAP-hEAT Intervention |
| 10-Hour Healthy Eating Timeframe (hEAT)Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily. | Behavioural | EXCAP-hEAT Intervention |
Primary outcome
Proportion of Participants Meeting Pre-Specified Adherence Criteria
Time frame: Baseline to Day 42
Percentage of participants who meet all three adherence criteria during the 6-week intervention: Maintain a ≤10-hour eating timeframe on at least 50 percent of intervention days (21 of 42 days) Complete resistance band exercises at least 12 total sessions during the 6-week period Increase average weekly step count by at least 20 percent from baseline to Week 6
6 secondary outcomes
Mean Change in Brief Fatigue Inventory Total Score
Time frame: Baseline to Day 42
Mean Change in Multidimensional Fatigue Symptom Inventory Total Score
Time frame: Baseline to Day 42
Mean Change in Body Mass Index
Time frame: Baseline to Day 42
Mean Change in 30-Second Bicep Curl Test Repetitions
Time frame: Baseline to Day 42
Mean Change in 30-Second Chair Stand Test Repetitions
Time frame: Baseline to Day 42
Mean Change in Estimated Submaximal VO2
Time frame: Baseline to Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lindsey Mattick, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXCAP Exercise Program and 10-Hour Healthy Eating Timeframe (hEAT) in people with Breast Cancer and Cancer Related Fatigue, run by University of Rochester 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 7 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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey Mattick, PhD (5852740473, Lindsey_Mattick@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Meeting Pre-Specified Adherence Criteria (time frame: Baseline to Day 42). 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 17 Aug 2026.