Clinical trial NCT03528473: Adapted Physical Activity (APA) in a Breast Cancer Population.
Official title: Adapted Physical Activity (APA), Insulin Resistance, Oxidative Stress and Microcirculatory Haemodynamics in Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Exercise
Exercise Therapy
Insulin Resistance
Oxidative Stress
Microcirculation
Quality of Life
Atherosclerosis
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, double-group assignment, open label study with intermediate crossover
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in physical activity levels
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Change in BMI
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Secondary outcomes:
measure: Change in Post-Occlusive Reactive Hyperemia (PORH)
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Carotid intima-media thickness (IMT)
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Arterial stiffness
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Hemorheological profile
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Serum adiponectin
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Serum IGF-1
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: VFA (Visceral Fat Area)
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: HOMA-IR index
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: Maximal aerobic capacity (VO2max)
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
measure: miRNA
timeFrame: Evaluation baseline and after 6, 12 and 24 months from enrollment.
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia
Study officials:
affiliation: University Of Perugia
name: Leonella Pasqualini, MD
role: STUDY_DIRECTOR
References:
citation: Adraskela K, Veisaki E, Koutsilieris M, Philippou A. Physical Exercise Positively Influences Breast Cancer Evolution. Clin Breast Cancer. 2017 Oct;17(6):408-417. doi: 10.1016/j.clbc.2017.05.003. Epub 2017 May 19.
citation: Foucaut AM, Berthouze-Aranda SE, Touillaud M, Kempf-Lepine AS, Baudinet C, Meyrand R, Carretier J, Bachmann P, Fervers B. Reduction of health risk factors through an adapted physical activity program in patients with breast cancer. Support Care Cancer. 2014 Apr;22(4):1097-104. doi: 10.1007/s00520-013-2065-3. Epub 2013 Dec 3.
citation: Franses JW, Edelman ER. The evolution of endothelial regulatory paradigms in cancer biology and vascular repair. Cancer Res. 2011 Dec 15;71(24):7339-44. doi: 10.1158/0008-5472.CAN-11-1718. Epub 2011 Dec 5.
citation: Ye J, Jia J, Dong S, Zhang C, Yu S, Li L, Mao C, Wang D, Chen J, Yuan G. Circulating adiponectin levels and the risk of breast cancer: a meta-analysis. Eur J Cancer Prev. 2014 May;23(3):158-65. doi: 10.1097/CEJ.0b013e328364f293.
citation: Tesarova P, Kalousova M, Zima T, Suchanek M, Malikova I, Kvasnicka J, Duskova D, Tesar V, Vachek J, Krupickova-Kasalova Z, Malik J. Endotelial activation and flow-mediated vasodilation in young patients with breast cancer. Neoplasma. 2013;60(6):690-7. doi: 10.4149/neo_2013_088.