Assessment of Bioequivalence of a Generic Cyclosporine (Equoral) by a Prospective Randomized Controlled Trial on Allogeneic Stem Cell Transplant Recipients

2010 ◽  
Vol 42 (9) ◽  
pp. 3735-3738 ◽  
Author(s):  
B.O. Tarek ◽  
B.F. Nadia ◽  
K. Anis ◽  
L. Saloua ◽  
A. Abderrahmane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stem Cell ◽  
Stem Cell Transplant ◽  
Controlled Trial ◽  
Cell Transplant ◽  
Allogeneic Stem Cell Transplant ◽  
Transplant Recipients ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

scholarly journals Acupressure to Reduce Treatment-Related Symptoms for Children With Cancer and Recipients of Hematopoietic Stem Cell Transplant: Protocol for a Randomized Controlled Trial

2019 ◽  
Vol 8 ◽  
pp. 216495611987044 ◽  
Author(s):  
E Anne Lown ◽  
Anu Banerjee ◽  
Eric Vittinghoff ◽  
Christopher C Dvorak ◽  
Wendy Hartogensis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stem Cell ◽  
Usual Care ◽  
Symptom Management ◽  
Hematopoietic Stem Cell Transplant ◽  
Stem Cell Transplant ◽  
Controlled Trial ◽  
Cell Transplant ◽  
Hematopoietic Stem ◽  
Randomized Controlled

Background We describe the study design and protocol of a pragmatic randomized controlled trial (RCT) Acupressure for Children in Treatment for a Childhood Cancer (ACT-CC). Objective To describe the feasibility and effectiveness of an acupressure intervention to decrease treatment-related symptoms in children in treatment for cancer or recipients of a chemotherapy-based hematopoietic stem cell transplant (HSCT). Design Two-armed RCTs with enrollment of 5 to 30 study days. Setting Two pediatric teaching hospitals. Patients Eighty-five children receiving cancer treatment or a chemotherapy-based HSCT each with 1 parent or caregiver. Intervention Patients are randomized 1:1 to receive either usual care plus daily professional acupressure and caregiver delivered acupressure versus usual care alone for symptom management. Participants receive up to 20 professional treatments. Main Outcome A composite nausea/vomiting measure for the child. Secondary Outcomes Child’s nausea, vomiting, pain, fatigue, depression, anxiety, and positive affect. Parent Outcomes Depression, anxiety, posttraumatic stress symptoms, caregiver self-efficacy, and positive affect. Feasibility of delivering the semistandardized intervention will be described. Linear mixed models will be used to compare outcomes between arms in children and parents, allowing for variability in diagnosis, treatment, and age. Discussion Trial results could help childhood cancer and HSCT treatment centers decide about the regular inclusion of trained acupressure providers to support symptom management.

scholarly journals Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial

2020 ◽  
Vol 9 (6) ◽  
pp. 1854
Author(s):  
Daniel Santa Mina ◽  
Lianne B. Dolan ◽  
Jeffrey H. Lipton ◽  
Darren Au ◽  
Encarna Camacho Pérez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stem Cell ◽  
Stem Cell Transplant ◽  
Controlled Trial ◽  
Retention Rates ◽  
Cell Transplant ◽  
Walk Test ◽  
Randomized Controlled ◽  
Six Minute Walk Test ◽  
Minute Walk

People with cancer who undergo allogeneic hematological stem cell transplant (allo-HSCT) experience significant deconditioning that can compromise quality of life. Exercise has shown to be beneficial before or after allo-HSCT; however, little is known about exercise therapy delivered across the continuum of care. We conducted a feasibility randomized controlled trial of exercise delivered prior to admission, during the inpatient stay, and after discharge versus control in people with planned allo-HSCT. Feasibility was assessed via recruitment and retention rates, the incidence of adverse events, and adherence to the exercise prescription. Estimates of efficacy were measured at baseline, one week prior to hospital admission, and 100 days and one year after transplant. The recruitment and retention rates were 20% and 33%, respectively. One serious adverse event occurred during the baseline six-minute walk test that precluded participation in the study and no adverse events were associated with the intervention. From baseline to pre-transplant, the intervention group improved six-minute walk test distances by 45 m (95% CI: −18.0 to 108.7)—a finding that warrants further investigation with an adequately powered trial. Our study contributes important feasibility considerations and pilot data for future exercise intervention research in allo-HSCT recipients.

scholarly journals EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol

BMC Cancer ◽  
2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Carolina Chamorro-Viña ◽  
Gregory MT Guilcher ◽  
Faisal M Khan ◽  
Karen Mazil ◽  
Fiona Schulte ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Stem Cell ◽  
Stem Cell Transplant ◽  
Controlled Trial ◽  
Autologous Stem Cell Transplant ◽  
Cell Transplant ◽  
Trial Protocol ◽  
Randomized Controlled ◽  
Transplant Patients
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