Correlation Between Psychological Stress and Progression of Diffuse Astrocytoma Towards Secondary Glioma

Launched by HENAN PROVINCIAL PEOPLE'S HOSPITAL · Sep 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how psychological stress affects the progression of a brain tumor called diffuse astrocytoma, which can develop into a more serious condition known as secondary glioma. The researchers will observe patients over eight years after they are diagnosed with diffuse astrocytoma. They will assess patients' stress levels, immune system changes, quality of life, and how the disease progresses. Participants will be divided into two groups based on their stress levels—high stress and low stress—after they join the study. All patients will receive the same treatment that includes surgery to remove the tumor, followed by three months of radiation and chemotherapy.

To be eligible for this study, participants must be at least 18 years old, have a confirmed diagnosis of diffuse astrocytoma, and be able to communicate independently. They should not have a history of serious mental illness or substance abuse and must be willing to follow the study's protocols. During the first year, patients will have follow-up visits at one month, three months, six months, and one year, and then every six months after that. It's important to know that no one, including the doctors, will know which stress group a patient belongs to, and the trial is not yet recruiting participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age ≥18 years
• • Karnofsky Performance Score ≥ 70 %
• • histologically confirmed, previously untreated glioma
• • receiving a standardized chemoradiotherapy regimen
• • no previous history of mental illness, drug abuse, or alcohol abuse
• • ability to communicate and read and write independently
• • willing and able to comply with the protocol as judged by the investigator's signed informed consent.
• Exclusion Criteria:
• • Patients who have any other disease, either metabolic or psychological, or who have any evidence on clinical examination or special investigations (including laboratory findings) which give reasonable suspicion of a condition that interferes with the adequate measurement of the stress axis (e.g. chronic use of corticosteroids ≥ 3 months before study entry for diseases other than glioblastoma, (dexamethasone use in the context of glioblastoma is allowed) severe, medically treated psychiatric disorder prior to the diagnosis of glioblastoma Participation in a study with investigational drugs.
• • pregnancy or breast-feeding
• • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurologic deficits that interfere with the planned walking tests, dementia, or confusional state.