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

NCT02804308 | Completed

• 1 other identifier: CAAE46727715100005402
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Aromatase Inhibitors; Postmenopausal

Keywords

Combined Training; Breast Cancer; Body Composition; Postmenopausal Women; Aromatase Inhibitors; Quality of life

Outcome Measures

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

  At baseline, 3, 6 and 9 months timepoint

Secondary Outcomes (14)

• Quality of life assessed via the questionnaire EORTC (European Organization for Research and Treatment of Cancer Quality of Life Questionnarie).

  At baseline, 3, 6 and 9 months timepoint

• 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.

  At baseline, 3, 6 and 9 months timepoint

• Serum levels of glucose in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5

  At baseline, 3, 6 and 9 months timepoint

• Serum levels of C-reactive protein (CRP) in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5

  At baseline, 3, 6 and 9 months timepoint

• Serum levels of total cholesterol and fractions in these participants measured by enzymatic colorimetric kit processed in Autohumalyzer A5.

  At baseline, 3, 6 and 9 months timepoint

Study Arms (2)

Group Control with breast cancer and without breast cancer

NO INTERVENTION

Stretching exercises, lasting 40 minutes each session, 2 times a week for nine months

Combined Training with breast cancer and without breast cancer

EXPERIMENTAL

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

Interventions

Combined Training BEHAVIORAL

Combined Training with breast cancer and without breast cancer

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Related Publications (1)

• Felipe J, Viezel J, Reis AD, da Costa Barros EA, de Paulo TRS, Neves LM, Junior IFF. Relationship of different intensities of physical activity and quality of life in postmenopausal women. Health Qual Life Outcomes. 2020 May 6;18(1):123. doi: 10.1186/s12955-020-01377-1.

  PMID: 32375779 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ismael F Freitas Junior, Doctor

  UPECLIN HC FM Botucatu Unesp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: masters degree

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 17, 2016
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2015-03