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Memory Preservation of Hippocampal Avoidance Whole Brain Radiotherapy

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ClinicalTrials.gov Identifier: NCT03247127
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Metastases Neurocognitive Function Radiation: Hippocampal avoidance whole brain radiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Memory Preservation Study of Whole Brain Radiotherapy With Hippocampal Avoidance for Patients With Brain Metastases
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
HA-WBRT
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.
Radiation: Hippocampal avoidance whole brain radiotherapy
Planning target volume(PTV) for whole brain is Whole brain parenchyma plus2mm margin excluding metastases and HA region, 30Gy in 10 fractions will be delivered to PTVwhole brain. Bilateral Hippocampus will be contoured according to Radiation Therapy Oncology Group 0933 and hippocampal avoidance region is Hippocampi + 5mm margin. According to Radiation Therapy Oncology Group 0933 trial, dose to 100% of the hippocampus could not exceed 9 Gy, and maximal hippocampal dose could not exceed 16 Gy; dose to 100% of the hippocampus exceeding 10 Gy




Primary Outcome Measures :
  1. Changes of Memory immediate recall and delayed recall [ Time Frame: 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.

  2. Changes of general cognitive function [ Time Frame: 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 :
  1. Changes of Quality of life [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247127


Contacts
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Contact: Pen-Tzu Fang, MD 886-7-3121101 ext 7158 ptmonicafang@gmail.com

Locations
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Taiwan
Fang, Pen-Tzu Recruiting
Kaohsiung, Taiwan, 80660
Contact: Fang Pen-Tzu, MD    886-7-3121101 ext 7158    ptmonicafang@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Principal Investigator: Pen-Tzu Fang, MD Department of Radiation Oncology, Kaohsiung Medical University Hospital

Publications of Results:

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03247127     History of Changes
Other Study ID Numbers: KMUHIRB-E(II)20170081
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
hippocampal avoidance whole brain radiotherapy (HA-WBRT)
brain metastases
memory preservation
neurocognitive function

Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases