Lymphoma, Non-Hodgkin Clinical Trial
— SportTherapyOfficial title:
Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
NCT number | NCT04090268 |
Other study ID # | 284 BIONDI |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2017 |
Est. completion date | April 3, 2026 |
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.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | April 3, 2026 |
Est. primary completion date | April 3, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: - Children with malignant hemopathies attending the Maria Letizia Verga Center Exclusion Criteria: - Children under 2 years |
Country | Name | City | State |
---|---|---|---|
Italy | Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child | Monza | MB |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca | Comitato Maria Letizia Verga,Italy |
Italy,
Arico M, Valsecchi MG, Rizzari C, Barisone E, Biondi A, Casale F, Locatelli F, Lo Nigro L, Luciani M, Messina C, Micalizzi C, Parasole R, Pession A, Santoro N, Testi AM, Silvestri D, Basso G, Masera G, Conter V. Long-term results of the AIEOP-ALL-95 Trial for Childhood Acute Lymphoblastic Leukemia: insight on the prognostic value of DNA index in the framework of Berlin-Frankfurt-Muenster based chemotherapy. J Clin Oncol. 2008 Jan 10;26(2):283-9. doi: 10.1200/JCO.2007.12.3927. — View Citation
Aznar S, Webster AL, San Juan AF, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Garcia-Castro J, Ramirez M, Madero L, Lucia A. Physical activity during treatment in children with leukemia: a pilot study. Appl Physiol Nutr Metab. 2006 Aug;31(4):407-13. doi: 10.1139/h06-014. — View Citation
Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. doi: 10.2165/00007256-200838010-00004. — View Citation
Geiger R, Strasak A, Treml B, Gasser K, Kleinsasser A, Fischer V, Geiger H, Loeckinger A, Stein JI. Six-minute walk test in children and adolescents. J Pediatr. 2007 Apr;150(4):395-9, 399.e1-2. doi: 10.1016/j.jpeds.2006.12.052. — View Citation
Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16. — View Citation
Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18. — View Citation
Hartman A, te Winkel ML, van Beek RD, de Muinck Keizer-Schrama SM, Kemper HC, Hop WC, van den Heuvel-Eibrink MM, Pieters R. A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 Jul;53(1):64-71. doi: 10.1002/pbc.21942. — View Citation
Haupt R, Spinetta JJ, Ban I, Barr RD, Beck JD, Byrne J, Calaminus G, Coenen E, Chesler M, D'Angio GJ, Eiser C, Feldges A, Gibson F, Lackner H, Masera G, Massimo L, Magyarosy E, Otten J, Reaman G, Valsecchi MG, Veerman AJ, Penn A, Thorvildsen A, van den Bos C, Jankovic M; International Berlin-Frankfurt-Munster Study Group Early and Late Toxicity Educational Committee (I-BFM-SG ELTEC). Long term survivors of childhood cancer: cure and care. The Erice statement. Eur J Cancer. 2007 Aug;43(12):1778-80. doi: 10.1016/j.ejca.2007.04.015. Epub 2007 May 31. — View Citation
Hogarty AN, Leahey A, Zhao H, Hogarty MD, Bunin N, Cnaan A, Paridon SM. Longitudinal evaluation of cardiopulmonary performance during exercise after bone marrow transplantation in children. J Pediatr. 2000 Mar;136(3):311-7. doi: 10.1067/mpd.2000.103444. — View Citation
Jenney ME, Faragher EB, Jones PH, Woodcock A. Lung function and exercise capacity in survivors of childhood leukaemia. Med Pediatr Oncol. 1995 Apr;24(4):222-30. doi: 10.1002/mpo.2950240403. — View Citation
Lanfranconi F, Pollastri L, Ferri A, Fraschini D, Masera G, Miserocchi G. Near infrared spectroscopy (NIRS) as a new non-invasive tool to detect oxidative skeletal muscle impairment in children survived to acute lymphoblastic leukaemia. PLoS One. 2014 Jun 23;9(6):e99282. doi: 10.1371/journal.pone.0099282. eCollection 2014. — View Citation
Lucia A, Ramirez M, San Juan AF, Fleck SJ, Garcia-Castro J, Madero L. Intrahospital supervised exercise training: a complementary tool in the therapeutic armamentarium against childhood leukemia. Leukemia. 2005 Aug;19(8):1334-7. doi: 10.1038/sj.leu.2403799. No abstract available. — View Citation
Maggiani A, Tremolizzo L, Della Valentina A, Mapelli L, Sosio S, Milano V, Bianchi M, Badi F, Lavazza C, Grandini M, Corna G, Prometti P, Lunetta C, Riva N, Ferri A, Lanfranconi F; ME&SLA Study #. Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study. Open Neurol J. 2016 Aug 26;10:59-66. doi: 10.2174/1874205X01610010059. eCollection 2016. — View Citation
Nagashima T, Sato F, Chuma T, Mano Y, Sasaki I, Mori M, Higa T, Masauji N, Kasai M, Orba Y, Shinohara T, Nagashima K. Chronic demyelinating polyneuropathy in graft-versus-host disease following allogeneic bone marrow transplantation. Neuropathology. 2002 Mar;22(1):1-8. — View Citation
San Juan AF, Fleck SJ, Chamorro-Vina C, Mate-Munoz JL, Moral S, Garcia-Castro J, Ramirez M, Madero L, Lucia A. Early-phase adaptations to intrahospital training in strength and functional mobility of children with leukemia. J Strength Cond Res. 2007 Feb;21(1):173-7. doi: 10.1519/00124278-200702000-00031. — View Citation
San Juan AF, Fleck SJ, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Cardona C, Del Valle MF, Hernandez M, Ramirez M, Madero L, Lucia A. Effects of an intrahospital exercise program intervention for children with leukemia. Med Sci Sports Exerc. 2007 Jan;39(1):13-21. doi: 10.1249/01.mss.0000240326.54147.fc. — View Citation
Tan SY, Poh BK, Chong HX, Ismail MN, Rahman J, Zarina AL, Juraida AR, Tahir A, Ruzita AT, Roslee R, Shanita SN, Hamidah A, Shah MI, Norimah AK. Physical activity of pediatric patients with acute leukemia undergoing induction or consolidation chemotherapy. Leuk Res. 2013 Jan;37(1):14-20. doi: 10.1016/j.leukres.2012.09.005. Epub 2012 Oct 23. — View Citation
Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline oxidative metabolism at 12 weeks | Maximal O2 uptake and skeletal muscle O2 extraction | 12 weeks | |
Primary | Change from baseline strength of upper and lower limbs (1RM) at 12 weeks | 1 repetition maximal | 12 weeks | |
Primary | Change from baseline balance at 12 weeks | Stabilometry | 12 weeks | |
Primary | Change from baseline Quality of Life questionnaire at 12 weeks | 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. | 12 weeks | |
Secondary | Change from baseline Satisfaction at 12 weeks | Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction. | 12 weeks | |
Secondary | Change from baseline 6 minute walking test at 12 weeks | 6 minute walking test | 12 weeks | |
Secondary | Change from baseline Time up and down stairs test at 12 weeks | Time up and down stairs test | 12 weeks | |
Secondary | Change from baseline yo yo test at 12 weeks | Shuttle incremental walking/run test | 12 weeks | |
Secondary | Change from baseline MOON test at 12 weeks | MOON test | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT03484702 -
Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
|
Phase 2 | |
Completed |
NCT01410630 -
FLT-PET/CT vs FDG-PET/CT for Therapy Monitoring of Diffuse Large B-cell Lymphoma
|
||
Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
Completed |
NCT06190457 -
Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
|
||
Completed |
NCT02369016 -
Phase III Copanlisib in Rituximab-refractory iNHL
|
Phase 3 | |
Recruiting |
NCT01676805 -
Tissue Collection for Studies of Lymph Cancer
|
||
Terminated |
NCT00916045 -
Pilot Study of Unrelated Cord Blood Transplantation
|
Phase 2 | |
Completed |
NCT00534989 -
Use of FDG PET as Predictor of Residual Disease and Subsequent Relapse in Patients With NHL and HD Undergoing HDC and ASCT
|
N/A | |
Withdrawn |
NCT00538096 -
A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma
|
Phase 1 | |
Terminated |
NCT00529503 -
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
|
Phase 2 | |
Completed |
NCT00156013 -
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00319332 -
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
|
Phase 3 | |
Completed |
NCT00141297 -
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
|
Phase 1 | |
Completed |
NCT00322842 -
Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients
|
Phase 2 | |
Completed |
NCT02509039 -
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)
|
Phase 1 | |
Completed |
NCT01573000 -
A Randomized Study of Iodine-131 Anti-b1 Antibody Versus Anti-b1 Antibody in Chemotherapy-relapsed/Refractory Low-grade or Transformed Low-grade Non-Hodgkin's Lymphoma (NHL)
|
Phase 2 | |
Completed |
NCT00268203 -
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
|
Phase 2 | |
Completed |
NCT03289182 -
An Observational Study of MabThera Subcutaneous (SC) Safety in Participants With Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)
|