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Aerobic Training in Treatment for Breast Cancer (ATTBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494400
Recruitment Status : Active, not recruiting
First Posted : April 11, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Andréa Dias Reis, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:

Introduction. Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.

Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.

Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers (TNFα, LDL, HDL, VLDL, as well as in the lipid profile (triglycerides, total cholesterol and LDL fractions ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.


Condition or disease Intervention/treatment Phase
Cancer of Breast Healthy Other: Aerobic Training Presential Other: Aerobic Training Home-based Not Applicable

Detailed Description:

Introduction. Breast cancer is one of the leading causes of morbidity and mortality in the world.Treatment with hormone therapy reduced the likelihood of tumor recurrence and metastasis in the patient. However, it has adverse effects such as: loss of bone mineral density, increase in body weight, metabolic changes (lipid and low grade systemic inflammation) and, consequently, lower quality of life. Physical training has been used as a means of reducing these and other adverse effects, but there is no definite protocol on which training model is effective, especially in patients who only use Tamoxifen or Aromatase Inhibitor as an adjuvant therapy for treatment of breast cancer.

Objective: To compare the effect of aerobic training on body composition, metabolic and inflammatory variables, physical activity level, sleep, anxiety, depression, body image, fatigue, strength, flexibility and quality of life of women undergoing breast cancer treatment use Tamoxifen and Aromatase Inhibitor and women without cancer.

Method. The sample will be formed by women without cancer and under treatment with hormone therapy being accompanied by the public service for treatment of breast cancer of the city of Presidente Prudente. Where participants will be distributed in six groups submitted to intervention with aerobic training: Tamoxifen group with face-to-face training (GTP); Aromatase Inhibitor Group with face-to-face training (GIP); Tamoxifen training group by distance monitoring (GTA); Training group Aromatase inhibitor by distance monitoring (GIA); Group without training with cancer (GC) and Group training face-to-face without cancer (GTSC). A 24-week notification in which the face-to-face training group will undergo aerobic training three times a week on interspersed days and the group accompanied at a distance will perform as a preferred activity under a distance supervision of professionals every 14 days of return to attend the UNESP for the adequacy of the analysis and selection of attendance to the proposed activities. Evaluations of the variables of interest at the baseline of the intervention will be performed after 12 weeks and soon after the intervention. The investigators will analyze: biomarkers will analyze: biomarkers (Tumor Necrosis Factor-Alpha (TNFα), (LDL), High Density Lipoprotein (HDL), and Very Low Density Lipoprotein (VLDL), as well as in the lipid profile (triglycerides, total cholesterol and low density lipoprotein (LDL) fractions) ), glycemia, insulin, anthropometric measurements, physical activity level, sleep, pain, anxiety, depression, body image, fatigue, strength, flexibility. Trainings will be performed within the target zone of maximum heart rate. Comparisons between groups at each time point will be performed using Student's T-test for independent samples. The comparisons of the variables of interest at the initial moment and after 12 and 24 weeks will be made through the multivariate analysis, where the group effects, time and interaction of both will be compared. All analyzes will be performed in SPSS software version 24.0 and significance of 5%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Aerobic Training in Treatment for Breast Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 23, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Tamoxifen Aerobic Training Presential
A group of women with breast cancer who use Tamoxifen and will perform aerobic training presential.
Other: Aerobic Training Presential
The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days.
Other Name: Physical exercise Presential

Experimental: Aromatase Inhibitor Training Presential
A group of women with breast cancer who use Aromatase Inhibitor and will perform aerobic training presential.
Other: Aerobic Training Presential
The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days.
Other Name: Physical exercise Presential

Active Comparator: Training Presential without Cancer
A group of women without breast cancer who use Aromatase Inhibitor and will perform aerobic training presential.
Other: Aerobic Training Presential
The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days.
Other Name: Physical exercise Presential

No Intervention: Training with Breast Cancer
A group of women with breast cancer who use hormone therapy and will not perform any physical training
Experimental: Tamoxifen Training Home-based
A group of women with breast cancer who use Tamoxifen and will perform aerobic training home-based.
Other: Aerobic Training Home-based
The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities
Other Name: Physical exercise Home-based

Experimental: Aromatase Inhibitor Home-based
A group of women with breast cancer who use Aromatase Inhibitor and will perform aerobic training presential.
Other: Aerobic Training Home-based
The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities
Other Name: Physical exercise Home-based




Primary Outcome Measures :
  1. Evaluation of body composition by Bone Densitometry (DEXA) equipment [ Time Frame: 24 week ]
    Reduction of body mass and of increased fat free mass


Secondary Outcome Measures :
  1. Evaluation of quality of life by questionnarie EORTC-QLQ-30 [ Time Frame: 24 week ]
    Increased of quality of life global

  2. Evaluation inflammatory response by ELISA equipment [ Time Frame: 24 week ]
    Reduction of interleukin- IL 6

  3. Evaluation of pain by questionnarie BPI. [ Time Frame: 24 week ]
    Reduction of pain intensity to increased of functional capacity

  4. Evaluation of level of physical activity by triaxial accelerometer equipment [ Time Frame: 24 week ]
    Increased of level of physical activity

  5. Nutritional evaluation by food register [ Time Frame: 24 week ]
    Increased of quality of food



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of breast cancer;
  • Perform Tamoxifen or Aromatase Inhibitor Treatment;
  • Being in stages 1 to 3 of breast cancer;
  • Do not present physical limitations or any health problem that prevents the performance of the evaluations and the training;
  • Have a medical certificate to perform the ergometric test and participate in physical training;
  • Not practicing physical training in the last six months;
  • Sign the Term of Free Consent and Clarification.

Inclusion Criteria for the group without cancer

  • Do not use Tamoxifen or Aromatase Inhibitor;
  • Not being diagnosed with any type of cancer.

Exclusion Criteria:

  • Accumulate three consecutive absences or four non-consecutive absences in presential training during the month;
  • Failure to attend the scheduled bi-weekly activities in the case of the home-based training group;
  • Do not send information about the activities carried out in the case of the home-based group

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494400


Locations
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Brazil
Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, Brazil, 19060-560
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: ISMAEL F FREITAS JUNIOR Universidade Estadual Paulista Júlio de Mesquita Filho
Publications:

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Responsible Party: Andréa Dias Reis, Clinical Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03494400    
Other Study ID Numbers: State University of São Paulo
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andréa Dias Reis, Universidade Estadual Paulista Júlio de Mesquita Filho:
Breast cancer
Physical exercise
Body mass
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases