Early Stage Breast Cancer (Stage 0-III)NCT01157130
Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory
A study testing Exercise Regimen in people with Early Stage Breast Cancer (Stage 0-III), run by Nevada Cancer Institute at 1 site in United States.
Trial summary
The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer (Stage 0-III)
- What is being tested?
- Exercise Regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to not given
- 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
- Consent to participate in study
- Women aged 18 and older
- Stage 0 to III breast cancer prior to any treatment and at time of diagnosis
- Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy
- Adequate fitness to participate in a physical activity as assessed by the investigator
- Willing and able to participate in a prescribed exercise program
Who cannot join
- Metastatic breast cancer (Stage IV)
- Initiation of treatment regimen prior to enrollment
- Treatment for breast cancer not requiring chemotherapy or radiation therapy
- Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential).
- Currently lactating
- Do not read, understand, or speak English
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- Eligible participants will not be included if they have:
- known cardiac disease,
- uncontrolled hypertension,
- uncontrolled thyroid disease,
- diabetes mellitus,
- mental illness,
- infection,
- immune or endocrine abnormality,
- body weight reduction I10% in past 6 months, and
- positive exercise stress test.
- Major surgery within last 6 months that requires exercise restriction
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Breanne Eddington, 702-821-0062, beddington@nvcancer.org
Karen Milligan, MD, 702-822-5433
About this study
Official title: Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory
The proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.
Read the detailed description
Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.
- Conditions
- Early Stage Breast Cancer (Stage 0-III)
- Being tested
- Exercise Regimen
- Keywords
- Breast Cancer, Exercise, CRP, C-reactive protein, BMI, Nevada Cancer Institute, Rehabilitation, Prescriptive exercise, Physical Activity, DEXA, Obesity, lifestyle intervention, Early Stage Breast Cancer Patients (stage 0-III)
- Medical subject headings
- Breast Neoplasms, Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise RegimenOther
Exercise instruction
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. Receives: Other: Exercise Regimen |
| Control Group | No intervention | The control group will receive basic information on physical activity but not be instructed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CRP
The primary endpoint for this study change in C-reactive protein.
Secondary outcomes (4)
Change in laboratory values
Compare changes in:
- Glucose
- Insulin
- Estradiol
- Testosterone
Change in body composition
Body composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.
Quality of Life
Quality of Life will be measured and compared between the groups
Overall Survival
Comparing overall survival and progression free survival between groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast Cancer (Stage 0-III)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nevada Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vons
- Investigators
- Karen Milligan, MD, Principal investigator, Nevada Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157130
- Sponsor's protocol ID
- NVCI 10-09
- Status last verified
- Jul 2011
- First submitted
- 1 Jul 2010
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory
- ClinicalTrials.gov ID
- NCT01157130
- Acronym / sponsor ID
- NVCI 10-09
- Conditions
- Early Stage Breast Cancer (Stage 0-III)
- Keywords
- Breast Cancer, Exercise, CRP, C-reactive protein, BMI, Nevada Cancer Institute, Rehabilitation, Prescriptive exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nevada Cancer InstituteUniversity, hospital or other
- Collaborators
- Vons
- Study start
- Jul 2010
- First posted
- 5 Jul 2010 (estimated)
- 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 proposed study compares the outcomes of a physical activity intervention begun at diagnosis, continuing through active cancer treatment and into six months of survivorship compared to the outcomes of a control group receiving limited information on activity.
Detailed description
Patients (with stage 0 to stage III breast cancer)receiving chemotherapy, radiation or both chemotherapy and radiation will be included in the study.Randomization will be stratified by disease stage at diagnosis, treatment modalities planned, and hormonal status. Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. The control group will receive basic information on physical activity but not be instructed. Any physical activity in this group will be self-reported. Change in C-reactive protein will be the primary endpoint. Changes in other laboratory values, DEXA measurements, and quality of life measurements will be secondary endpoints.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Exercise RegimenEach patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group. |
| Control Group | No intervention | –The control group will receive basic information on physical activity but not be instructed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consent to participate in study
- Women aged 18 and older
- Stage 0 to III breast cancer prior to any treatment and at time of diagnosis
- Requires treatment that includes chemotherapy, radiation therapy or both chemotherapy and radiation therapy
- Adequate fitness to participate in a physical activity as assessed by the investigator
Key exclusion criteria (17 listed)
- Metastatic breast cancer (Stage IV)
- Initiation of treatment regimen prior to enrollment
- Treatment for breast cancer not requiring chemotherapy or radiation therapy
- Patients who are pregnant (negative urine pregnancy test required at baseline to determine eligibility in women of child bearing potential).
- Currently lactating
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 |
|---|---|---|
| Exercise RegimenExercise instruction | Other | Intervention Group |
Primary outcome
Changes in CRP
The primary endpoint for this study change in C-reactive protein.
4 secondary outcomes
Change in laboratory values
Change in body composition
Quality of Life
Overall Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
- Nevada Cancer InstituteLink provided by the sponsor.
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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.
Karen Milligan, MD principal investigator
Nevada 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 Exercise Regimen in people with Early Stage Breast Cancer (Stage 0-III), run by Nevada 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in CRP. 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 20 Jul 2011.