Actively Recruiting

Phase Not Applicable
Age: 18Years - 84Years
All Genders
NCT02504788

A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline

Led by Chang Gung Memorial Hospital · Updated on 2023-05-01

100

Participants Needed

1

Research Sites

832 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Whole brain radiotherapy (WBRT) has long been a practical and effective therapeutic modality for various settings of management in radiation oncology. For example, the indications for WBRT should include brain metastasis or metastases, the setting of prophylactic cranial irradiation (PCI) used mainly for patients with limited-stage small cell lung cancer, and even some patients with extensive-stage small cell lung cancer. The rationales for WBRT are essentially based on that it can target both microscopic and gross intracranial disease. In addition to providing rapid alleviation of neurologic symptoms and enhanced intracranial disease control, WBRT might also prolong the time to develop neurocognitive function (NCF) decline. However, paradoxically NCF decline can also occur due to a sequel of WBRT. In terms of the time course of WBRT-induced NCF decline, it might vary considerably according to the specific domains which are selected to be measured. Early neurocognitive decline occurs within the first 1 - 4 months after WBRT for brain metastases. The domains of early neurocognitive decline principally involve verbal and short-term memory recall. Since several decades ago, it has been understood that hippocampus plays an essential role in memory function. Not little evidence supports that radiation-induced damage to hippocampus should be strongly associated with NCF impairment. Furthermore, several studies have shown that isodose distribution in hippocampus is closely related to neurocognitive function in patients with benign or low-grade brain tumors. As a consequence, it is hypothesized that conformal hippocampal sparing during the course of WBRT (HS-WBRT) might provide significant preservation in terms of cognitive function. This prospective cohort study aims to explore and evaluate the impact of the delivery of HS-WBRT on the pattern of NCF change and the extent of NCF decline in patients receiving prophylactic or therapeutic WBRT. As compared with previous related and relevant studies, it will also be investigated whether neurocognitive functional preservation can be achieved via the integration of hippocampal sparing with the course of WBRT.

CONDITIONS

Official Title

A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline

Who Can Participate

Age: 18Years - 84Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathologically-confirmed non-hematopoietic malignancy referred for therapeutic or prophylactic WBRT
  • Good performance status with ECOG score no worse than 2 or Karnofsky Score at least 70%
  • Brain metastases limited to no more than three lesions with greatest diameter no more than 4 cm
Not Eligible

You will not qualify if you...

  • Presence of MRI-identified metastasis within 5 mm of the hippocampus
  • Clinical suspicion of leptomeningeal spreading
  • History of prior brain or head radiotherapy including stereotactic radiosurgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

C

Chi-Cheng Chuang, M.D.

CONTACT

S

Shinn-Yn Lin, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Prospective Study of the Impact of Hippocampal Avoidance During Whole Brain Radiotherapy on Neurocognitive Function Decline | DecenTrialz