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

Cancer, Breast Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04554823
• Other study ID #: 328717
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

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