Breast CancerNCT06018038
Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer
An observational study of Breast Cancer and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Upper Extremity, Oxygen Consumption
- What is being tested?
- Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak) and Muscle oxygenation
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Dec 2024
- Phase
- Observational
- 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 15 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study
Who may be able to join
- 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),
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arm Function in Breast Cancer Survivors: Is There a Decrease in Maximal Capacity and Oxygen Utilization?
Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Survival can be increased with early diagnosis and more effective treatment methods. However, a wide range of treatment-related complications are observed during and/or after breast cancer treatment. Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal components. Oxygen consumption in cancer patients may be adversely affected by aging, deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
Read the 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.
- Conditions
- Breast Cancer, Upper Extremity, Oxygen Consumption, Healthy
- Being tested
- Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak), Muscle oxygenation
- Keywords
- Maximal Oxygen Consumption, breast cancer, Upper Extremity Exercise Capacity, Physical Activity Level
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak)Diagnostic test
peak arm exercise capacity
Muscle oxygenationDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak); Diagnostic Test: Muscle oxygenation | |
| 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. Receives: Diagnostic Test: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak); Diagnostic Test: Muscle oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm ergometer test
estimated Oxygen Consumption (VO2max)
Measured: One Year
Secondary outcomes (6)
Upper Extremity Oxidative Muscle Metabolism
Muscle Oxygen Saturation (SmO2 )
Measured: One Year
Peripheral Muscle Strength
Hand grip strength by hand dynamometer
Measured: One Year
Upper extremity muscle endurance
Functional Impairment Test-Hand, Neck, and Shoulder/Arm (FIT-HaNSA)
Measured: one year
Evaluation of Quality of Life
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
Measured: One Year
Fatigue Measurement
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.
Measured: One Year
anthropometric measurements
Arm Circumference
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Jun 2024
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe UniversityMelda Saglam, PhD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018038
- Sponsor's protocol ID
- GO 23/489
- Status last verified
- Jul 2025
- First submitted
- 24 Aug 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Function in Breast Cancer Survivors: Is There a Decrease in Maximal Capacity and Oxygen Utilization?
- ClinicalTrials.gov ID
- NCT06018038
- Acronym / sponsor ID
- GO 23/489
- Conditions
- Breast Cancer, Upper Extremity, Oxygen Consumption, Healthy
- Keywords
- Maximal Oxygen Consumption, breast cancer, Upper Extremity Exercise Capacity, Physical Activity Level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 30 Aug 2023 (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.
Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Survival can be increased with early diagnosis and more effective treatment methods. However, a wide range of treatment-related complications are observed during and/or after breast cancer treatment. Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal components. Oxygen consumption in cancer patients may be adversely affected by aging, deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Group | – | Diagnostic Test: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak), Diagnostic Test: Muscle oxygenationInclusion 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. |
| Control Group | – | Diagnostic Test: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak), Diagnostic Test: Muscle oxygenationInclusion 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients between the ages of 18-65 years who are diagnosed with breast cancer at Hacettepe University Hospital, Department of Internal Medicine, Division of Medical Oncology, and who volunteer to participate in the study will be included in the study. For healthy groups, age and gender appropriate volunteers will be recruited for the study
Key inclusion criteria (12 listed)
- 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),
Key exclusion criteria (7 listed)
- 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.
- 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
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 |
|---|---|---|
| Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak)peak arm exercise capacity | Diagnostic test | Breast Cancer Group, Control Group |
| Muscle oxygenationMuscle 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) | Diagnostic test | Breast Cancer Group, Control Group |
Primary outcome
Arm ergometer test
Time frame: One Year
estimated Oxygen Consumption (VO2max)
6 secondary outcomes
Upper Extremity Oxidative Muscle Metabolism
Time frame: One Year
Peripheral Muscle Strength
Time frame: One Year
Upper extremity muscle endurance
Time frame: one year
Evaluation of Quality of Life
Time frame: One Year
Fatigue Measurement
Time frame: One Year
anthropometric measurements
Time frame: One 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 19 May 2026.
- 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.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe University
Melda Saglam, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Upper Extremity, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 12 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 19 May 2026. 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 Turkey (Türkiye). 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?
Arm ergometer test (time frame: One Year). 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 19 May 2026.