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Completed

NCT Number: NCT02804308

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

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.

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Key information

Conditions

Breast Cancer Aromatase Inhibitors Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Postmenopausal Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined training

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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