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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04554823
Enrollment
136
Registered
2020-09-18
Start date
2019-03-01
Completion date
2023-01-31
Last updated
2020-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Breast

Keywords

Cancer, Physical Exercise, Health Education Program

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.

Interventions

BEHAVIORALHealth 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

BEHAVIORALPhysical 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.

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Chemotherapy completion rate6 monthsEffect 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 Life6 monthseffect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.
Physical aptitude6 monthsEffect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026