Breast CancerNCT04013568
Exercise Post-Diagnosis of Breast Cancer
A study testing Exercise in people with Breast Cancer, run by University of Hawaii at 1 site in United States.
Trial summary
The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 6 Mar 2026
- 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
- New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
- Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
- Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
- Participant must be able to lie flat on their back for up to 10 minutes
- Participant must be able to stand without aid for at least 2 minutes
Who cannot join
- Participant with breast cancer recurrence
- Metastatic breast cancer
- Uncontrolled psychiatric disorder that can affect self-assessment
- Pregnant patient
- Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
About this study
Official title: A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.
Read the detailed description
The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.
- Conditions
- Breast Cancer
- Being tested
- Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students
Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Agree to Exercise Program | Active comparator | 12-week exercise program Receives: Other: Exercise |
| Group 2 - Declines Exercise Program | No intervention | Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Measured: 1 day
Isometric peak torque
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Measured: 1 day
Lean mass
Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Measured: 1 day
Bone mass
Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Measured: 1 day
Waist to Hip ratio (WHR) from manual tape measurement
Manual physical anthropometry of waist and hip circumferences
Measured: 1 day
Automatic 3D optical (3DO) scan measurement: girth measurement
Automated 3DO measurements generate the following: girth in cm measurements across the whole body
Measured: 1 day
Muscle Function
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Measured: 1 day
Percent fat
Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data
Measured: 1 day
Automatic 3D optical (3DO) scan measurement: length measurement
Automated 3DO measurements generate the following: length in cm measurements across the whole body
Measured: 1 day
Automatic 3D optical (3DO) scan measurement: volume measurement
Automated 3DO measurements generate the following: volume in cm measurements across the whole body
Measured: 1 day
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Measured: 1 day
Secondary outcomes (7)
Recurrence Free Survival
obtained from last physician note
Measured: 5 years
BIBCQ-Body Image After Breast Cancer questionnaire
45 items
Measured: 5 years
BFI-Brief Fatigue Innovatory questionnaire
9 items
Measured: 5 years
PHQ-9- Patient Health (Depression) questionnaire
9 items
Measured: 5 years
FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire
27 items
Measured: 5 years
Diet History Questionnaire II
Self-reported energy intake, measured as kcal/day
Measured: 5 years
Biomarkers
Adipokines: leptin, HMW-high molecular weight adiponectin, PAI1-plasminogen activator inhibitor
Cytokines \& Inflammation: TNF-tumor necrosis factor α, IL-interleukin 1β, IL2, IL4, IL5, IL6, IL8, IL10, interferon, CRP-C reactive protein, uric acid, cortisol
Insulin Resistance \& IGFs: glucose, insulin, Hb-hemoglobin A1C, IGF-insulin growth factor 1, IGFBP-insulin like growth factor binding protein 1-3
Sex Steroid Hormones: total estradiol \& estrone, total testosterone, SHBG-sex hormone-binding globulin (for free estradiol and free testosterone will be derived)
Lipid Profile \& Lipid-soluble Micronutrients: TG-triglycerides , total cholesterol, HDLC-high density lipoprotein cholesterol , free fatty acids, lycopene, 25OH-vitamin D3, alpha-tocopherol
Liver Enzymes: ALT-alanine aminotransferase
Neuropeptides \& Gut Hormones: ghrelin
MOTS-mitochondrial derived peptide-c
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start28 Aug 2019
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital of the Pacific
- Responsible party
- Sponsor
- Investigators
- Jami Fukui, MD, Principal investigator, University of Hawaii Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013568
- Sponsor's protocol ID
- Fukui-2019-1
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: The Effect of Longitudinal Exercise Programming in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04013568
- Acronym / sponsor ID
- Fukui-2019-1
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital of the Pacific
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 9 Jul 2019 (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 investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.
Detailed description
The study is enrolling breast cancer patients up to 2 years after their diagnosis in a 12-week exercise program. The participants will either participate in: Group 1-participating in an exercise program with biometric evaluations or Group 2-biometric evaluations but not participating in the exercise program. At the end of the 12-week exercise program, participants in Group 1 will be randomized to either: a) continuing with exercise group classes or b) continuing with exercise individual classes. Both Group 1a and 1b participants will be followed for the remainder of the year and be evaluated for continued physical activity. All Group study participants' biometrics will be assessed at baseline and at the end of 12-weeks, with continued annual medical review follow-up for a total of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Agree to Exercise Program | Active comparator | Other: Exercise12-week exercise program |
| Group 2 - Declines Exercise Program | No intervention | –Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
- Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
- Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
- Participant must be able to lie flat on their back for up to 10 minutes
- Participant must be able to stand without aid for at least 2 minutes
Key exclusion criteria (5 listed)
- Participant with breast cancer recurrence
- Metastatic breast cancer
- Uncontrolled psychiatric disorder that can affect self-assessment
- Pregnant patient
- Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment
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 |
|---|---|---|
| ExerciseFirst Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes | Other | Group 1 - Agree to Exercise Program |
Primary outcome
Fat mass
Time frame: 1 day
Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Isometric peak torque
Time frame: 1 day
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Lean mass
Time frame: 1 day
Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Bone mass
Time frame: 1 day
Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data
Waist to Hip ratio (WHR) from manual tape measurement
Time frame: 1 day
Manual physical anthropometry of waist and hip circumferences
Automatic 3D optical (3DO) scan measurement: girth measurement
Time frame: 1 day
Automated 3DO measurements generate the following: girth in cm measurements across the whole body
Muscle Function
Time frame: 1 day
Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device
Percent fat
Time frame: 1 day
Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data
Automatic 3D optical (3DO) scan measurement: length measurement
Time frame: 1 day
Automated 3DO measurements generate the following: length in cm measurements across the whole body
Automatic 3D optical (3DO) scan measurement: volume measurement
Time frame: 1 day
Automated 3DO measurements generate the following: volume in cm measurements across the whole body
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
Time frame: 1 day
Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data
7 secondary outcomes
Recurrence Free Survival
Time frame: 5 years
BIBCQ-Body Image After Breast Cancer questionnaire
Time frame: 5 years
BFI-Brief Fatigue Innovatory questionnaire
Time frame: 5 years
PHQ-9- Patient Health (Depression) questionnaire
Time frame: 5 years
FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire
Time frame: 5 years
Diet History Questionnaire II
Time frame: 5 years
Biomarkers
Time frame: 5 years
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 31 Mar 2026.
- 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.
Jami Fukui, MD principal investigator
University of Hawaii Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Breast Cancer, run by University of Hawaii 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 5 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 31 Mar 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?
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?
Fat mass (time frame: 1 day). The study lists 11 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 31 Mar 2026.