Surgical Pre-habilitation in Breast Cancer.

NCT04861220 | Unknown

• 1 other identifier: CAAE 42627521600005274
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast Neoplasm; Pre-habilitation

Outcome Measures

Primary Outcomes (7)

• Changes in functional capacity and muscle strength - dynamometry assessment using handgrip strength

  The handgrip strength will be assessed using the Kratos dynamometer (model ZM - manual, Brazil). During the execution of the grasping movement, the patients are positioned seated with the adducted arm parallel to the trunk, shoulder in neutral rotation and elbow flexed at 90 °. Three measurements are made, with a minimum interval of 30 seconds between them, and the highest value obtained is considered.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in functional and cardiopulmonary capacity - evaluation of the 6-minute walk test

  The six-minute walk test will be performed in a 20-meter flat corridor, with previously demarcated distances, following the recommendations of the American Thoracic Society. Monitoring of blood pressure (BP), heart rate (HR), partial oxygen saturation (SpO2) and BORG effort perception scale will be performed before, during and after the test. For the collection of HR and SpO2 the pulse oximeter G-TECH model LED (MD 300C19) will be used and for blood pressure measurement the sphygmomanometer Heidji.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes cardiopulmonary capacity - evaluation of the cardiac autonomic modulation through heart rate variability.

  It will be evaluated through the collection of HRV. Data will be extracted via Polar V800.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in Sarcopenia - muscle strength and performance assessment using Time Up and Go Test

  Individuals will be asked to get up from a standard chair, walk to a marker 3 meters away and return the chair, sitting down again. The time spent will be measured with a stopwatch.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in Sarcopenia - muscle strength and performance assessment using SARC-F questionnaire

  The questionnaire consists of 5 questions for the assessment of muscle strength limitations, the ability to walk, get up from a chair, up and down stairs and experiences with falls, used to assess physical performance in sarcopenia. In 2016, a change in this questionnaire was suggested, in addition to the questions, adding the calf circumference measurement.Such an evaluation will be performed by adopting the measurement of the largest perimeter (maximum measurement in the plane perpendicular to the longitudinal line of the calf) with the patient sitting with the knees and ankles flexed at an angle of ninety degrees and feet 20 cm apart from each other using an inextensible tape ( Sanny®, model TR-4010, Brazil). The measuring tape will be passed along the entire length of the calf in an adjusted manner, but without compressing the skin. The measurements will be recorded in the nearest cm.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in Sarcopenia - Evaluation of the corrected arm muscle area

  To calculate this measure, the equations proposed by Heymsfield will be used, according to gender, using in the formula the triciptal skin fold.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in functional and cardiopulmonary capacity - evaluation of the 6-minute step test

  The six-minute step test will be performed with a step measuring 17 cm in height, 80 cm in width and 30 cm in length, following the same recommendations of the American Thoracic Society to the six-minute walk test. The patient must go up and down the steps for 6 minutes and the evaluator must have at the end of the test the total amount of ups and downs performed. Monitoring of blood pressure (BP), heart rate (HR), partial oxygen saturation (SpO2) and BORG effort perception scale will be performed before, during and after the test. For the collection of HR and SpO2 the pulse oximeter G-TECH model LED (MD 300C19) will be used and for blood pressure measurement the sphygmomanometer Heidji.

  Inclusion, post chemotherapy, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

Secondary Outcomes (11)

• Changes in Nutritional Risk

  Inclusion and pre-surgical moment

• Changes in Fatigue

  Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in Physical activity level

  Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Changes in Health-related quality of life

  Inclusion, pre-surgical moment, 30 days after surgery, 6 months after surgery and 1 year after surgery.

• Assessment of adherence to physical exercises

  pre-surgical moment

Study Arms (4)

Pre-habilitation group + neoadjuvant treatment

EXPERIMENTAL

The patients in the Pre-habilitation group + neoadjuvant treatment (Group A), will undergo neoadjuvant cancer therapy and be instructed to practice physical exercises at home 03 times a week, during neoadjuvant therapy, until the date of surgery. The pre-habilitation program (intervention) will consist of prescription of physical exercises and guidance on its importance, through a booklet and practice practice diary. The intervention group will be accompanied weekly by a call to encourage the performance of the exercises, and in case of doubts, new explanations regarding the performance of these exercises.

Behavioral: Physical exercise

Prehabilitation Program + immediate surgical treatment

EXPERIMENTAL

The patients in the Pre-habilitation group + immediate surgical treatment (Group B), will be instructed to practice physical exercises at home 03 times a week until the date of surgery. The pre-habilitation program (intervention) will consist of prescription of physical exercises and guidance on its importance, through a booklet and practice practice diary. The intervention group will be accompanied weekly by a call to encourage the performance of the exercises, and in case of doubts, new explanations regarding the performance of these exercises.

Behavioral: Physical exercise

Usual activities + neoadjuvant treatment

NO INTERVENTION

Patients allocated to this group (Group C) will not participate in the pre-habilitation program and will be instructed to continue their usual activities during the neoadjuvant cancer therapy, until the date of surgery.

Usual activities + immediate surgical treatment

NO INTERVENTION

Patients allocated to this group (Group D) will not participate in the pre-habilitation program and will be instructed to continue their usual activities until the date of surgery.

Interventions

Physical exercise BEHAVIORAL

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.

Pre-habilitation group + neoadjuvant treatment; Prehabilitation Program + immediate surgical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- have a diagnosis of breast cancer and indication for cancer treatment with a curative therapeutic proposal

You may not qualify if:

• having a previous cancer diagnosis
• staging IV
• practitioner of physical exercise at least 90 minutes per week
• not being able to answer the questionnaires
• be unable to practice unsupervised exercises for any reason, including: dysfunctionss orthopedic, neurological, decompensated cardiorespiratory and severe renal.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Instituto Nacional do Câncer / HCIII

Rio de Janeiro, 20560121, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Simone A Saraiva

  Instituto Nacional de Cancer, Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone A Saraiva

CONTACT

55 21 99814-9082; siabrantes2@gmail.com

Rejane M Costa

CONTACT

55 21 998340428; rmcosta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher by statistical analysis will be blind, as he will not be participating in the data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial in women diagnosed with breast cancer who will undergo cancer treatment with a curative therapeutic proposal. Women who attend the Hospital do Câncer III / INCA for clinical screening consultation, before starting cancer treatment, will be evaluated by physiotherapy and nutrition and recruited as to the eligibility criteria for the study. Women who agree to participate will sign the Informed Consent Form and will be submitted to an initial inclusion assessment. After recruitment and definition of their initial treatment - neoadjuvant treatment or immediate surgical treatment, women will be randomly allocated to the Intervention Group (Group A - Prehabilitation Program + neoadjuvant treatment or Group B - Prehabilitation Program + immediate surgical treatment) and Control Group (Group C - Usual activities + neoadjuvant treatment or Group D - Usual activities + immediate surgical treatment).

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 27, 2021
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)