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

Sponsor

Hospital Israelita Albert Einstein (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04554823

Collaborator

(none)

136

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast	Behavioral: Health Education Behavioral: Physical Exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Sep 13, 2020

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group Will attend lectures on health education.	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 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.
Experimental: 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.	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 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.

Arm

Intervention/Treatment

Placebo Comparator: Control Group

Will attend lectures on health education.

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

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.

Experimental: 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.

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Municipal Vila Santa Catarina	São Paulo		Brazil	04378500

Sponsors and Collaborators

Hospital Israelita Albert Einstein

Investigators

Study Chair: Mayra Trevisani, External Researcher
Study Chair: Luana Queiroga, Employee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital Israelita Albert Einstein

ClinicalTrials.gov Identifier:

NCT04554823

Other Study ID Numbers:

328717

First Posted:

Sep 18, 2020

Last Update Posted:

Sep 18, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Israelita Albert Einstein

Cancer

Physical Exercise

Health Education Program

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Sep 18, 2020