Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy

Not Applicable

• Conditions: Cancer, Breast
• Interventions: Behavioral: Health Education; Behavioral: Physical Exercise

• Registration Number: NCT04554823
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The purpose of this study is to verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy.

Detailed Description

According to the National Cancer Institute (INCA), the estimate for Brazil, 2016-2017 biennium, points to the occurrence of about 600,000 new cases of cancer, and breast cancer (58000) in women will be the most frequent. One study revealed that only 12% of women undergoing chemotherapy in CM who participated in a physical exercise program had to readjusted the dose of the medications, while 34% of those who received the conventional treatment needed to readjust the Treatment doses, with neuropathy being one of the most present adverse effects that influenced this adjustment. In this sense, the conduct to keep the patient at rest during the treatment seems to potentiate her side effects, and sedentarism is another factor detrimental to the patient's health. Objective: To verify the effect of the intervention of a program of physical exercises and health education in women with breast cancer undergoing chemotherapy. Methodology: A sample will consist of 136 (136) Women, over 18 years of age, sedentary, diagnosed with non-metastatic breast cancer and initiating the first cycle of chemotherapy. They will be divided into two groups, randomly and stratified: control group: (CG n = 68) and exercise group: (eg n = 68) that will undergo a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times Weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and both groups (GC and EG) will attend lectures on health education, which are held monthly.

Study Timeline

• Study First Submitted: 2019-01-11
• Study Start: 2019-03-01
• Status Verified: 2020-09
• Primary Completion: 2020-09-13
• Study First Submitted QC: 2020-09-14
• Last Update Submitted: 2020-09-14
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-18
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 136

Inclusion Criteria

• women over 18 years of age;
• with the first diagnosis of non-metastatic breast cancer;
• Sedentary for 6 months;
• who are in the initial cycle of chemotherapy;
• with the release of the responsible physician;
• availability to participate in the exercise program;
• signing of the free and clarified consent term.

Exclusion Criteria

• women with clinical risk for physical exercise (e.g. severe anemia, ICC, CRI);
• Pregnant women;
• Osteoarticular problems that preclude the practice of physical exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Health Education	Will attend lectures on health education.
Exercise Group	Health Education	Will be subjected to a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and Will attend lectures on health education.
Exercise Group	Physical Exercise	Will be subjected to a supervised training program of combined exercises for 24 weeks, with a frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week and Will attend lectures on health education.
Control Group	Physical Exercise	Will attend lectures on health education.

Primary Outcome Measures

Name	Time	Method
Chemotherapy completion rate	6 months	Effect of physical training on the rate of chemotherapy completion in the anthropometric profile, habitual food consumption, prevalence of comorbidities, cardiovascular, neurofunctional, bone and respiratory toxicity, myelosuppression, sarcopenia induced by chemotherapy, myalgia, nausea and vomiting symptoms.
Analysis of the level of Quality of Life	6 months	effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.
Physical aptitude	6 months	Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.

Trial Locations

Locations (1)

Hospital Municipal Vila Santa Catarina; 🇧🇷 São Paulo, Brazil