Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Training on Body Composition of Postmenopausal Women Undergoing Treatment for Breast Cancer

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: NCT02804308
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Thais Reis Silva de Paulo, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
Breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. Aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. In this way, the Combined Training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.

Condition or disease Intervention/treatment Phase
Breast Cancer Aromatase Inhibitors Postmenopausal Behavioral: Combined Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Physical Training on Body Composition, Physical Activity Level and Quality of Life of Postmenopausal Women Undergoing Treatment for Breast Cancer With Aromatase Inhibitors: The Randomized Clinical Trial.
Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
No Intervention: Group Control with breast cancer and without breast cancer
Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months
Experimental: Combined Training with breast cancer and without breast cancer
Combined Training: 36 weeks duration, 3 times a week on nonconsecutive days. The combined training program lasts 70 minutes per session, with 40 minutes of resistance training and 30 minutes of aerobic training.
Behavioral: Combined Training



Primary Outcome Measures :
  1. Chance from Body composition at 9 months assessment by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]

Secondary Outcome Measures :
  1. Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie). [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  2. Bone mineral density (total, spine and femur) in these participants by bone densitometry (Dual-energy x-ray absorptiometry), using the equipment model GE Lunar - DPX-NT. [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  3. Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  4. Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  5. Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5. [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  6. Serum levels of triacylglycerol in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5 [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  7. Serum of osteocalcin and the carboxyterminal telopeptides of collagen type I (CTX) measured at Serum CrossLaps Assay [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  8. Physical Activity of accelerometer motion sensor type triaxial Actigraph brand, mode GT3X. [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  9. The perception of pain is measured by Pain Brief Questionnaire (PBQ [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  10. VO2max by test of submaximal effort [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]
  11. Responsiveness on body composition by bone densitometry (Dual-energy x-ray absorptiometry). [ Time Frame: At baseline, 3 and 6 months timepoint ]
  12. Responsiveness on habitual physical activity by accelerometer motion sensor type triaxial Actigraph brand, mode GT3X (Actigraph LLC, Pensacola, FL). [ Time Frame: At baseline, 3 and 6 months timepoint ]
  13. Use time of aromatase inhibitor and the response to combined training in the variables of body composition and level of physical activity by bone densitometry (GE Lunar - DPX-NT) and accelerometer motion sensor type triaxial Actigraph brand, mode GT3X [ Time Frame: At baseline, 3 and 6 months timepoint ]
  14. Self reported Drug consumption questionnaire [ Time Frame: At baseline, 3, 6 and 9 months timepoint ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal, defined by the absence of periods for the past 12 months;
  • Breast cancer diagnosis stages 1 to 3;
  • The adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors
  • No abnormalities on screening physical or any health problems that contraindicate study participation;
  • No contraindications for treadmill testing or entry into a training program, including any of the following:
  • Myocardial infarction within the past 6 months
  • Pulmonary edema
  • Myocarditis Pericarditis
  • Unstable angina
  • Pulmonary embolism or deep vein thrombosis
  • Uncontrolled hypertension (i.e., blood pressure > 200/100 mm Hg)
  • Uncontrolled arrhythmia
  • No significant mental illness
  • Have medical certificate to perform exercise testing and participate in combined training
  • Able to answer Questionnaires
  • No concurrent participation in any other organized exercise program;
  • Live in Presidente Prudente
  • Sign the consent form and formal clarification for participation in the study.

Exclusion Criteria:

  • Accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

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): NCT02804308


Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
Layout table for investigator information
Study Director: Ismael F Freitas Junior, Doctor UPECLIN HC FM Botucatu Unesp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Thais Reis Silva de Paulo, masters degree, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02804308    
Other Study ID Numbers: CAAE46727715100005402
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: March 2015
Keywords provided by Thais Reis Silva de Paulo, Universidade Estadual Paulista Júlio de Mesquita Filho:
Combined Training
Breast Cancer
Body Composition
Postmenopausal Women
Aromatase Inhibitors
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases