Radiation Toxicity Clinical Trial
Official title:
Health Related Quality of Life (HRQL) and Symptom Assessment in Patients Diagnosed With Diffuse Intrinsic Pontine Glioma (DIPG) or Recurrent and Re-irradiated Brain Tumours and Their Caregivers: A Non-Therapeutic Study
Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.
Status | Recruiting |
Enrollment | 57 |
Est. completion date | December 2023 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 21 Years |
Eligibility | Inclusion Criteria: 1. Patient aged >2 and <21 years treated with a repeat course of radiation for DIPG or other recurrent or progressive brain tumour. 2. Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia). 3. Enrollment within 14 days of starting re-irradiation (RT2). 4. Patients with malignant transformation of the first tumour are eligible. 5. There are no restrictions on histology or RT1/RT2 dose-fractionation or RT2 body site. In other words, RT2 may be directed at a different location to RT1. 6. The patient is treated at a site where the study is approved by the local ethics board 7. Consent, and, if applicable, assent, has been obtained according to institutional standards Exclusion Criteria: 1. Inability to complete questionnaires in English or French. |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | IWK Health Centre | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Canada | Children's Hospital | London | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Centre hospitalier de l'Université de Montréal | Montréal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | CHU de Quebec-Universite Laval | Quebec | |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | The Hospital for Sick Children | Toronto | Ontario |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alberta Children's Hospital, British Columbia Children's Hospital, CancerCare Manitoba, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Eastern Ontario, CHU de Quebec-Universite Laval, IWK Health Centre, Janeway Children's Health and Rehabilitation Centre, London Health Sciences Centre, McMaster Children's Hospital, McMaster University, Montreal Children's Hospital of the MUHC, Princess Margaret Hospital, Canada, St. Justine's Hospital, Stollery Children's Hospital, The Hospital for Sick Children, The Ottawa Hospital, Université de Montréal, University of Ottawa, University of Toronto, Western University, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility of conducting routine assessment of HRQOL in children diagnosed with DIPG/recurrent brain tumours and their caregivers. | Recruitment (patients participating vs. patients eligible) and retention rates | 4 months after the second radiation | |
Primary | Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour | Health-related quality-of-life will be measured using the Pediatric Quality of Life Inventory (PedsQL) General Core Scales | 2 months after the second radiation | |
Secondary | HRQOL disease specific modules and family impact | PedsQL Brain Tumor and Family Impact Module | 2 months after the second radiation] | |
Secondary | Symptom burden for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour | Symptom Screening in Pediatrics (SSPEDI) | 2 months after the second radiation] | |
Secondary | Caregiver HRQOL | Short Form 36 (SF-36) | 2 months after the second radiation] | |
Secondary | Anxiety, Depression and Pain Interference | Patient Reported Outcomes Measurement Information System (PROMIS): Anxiety, Depression and Pain Interference Short Forms | 2 months after the second radiation] | |
Secondary | Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation. | Radiation necrosis without obvious tumour progression | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
Completed |
NCT02058550 -
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy
|
Phase 1 | |
Completed |
NCT01434290 -
Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 2 | |
Completed |
NCT01399372 -
Rituximab, Methotrexate, Vincristine Sulfate, Procarbazine Hydrochloride, and Cytarabine With or Without Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
|
Phase 2 | |
Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
Completed |
NCT01407770 -
Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
|
||
Completed |
NCT00003313 -
Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT03783364 -
Pre- or Postoperative Accelerated Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT04305613 -
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated With Chemoradiation Therapy
|
||
Recruiting |
NCT06036706 -
Neurocognitive Impact of Different Irradiation Modalities for Patients With Grade I-II Skull Base Meningioma:
|
N/A | |
Withdrawn |
NCT04593914 -
A Novel Skin Barrier Protectant for Acute Radiodermatitis
|
N/A | |
Recruiting |
NCT04110223 -
Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
|
||
Active, not recruiting |
NCT02259218 -
Metabolomic and Epigenetic Profiling of Bodyfluids From Lung and Brain Cancer Receiving Radiation Therapy
|
||
Recruiting |
NCT06073509 -
Atrial Fibrillation and Other Cardiac Arrhythmias and Diseases After Radiotherapy for Breast Cancer : Watch Your HeaRT
|
||
Withdrawn |
NCT02017925 -
Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation
|
N/A | |
Completed |
NCT01170299 -
Low-Fiber Diet or High-Fiber Diet in Preventing Bowel Side Effects in Patients Undergoing Radiation Therapy for Gynecological Cancer, Bladder Cancer, Colorectal Cancer, or Anal Cancer
|
N/A | |
Completed |
NCT00974168 -
Spinal Cord Compression Re-Treat Study
|
Phase 2 | |
Completed |
NCT00008398 -
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
|
Phase 3 | |
Enrolling by invitation |
NCT04047823 -
Temperature and Injury in Radiotherapy Radiation Skin Injury
|