Breast CancerNCT02328313
Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
A study testing Walk with Ease Program in people with Breast Cancer and Aging, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Aging, Physical Activity
- What is being tested?
- Walk with Ease Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 16 Jan 2019
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 or older, female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
- English speaking
- IRB approved, signed written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Who cannot join
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
Read the detailed description
LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.
- Conditions
- Breast Cancer, Aging, Physical Activity
- Being tested
- Walk with Ease Program
- Keywords
- Cancer, Breast Cancer, Geriatric, Advance Age, Exercise, Physical Activity, Genetic Marker, p16, Chemotherapy, Breast Cancer Treatment
- Medical subject headings
- Breast Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk with Ease ProgramBehavioural
The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort | Experimental | Breast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention. Receives: Behavioral: Walk with Ease Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
The comparison group will be taken from another study
Measured: 12 months
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
The study will look at the change of p16 expression within patients on this study.
Measured: 2 - 6 months
Secondary outcomes (12)
To measure changes in body compositional aspects of lean body mass (LBM)
As measured by DEXA
Measured: 12 months
To measure changes in body compositional aspects of fat tissue mass (FM)
As measured by DEXA
Measured: 12 months
To measure changes in body compositional aspects of percentage body fat (BF)
As measured by DEXA
Measured: 12 months
To measure change in physical activity over the course of the study
As measured by engagement in walking survey
Measured: 12 months
To measure change in physical function over the course of the study
As measured by the Short Physical Performance Battery
Measured: 12 months
To measure change in fatigue over the course of the study
As measured by the FACIT-F
Measured: 12 months
To measure change in quality of life over the course of the study
As measured by the FACT-B
Measured: 12 months
To measure change in self-efficacy over the course of the study
As measured by the PSEFSM and OEE
Measured: 12 months
To measure retention during the study
- Retention will be assessed as the proportion of patients who enroll in the study who complete all questionnaires and assessments at all time points.
Measured: 12 months
To measure safety of the walking program
- Safety will be defined as any adverse events potentially related to the intervention, including falls, which are reported by study participants to the Study Team.
Measured: 12 months
To measure overall satisfaction with the program
As measured by a satisfaction questionnaire
Measured: 12 months
To average the number of daily and weekly steps per participant
As measure via an continuous accelerometer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startOct 2014
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328313
- Sponsor's protocol ID
- LCCC1410
- Other IDs
- 14-2074
- Status last verified
- Apr 2019
- First submitted
- 21 Oct 2014
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4.
PubMed 38153568
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
- ClinicalTrials.gov ID
- NCT02328313
- Acronym / sponsor ID
- LCCC1410
- Conditions
- Breast Cancer, Aging, Physical Activity
- Keywords
- Cancer, Breast Cancer, Geriatric, Advance Age, Exercise, Physical Activity, Genetic Marker, p16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 31 Dec 2014 (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.
To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
Detailed description
LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | Experimental | Behavioral: Walk with Ease ProgramBreast cancer patients 65 and older undergoing chemotherapy and participating in a home-based physical activity intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Age 65 or older, female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
- Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
- English speaking
- IRB approved, signed written informed consent
Key exclusion criteria (1 listed)
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
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 |
|---|---|---|
| Walk with Ease ProgramThe Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal. | Behavioural | Intervention Cohort |
Primary outcome
To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
Time frame: 12 months
The comparison group will be taken from another study
To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
Time frame: 2 - 6 months
The study will look at the change of p16 expression within patients on this study.
12 secondary outcomes
To measure changes in body compositional aspects of lean body mass (LBM)
Time frame: 12 months
To measure changes in body compositional aspects of fat tissue mass (FM)
Time frame: 12 months
To measure changes in body compositional aspects of percentage body fat (BF)
Time frame: 12 months
To measure change in physical activity over the course of the study
Time frame: 12 months
To measure change in physical function over the course of the study
Time frame: 12 months
To measure change in fatigue over the course of the study
Time frame: 12 months
To measure change in quality of life over the course of the study
Time frame: 12 months
To measure change in self-efficacy over the course of the study
Time frame: 12 months
To measure retention during the study
Time frame: 12 months
To measure safety of the walking program
Time frame: 12 months
To measure overall satisfaction with the program
Time frame: 12 months
To average the number of daily and weekly steps per participant
Time frame: 12 months
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 30 Apr 2020.
- Derived from this study: PubMed 38153568Nyrop KA, Page A, Deal AM, Wagoner C, Kelly EA, Kimmick GG, Copeland A, Speca J, Wood WA, Muss HB. Association of self-directed walking with toxicity moderation during chemotherapy for the treatment of early breast cancer. Support Care Cancer. 2023 Dec 28;32(1):68. doi: 10.1007/s00520-023-08275-4.
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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.
Hyman Muss, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk with Ease Program in people with Breast Cancer and Aging, run by UNC Lineberger Comprehensive Cancer 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 8 inclusion and 1 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 30 Apr 2020. 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 measure the change in level of p16 expression from baseline to end of chemotherapy to a control group (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02328313, which also lists 1 linked publication.
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 30 Apr 2020.