Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors

NCT04479098 | Completed DMC

• 1 other identifier: CEP 57837416.5.0000.5152/2016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

Conditions

Breast Neoplasm Female

Keywords

Breast Cancer; Immune function; Inflammation; Resistance exercise; Oxidative Stress; Menopause

Outcome Measures

Primary Outcomes (5)

• Changes in blood biomarkers (pg/mL)

  Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. Serum levels of IL-4, IL-6, IFN-γ, TNF-α and Adiponectin will be determined by enzyme-linked immunosorbent assays (ELISA) using commercial kits (BD Biosciences, San Jose, CA, USA), according to the manufacturer's instructions, in an Immulite 2000 analyzer (BD Biosciences, San Jose, CA, USA). Expressed in pg/mL.

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Changes in blood biomarkers (mmol/L)

  Blood samples will be collected after 8-10 hours overnight fasting in evacuated tubes containing separator gel. After 10 min centrifugation at 3000 rpm, the serum will be stored at -80 °C for further analysis. Lipid peroxidation was estimated by determining the serum concentration of thiobarbituric acid reactive substances (TBARS). The TBARS concentration will be obtained by spectrophotometric reading at 535 nm and interpolation in a malondialdehyde calibration curve. Oxidative damage to serum proteins will be estimated by determining the concentration of carbonylated proteins by reading the absorbance at 370 nm and using the molar absorptivity coefficient of 22.000 M-1cm-1. The levels of non-protein thiols will be obtained by the colorimetric method based on the reaction of the sulfhydryl group with 5,5'-dithiobis (2-nitrobenzoic acid) (DTNB). Expressed in mmol/L.

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Changes in blood biomarkers (K/gHb.s)

  Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis.Catalase (Cat) activity was evaluated by the ability of this enzyme to convert H2O2 into O2 and H2O. Expressed in K/gHb.s.

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Changes in blood biomarkers (U/gHb)

  Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The activity of superoxide dismutase (SOD) was evaluated based on their ability to inhibit pyrogallol auto-oxidation and promote a decline in absorbance at 420 nm over time. Expressed in U/gHb.

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Changes in blood biomarkers (mg/dL)

  Blood samples will be collected after 8-10 hours overnight fasting directly in evacuated tubes containing separator gel. After centrifugation for 10 min at 3000 rpm, the serum will be separated for immediate analysis or stored at -80 °C for further analysis. The serum levels of triglycerides (TGC), total cholesterol (t-C), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) will be determined using commercial kits (Labtest, Lagoa Santa, MG, Brazil) in a Technicon RA-XT biochemical analyzer (Bayer, New York, NY, USA). Expressed in mg/dL.

  Before and within 72 hours after 12 weeks of exercise training/detraining

Secondary Outcomes (4)

• Strength (kg)

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Anthropometry (kg)

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Anthropometry (%)

  Before and within 72 hours after 12 weeks of exercise training/detraining

• Anthropometry (kg/m²)

  Before and within 72 hours after 12 weeks of exercise training/detraining

Study Arms (1)

Exercise training

EXPERIMENTAL

Postmenopausal breast cancer survivors undergoing tamoxifen treatment, who will do the evaluations before the beginning and after 12 weeks of exercise training and subsequently 12 weeks of detraining.

Other: Resistance exercise training; Other: Exercise detraining

Interventions

Resistance exercise training OTHER

The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.

Exercise training

Exercise detraining OTHER

The exercise detraining will last 12 weeks without exercise.

Exercise training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age between 40 and 65 years; 2) stage 0-IIIA Breast Cancer; 3) submission to axillary lymphadenectomy); 4) completion of chemotherapy and radiation therapy at least 6 months before the study; 5) lack of participation in supervised physical exercise programs in the six months before the beginning of the research; 6) absence of a problem and/or musculoskeletal limitation that would prevent the performance of the proposed exercises; 7) release by a medical professional to participate in the physical training program; 8) residency in Uberlândia

You may not qualify if:

• missing more than 20% of the exercise sessions; unable to perform the proposed training protocols; change in drug therapy during the intervention.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: July 1, 2016
• Primary Completion: July 31, 2017
• Study Completion: June 30, 2018
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

BR (1)