Early Stage Breast CancerNCT02159157
A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
A study testing Exercise prescription in people with Early Stage Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Exercise prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 31 Dec 2018
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
- Patients must have recovered from prior surgery.
- Patients must be able to walk unassisted without oxygen
- Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
- Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
- Karnofsky performance status > or = to 80%.
Show all 9Show fewer
- Previous or ongoing Physical therapy treatments are acceptable.
- Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
- Participants must have a baseline activity level of < 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).
Who cannot join
- Patients less than 18 years of age.
- Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
- Patients who are oxygen dependent.
- Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
- Patients with a Karnofsky performance status of < 80%.
- Pregnant.
- Unable to read or write in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.
Read the detailed description
This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Exercise prescription
- Keywords
- breast cancer, exercise
- 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.
Exercise prescriptionBehavioural
A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy. Phone calls designed to support the patient to maintain current activity level. |
| Arm B | Placebo comparator | Physical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy.
Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week.
Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription. Receives: Behavioral: Exercise prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity as measured by the Activity Log
A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.
Measured: from baseline to week 32
Secondary outcomes (11)
Received Dose Intensity of chemotherapy (RDI)
The RDI is calculated by (delivered dose)/(standard dose) x 100. Delivered dose = (actual total dose in mg/m2)/ (total days required to complete the treatment) Standard dose = (recommended total dose) / (total days planned to complete the treatment)
Measured: 32 weeks
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F
Fatigue as measured by the FACIT-F survey
Measured: baseline (Day -28 to 1), week 24, 32 weeks
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin
Measured: baseline (Day -28 to 1), 32 weeks
Change from Baseline (day -28 to day 1) C-reactive protein
levels of C- reactive protein
Measured: Baseline (day -28 to day 1) and week 32
Change from Baseline (Day -28 to day 1) Fasting insulin
Fasting insulin levels measured in blood at baseline (day -28 to day 1) and week 32
Measured: Baseline (day -28 to day 1) and week 32
Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day)
Measured: baseline (day -28 to day 1) and week 32
Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score
Measured: baseline (day -28 to day 1) and week 32
Change in Resting heart rate from baseline (day -28 to day 1)
Measured: baseline (day -28 to day 1) and week 32
Change in Waist-hip ratio from baseline (day -28 to day 1)
Measured: baseline (day -28 to day 1) and week 32
Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data
Average steps per week for weeks 1-32
Measured: weekly for 32 weeks
Measures how likely a person is to continue with exercise prescription.
How the participant is feeling about the exercise.
Measured: From baseline to Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Chamberlin, Dartmouth-Hitchcock Medical Center
- Investigators
- Mary Chamberlin, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159157
- Sponsor's protocol ID
- D12030
- Status last verified
- Aug 2020
- First submitted
- 5 May 2014
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02159157
- Acronym / sponsor ID
- D12030
- Conditions
- Early Stage Breast Cancer
- Keywords
- breast cancer, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jun 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.
This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.
Detailed description
This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Physical Therapy consult for post op care and general physical activity recommendation 1-4 weeks prior to starting chemotherapy. Phone calls designed to support the patient to maintain current activity level. |
| Arm B | Placebo comparator | Behavioral: Exercise prescriptionPhysical Therapy consult for post-op care 1-4 weeks prior to starting chemotherapy. Exercise prescription aimed at increasing physical activity by a minimum of 10 MET hours/week. Motivational phone calls aimed at encouraging the patient to adhere to their exercise prescription. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
- Patients must have recovered from prior surgery.
- Patients must be able to walk unassisted without oxygen
- Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
- Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
Key exclusion criteria (7 listed)
- Patients less than 18 years of age.
- Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
- Patients who are oxygen dependent.
- Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
- Patients with a Karnofsky performance status of < 80%.
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 prescriptionA physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription. | Behavioural | Arm B |
Primary outcome
Change in activity as measured by the Activity Log
Time frame: from baseline to week 32
A log will be used to record patient's exercise activity and pedometer data on a weekly and monthly basis.
11 secondary outcomes
Received Dose Intensity of chemotherapy (RDI)
Time frame: 32 weeks
Change from baseline (day -28 to day 1) fatigue as measured by FACIT-F
Time frame: baseline (Day -28 to 1), week 24, 32 weeks
Change from baseline (day -28 to 1) Absolute neutrophil count and hemoglobin
Time frame: baseline (Day -28 to 1), 32 weeks
Change from Baseline (day -28 to day 1) C-reactive protein
Time frame: Baseline (day -28 to day 1) and week 32
Change from Baseline (Day -28 to day 1) Fasting insulin
Time frame: Baseline (day -28 to day 1) and week 32
Change from Baseline (day -28 to day 1) of Resting metabolic rate (calculated by Respiratory quotient/ resting energy expenditure measured in kcal/day)
Time frame: baseline (day -28 to day 1) and week 32
Change in Body composition as indicated by % of total body fat, bone density (g/cm2), and T score
Time frame: baseline (day -28 to day 1) and week 32
Change in Resting heart rate from baseline (day -28 to day 1)
Time frame: baseline (day -28 to day 1) and week 32
Change in Waist-hip ratio from baseline (day -28 to day 1)
Time frame: baseline (day -28 to day 1) and week 32
Change in steps recorded from baseline (day -28 to day 1) as measure by Pedometer data
Time frame: weekly for 32 weeks
Measures how likely a person is to continue with exercise prescription.
Time frame: From baseline to Week 32
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 21 Aug 2020.
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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.
Mary Chamberlin, MD principal investigator
Dartmouth-Hitchcock Medical 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 Exercise prescription in people with Early Stage Breast Cancer, run by Dartmouth-Hitchcock 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 9 inclusion and 7 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 21 Aug 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. Some participants in this study may receive a placebo. 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?
Change in activity as measured by the Activity Log (time frame: from baseline to week 32). 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 21 Aug 2020.