NCT02504788

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

Recruiting now NA Last updated 1 May 2023

What this trial tests

NA trial testing hippocampal-sparing WBRT in Brain Metastasis in 100 participants. Currently enrolling.

Timeline

18 January 2013

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	18 January 2013
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Taiwan

Drugs / interventions tested

• hippocampal-sparing WBRT

Conditions studied

• Brain Metastasis — all drugs for Brain Metastasis →
• Brain Metastases — all drugs for Brain Metastases →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 84, any sex, with Brain Metastasis or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hippocampal dosimetry correlates with the change in neurocognitive function after hippocampal sparing during whole brain radiotherapy: a prospective study.
   Tsai PF, Yang CC, Chuang CC, Huang TY, et al · · 2015 · cited 102× · PMID 26654128 · DOI 10.1186/s13014-015-0562-x
2. Oncological Outcomes After Hippocampus-Sparing Whole-Brain Radiotherapy in Cancer Patients With Newly Diagnosed Brain Oligometastases: A Single-Arm Prospective Observational Cohort Study in Taiwan.
   Lin SY, Tsan DL, Chuang CC, Yang CC, et al · · 2021 · cited 3× · PMID 35096584 · DOI 10.3389/fonc.2021.784635
3. Prophylactic Cranial Irradiation for Extensive-Stage Small-Cell Lung Cancer: A Retrospective Analysis.
   Matutino A, Mak MP, Takahashi TK, Bitton RC, et al · · 2018 · cited 3× · PMID 30241202 · DOI 10.1200/jgo.17.00059