Breast CancerNCT00153894
Effects of Exercise Intervention on Insulin Levels in Breast Cancer Survivors
A study testing Strength training and Endurance training in people with Breast Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether an exercise program comprised of strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. Insulin may be involved in the risk of breast cancer recurrence. 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?
- Strength training and Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Feb 2008
- 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
- History of pathologically confirmed stage I-IIIa invasive breast cancer
- Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to enrollment
- Body mass index > 25 and/or a body composition analysis of >30
Who cannot join
- Patients taking herceptin
- Evidence of residual or distant disease
- Use of any medication expected to affect insulin levels
- Baseline exercise of more than 20 minutes two times per week
- Active malignancy
- Diabetes mellitus
- Heart disease or uncontrolled hypertension
- Presence of any condition that might be expected to impact a participant's ability to perform physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors
The purpose of this study is to determine whether an exercise program comprised of strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. Insulin may be involved in the risk of breast cancer recurrence.
Read the detailed description
- All women taking part in this study will take part in an exercise program. Group A will start exercising immediately and Group B wil have a delay period of 16 weeks before starting to exercise so investigators can look at the changes in insulin levels that occur in a women who is not exercising.
- The exercise program will be made up of two parts: strength (or weight) training and cardiovascular exercise. The strength exercise will take place at a gym close to Dana-Farber Cancer Institute. Patients will work one on one with a personal trainer twice a week for 50 minutes. During each of these sessions, participants will have a brief warm up period and then will perform a series of Nautilus machine-based exercises under the guidance of the personal trainer. The goal of each session will be to increase strength by increasing weight lifted and repetitions.
- Participants will also do cardiovascular exercises on their own at home. Each participant will receive a pedometer and heart rate monitor. Women will be advised to exercise for at least 30 minutes three times per week on their own and will keep a journal recording how long and how intensively they exercised. Participants will receive weekly phone calls from the project manager to review the cardiovascular exercise.
- Women will undergo a series of measurements before and after the 16 week exercise intervention. They will be asked to fast for 12 hours prior to each of these measurement sessions. Measurements will include blood testing for insulin and glucose levels. Women will also be weighed, height will be measured, body composition will be computed using a noninvasive bioelectric impedance monitor, and hip/waist measurements will be taken. Group A participants will undergo testing at the time of enrolling in the study and after 16 weeks of exercise. Group B participants will undergo these tests after enrollment, after the 16 week waiting period and at the end of the exercise program.
- Participants will also complete two surveys by mail, 3 months and 9 months after completing the exercise portion of the protocol.
- Conditions
- Breast Cancer
- Being tested
- Strength training, Endurance training
- Keywords
- Breast cancer survivor, Insulin levels, exercise regimen, endurance training, strength training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingBehavioural
One-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks.
Endurance trainingBehavioural
Cardiovascular training at home for 30 minutes three times per week for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Immediate Exercise Receives: Behavioral: Strength training; Behavioral: Endurance training |
| Group B | Active comparator | Delayed Exercise (delay by 16 weeks) Receives: Behavioral: Strength training; Behavioral: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors.
Measured: 3 years
Secondary outcomes (3)
To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention
Measured: 3 years
to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period
Measured: 3 years
to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJun 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT00153894
- Sponsor's protocol ID
- 03-327
- Status last verified
- Jun 2016
- First submitted
- 8 Sep 2005
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ligibel JA, Giobbie-Hurder A, Olenczuk D, Campbell N, Salinardi T, Winer EP, Mantzoros CS. Impact of a mixed strength and endurance exercise intervention on levels of adiponectin, high molecular weight adiponectin and leptin in breast cancer survivors. Cancer Causes Control. 2009 Oct;20(8):1523-8. doi: 10.1007/s10552-009-9358-3. Epub 2009 May 13.
PubMed 19434504Ligibel JA, Campbell N, Partridge A, Chen WY, Salinardi T, Chen H, Adloff K, Keshaviah A, Winer EP. Impact of a mixed strength and endurance exercise intervention on insulin levels in breast cancer survivors. J Clin Oncol. 2008 Feb 20;26(6):907-12. doi: 10.1200/JCO.2007.12.7357.
PubMed 18281663
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of an Exercise Intervention on Insulin Levels in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00153894
- Acronym / sponsor ID
- 03-327
- Conditions
- Breast Cancer
- Keywords
- Breast cancer survivor, Insulin levels, exercise regimen, endurance training, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 12 Sep 2005 (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 this study is to determine whether an exercise program comprised of strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. Insulin may be involved in the risk of breast cancer recurrence.
Detailed description
- All women taking part in this study will take part in an exercise program. Group A will start exercising immediately and Group B wil have a delay period of 16 weeks before starting to exercise so investigators can look at the changes in insulin levels that occur in a women who is not exercising.
- The exercise program will be made up of two parts: strength (or weight) training and cardiovascular exercise. The strength exercise will take place at a gym close to Dana-Farber Cancer Institute. Patients will work one on one with a personal trainer twice a week for 50 minutes. During each of these sessions, participants will have a brief warm up period and then will perform a series of Nautilus machine-based exercises under the guidance of the personal trainer. The goal of each session will be to increase strength by increasing weight lifted and repetitions.
- Participants will also do cardiovascular exercises on their own at home. Each participant will receive a pedometer and heart rate monitor. Women will be advised to exercise for at least 30 minutes three times per week on their own and will keep a journal recording how long and how intensively they exercised. Participants will receive weekly phone calls from the project manager to review the cardiovascular exercise.
- Women will undergo a series of measurements before and after the 16 week exercise intervention. They will be asked to fast for 12 hours prior to each of these measurement sessions. Measurements will include blood testing for insulin and glucose levels. Women will also be weighed, height will be measured, body composition will be computed using a noninvasive bioelectric impedance monitor, and hip/waist measurements will be taken. Group A participants will undergo testing at the time of enrolling in the study and after 16 weeks of exercise. Group B participants will undergo these tests after enrollment, after the 16 week waiting period and at the end of the exercise program.
- Participants will also complete two surveys by mail, 3 months and 9 months after completing the exercise portion of the protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Behavioral: Strength training, Behavioral: Endurance trainingImmediate Exercise |
| Group B | Active comparator | Behavioral: Strength training, Behavioral: Endurance trainingDelayed Exercise (delay by 16 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of pathologically confirmed stage I-IIIa invasive breast cancer
- Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to enrollment
- Body mass index > 25 and/or a body composition analysis of >30
Key exclusion criteria (8 listed)
- Patients taking herceptin
- Evidence of residual or distant disease
- Use of any medication expected to affect insulin levels
- Baseline exercise of more than 20 minutes two times per week
- Active malignancy
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 |
|---|---|---|
| Strength trainingOne-on-One training with a personal trainer for 50 minutes twice a week using Nautilus machines for 16 weeks. | Behavioural | Group A, Group B |
| Endurance trainingCardiovascular training at home for 30 minutes three times per week for 16 weeks. | Behavioural | Group A, Group B |
Primary outcome
To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors.
Time frame: 3 years
3 secondary outcomes
To assess the compliance of a group of breast cancer survivors to a 16 week exercise intervention
Time frame: 3 years
to determine whether a combination strength and endurance training intervention can increase strength and endurance by 25% over a 16 week training period
Time frame: 3 years
to evaluate the impact of an exercise intervention on weight, waist-hip ratio and body composition in breast cancer survivors.
Time frame: 3 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 27 Jun 2016.
- Results publication: PubMed 19434504Ligibel JA, Giobbie-Hurder A, Olenczuk D, Campbell N, Salinardi T, Winer EP, Mantzoros CS. Impact of a mixed strength and endurance exercise intervention on levels of adiponectin, high molecular weight adiponectin and leptin in breast cancer survivors. Cancer Causes Control. 2009 Oct;20(8):1523-8. doi: 10.1007/s10552-009-9358-3. Epub 2009 May 13.
- Results publication: PubMed 18281663Ligibel JA, Campbell N, Partridge A, Chen WY, Salinardi T, Chen H, Adloff K, Keshaviah A, Winer EP. Impact of a mixed strength and endurance exercise intervention on insulin levels in breast cancer survivors. J Clin Oncol. 2008 Feb 20;26(6):907-12. doi: 10.1200/JCO.2007.12.7357.
- 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.
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 Strength training and Endurance training in people with 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 3 inclusion and 8 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 27 Jun 2016. 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?
To determine whether strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153894, which also lists 2 linked publications.
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 27 Jun 2016.