Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

Not Applicable

• Conditions: Brain Metastases; Neurocognitive Function
• Interventions: Radiation: Hippocampal avoidance whole brain radiotherapy

• Registration Number: NCT03247127
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Study Timeline

• Study Start: 2017-03-27
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-26
• Last Update Posted: 2018-08-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HA-WBRT	Hippocampal avoidance whole brain radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
Changes of Memory immediate recall and delayed recall	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.	The memory battery is using Wechsler Memory Scale (Chinese), including Logical Memory I \& II, Word Lists Ⅰ \& II, Faces Ⅰ and spatial span.
Changes of general cognitive function	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.	General cognitive function are tested using cognitive abilities screening instrument, CASI for screening and to test cognitive function as a whole.

Secondary Outcome Measures

Name	Time	Method
Changes of Quality of life	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.	Quality of life are assessed using The Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire

Trial Locations

Locations (1)

Fang, Pen-Tzu; 🇨🇳 Kaohsiung, Taiwan