Surgical Pre-habilitation in Breast Cancer.

Summary

The National Cancer Institute estimated 625 thousand new cases of cancer (excluding cases of non-melanoma skin cancer) in Brazil for each year between 2020-2022. In 2018, there were 2.1 million new cases of breast cancer in the world, being the first in the ranking of cancers in women. Practices in healthy eating and exercise can protect and / or decrease the risk of breast cancer and improve treatment results. Breast cancer treatments cause cardiovascular changes due to age-related factors, pre-existing chronic diseases and comorbidities such as obesity, smoking and dyslipidemia. Obesity is associated with the development of several types of cancer, including breast cancer. Therapies for breast cancer have a strong association with impaired cardiac function, ranging from permanent, transient cardiotoxic effects and changes in lipid metabolism. In addition to the cardiotoxic effects, the pathophysiology of cancer and treatment favor the appearance of muscle changes, such as sarcopenia. There is sufficient evidence to support that exercise improves fitness before, during and after the completion of cancer treatment. Pre-qualification in cancer treatment is an opportunity to increase physiological reserves before neoadjuvant therapies or surgery, with the intention of improving results and accelerating recovery. It can be composed of physical exercises, nutritional interventions, and psychosocial. Excess weight or depletion are factors that negatively influence surgical and cancer outcomes. In view of the evidence, the aim of this project is to evaluate the effectiveness of physical exercise in a surgical pre-habilitation program for women diagnosed with breast cancer undergoing cancer treatment with a curative therapeutic proposal at the National Cancer Institute in Rio de Janeiro. This is a randomized clinical trial, where patients will be randomly allocated to the Intervention Group and the Control Group. The patients in the intervention group will be instructed to practice physical exercises at home until the date of surgery and those in the control group will only be instructed to maintain their usual activities. All patients will be guided individually by a nutritionist with a view to a healthier nutritional status and control of comorbidities.

Conditions

• Breast Neoplasm

Interventions

BEHAVIORAL

Physical exercise

The prescription will be divided into 3 phases: Warm-up: with the object of removing the body from rest and preparing it to start the activity, it consists of exercises for upper and lower limbs, 1 minute each. Physical exercise: Object of physical conditioning, it consists or aerobic training with walking and muscle activation through concentric contraction of the rectus abdominis in supine position, sit and get up from a chair and resistance exercises for upper members. The patient must perform 2 sets of 12 repetitions for each exercise with a 1-minute interval between the sessions. Stretching and relaxing: Streching the arms above the head, stretching the legs and stretching the trunk to the left and right side will be oriented. Each stretching exercise should be done for 20 seconds. The relaxation should be performed in a sitting position, eyes closed, calm and silent place, soft breathing, for 5 minutes.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil

  lead OTHER_GOV

Principal Investigators

• Simone A Saraiva · Instituto Nacional de Cancer, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-12-30

Completion

2023-12-30

Countries

• Brazil

Study Locations