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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04554823
Other study ID # 328717
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date January 31, 2023

Study information

Verified date September 2020
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 136
Est. completion date January 31, 2023
Est. primary completion date September 13, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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
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.

Locations

Country Name City State
Brazil Hospital Municipal Vila Santa Catarina São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chemotherapy completion rate 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. 6 months
Primary Analysis of the level of Quality of Life effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image. 6 months
Primary Physical aptitude Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity. 6 months
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