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

Hospital Israelita Albert Einstein

Status: Unknown

Conditions: Cancer, Breast

Treatments: Behavioral: Health Education; Behavioral: Physical Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04554823

328717

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Will attend lectures on health education.

Treatment:

Behavioral: Health Education

Behavioral: Physical Exercise

Exercise Group

Experimental group

Description:

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.

Treatment:

Behavioral: Health Education

Behavioral: Physical Exercise