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

NCT ID: NCT04554823

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2023-01-31

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.

Conditions

Cancer, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Will attend lectures on health education.

Group Type: PLACEBO_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression

Physical Exercise

Intervention Type: BEHAVIORAL

Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.

Exercise Group

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.

Group Type: EXPERIMENTAL

Health Education

Intervention Type: BEHAVIORAL

Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression

Physical Exercise

Intervention Type: BEHAVIORAL

Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.

Interventions

Health Education

Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression

Intervention Type: BEHAVIORAL

Physical Exercise

Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mayra Trevisani

Role: STUDY_CHAIR

External Researcher

Luana Queiroga

Role: STUDY_CHAIR

Employee

Locations

Hospital Municipal Vila Santa Catarina

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

328717

Identifier Type: -

Identifier Source: org_study_id