Clinical trial NCT03908502: A Study in Radiotherapy-related Nervous System Complications
Official title: An Observational Study in Clinical Manifestations, Therapeutic Effects, Progress, and Prognosis of Radiotherapy-related Nervous System Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nervous System Complication
Keywords: Radiotherapy
Nervous System Complications
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. The outcomes of various radiation protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.

Brief summary: Purpose: This observational study aims to evaluate the clinical manifestations, therapeutic effects, progress and prognosis in radiotherapy-related nervous system complications.

OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Blood, urine, stool, cerebrospinal fluid (CSF), imaging and other examinations, and scale assessments are regularly performed to evaluate the state of the disease.

Further study details are provided by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University/Yamei Tang.

Primary outcome measure: The primary endpoint is overall survival.

Detailed description: BACKGROUND

Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. Various radiation treatment methods employ different types of fractionation and conformational protocols designed to deliver focused radiation to target regions to maximize the lethal effect on the neoplasm and minimize the extraneous dose on normal brain tissue and other adjacent organs at risk. The outcomes of these clinical protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.

STUDY DESIGN:

Interventions Patients are enrolled and administrated with optimized clinical treatment.

Follow-up examinations

1. Blood, urine and stool examinations, such as biochemical A, coagulation routine, thyroid function, EB virus DNA, erythrocyte sedimentation rate, morning cortisol, urine sodium and potassium, gonadal hormone, growth hormone, glycosylated hemoglobin.
2. Imaging examinations, such as MR, CT, ultrasound. X ray is performed if needed.
3. Other examinations, such as pure tone audiometry, fundus exam, visual exam, VEP, OCTA, visual field exam.
4. Scale assessments about neurological function, radiation injury, common psychiatric disorders, cognitive function, quality of life, drug side effect, sleep and pain, such as LENT/SOMA, WHO-QOL, MoCA, MMSE, Hamilton anxiety scale, Hamilton depression scale, Pain numerical rating scale, Drug side effect scale, ADAS-cog, fatigue self-assessment scale (FSAS), Neuropsychiatric Inventry (NPI) total score, Clinical Dementia Rating Scale, Barthel index, UPDRS, Self-Rating Scale of Sleep (SRSS), NCI-CTCAE, CIBIC-plus and SSA.
5. Blood sample are obtained in order to investigate significant genes, proteins and metabolites involved in the development and progress of radiotherapy-related nervous system complications. Genomics, metabolomics and proteomics are performed to detect potential genes, proteins and metabolites. Stool sample are obtained in order to investigate interactions between the gut microbiota, immune and nervous systems in radiotherapy-related nervous system complications. Cerebrospinal fluid (CSF) and biopsy samples are obtained if needed.

Eligibility criteria: Inclusion Criteria

* Receipt of radiotherapy

Exclusion Criteria

* Inability to sign a written informed consent.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death or up to Year 20
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Yamei Tang, M.D., PhD.
role: STUDY_DIRECTOR
References:
citation: Li H, Rong X, Hu W, Yang Y, Lei M, Wen W, Yue Z, Huang X, Chua MLK, Li Y, Cai J, He L, Pan D, Cheng J, Pi Y, Xue R, Xu Y, Tang Y. Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis. Front Oncol. 2021 Sep 28;11:746941. doi: 10.3389/fonc.2021.746941. eCollection 2021.