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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?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06018038
Enrollment
60
Registered
2023-08-30
Start date
2024-06-01
Completion date
2024-12-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Healthy, Oxygen Consumption, Upper Extremity

Keywords

Maximal Oxygen Consumption, breast cancer, Upper Extremity Exercise Capacity, Physical Activity Level

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTArm Exercise Capacity, Peak Oxygen Consumption (VO2peak)

peak arm exercise capacity

DIAGNOSTIC_TESTMuscle oxygenation

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)

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Breast Cancer Group: 1. Being between 18-65 years of age, 2. Volunteering to participate in the research, 3. Stage I-III breast cancer, 4. At least 15 months after breast cancer surgery, 5. Six months after active breast cancer treatment (i.e. surgery/chemotherapy), 6. No lymphedema 7. No problems in reading and/or understanding the scales and being able to cooperate with the tests, Healthy group: 1. Age between 18-65 years, 2. Volunteering to participate in the research, 3. No problems in reading and/or understanding the scales and being able to cooperate with the tests.

Exclusion criteria

Breast Cancer Group: 1. Presence of active infection, 2. Musculoskeletal and neurological diseases that may affect exercise performance, symptomatic heart disease, 3. Having a neurological disease or other clinical diagnosis that may affect cognitive status. Healthy group: 1. Having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, 2. Having any chronic disease or psychiatric disorders or mental impairments that may interfere with cooperation or compliance with exercise tests

Design outcomes

Primary

MeasureTime frameDescription
Arm ergometer testOne Yearestimated Oxygen Consumption (VO2max)

Secondary

MeasureTime frameDescription
Upper Extremity Oxidative Muscle MetabolismOne YearMuscle Oxygen Saturation (SmO2 )
Peripheral Muscle StrengthOne YearHand grip strength by hand dynamometer
Upper extremity muscle enduranceone yearFunctional Impairment Test-Hand, Neck, and Shoulder/Arm (FIT-HaNSA)
Evaluation of Quality of LifeOne YearEuropean 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
Fatigue MeasurementOne YearPiper 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.
anthropometric measurementsOne YearArm Circumference

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREbru Calik Kutukcu, PhD

Hacettepe University

STUDY_CHAIRMelda Saglam, PhD

Hacettepe University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026