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

Primary Purpose

Cancer, Breast

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health Education
Physical Exercise
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast focused on measuring Cancer, Physical Exercise, Health Education Program

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hospital Municipal Vila Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Exercise Group

Arm Description

Will attend lectures on health education.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2019
Last Updated
September 14, 2020
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT04554823
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
September 13, 2020 (Actual)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast
Keywords
Cancer, Physical Exercise, Health Education Program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Will attend lectures on health education.
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chemotherapy completion rate
Description
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.
Time Frame
6 months
Title
Analysis of the level of Quality of Life
Description
effect of physical training on the level of physical activity, perception of fatigue and pain, mood, sexual life, anxiety and depression and body image.
Time Frame
6 months
Title
Physical aptitude
Description
Effect of physical training during adjuvant and neoadjuvant chemotherapy on the levels of fragility, muscle strength, joint amplitude of the shoulder and cardiorespiratory capacity.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayra Trevisani
Organizational Affiliation
External Researcher
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luana Queiroga
Organizational Affiliation
Employee
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Municipal Vila Santa Catarina
City
São Paulo
ZIP/Postal Code
04378500
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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