Breast CancerNCT03761706
Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging
A study testing Engagement in Physical Activity and Questionnaires in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. Participants: 200 patients age 21 or older with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Engagement in Physical Activity and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 1 Feb 2025
- 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 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study subjects must meet all of the inclusion criteria listed below to participate in this study:
- 21 years of age 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 neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
- English speaking
- IRB approved, signed written informed consent
Show all 9Show fewer
- 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
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria are:
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
- Unable to walk or engage in moderate-intensity physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging and Patient-reported Symptoms and Outcomes
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy.
Participants: 200 patients age 21 or older with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy.
Procedures: The study entails screening, recruiting and consenting 200 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.
Read the detailed description
The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) and patient-reported measures of function and quality of life. The research team has determined that p16 increases dramatically during chemotherapy and that p16 levels among persons of similar age are lower among those who exercise as compared to those who are sedentary. The research team hypothesizes that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll 200 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and resistance exercises.
Results from both LCCC1334 and LCCC1410 and the proposed study, LCCC1749, will be used to provide evidence for a future grant application to conduct a randomized controlled trial in a larger study population to (1) establish the effect of physical activity on p16 levels during chemotherapy and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with measures of treatment-related toxicity and patient-reported outcomes over time. Findings from this study will also provide preliminary evidence for further investigations of the potential benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived cognition deficits.
- Conditions
- Breast Cancer
- Being tested
- Engagement in Physical Activity, Questionnaires
- Keywords
- breast cancer, exercise, chemotherapy and aging
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement in Physical ActivityBehavioural
Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits. Participants will also complete a daily exercise log to record the total number of minutes walked and the total number of steps from the FitBit.
QuestionnairesOther
Study participants will complete the following questionnaires: Health Behavior Questionnaire (HBQ), Short Physical Performance Battery (SPPB), Functional Assessment of Cancer Therapy-General (FACT-G), 4.4.5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), PROMIS Cognitive Function (Short Form 8a), Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) Version 4, Nutrition Survey, Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM),
| Study group | Role | What they receive |
|---|---|---|
| Intervention Cohort | Experimental | This is a one-arm intervention study that includes assessments and questionnaires at several time points as early stage breast cancer patients undergo chemotherapy and at 6 months post-chemotherapy. Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits to evaluate engagement in physical activity. Study participants will complete questionnaires, an exercise log, and submit blood samples as multiple time points. Receives: Behavioral: Engagement in Physical Activity; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change in p16 from baseline to end of chemotherapy
Compare the change in p16 from baseline to end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention.
Measured: Baseline, 6-months post Baseline, 12-months post-Baseline
Secondary outcomes (21)
Measure association of physical activity levels (Fitbit steps and strength training) with change in p16 levels
Will upload Fitbit and collect strength training data to evaluate the association of physical activity levels (Fitbit steps) with change in p16 levels.
Measured: Baseline, during Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks) , and 12-months post-Baseline
Measure associations between weight, physical activity and diet during chemotherapy.
Will administer the NHANES Nutrition Survey at several time points during the study. The NHANES survey is not a scale. It is not scored. It is descriptive, asking about the frequency of consumption of specific items.
Measured: Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX
Will administer the FACT/GOG-NTX instrument.
Measured: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.
Will administer the CTCAE.
Measured: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.
Will administer the PRO-CTCAE.
Measured: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB.
Will administer the Short Physical Performance Battery (SPPB).
Measured: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the FACT-G
Will administer the FACT-G Questionnaire. The FACT-G is scored in a Likert-type scale from 0+not at all to 4=very much. Higher scores signify higher quality of life. Subscales are physical, social/family, emotional and functional -- which are analyzed separately and can be combined into a total FACT-G score.
Measured: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the FACIT-F
Will administer the FACIT-F Questionnaire. This Likert-type scale ranges from 0=not at all to 4=very much, with higher scores signifying higher fatigue. No subscales.
Measured: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the MHI-17
Will administer the MHI-17 Health Questionnaire. This 17 item measure consists of two subscales -- Anxiety and Depression. The Likert-type scale ranges from 0=all of the time to 5=none of the time. Higher scores indicate higher anxiety or depression. The two subscales are not combined into one MHI score.
Measured: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire
Administer the MOS Social Activity Limitation Questionnaire. We are using only one item from this scale. Likert-type scoring is 0=all of the time to4=none of the time. Higher score signifies less interference with social activities.
Measured: Baseline, 6-months post-Baseline, 12-months post Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support
Administer the PROMIS Instrumental Support Questionnaire. This Likert-type scale is from 1=never to 5=always. Higher score signifies higher instrumental support. No subscales.
Measured: Baseline, 6-months post Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire.
Administer PROMIS Social Isolation Questionnaire. Likert-type scoring is 0=never to 5=alwayse. Higher score signifies more social isolation. No subscales.
Measured: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health
Administer PROMIS Global Health Questionnaire. Likert-type scale from 0=excellent to 4=poor. Higher score signifies lower global health. No subscales.
Measured: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form
Will administer the PROMIS Cognitive Function-Short Form (8a). This Likert-type scale is from 1=very often to 5=never. Higher scores signify higher cognitive function. No subscales.
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC)
Will administer the Blessed Memory Concentration test (BOMC).
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status by the Timed Up and Go Test
Administer theTimed Up and Go Test
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status by the Medical Outcomes Survey.
Administer the Medical Outcomes Survey. Likert-type scale from 0=without help to 2=completely unable. Higher score signifies more limitations. No subscale.
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey
Administer the Instrumental Activities of Daily Living Survey. This Likelrt-type scale is from 0=without help to 2=completely unable. Higher scores signify greater limitations. No subscale.
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status with the Karnofsky Performance Status
Administer the Karnofsky Performance Status
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with number of Fall Questionnaire
One question will inquire about falls within the past 6 months.
Measured: Baseline, 6-months post-Baseline
Measure association of p16 with limitations in walking one block
One question will inquire whether the participant's health limits their ability to walk one block = range 0=limited a lot to 2=not limited at all
Measured: Baseline, 6-months post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start28 Feb 2018
- Primary completion1 Aug 2024
- Study completion1 Feb 2025
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Hyman B. Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761706
- Sponsor's protocol ID
- LCCC 1749
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2018
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home-based Aerobic and Strength Exercises During Chemotherapy for Early Breast Cancer on Biomarkers of Aging and Patient-reported Symptoms and Outcomes
- ClinicalTrials.gov ID
- NCT03761706
- Acronym / sponsor ID
- LCCC 1749
- Conditions
- Breast Cancer
- Keywords
- breast cancer, exercise, chemotherapy and aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Dec 2018 (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.
Purpose: To determine if engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy.
Participants: 200 patients age 21 or older with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy.
Procedures: The study entails screening, recruiting and consenting 200 eligible breast cancer patients who are about to begin adjuvant or neoadjuvant chemotherapy and agree to participate in a physical activity intervention, maintain a printed daily exercise log, wear a FitBit, complete questionnaires and assessments, and provide blood samples at various time points.
Detailed description
The overall focus of this study remains the investigation of associations between p16 and assessments (independent and patient-reported) of chemotherapy-related toxicity (adverse events and symptoms) and patient-reported measures of function and quality of life. The research team has determined that p16 increases dramatically during chemotherapy and that p16 levels among persons of similar age are lower among those who exercise as compared to those who are sedentary. The research team hypothesizes that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, the study proposes to build on a completed trial, LCCC1334, and enroll 200 evaluable patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in an intervention that entails both aerobic and resistance exercises.
Results from both LCCC1334 and LCCC1410 and the proposed study, LCCC1749, will be used to provide evidence for a future grant application to conduct a randomized controlled trial in a larger study population to (1) establish the effect of physical activity on p16 levels during chemotherapy and (2) further evaluate how baseline and post-chemotherapy p16 levels correlate with measures of treatment-related toxicity and patient-reported outcomes over time. Findings from this study will also provide preliminary evidence for further investigations of the potential benefits of exercise during early breast cancer chemotherapy for (1) reducing the incidence and severity of peripheral neuropathy and (2) managing the interface of fatigue and perceived cognition deficits.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Cohort | Experimental | Behavioral: Engagement in Physical Activity, Other: QuestionnairesThis is a one-arm intervention study that includes assessments and questionnaires at several time points as early stage breast cancer patients undergo chemotherapy and at 6 months post-chemotherapy. Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits to evaluate engagement in physical activity. Study participants will complete questionnaires, an exercise log, and submit blood samples as multiple time points. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Study subjects must meet all of the inclusion criteria listed below to participate in this study:
- 21 years of age 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 neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
- English speaking
Key exclusion criteria (3 listed)
- All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria are:
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
- Unable to walk or engage in moderate-intensity physical activity.
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 |
|---|---|---|
| Engagement in Physical ActivityStudy participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits. Participants will also complete a daily exercise log to record the total number of minutes walked and the total number of steps from the FitBit. | Behavioural | Intervention Cohort |
| QuestionnairesStudy participants will complete the following questionnaires: Health Behavior Questionnaire (HBQ), Short Physical Performance Battery (SPPB), Functional Assessment of Cancer Therapy-General (FACT-G), 4.4.5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), PROMIS Cognitive Function (Short Form 8a), Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) Version 4, Nutrition Survey, Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM), | Other | Intervention Cohort |
Primary outcome
Compare the change in p16 from baseline to end of chemotherapy
Time frame: Baseline, 6-months post Baseline, 12-months post-Baseline
Compare the change in p16 from baseline to end of chemotherapy for patients receiving a physical activity intervention to the historical value seen in previous studies (LCCC810 and 1027) of similar patients who did not participate in a physical activity intervention.
21 secondary outcomes
Measure association of physical activity levels (Fitbit steps and strength training) with change in p16 levels
Time frame: Baseline, during Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks) , and 12-months post-Baseline
Measure associations between weight, physical activity and diet during chemotherapy.
Time frame: Baseline, 3-months post-Baseline, 6-months post-Baseline, and 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the FACT/GOG-NTX
Time frame: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the CTCAE.
Time frame: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the PRO-CTCAE.
Time frame: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Chemotherapy-induced peripheral neuropathy (CIPN) as assessed by the SPPB.
Time frame: Baseline, During Chemotherapy (from 1st infusion through last infusion, which varies widely by chemotherapy regimen -- from 12 weeks to 30 weeks), 6-months post Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the FACT-G
Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the FACIT-F
Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the MHI-17
Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the MOS Social Activity Limitation Questionnaire
Time frame: Baseline, 6-months post-Baseline, 12-months post Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Instrumental Support
Time frame: Baseline, 6-months post Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Social Isolation Questionnaire.
Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in QOL measures as assessed by the PROMIS Global Health
Time frame: Baseline, 6-months post-Baseline, 12-months post-Baseline
Measure association of p16 with changes in cognition by the PROMIS Cognitive Function-Short Form
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with changes in cognition by the Blessed Memory Concentration test (BOMC)
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status by the Timed Up and Go Test
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status by the Medical Outcomes Survey.
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status with the Instrumental Activities of Daily Living Survey
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with changes in functional status with the Karnofsky Performance Status
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with number of Fall Questionnaire
Time frame: Baseline, 6-months post-Baseline
Measure association of p16 with limitations in walking one block
Time frame: Baseline, 6-months post-Baseline
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 Apr 2025.
- 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.
- 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.
Hyman B. Muss, MD principal investigator
UNC Lineberger Comprehensive Cancer 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 Engagement in Physical Activity and Questionnaires in people with Breast Cancer, 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 9 inclusion and 3 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 Apr 2025. 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?
Compare the change in p16 from baseline to end of chemotherapy (time frame: Baseline, 6-months post Baseline, 12-months post-Baseline). 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 NCT03761706, 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 1 Apr 2025.