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

U

University Of Perugia

Status

Unknown

Conditions

Exercise Therapy
Quality of Life
Insulin Resistance
Oxidative Stress
Breast Neoplasms
Atherosclerosis
Microcirculation
Exercise

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03528473
APA-PG1

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Exercise
Experimental group
Description:
Patients involved in the 6 months-physical training group.
Treatment:
Other: Exercise
Control
No Intervention group
Description:
Patients in control group carry on their usual follow-up programme.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems