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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05241925
Other study ID # Breast Cancer
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2023
Est. completion date December 30, 2025

Study information

Verified date September 2022
Source University of Nove de Julho
Contact Luciana Sampaio, PhD
Phone +5511 996002075
Email lucianamalosa@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cancer on the world stage remains a major public health problem and the most common type among women. Female breast cancer survivors often have multiple comorbidities such as diabetic, heart disease, sarcopenia, arthritis, hypertension, and others. In addition to fatigue, reduced functional capacity of the affected upper limb and decreased quality of life. The effects of antineoplastic treatment associated with chronic diseases predispose the emergence of cardiotoxicity, increasing the risk of developing cardiovascular diseases (CVD) and may lead to a decline in quality of life. This situation is due to the adverse effects that antineoplastic therapy exerts on the cardiovascular system. According to the American Heart Association and American Cancer Society, physical exercise is one of the strategies adopted to prevent and reduce the effects of anticancer therapy, promoting effects on cardiovascular reserve5,6. Currently, although physical activity is essential for cancer survivors, the most effective exercise strategies (intensity, duration and type of exercise) to improve complications from breast cancer have not yet been defined. The aim of the study is to investigate the effects of different types of physical training associated with functional capacity and quality of life in women undergoing antineoplastic treatment for breast cancer.


Description:

Cancer is a universal term used for a large group of diseases, characterized by the disordered growth of cells beyond their usual limits, which can affect adjacent parts of the body and/or spread to other organs and tissues. Breast cancer worldwide is a major public health problem, being among all types of neoplasm the most common among women, regardless of age and ethnicity. Treatment for breast cancer may include surgery, radiation therapy, and systemic therapies such as chemotherapy, hormone therapy, or biological therapy. A number of factors are considered to determine the treatment and sequence of therapies. With advances in early detection and treatment of cancer, the survival rate has increased in more developed countries, reaching 85% in the first five years after diagnosis. The survival of patients with breast cancer has increased, generating greater concern for the individual's overall well-being. Chemotherapy treatments can cause short or long-term cardiorespiratory limitations, reduced functional capacity and worse quality of life, making daily activities difficult for these patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Diagnosis of confirmed breast cancer. Duration of adjuvant chemotherapy treatment. Undergoing surgery for breast cancer treatment. Exclusion Criteria: - neoplasm prior to breast cancer - heart disease; - musculoskeletal disorder; - respiratory disease; - uncontrolled arterial hypertension - factors that limit the performance of any of the assessments and/or training in the study. - Not having undergone chemotherapy or radiotherapy prior to the diagnosis of breast cancer.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation, exercise
Combined training (continuous aerobic + resistance) The protocol will consist of supervised exercise lasting 1h10min each session (5 min of warm-up, 30 min of aerobic exercise, 30 min of resistance exercise and 5 min of cool-down/relaxation). Combined training (high-intensity interval (IAI) + resistance) - Supervised exercise lasting 30 min each session (5 min warm-up, 20 min IAI and 5 min cool-down/relaxation). And Resistance Training - Resistance exercise will be performed at 70-80% of one repetition maximum (1-RM); 2 to 3 sets of 8 to 12 repetitions. The main muscle groups will be trained using training equipment with free weights and body mass of the participants. Exercises included leg extension, seated bicep curl, squat, seated triceps extension, sit-up, seated shoulder press, and standing pulldown

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Outcome

Type Measure Description Time frame Safety issue
Primary Distance Incremental Shuttle Walk Test (SWTI) Distance walking meters Distance Incremental Shuttle Walk Test (SWTI)
Primary Maximum endurance test (1RM) Kg Maximum endurance test (1RM)
Secondary Time Grocery Shelving Task Test Seconds Time Grocery Shelving Task Test
Secondary European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Score European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)
Secondary Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B) Score Functional Assessment of Breast Cancer Therapy Questionnaire (FACT-B)
Secondary Brief Fatigue Inventory Questionnaire (BFI) Score Brief Fatigue Inventory Questionnaire (BFI)
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