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Epoetin Alfa

Epoetin biosimilar

The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology

Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.

Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

Hospira, now a wholly owned subsidiary of Pfizer

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beta-Thalassemia

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Children with malignant hemopathies attending a precision exercise training

Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training

Sport Therapy

Francesca Lanfranconi, MD, PhD

Adriana Balduzzi, MD, PhD

Adriana Balduzzi

Andrea Biondi, MD, PhD

In the early years of life and during adolescence, physical activity is crucial for good development of motor skills. It is even more so for those children and young people who are forced to undergo anti-cancer therapies and therefore undergo long periods of hospitalization (often bedridden) and prolonged periods of physical inactivity.

The research project "Sport Therapy" was born with the aim of demonstrating that, through targeted physical activity administered by the sports physician in collaboration with the pediatrician hematologist, it is possible to facilitate the full recovery of these patients, avoiding the high risk of chronic diseases related to a sedentary lifestyle and allowing them to better reintegrate, once healed, in their community of origin (school, sport and social relations).

The research project "Sport Therapy" was born within the Maria Letizia Verga Center at the Pediatric Clinic of the University of Milan Bicocca, at the Foundation for the Mother and Her Child, San Gerardo Hospital in Monza. Every year, around 80 children and adolescents with leukemia, lymphoma or blood disorders leading to bone marrow transplantation are treated here.

State of the art. Today, thanks to the progress made in the early diagnosis and treatment of cancer, there are more than 300 thousand young patients in Europe who have been cured of pediatric cancer, and by 2020 there will be almost half a million . For these children and young people, having the opportunity to perform targeted physical activity during treatment plays a key role in preventing diseases due to physical inactivity, which are one of the worst and most widespread consequences for healed patients.

Children and adolescents suffering from cancer of the blood, because of the therapies to which they are subjected, suffer a progressive reduction in respiratory and cardiac capacity, as well as muscle strength. Targeted physical exercise is a possible therapeutic approach to solving their significant problems of reduced ability to perform exercise. It is possible to administer this type of therapy thanks to the synergy created by the collaboration between pediatricians, hematologists, and sports physicians.

Why is this research important? For at least three reasons:

1. the results of the "Sport Therapy" research project will launch precision training as one of the therapeutic weapons available to combat the consequences of hematological diseases in childhood;
2. by increasing the physical capacity of children and adolescents with malignant hemopathies during the phases of cancer treatment, the investigators will reduce the heavy legacy left by treatment, thus bridging the gap regarding their disadvantage towards healthy peers and ensuring their full reintegration into their communities (school, sport, social relations);
3. a standardization of the methodology for using precision exercise in hospitalized children and adolescents will facilitate the monitoring of the progress of these type of interventions at the international level and the data from the "Sport Therapy" project will allow governments and concerned bodies not to further postpone the establishment of strategies necessary to improve the health and welfare of people cured of cancer diseases.

Innovative aspects of research. At the end of the research project "Sport Therapy":

* new strategies will be available to combat cardiopulmonary and skeletal muscle damage resulting from anticancer therapies;
* it will be definitively demonstrated how, from the very beginning of the disease, physical exercise can be a therapeutic option and not just a decorative element in the critical process of caring for children and adolescents suffering from oncological blood diseases, from the beginning of the disease;
* the possibility of introducing new technical figures in the hospital context will be clear. Sports medicine physician and exercise physiologists will be part of the multidisciplinary team that connects the hospital environment to the territory;
* the future perspective, once the experimentation has been completed and the effectiveness of the precision training intervention on the psycho-physical health of children and adolescents suffering from cancer has been demonstrated, will be to make "Sport Therapy" a permanent care service during the treatment of patients of developing age.

Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)

Precision Exercise in Children With Malignant Hemopathies

Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project

Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols

Maximal O2 uptake and skeletal muscle O2 extraction

The PedsQL Measurement Model is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales (physical, emotional, social, school) and 3 Summary Scores (physical health, psycho-social health and total). Each item has a score between 0 and 4, so the scale score is between 0-100. Higher scores indicate a better QoL.

Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.

Comitato Maria Letizia Verga,Italy

University of Milano Bicocca

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology	NCT02140736	Chemotherapy-in... Solid Tumors Malignant Hemop... Lymphomas Myelomas	Epoetin biosimi...	18 Years -	Hospira, now a wholly owned subsidiary of Pfizer
Precision Exercise in Children With Malignant Hemopathies	NCT04090268	Leukemia, Myelo... Leukemia, B-cel... Leukemia, T Cel... Lymphoma, Hodgk... Lymphoma, Non-H... Drepanocytosis Thalassemia Maj... Adrenoleukodyst...	Sport Therapy	2 Years - 18 Years	University of Milano Bicocca
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology	NCT02140736	Chemotherapy-in... Solid Tumors Malignant Hemop... Lymphomas Myelomas	Epoetin biosimi...	18 Years -	Hospira, now a wholly owned subsidiary of Pfizer
Precision Exercise in Children With Malignant Hemopathies	NCT04090268	Leukemia, Myelo... Leukemia, B-cel... Leukemia, T Cel... Lymphoma, Hodgk... Lymphoma, Non-H... Drepanocytosis Thalassemia Maj... Adrenoleukodyst...	Sport Therapy	2 Years - 18 Years	University of Milano Bicocca

Spots Global Cancer Trial Database for malignant hemopathies