Stage II Breast CancerNCT03102866
Aerobic and Strength Training Exercise in Improving Fitness and Arm Health During and After Radiation Therapy in Patients With Stage II-III Breast Cancer
A study testing Best Practice, Exercise Intervention and Quality-of-Life Assessment in people with Stage II Breast Cancer and Stage IIA Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- What is being tested?
- Best Practice, Exercise Intervention and Quality-of-Life Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 4 Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage II-III breast cancer
- Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
- Prior chemotherapy in the neoadjuvant or adjuvant setting
- Radiation plan consisting of regional nodal radiation
- Must be suitable for an exercise program
Who cannot join
- Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
- Physical handicap that would prevent participation in program
- Patients with metastatic breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)
SECONDARY OBJECTIVES:
- Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.
II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).
III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.
VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
After completion of study, patients are followed up at 1 year.
- Conditions
- Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Being tested
- Best Practice, Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Exercise InterventionBehavioural
Undergo aerobic and strength training exercise
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (usual care) | Active comparator | Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (aerobic and strength training exercise) | Experimental | Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. Receives: Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)
determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program.
Measured: Up to 1 year
Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)
Will be compared to usual care group.
Measured: At 1 year
Secondary outcomes (7)
Arm lymphedema as measured by arm circumference
Lymphedema will be classified into 3 stages. Stage I edema is reversible and characterized by pitting edema, increase in arm girth, and heaviness. Stage II is characterized by a spongy consistency of the arm without pitting edema. Stage III is the most advanced stage, lymphostatic elephantiasis
Measured: Baseline up to 1 year
Arm range of motion as measured by goniometry
Shoulder flexion, external and internal rotation, and abduction will be measured.
Measured: Baseline up to 1 year
Change in weight and BMI
BMI will be measured to evaluate body composition using the metric formula weight (kg)/ height 2 (m2).
Measured: Baseline up to 1 year
Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs
Duration of exercise will be calculated based on questionnaire and exercise log. Percentage of exercise adherence at 1-year follow-up will be compared between two groups. Generalized linear models will be utilized to model follow-up as a function of baseline and group.
Measured: Baseline up to 1 year
Percent increase in arm strength as measured by one repetition maximum
Change in strength from baseline to post-intervention and follow-up will be obtained.
Measured: Baseline up to 1 year
Quality of life as measured by FACT-B+4
The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.
Measured: Baseline up to 1 year
Subjective arm health as measured by FACT-B+4
The FACT B + 4 has been shown to have good internal consistency and stability. It is a 40 item Likert scale questionnaire with subscales (0 - 4) for physical well being, social/family well being, emotional well being, function well being, and 4 specific questions related to arm symptoms.
Measured: Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start30 Aug 2017
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sasha Beyer, Ohio State University Comprehensive Cancer Center
- Investigators
- Sasha Beyer, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102866
- Sponsor's protocol ID
- OSU-16125
- Other IDs
- NCI-2017-00318
- Status last verified
- Dec 2023
- First submitted
- 20 Mar 2017
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Aerobic and Strength Training Exercise Initiated During and Continued After Radiation Therapy for Breast Cancer Improve Fitness and Arm Health 1 Year Later?
- ClinicalTrials.gov ID
- NCT03102866
- Acronym / sponsor ID
- OSU-16125
- Conditions
- Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 6 Apr 2017 (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.
This randomized pilot phase I/II trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage II-III breast cancer. Aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (Pilot) II. To determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (Phase II)
SECONDARY OBJECTIVES:
- Percent adherence to exercise at 1 year as measured by the International Physical Activity Questionnaire and exercise logs.
II. Subjective arm health at 1 year as measured by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer version 4 (FACT-B+4).
III. Arm lymphedema at 1 year as measured by arm circumference. IV. Arm range of motion at 1 year as measured by goniometry. V. Quality of life at 1 year as measured by FACT-B+4. VI. Percent increase in arm strength as measured by one repetition maximum at 1 year.
VII. Change in weight and body mass index (BMI) 1 year after completion of radiation.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
ARM II: Patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy.
After completion of study, patients are followed up at 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. |
| Arm II (aerobic and strength training exercise) | Experimental | Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Stage II-III breast cancer
- Prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection
- Prior chemotherapy in the neoadjuvant or adjuvant setting
- Radiation plan consisting of regional nodal radiation
- Must be suitable for an exercise program
Key exclusion criteria (3 listed)
- Serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician
- Physical handicap that would prevent participation in program
- Patients with metastatic breast cancer
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 |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (usual care) |
| Exercise InterventionUndergo aerobic and strength training exercise | Behavioural | Arm II (aerobic and strength training exercise) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (usual care), Arm II (aerobic and strength training exercise) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (usual care), Arm II (aerobic and strength training exercise) |
Primary outcome
Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot)
Time frame: Up to 1 year
determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program.
Percent increase in fitness as measured by the 6 minute walk test in patients randomized to exercise program (Phase II)
Time frame: At 1 year
Will be compared to usual care group.
7 secondary outcomes
Arm lymphedema as measured by arm circumference
Time frame: Baseline up to 1 year
Arm range of motion as measured by goniometry
Time frame: Baseline up to 1 year
Change in weight and BMI
Time frame: Baseline up to 1 year
Percent adherence to exercise as measured by the International Physical Activity Questionnaire and exercise logs
Time frame: Baseline up to 1 year
Percent increase in arm strength as measured by one repetition maximum
Time frame: Baseline up to 1 year
Quality of life as measured by FACT-B+4
Time frame: Baseline up to 1 year
Subjective arm health as measured by FACT-B+4
Time frame: Baseline up to 1 year
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 14 Dec 2023.
- The JameslineLink provided by the sponsor.
- 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.
Sasha Beyer, MD principal investigator
Ohio State University 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 Best Practice, Exercise Intervention and Quality-of-Life Assessment in people with Stage II Breast Cancer and Stage IIA Breast Cancer, run by Ohio State University 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 5 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 14 Dec 2023. 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?
Number of participants who complete 70% of all exercise sessions throughout the supervised program during and after radiation therapy (Pilot) (time frame: Up to 1 year). 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?
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 14 Dec 2023.