Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

Kaohsiung Medical University

Status: Unknown

Conditions: Brain Metastases; Neurocognitive Function

Treatments: Radiation: Hippocampal avoidance whole brain radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03247127

KMUHIRB-E(II)20170081

Details and patient eligibility

About

The study aimed to investigate the memory preservation and neurocognitive function protection of hippocampal avoidance whole brain radiotherapy (HA-WBRT) among people who speak Mandarin Chinese or Taiwanese.

Full description

Brain metastasis is very common, about 30% incidence rate for all patients with a diagnosis of cancer. The rising incidence of brain metastasis is most likely due to recent advances in systemic therapy, and use of magnetic resonance imaging (MRI). The most common primary site is the lung followed by breast. One of the standard treatments is whole brain radiotherapy; it can prolong the decline of neurocognitive function and improve quality of life. However, it can also cause decline in neurocognitive function as a late sequela. Memory impairment is the main cognitive function that affected by radiotherapy, and the neuronal stem cells located at hippocampal subgranular zone are highly sensitive to radiotherapy. There have been large randomized trials confirming that by HA-WBRT, the neurocognitive function decline can be reclaimed. In Taiwan, HA-WBRT is a popular and emerging treatment. However, not much study focused on its effects on neurocognitive function. The study is aimed to objectively investigate the memory preservation and neurocognitive function protection of HA-WBRT in people speaking Mandarin Chinese or Taiwanese by utilizing neurocognitive function test and QoL questionnaire.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with brain metastases, the brain metastases are located 5mm outside the hippocampus
• Pathologically proven diagnosis of nonhematopoietic malignancy other than germ cell malignancy
• No psychologic disorders
• Radiation Therapy Oncology Group recursive partitioning analysis class I or II
• First or second language: Mandarin Chinese or Taiwanese
• Signed the inform consensus

Exclusion criteria

• Less than 20 years old
• Leptomeningeal metastases or hydrocephalus
• Previous radiotherapy to head and neck region
• Creatinine >1.5mg/dl
• More than 2 extracranial metastases
• Patients who cannot tolerate memory or neurocognitive function test or cannot complete QoL questionnaire

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

HA-WBRT

Other group

Description:

Patients with brain metastases outside a 5-mm margin around either hippocampus and are eligible to this study will receive hippocampal avoidance whole brain radiotherapy 30 gray (Gy) in 10 fractions. The primary endpoint is Wechsler Memory Scale (Chinese) and cognitive abilities screening instrument (CASI) at 4 months.

Treatment:

Radiation: Hippocampal avoidance whole brain radiotherapy