- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06018038
Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer
Arm Function in Breast Cancer Survivors: Is There a Decrease in Maximal Capacity and Oxygen Utilization?
Study Overview
Status
Conditions
Detailed Description
In recent years, thanks to the increasing treatment possibilities with the developing technology, the majority of patients show good functional recovery after breast cancer. However, it has been reported that the treatments negatively affect the functional capacity of the upper extremities, daily life, work and social activities and reduce the quality of life. It has also been reported that breast cancer-related lymphedema (BCRL) may both cause and exacerbate treatment-related complications such as decreased functional capacity of the upper extremities and worsened quality of life after breast cancer treatments. In addition, it has been found that lymphedema decreases the muscle strength and range of motion of the limb in which it develops and causes an increase in symptoms such as pain, fatigue and discomfort. These complications caused by lymphedema lead to decreased functional level of the upper extremity, activity limitations and decreased quality of life. Cardiovascular health is negatively affected after breast cancer. Decreased cardiorespiratory performance also has direct consequences on daily task performance and therefore quality of life is negatively affected.
The gold standard method of measuring cardiorespiratory exercise capacity is cardiopulmonary exercise testing (CPET). This method determines the causes of limitation during exercise and gives maximal oxygen consumption (VO2max) as a measure of maximum performance. In cancer patients, the oxygen system may be adversely affected by chemotherapy. Effects of chemotherapeutic agents on respiratory, cardiac, blood, vascular or skeletal muscle functions have been observed, potentially contributing to impaired cardiorespiratory fitness. Cardiorespiratory function is not routinely measured at any stage of breast cancer treatment and CPET is rarely used in clinical settings. Although low VO2max measurements have been observed in intervention studies during breast cancer survivorship and these studies were conducted without the use of an arm ergometer, to our knowledge, there is very limited information on the impact of cancer treatment on cardiorespiratory fitness using gold standard testing methods.
Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
State
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Ankara, State, Turkey (Türkiye), 06100
- Hacettepe University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Breast Cancer Group:
- Being between 18-65 years of age,
- Volunteering to participate in the research,
- Stage I-III breast cancer,
- At least 15 months after breast cancer surgery,
- Six months after active breast cancer treatment (i.e. surgery/chemotherapy),
- No lymphedema
- No problems in reading and/or understanding the scales and being able to cooperate with the tests,
Healthy group:
- Age between 18-65 years,
- Volunteering to participate in the research,
- No problems in reading and/or understanding the scales and being able to cooperate with the tests.
Exclusion Criteria:
Breast Cancer Group:
- Presence of active infection,
- Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease,
- Having a neurological disease or other clinical diagnosis that may affect cognitive status.
Healthy group:
- Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance,
- Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Breast Cancer Group
Inclusion criteria for BCS were as follows: an age between 18 and 65 years; diagnosis of stage I-III BC; individuals with unilateral BC; ≥ 15 months must have passed since BC surgery; participants must have completed active cancer treatment (CT and/or RT) ≥ 6 months prior to joining the study; absence of BCRL; ability to read and understand questionnaires; and ability to cooperate with the assessments.
Exclusion criteria for BCS included the presence of active infection, presence of BCRL; musculoskeletal or neurological conditions affecting exercise performance, symptomatic cardiovascular disease, neurological disorders, or any condition that could impair cognitive function.
|
peak arm exercise capacity
Muscle oxygenation (SmO2 ) was recorded using a device (Moxy, Fortiori Design LLC, Minnesota, USA) that measures local SmO2 in muscle capillaries using near-infrared spectroscopy (NIRS)
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|
Control Group
Inclusion criteria for healthy controls were an age between 18 and 65 years, the willingness to participate, the ability to read and understand questionnaires, and the ability to cooperate with the assessments.
Exclusion criteria for healthy controls were the presence of orthopedic or neuromuscular conditions, chronic diseases, psychiatric or other mental conditions that could interfere with exercise testing.
|
peak arm exercise capacity
Muscle oxygenation (SmO2 ) was recorded using a device (Moxy, Fortiori Design LLC, Minnesota, USA) that measures local SmO2 in muscle capillaries using near-infrared spectroscopy (NIRS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arm ergometer test
Time Frame: One Year
|
estimated Oxygen Consumption (VO2max)
|
One Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Oxidative Muscle Metabolism
Time Frame: One Year
|
Muscle Oxygen Saturation (SmO2 )
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One Year
|
|
Evaluation of Quality of Life
Time Frame: One Year
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European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale.
A high or healthy level of functioning is represented by a high functional score
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One Year
|
|
Peripheral Muscle Strength
Time Frame: One Year
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Hand grip strength by hand dynamometer
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One Year
|
|
Fatigue Measurement
Time Frame: One Year
|
Piper Fatigue Scale (PFS) Responses for each item It is evaluated between 0-10 points.
The total fatigue score is based on 22 items scores are summed and divided by the number of items.
Scale obtained from high scores indicate a high level of perceived fatigue shows.
|
One Year
|
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anthropometric measurements
Time Frame: One Year
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Arm Circumference
|
One Year
|
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Upper extremity muscle endurance
Time Frame: one year
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Functional Impairment Test-Hand, Neck, and Shoulder/Arm (FIT-HaNSA)
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one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University
- Study Chair: Melda Saglam, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 23/489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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