Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

STEEL strength training will consist of progressive periodised training, in which the intensity is set to fit the individual's starting level and then gradually increases. During Week 1 to Week 5, the relative load will correspond to a 12-repetition maximum (RM). During Week 5 to Week 10, the relative load will be 10 RM, and during Week 11 to Week 16, the relative load will be 8 RM. The exercises will mostly consist of compound movements that activate the large muscle groups of the legs, back, arms and torso.

There will be 10 stations that include both strengthening and cardiovascular exercises, such as squats, hopping, crunches, stationary running, front-lying swimming, ski jumps, push-ups, ball throws, ring pulls, and hopscotch. Each station lasts 45 seconds, and there will be a 15-second break between each station. The circuit is repeated for three rounds. To ensure progression in intensity similar, we will progress the participants' rating of perceived exertion (RPE) over time. During Week 1 to Week 5, the RPE during exercises will be 6-7. During Week 5 to Week 10, the RPE will be 8-9, and during Week 11 to Week 16, the RPE will be 10.

STEEL

Circuit training

Henrik Riel, PhD

Pascal Madeleine, DSc

Martin K Fridh

Henrik Riel

Mathias Rathe

Clara Vad

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

The trial is designed as a national randomised clinical trial. Participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or the circuit training programme. A researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. The study will be conducted at Aalborg University Hospital, Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. Participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - The STEEL Study - a National Multicenter Randomised Controlled Study

De-identified data will be made available upon reasonable request.

Measured in Nm based on tests of knee extension and flexion and elbow extension and flexion using handheld dynamometry

We will use the Danish version of the Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core scales and the PedsQL™ Multidimensional Fatigue scales (5,9) to assess health-related quality of life. The PedsQL is a brief 23-item measurement model that evaluates quality of life in four areas: physical, emotional, social and school functioning. The questionnaire scores range from 0 to 100, and higher scores indicate better quality of life. The PedsQL™ Multidimensional Fatigue includes 18 questions related to fatigue and uses the same scoring as the PedsQL

We will assess participants' step counts throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).

We will assess participants' caloric expenditure (KCAL) throughout the intervention using a Garmin vívosmart® 5 watch (Garmin Ltd., Kansas, USA).

we will test the 1 repetition maximum (RM) in the leg press and chest press machines

We will measure the bone mineral density of the lumbar spine (L1-L4) calculated as the Z-score and body composition (%body fat, lean body mass, and skeletal muscle mass) by a dual-energy-X-ray absorptiometry scanner located at each hospital.

Using a digital hand dynamometer, we will measure continuous isometric handgrip force and rate of force development.

We will use a 30-second sit-to-stand test to evaluate strength, endurance, and rate of force development of the lower extremities.

We will perform a 6-minute walk test to evaluate cardiorespiratory fitness and walking endurance

Exercise compliance and fidelity will be measured using training diaries, which the participants fill out themselves after the unsupervised training sessions and by the physiotherapist during the supervised training sessions. Exercise compliance relates to whether the training sessions have been performed, and fidelity relates to whether the exercises have been performed as prescribed regarding the number of repetitions, sets, and intensity.

Adverse events will be collected throughout the trial and graded 1 to 5 according to the Common Terminology Criteria for Adverse Events v4.03. Participants are asked to contact the responsible clinician at the hospital where they were enrolled as soon as they experience any adverse event.

We will use a 0 (no pain) to 10 (worst pain imaginable) Numerical Rating Scale to assess movement-evoked pain during the past week

We will assess participant satisfaction with their respective intervention using a 5-point rank scale ranging from 'very dissatisfied' to 'very satisfied'.

Analysed from a blood sample and measured in mmol/L

Analysed from a blood sample and measured in mmol/mol

Analysed from a blood sample and measured in mU/L

Analysed from a blood sample and measured in ng/mL

Analysed from a blood sample and measured in pg/mL

Calculated as fasting plasma glucose (mmol/L x fasting plasma glucose ((μU/L)/22.5) to estimate β-cell function (HOMA-B) and insulin-resistance (HOMA-IR2)

Measured as kg/m² for adolescents aged 18 or 19 years and BMI standard deviation (SD) scores for children aged 10-17 years based on national reference material.

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA)

Measured in kilograms based on dual-energy X-ray absorptiometry (DXA) adjusted for sex and pubertal stage

Visual illustration of Tanner staging (I-V) regarding both genders

Aalborg University

Postdoctoral researcher

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Recurrence

Prostatic Neoplasms

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Hormones

Leuprolide

Goserelin

Triptorelin Pamoate

Bicalutamide

Androgen Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog with or without 1-4 months of bicalutamide.

Salvage RT will be given 66.0 - 70.2 Gy along with 24 months of a GnRH analog + 24 months of enzalutamide.

Radiation Therapy

Enzalutamide

GnRH analog

Edwin Posadas, MD

Hiram Gay, MD

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

PRIMARY OBJECTIVE:

To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog -based ADT.

A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

STEEL: A Randomized Phase II Trial of Salvage Radiotherapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

The time from the date of randomization to the date of progression, death from any cause or last known follow-up date.

Pfizer

Astellas Pharma Inc

RTOG Foundation, Inc.

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Biliary Tract Neoplasms

Jaundice

Cholestasis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Biliary Tract Diseases

Pancreatic Cancer

Insertion of Metalic Steel Stent, Wallstent® in malignant distal bile duct obstruction

Insertion of Metalic nitinol Stent, Wallflex® in malignant distal bile duct obstruction

ERCP procedure insertion of Metalic Steel Stent, Wallstent®

Steel

Nitinol

Claes soderlund, assist prof

Less than 20% of patients with malignant distal bile duct (BD) obstruction (often pancreatic cancer) are suitable for resection surgery.In the rest,palliation treatment comes into focus. Jaundice caused by BD obstruction gives pain, infection (cholangitis), often itching and increased weight loss, and the patient is stigmatized by the deep yellow colour of the skin.Therefore palliation with endoscopic stenting by ERCP-technique is important. Modern self-expanding metal stents (SEMS) are now widely used in this context. Comparison in a RCT between steel and nitinol SEMS has never been performed.

The steel stent (Wallstent®) is the "original",is widely used, and has more expanding power. Nitinol stents are softer and claimed to be easier to insert,and are more and more popular.A newly developed nitinol stent (Wallflex®)may have these advantages, but is some 120 Euros more expensive.

Regarding the most important outcome measure, time to stent failure (obstruction), no one knows if there is any difference.Our hypothesis is that there is no difference in this main outcome endpoint.

Secondary outcome measures (compare above) are complications caused by the stent or stent insertion and technical ease to insert the stent. To discover a 12% difference between the 2 groups, regarding patency, 400 patients must be included in the trial, alfa 0.05, beta 0.8. Investigators know from previous trials (Single center trial South Hospital GIE 2006;63:986-995 and a newly finished similar swedish multicenter trial,prel data DDW- 09)that the 9 hospitals recruited will be able to include this no of patients in approximately 2.5 years.

Investigators will have a shortest follow-up period of 10 months, followup will be by phone with standard questions connected to stent failure, which is defined clinically AND by a new ERCP with intervention because of an obstructed stent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery	NCT03809000	Prostate Cancer	Radiation Thera... Enzalutamide Bicalutamide GnRH analog	18 Years -	RTOG Foundation, Inc.
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction	NCT00980889	Biliary Tract N... Pancreatic Neop... Stent Occlusion	Steel Nitinol	20 Years -	Stockholm South General Hospital
RCT Steel (Wallstent®) vs Nitinol (Wallflex®) Bile Duct Stent for Palliation of Malignant Obstruction	NCT00980889	Biliary Tract N... Pancreatic Neop... Stent Occlusion	Steel Nitinol	20 Years -	Stockholm South General Hospital
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents	NCT06299722	Cancer	STEEL Circuit trainin...	10 Years - 19 Years	Aalborg University

Spots Global Cancer Trial Database for steel

Every month we try and update this database with for steel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for steel

Every month we try and update this database with for steel cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for steel cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.