Trial Outcomes & Findings for Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer (NCT NCT01797159)
NCT ID: NCT01797159
Last Updated: 2021-10-18
Results Overview
The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome.
COMPLETED
NA
20 participants
Baseline, 6 months and 12 months post radiation treatment
2021-10-18
Participant Flow
Participant milestones
| Measure |
Hippocampal-sparing PCI
Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) 25 Gy in 10 fractions
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 months post radiation treatmentPopulation: At the 6 month timepoint, only 17 participants completed the test, and at the 12 month time point only 14 participants took the test.
The primary endpoint of this study is cognitive function or memory. Memory is measured by participant performance on the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R-Delayed Recall) at 6 months following hippocampal-sparing PCI. The HVLT-Delayed minimum and Maximum scores are 0-12. A higher score means a better outcome.
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall
Baseline
|
7.45 score on a scale
Standard Deviation 2.64
|
|
Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall
6 months
|
7.06 score on a scale
Standard Deviation 2.77
|
|
Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall
12 months
|
7.36 score on a scale
Standard Deviation 2.87
|
SECONDARY outcome
Timeframe: BaselinePopulation: Data is presented for Hippocampal-sparing PCI (from this study). 19 participants completed the test at baseline. No data from standard PCI for comparison to be done.
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A \& B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=19 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Total Recall
|
23.2 score on a scale
Standard Deviation 3.35
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Delayed Recall
|
7.45 score on a scale
Standard Deviation 2.64
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Discrimination
|
10.75 score on a scale
Standard Deviation 1.25
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making A
|
30.1 score on a scale
Standard Deviation 9.79
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making B
|
89.7 score on a scale
Standard Deviation 59
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
COWA
|
32.4 score on a scale
Standard Deviation 13.7
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
MMSE
|
28.3 score on a scale
Standard Deviation 1.05
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
PCT
|
59.1 score on a scale
Standard Deviation 13.7
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BTA
|
16.2 score on a scale
Standard Deviation 2.93
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Letter Word Fluency
|
25.3 score on a scale
Standard Deviation 7.75
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Category Word Fluency
|
44.2 score on a scale
Standard Deviation 8.39
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Verbal Fluency
|
68.9 score on a scale
Standard Deviation 12.3
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Total Recall
|
19.7 score on a scale
Standard Deviation 7.9
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Delayed Recall
|
8.63 score on a scale
Standard Deviation 4.62
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Discrimination
|
5.74 score on a scale
Standard Deviation .562
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Verbal
|
93.2 score on a scale
Standard Deviation 15.2
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Visual
|
96.4 score on a scale
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: 6 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 6 months. No data from standard PCI for comparison to be done.
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A \& B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=14 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Total Recall
|
23.6 score on a scale
Standard Deviation 5.44
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Delayed Recall
|
7.06 score on a scale
Standard Deviation 2.77
|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Discrimination
|
11.1 score on a scale
Standard Deviation 4.76
|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making A
|
34.0 score on a scale
Standard Deviation 10.3
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making B
|
101 score on a scale
Standard Deviation 69.5
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
COWA
|
31.4 score on a scale
Standard Deviation 13.1
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
MMSE
|
27.2 score on a scale
Standard Deviation 2.10
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
PCT
|
54.9 score on a scale
Standard Deviation 15
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BTA
|
15.1 score on a scale
Standard Deviation 3.22
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Letter Word Fluency
|
24.1 score on a scale
Standard Deviation 10.7
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Category Word Fluency
|
40.9 score on a scale
Standard Deviation 10.1
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Verbal Fluency
|
65.1 score on a scale
Standard Deviation 19.9
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Total Recall
|
18.7 score on a scale
Standard Deviation 6.5
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Delayed Recall
|
7.64 score on a scale
Standard Deviation 2.28
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Discrimination
|
5.64 score on a scale
Standard Deviation 1.08
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Verbal
|
95.4 score on a scale
Standard Deviation 18
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Visual
|
96.0 score on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 12 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). 14 participants completed the test at 12 months. No data from standard PCI for comparison to be done.
Composite cognitive function following hippocampal-sparing PCI relative to a historical control receiving standard PCI. HVLT-R Hopkins Verbal Learning Test Revised and Brief Visuospatial Memory Test-Revised (BVMT-R) * Total Recall (0-36) higher = better * Delayed Recall (0-12) higher = better * Discrimination (-12 to 12) higher = better Trail Making A \& B (0-300 seconds) higher = poorer Controlled Oral Word Association (COWA) (0-180) higher = better Mini-Mental State Exam (MMSE) (0-30) higher = better Perceptual Comparison Test (PCT) (0-128) higher = better Brief Test of Attention (BTA) (0-20) higher = better Calibrated Ideational Fluency Assessment (CIFA) * Letter Word Fluency (0-120) higher = better * Category Word Fluency (0-120) higher = better * Verbal Fluency (0-240) higher = better Learning and Memory * Verbal Composite T score (mean = 100, standard deviation = 15), higher = better * Visual Composite T score (mean = 100, standard deviation = 15), higher = better
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=14 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Total Recall
|
21.5 score on a scale
Standard Deviation 4.94
|
|
Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Delayed Recall
|
7.36 score on a scale
Standard Deviation 2.87
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
HVLT-R Discrimination
|
10.6 score on a scale
Standard Deviation 1.22
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making A
|
29.6 score on a scale
Standard Deviation 10.3
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Trail Making B
|
101.2 score on a scale
Standard Deviation 72.3
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
COWA
|
34.2 score on a scale
Standard Deviation 13.5
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
MMSE
|
27.7 score on a scale
Standard Deviation 1.7
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
PCT
|
55.6 score on a scale
Standard Deviation 18.8
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BTA
|
14.7 score on a scale
Standard Deviation 4.31
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Letter Word Fluency
|
25.1 score on a scale
Standard Deviation 8.88
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Category Word Fluency
|
42.5 score on a scale
Standard Deviation 7.78
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
CIFA: Verbal Fluency
|
66.9 score on a scale
Standard Deviation 14.1
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Total Recall
|
19.1 score on a scale
Standard Deviation 6.29
|
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Delayed Recall
|
7.50 score on a scale
Standard Deviation 2.38
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
BVMT-R Discrimination
|
5.71 score on a scale
Standard Deviation 0.611
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Verbal
|
92.8 score on a scale
Standard Deviation 17.7
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Compare Cognitive Function Following Sparing PCI to That of Standard PCI
Learning and Memory: Visual
|
94.4 score on a scale
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline and 6 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Dyspnoea
|
11.1 score on a scale
Standard Deviation 30
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Insomnia
|
-9.5 score on a scale
Standard Deviation 30.5
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Appetite
|
20 score on a scale
Standard Deviation 32.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Constipation
|
6.7 score on a scale
Standard Deviation 44
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Diarrhoea
|
0 score on a scale
Standard Deviation 12.6
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Finances
|
2.4 score on a scale
Standard Deviation 35.7
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Fatigue
|
14.1 score on a scale
Standard Deviation 26.4
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Nausea/Vomiting
|
3.3 score on a scale
Standard Deviation 25.4
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Pain
|
2.2 score on a scale
Standard Deviation 31.4
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Physical Function
|
-11.6 score on a scale
Standard Deviation 19.8
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Role Function
|
-4.4 score on a scale
Standard Deviation 23.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Emotional Function
|
0 score on a scale
Standard Deviation 22
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Cognitive Function
|
11.1 score on a scale
Standard Deviation 16.3
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Social Function
|
8.9 score on a scale
Standard Deviation 35
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30
Global QoL
|
-5.2 score on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Baseline and 12 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire (QLQ-C30) assessment are on a four-point scale from "not at all" to "very much". Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden. Questions on the QLQ-C30 cover the following: * Dyspnoea * Insomnia * Appetite * Constipation * Diarrhoea * Finances * Fatigue * Nausea/Vomiting * Pain * Physical Function * Role Function * Emotional Function * Cognitive Function * Social Function * Global QoL
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Dyspnoea
|
2.8 score on a scale
Standard Deviation 26.4
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Insomnia
|
-5.6 score on a scale
Standard Deviation 31.2
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Appetite
|
-3 score on a scale
Standard Deviation 10
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Constipation
|
0 score on a scale
Standard Deviation 47.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Diarrhoea
|
2.8 score on a scale
Standard Deviation 17.2
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Finances
|
2.8 score on a scale
Standard Deviation 22.3
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Fatigue
|
-0.9 score on a scale
Standard Deviation 21.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Nausea/Vomiting
|
-1.4 score on a scale
Standard Deviation 26.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Pain
|
2.8 score on a scale
Standard Deviation 19.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Physical Function
|
-4.8 score on a scale
Standard Deviation 17.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Role Function
|
0 score on a scale
Standard Deviation 22.5
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Emotional Function
|
5.6 score on a scale
Standard Deviation 14.8
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Cognitive Function
|
-9.7 score on a scale
Standard Deviation 20.7
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Social Function
|
9.7 score on a scale
Standard Deviation 23
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30
Global QoL
|
2.1 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline and 6 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 6 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Headaches
|
13.3 score on a scale
Standard Deviation 32.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Seizures
|
-4.4 score on a scale
Standard Deviation 17.2
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Drowsy
|
0 score on a scale
Standard Deviation 25.2
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Hair loss
|
2.2 score on a scale
Standard Deviation 29.5
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Itching
|
6.7 score on a scale
Standard Deviation 28.7
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Weakness
|
13.3 score on a scale
Standard Deviation 24.6
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Bladder
|
11.1 score on a scale
Standard Deviation 20.6
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Future Uncertainty
|
0.6 score on a scale
Standard Deviation 27
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Visual Disorder
|
6.3 score on a scale
Standard Deviation 17.3
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Motor Dysfunction
|
7.1 score on a scale
Standard Deviation 22.5
|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20)
Communication Deficit
|
12.7 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline and 12 months post radiation treatmentPopulation: Data is presented for Hippocampal-sparing PCI (from this study). No data from standard PCI for comparison to be done.
Evaluate quality of life following hippocampal-sparing PCI relative to historical control receiving standard PCI. Difference between 12 months and baseline. Questions on the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) are rated on a four-point scale ('not at all', 'a little', 'quite a bit' and 'very much'), and are linearly transformed to a 0-100 scale. Higher scores represent more severe symptoms. Questions on the QLQ-BN20 cover the following: * Headaches * Seizures * Drowsy * Hair loss * Itching * Weakness * Bladder * Future Uncertainty * Visual Disorder * Motor Dysfunction * Communication Deficit Headaches Seizures Drowsy Hair loss Itching Weakness Bladder Future Uncertainty Scale Visual Disorder Scale Motor Dysfunction Scale Communication Deficit Scale
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Headaches
|
9.1 score on a scale
Standard Deviation 33.6
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Seizures
|
-3 score on a scale
Standard Deviation 10.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Drowsy
|
-6.1 score on a scale
Standard Deviation 29.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Hair loss
|
-15.2 score on a scale
Standard Deviation 22.9
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Itching
|
9.1 score on a scale
Standard Deviation 15.6
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Weakness
|
6.1 score on a scale
Standard Deviation 29.1
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Bladder
|
12.1 score on a scale
Standard Deviation 30.8
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Future Uncertainty
|
-3 score on a scale
Standard Deviation 23.9
|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Visual Disorder
|
3 score on a scale
Standard Deviation 17.3
|
|
Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Motor Dysfunction
|
6.7 score on a scale
Standard Deviation 17.5
|
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Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20).
Communication Deficit
|
6.7 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 12 monthsThe number of participants with brain metastases after sparing PCI treatment was assessed to be compared to two existing studies.
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Number Participants With Hippocampus Brain Metastases Following Sparing PCI
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months and 24 months post radiation treatmentPopulation: Data for this outcome measure was not collected.
Determine whether development of leptomeningeal carcinomatosis following hippocampal-sparing PCI is higher than expected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 months post radiation treatmentTo evaluate the survival rates of study participants following hippocampal-sparing PCI.
Outcome measures
| Measure |
Hippocampal-sparing PCI
n=20 Participants
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation: Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
Percentage of Participants Surviving Following Hippocampal-sparing PCI
|
88 percentage of participants
Interval 68.0 to 100.0
|
Adverse Events
Hippocampal-sparing PCI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hippocampal-sparing PCI
n=20 participants at risk
Hippocampal-sparing PCI 25 Gy in 10 fractions
Hippocampal-sparing Prophylactic Cranial Irradiation
|
|---|---|
|
General disorders
Fatigue
|
90.0%
18/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Alopecia
|
70.0%
14/20 • Adverse events were followed for a one-year period.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
75.0%
15/20 • Adverse events were followed for a one-year period.
|
|
Respiratory, thoracic and mediastinal disorders
Dsypnea
|
55.0%
11/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Dysphagia
|
45.0%
9/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Anorexia
|
35.0%
7/20 • Adverse events were followed for a one-year period.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
7/20 • Adverse events were followed for a one-year period.
|
|
Ear and labyrinth disorders
Tinnitus
|
35.0%
7/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Memory Loss
|
35.0%
7/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Insomnia
|
55.0%
11/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Taste Disturbance
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
Surgical and medical procedures
Pain due to radiation therapy
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
Skin and subcutaneous tissue disorders
Skin
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Mucus
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
30.0%
6/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Dizziness/lightheaded
|
25.0%
5/20 • Adverse events were followed for a one-year period.
|
|
Gastrointestinal disorders
Vomit
|
25.0%
5/20 • Adverse events were followed for a one-year period.
|
|
Respiratory, thoracic and mediastinal disorders
Pharynx and esophogus
|
20.0%
4/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Dysgeusia
|
15.0%
3/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Headache
|
15.0%
3/20 • Adverse events were followed for a one-year period.
|
|
Nervous system disorders
Neuropathy
|
15.0%
3/20 • Adverse events were followed for a one-year period.
|
|
Gastrointestinal disorders
Dyspepsia
|
55.0%
11/20 • Adverse events were followed for a one-year period.
|
|
Eye disorders
Ocular Visual
|
15.0%
3/20 • Adverse events were followed for a one-year period.
|
|
Psychiatric disorders
Personality Behavioral
|
20.0%
4/20 • Adverse events were followed for a one-year period.
|
|
Ear and labyrinth disorders
Hearing Changes
|
15.0%
3/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Hot Flash
|
10.0%
2/20 • Adverse events were followed for a one-year period.
|
|
Renal and urinary disorders
Urinary Incontinence
|
10.0%
2/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Voice changes
|
10.0%
2/20 • Adverse events were followed for a one-year period.
|
|
Nervous system disorders
Aphasia
|
10.0%
2/20 • Adverse events were followed for a one-year period.
|
|
General disorders
Pain
|
40.0%
8/20 • Adverse events were followed for a one-year period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place