Clinical trial NCT04554823: Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy
Official title: Effects of a Physical Exercise and Health Education Program for Women With Breast Cancer Undergoing Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer, Breast
Keywords: Cancer
Physical Exercise
Health Education Program
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Verificar o efeito de um Programa de exercicios fisicos e de educacao em saude em mulheres com cancer de mama submetidas a quimioterapia sobre a taxa de conclusao da quimioterapia e sobre as toxicidades do tratamento.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Chemotherapy completion rate
timeFrame: 6 months
measure: Analysis of the level of Quality of Life
timeFrame: 6 months
measure: Physical aptitude
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Municipal Vila Santa Catarina
Study officials:
affiliation: External Researcher
name: Mayra Trevisani
role: STUDY_CHAIR
affiliation: Employee
name: Luana Queiroga
role: STUDY_CHAIR
References: