Clinical trial NCT03247127: Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy
Official title: The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Metastases
Neurocognitive Function
Keywords: hippocampal avoidance whole brain radiotherapy (HA-WBRT)
brain metastases
memory preservation
neurocognitive function
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hippocampal avoidance -whole brain radiotherapy(HA-WBRT), which delivers radiation to whole brain and moreover, to reduce mean dose to hippocampal neural stem-cell compartment to minimize the neurocognitive function impairment
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Memory immediate recall and delayed recall
timeFrame: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
measure: Changes of general cognitive function
timeFrame: From baseline to 4 months after RT complete, tests are performed at baseline before radiotherapy begins, 2 months after radiotherapy complete and 4 months after radiotherapy complete.
Secondary outcomes:
measure: Changes of Quality of life
timeFrame: From baseline to 4 months after RT complete, the participants are requested to fill in the questionnaire of quality of life at baseline before radiotherapy begins, and 2 months after radiotherapy complete and 4 months after radiotherapy complete.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Fang, Pen-Tzu
Study officials:
affiliation: Department of Radiation Oncology, Kaohsiung Medical University Hospital
name: Pen-Tzu Fang, MD
role: PRINCIPAL_INVESTIGATOR
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