Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer

NCT06018038 | Completed

• 1 other identifier: GO 23/489
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Upper Extremity; Oxygen Consumption; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Arm ergometer test

  estimated Oxygen Consumption (VO2max)

  One Year

Secondary Outcomes (6)

• Upper Extremity Oxidative Muscle Metabolism

  One Year

• Peripheral Muscle Strength

  One Year

• Upper extremity muscle endurance

  one year

• Evaluation of Quality of Life

  One Year

• Fatigue Measurement

  One Year

Study Arms (2)

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.

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.

Diagnostic Test: Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak); Diagnostic Test: Muscle oxygenation

Interventions

Arm Exercise Capacity, Peak Oxygen Consumption (VO2peak) DIAGNOSTIC_TEST

peak arm exercise capacity

Breast Cancer Group; Control Group

Muscle oxygenation DIAGNOSTIC_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)

Breast Cancer Group; Control Group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ebru Calik Kutukcu, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Melda Saglam, PhD

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: August 30, 2023
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 19, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)