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Adapted Physical Activity (APA) in a Breast Cancer Population.

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ClinicalTrials.gov Identifier: NCT03528473
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ettore Marini, University Of Perugia

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE May 17, 2018
Last Update Posted Date April 3, 2020
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Change in physical activity levels [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Self reported physical activity, using IPAQ-SF (International Physical Activity Questionnairev - Short Form) score
  • Change in BMI [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Reduction of BMI expressed as body mass (kg) / height^2 (m^2)
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Maximal aerobic capacity (VO2max) [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Increase of maximal aerobic capacity after physical training, measured as ml/kg/min.
  • HOMA-IR index [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of insulin-sensitivity expressed as HOMA-IR index
  • BMI [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Reduction of BMI expressed as body mass (kg) / height^2 (m^2)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
  • Change in Post-Occlusive Reactive Hyperemia (PORH) [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of Area of Hyperemia (AH) at Post-Occlusive Reactive Hyperemia (PORH) on Laser Doppler velocimetry (Periflux System 5000, Perimed), expressed as Perfusion Units (PU).
  • Carotid intima-media thickness (IMT) [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of macrovascular structures, that will be explored by carotid intima-media thickness (IMT) (two-dimensional B-mode ultrasonography), measured in mm.
  • Arterial stiffness [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Reduction of arterial stiffness, that will be evaluated by radial applanation tonometry (SphygmoCor) and general transfer function assessing PWV (measure in m/s).
  • Hemorheological profile [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of Hemorheological profile, that will be studied with Serum, Plasma, and Blood Viscosity (Haake rotational viscometer), measured as mPas.
  • Serum adiponectin [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of serum adiponectin, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
  • Serum IGF-1 [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of serum IGF-1, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
  • VFA (Visceral Fat Area) [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Improvement of Ultrasound assesment of visceral fat area (VFA, by MyLab 50 Ultrasonography, Esaote), measured by Hirooka formula (cm^2)
  • HOMA-IR index [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Homeostatic model assessment (HOMA) for insulin resistance (IR) is a method for assessing β-cell function and insuline resistance from basal (fasting) glucose and insulin or C-peptide concentrations. HOMA-IR can be calculated with a simple mathematical approximation as HOMA-IR = (FPI × FPG)/22.5, where FPI is fasting plasma insulin concentration (mU/l) and FPG is fasting plasma glucose (mmol/l), or as HOMA-IR = (FPI × FPG)/405 if fasting plasma glucose is expressed in mg/dl. Values bethween 3 and 5 are considered expression of moderate insuline resistance; values upper 5 are considered expression of severe insuline resistance. Improvement of insulin-sensitivity expressed as HOMA-IR index reduction.
  • Maximal aerobic capacity (VO2max) [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Increase of maximal aerobic capacity after physical training, measured as ml/kg/min.
  • miRNA [ Time Frame: Evaluation baseline and after 6, 12 and 24 months from enrollment. ]
    Variation of serum miR-10b, 15a, 146, 155, 375 e let-7a,b,c concentrations.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2018)
  • Post-Occlusive Reactive Hyperemia (PORH) [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of Area of Hyperemia (AH) at Post-Occlusive Reactive Hyperemia (PORH) on Laser Doppler velocimetry (Periflux System 5000, Perimed), expressed as Perfusion Units (PU).
  • Carotid intima-media thickness (IMT) [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of macrovascular structures, that will be explored by carotid intima-media thickness (IMT) (two-dimensional B-mode ultrasonography), measured in mm.
  • Arterial stiffness [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Reduction of arterial stiffness, that will be evaluated by radial applanation tonometry (SphygmoCor) and general transfer function assessing PWV (measure in m/s).
  • Hemorheological profile [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of Hemorheological profile, that will be studied with Serum, Plasma, and Blood Viscosity (Haake rotational viscometer), measured as mPas.
  • Serum adiponectin [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of serum adiponectin, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
  • Serum IGF-1 [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of serum IGF-1, measured by ELISA-method (ng/ml). Blood samples will be collected in the morning between 7:00 and 9:00 am, after overnight fasting.
  • VFA (Visceral Fat Area) [ Time Frame: Evaluation baseline and after 1 year from enrollment. ]
    Improvement of Ultrasound assesment of visceral fat area (VFA, by MyLab 50 Ultrasonography, Esaote), measured by Hirooka formula (cm^2)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapted Physical Activity (APA) in a Breast Cancer Population.
Official Title  ICMJE Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
Brief Summary

The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) .

Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.

Detailed Description

This is a randomized controlled double-group assignment study with intermedial switch-over including post-menopausal, physically inactive breast cancer patients in oncological follow-up with or without hormone therapy, that had completed adjuvant post-surgical treatment (radiotherapy and/or chemotherapy) from at least 3 months and from not more than 3 years.

Patients in hormonal therapy and patient not in hormonal therapy will be assigned in two different groups, each one of 50 patients. In each groups, patients will be randomized divided in a control group (25 pt) and in a 6 months-physical training group (25 pt). After 6-months patient in control group will be switched in the physical training group.

The duration of the study is 2 year. Clinical evaluation of the patients will be made: at the enrollment, after 6, 12, and 24 months.

Physical activity will be adapted according to arm and shoulder morbidity, after fracture risk assessment. Exercise will be concentrated solely on leg muscles (pedalling on a cycle or bed ergometer) in individuals with limitations in the range of motion of the arms (eg, due to breast, axillary, or thoracic surgery). In patients experiencing ataxia, dizziness, or peripheral neuropathy, walking outdoors and mostly cycle-ergometry training will be preferred to other activities that also involve large muscle groups but require additional balance and coordination (eg, treadmill walking, outdoor cycling).

Exercises will be performed at the Unipolar Spinal Unit of "S. Maria della Misericordia" Hospital, Perugia.

The aim of the study is to confirm the positive effect of APA on metabolic stress, body mass composition, functional capacity, serum levels of specific circulating miRNA and quality of life in breast cancer patients in oncological follow-up.

Currently, only few data are available about the relationship between physical activity and microcirculatory hemodynamics that, together with oxidative stress, could be involved in genesis and progression of breast cancer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
This is a randomized, controlled, double-group assignment, open label study with intermediate crossover
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Neoplasms
  • Exercise
  • Exercise Therapy
  • Insulin Resistance
  • Oxidative Stress
  • Microcirculation
  • Quality of Life
  • Atherosclerosis
Intervention  ICMJE Other: Exercise

The exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises.

Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate.

Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines.

Study Arms  ICMJE
  • Experimental: Exercise
    Patients involved in the 6 months-physical training group.
    Intervention: Other: Exercise
  • No Intervention: Control
    Patients in control group carry on their usual follow-up programme.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
50
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • breast cancer patients in oncological follow-up
  • post-menopausal age
  • physically inactivity (light to moderate or vigorous leisure-time physical activity less than 10 minutes a day, US National Health Interview Survey)
  • assuming or not hormone therapy
  • after 3 months - 3 years from adjuvant post-surgical treatment (radiotherapy and/or chemotherapy)

Exclusion Criteria:

Permanent

  • Patients older than 80 years
  • Inability to carry on physical activity
  • Metastatic neoplasia or unknown stage and/or histology
  • Concomitant neoplasia
  • Patients on corticosteroid treatment
  • Known heart disease (heart failure NYHA II (New York Heart Association II) or superior, angina pectoris or positive exercise stress test, treatment-related cardiotoxicity)
  • Currently on a weight loss plan or on moderate physical activity before the start of the project (no more than three sessions a week)
  • Severe cachexia (loss of more than of 35% premorbid weight or weight loss more than 10% in the last 6 months).
  • Morbidly obesity (BMI >40 kg/m2),
  • Immunodepression (absolute neutrophils count < 500/mmc)

Temporary

  • Uncontrolled pain or new onset bone pain until further diagnostic study
  • Severe anemia (haemoglobin below 8 g/dL) or platelet count lower than <50000/μL
  • Fever (temperature above 38ºC) or acute infections
  • Severe nausea and vomiting within previous 24-36 h
  • Uncontrolled blood pressure (systolic blood pressure > 160 mm Hg and/or diastolic blood pressure >99 mm Hg)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leonella Pasqualini, MD 0039 0755784016 leonella.pasqualini@unipg.it
Contact: Rita Lombardini, BSc 0039 0755784030 rita.lombardini@unipg.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528473
Other Study ID Numbers  ICMJE APA-PG1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ettore Marini, University Of Perugia
Study Sponsor  ICMJE University Of Perugia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leonella Pasqualini, MD University Of Perugia
PRS Account University Of Perugia
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP