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)

• Cardiopulmonary Exercise Testing (CPET)

  Maximal Oxygen Consumption (VO2max)

  One Year

Secondary Outcomes (8)

• Upper Extremity Oxidative Muscle Metabolism

  One Year

• Peripheral Muscle Strength

  One Year

• Evaluation of Quality of Life

  One Year

• Physical activity levels

  One Year

• Upper Limb Functionality

  One Year

Study Arms (2)

Breast Cancer Group

Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.

Diagnostic Test: Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max)

Control Group

The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.

Diagnostic Test: Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max)

Interventions

Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max) DIAGNOSTIC_TEST

Cardiopulmonary Exercise Testing (CPET)

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: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)