Breast Cancer SurvivorshipNCT01151488
Nutrition, Exercise, and Breast Cancer Survivorship
A study testing Resistance Training in people with Breast Cancer Survivorship and Sarcopenia, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of resistance training on the reasons (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia), and impaired physical functioning (poor balance and walking) associated with breast cancer survivorship. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivorship, Sarcopenia
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 6 Dec 2016
- 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 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologic evidence of previous breast cancer
- Three months post active cancer therapy (i.e. radiation/chemotherapy)
- Non smoker (non smoking for at least 12 months: cigarettes, cigars, pipes)
- 45-80 years of age
- Menopause over one year (absence of menses for 12 months or greater)
- Sedentary lifestyle (structured physical activity </= 2x per week)
- BMI >/=18 and <50 kg/m2
Who cannot join
- Unstable lymphedema (no intensive therapy, no recorded 10% change in arm volume or circumference, no more than one lymphedema-related infection requiring antibiotics and no change in ADLs due to a lymphedema exacerbation for the past 3 months)
- Plans for surgery (e.g., breast reconstruction) during the study period
- Evidence of recurrent cancer or metastases
- Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (SBP over 180 mm HG) unless medically stabilized
- Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl<60mg/dl)
- Anemia HCT below 30 mg/dl, platelets below 100,000/cm3
Show all 19Show fewer
- History of seizures or taking anti-seizure or anti convulsion medication
- Untreated dyslipidemia with National Cholesterol ATPIII 10 year cardiac risk score greater than 10% (www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.htm)
- Allergic to lidocaine
- Abnormal liver function
- Abnormal response to exercise test (ST segment depression greater than 2mm, chest pain, significant arrhythmias, extreme shortness of breath, cyanosis, exercising BP above 240/120 mm HG, or other contraindications to exercise) confirmed with further diagnostic evaluations.
- Type 1 diabetes; insulin treatment for diabetes, poorly controlled diabetes, HgA1c>10%
- Taking oral steroids, warfarin, or other medications interfering with fat/muscle metabolism that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior)
- MMSE below 24, dementia, or unstable clinical depression by exam
- Chronic pulmonary disease (on supplemental O2)
- Metal implants or devices (i.e. pacemaker) if undergoing CT scan
- Participant is, in the opinion of the investigator, unable to adhere to the study protocol due to medical or orthopedic conditions that limit ability to exercise or travel to the Baltimore VA for protocol procedures
- Aerobically trained with VO2max greater than 2 SD above age-adjusted mean
- Alcohol consumption greater than 3 oz. liquor, 3x4 oz glass of wine, or 2x12 oz beers per day, by self report
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors
The purpose of the study is to examine the effects of resistance training on the reasons (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia), and impaired physical functioning (poor balance and walking) associated with breast cancer survivorship.
Read the detailed description
Breast cancer is the most frequently diagnosed cancer in women, representing 26% of all female cancers. It is also the second leading cause of cancer related deaths in the US for women. Side effects of the cancer and treatment therapies may result in inactivity and inadequate intakes of various nutrients, including protein and vitamin D, associated with cardiovascular disease (CVD) and type 2 diabetes. High concentrations of systemic and local inflammation correlate well with CVD and diabetes risk. There is substantial evidence to support that incorporating physical activity and nutrition into one's lifestyle can reduce inflammation and, ultimately, the progression to CVD and diabetes. Understanding the role of exercise and diet management in the health of breast cancer survivors will allow us to translate these findings into therapy guidelines.
- Conditions
- Breast Cancer Survivorship, Sarcopenia
- Being tested
- Resistance Training
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
Also called Exercise
RT 3x/wk for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Experimental | 16 weeks of moderate intensity resistance training, 3x/week Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle performance
muscle strength
Measured: change in muscle area between baseline and 16 weeks
Secondary outcomes (1)
glucose tolerance
glucose levels
Measured: change in glucose levels between baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startMay 2012
- Primary completionAug 2014
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorshipStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Alice S. Ryan, PhD, Baltimore VA Medical Center
- Investigators
- Andrew P Goldberg, M.D., Principal investigator, Baltimore VAMC/GRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151488
- Sponsor's protocol ID
- HP-00045555
- Other IDs
- P30AG028747
- Status last verified
- Jan 2017
- First submitted
- 25 Jun 2010
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutrition and Exercise on Glucose Metabolism, Inflammation, and Body Composition in Older Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01151488
- Acronym / sponsor ID
- HP-00045555
- Conditions
- Breast Cancer Survivorship, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 28 Jun 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 purpose of the study is to examine the effects of resistance training on the reasons (mechanisms) underlying the development of fatigue, muscle weakness and wasting (sarcopenia), and impaired physical functioning (poor balance and walking) associated with breast cancer survivorship.
Detailed description
Breast cancer is the most frequently diagnosed cancer in women, representing 26% of all female cancers. It is also the second leading cause of cancer related deaths in the US for women. Side effects of the cancer and treatment therapies may result in inactivity and inadequate intakes of various nutrients, including protein and vitamin D, associated with cardiovascular disease (CVD) and type 2 diabetes. High concentrations of systemic and local inflammation correlate well with CVD and diabetes risk. There is substantial evidence to support that incorporating physical activity and nutrition into one's lifestyle can reduce inflammation and, ultimately, the progression to CVD and diabetes. Understanding the role of exercise and diet management in the health of breast cancer survivors will allow us to translate these findings into therapy guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Experimental | Other: Resistance Training16 weeks of moderate intensity resistance training, 3x/week |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic evidence of previous breast cancer
- Three months post active cancer therapy (i.e. radiation/chemotherapy)
- Non smoker (non smoking for at least 12 months: cigarettes, cigars, pipes)
- 45-80 years of age
- Menopause over one year (absence of menses for 12 months or greater)
Key exclusion criteria (19 listed)
- Unstable lymphedema (no intensive therapy, no recorded 10% change in arm volume or circumference, no more than one lymphedema-related infection requiring antibiotics and no change in ADLs due to a lymphedema exacerbation for the past 3 months)
- Plans for surgery (e.g., breast reconstruction) during the study period
- Evidence of recurrent cancer or metastases
- Symptomatic heart disease, CAD, CHF, or uncontrolled hypertension (SBP over 180 mm HG) unless medically stabilized
- Abnormal renal function (BUN above 40 mg/dl, Cr above 1.3 mg/dl, CrCl<60mg/dl)
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 |
|---|---|---|
| Resistance TrainingAlso: ExerciseRT 3x/wk for 4 months | Other | Resistance Training |
Primary outcome
muscle performance
Time frame: change in muscle area between baseline and 16 weeks
muscle strength
1 secondary outcome
glucose tolerance
Time frame: change in glucose levels between baseline and 16 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 1 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Survivorship
RecruitingObservational study
Improving Survival for Metastatic Lobular Breast Cancer (PLUMB Registry)
Metastatic Breast Cancer, Lobular Breast Carcinoma
Active, not recruiting
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
Breast Cancer
Active, not recruitingObservational study
Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
Breast Cancer Survivors
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
RecruitingObservational study
Breast Cancer Rehabilitation Needs and Service Uptake
Breast Cancer, Cancer Survivorship
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.
Andrew P Goldberg, M.D. principal investigator
Baltimore VAMC/GRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Breast Cancer Survivorship and Sarcopenia, run by Baltimore VA Medical Center 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 7 inclusion and 19 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 1 Feb 2017. 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?
muscle performance (time frame: change in muscle area between baseline and 16 weeks). 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 1 Feb 2017.