Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287515
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-02-23
Brief Title:
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if hypophysectomy treatment of the pituitary gland using a type of radiation treatment called stereotactic radiosurgery SRS can help to relieve cancer-related pain
Detailed Description:
Primary Objective
To determine the feasibility of enrollment and treatment of patients within MD Anderson Cancer Center with SRS hypophysectomy to plan future trials Feasibility will be defined as completion of SRS hypophysectomy enrollment and treatment of the lead-in cohort n20 patients within one year of trial activation
Secondary Objectives
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the worst pain subscale of the Brief Pain Inventory BPI short form57
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the pain composite scale of the BPI short form57
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in the interference scale of the BPI short form57
To obtain estimates of the change in the daily usage of opioid medications calculated as oral morphine equivalents OME over time after SRS hypophysectomy in participants with refractory cancer-related pain
To obtain estimates of the change in mood and depressive symptoms using the Hospital Anxiety and Depression Scale HADS composite score over time after SRS hypophysectomy in participants with refractory cancer-related pain60
To obtain estimates of the change in beliefs on self-efficacy using the Pain Self-Efficacy Questionnaire PSEQ over time after SRS hypophysectomy in participants with refractory cancer-related pain61
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in quality of life as measured by the European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire Core 15 Palliative Care QLC C15 PAL59 To obtain estimates of neurologic toxicity related to SRS measured by the NCIs CTCAE v50
Correlative Objectives
To apply novel fMRI and DTI MRI protocols to characterize functional and connectome changes following SRS hypophysectomy
To study neuroanatomic and histobiochemical changes of the pituitary glandstalk after SRS hypophysectomy on post-mortem tissue
To obtain estimates of neurocognitive changes following SRS hypophysectomy in participants with refractory cancer-related pain including learning and memory Hopkins Verbal Learning Test-Revised attention WAIS-IV Digit Span Trail Making Test Part A Stroop test WAIS-IV Coding and executive function Trail Making Test Part B Controlled Oral Word Association referred to hereafter as neurocognitive battery63-66
To determine the feasibility of enrollment and treatment of patients within MD Anderson Cancer Center with SRS hypophysectomy to plan future trials Feasibility will be defined as completion of SRS hypophysectomy enrollment and treatment of the lead-in cohort n20 patients within one year of trial activation
Secondary Objectives
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the worst pain subscale of the Brief Pain Inventory BPI short form57
To obtain estimates of the change from baseline over time after SRS hypophysectomy in participants with refractory cancer-related pain in the pain composite scale of the BPI short form57
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in the interference scale of the BPI short form57
To obtain estimates of the change in the daily usage of opioid medications calculated as oral morphine equivalents OME over time after SRS hypophysectomy in participants with refractory cancer-related pain
To obtain estimates of the change in mood and depressive symptoms using the Hospital Anxiety and Depression Scale HADS composite score over time after SRS hypophysectomy in participants with refractory cancer-related pain60
To obtain estimates of the change in beliefs on self-efficacy using the Pain Self-Efficacy Questionnaire PSEQ over time after SRS hypophysectomy in participants with refractory cancer-related pain61
To obtain estimates of the change after SRS hypophysectomy in participants with refractory cancer-related pain in quality of life as measured by the European Organization for Research and Treatment of Cancer EORTC Quality of Life Questionnaire Core 15 Palliative Care QLC C15 PAL59 To obtain estimates of neurologic toxicity related to SRS measured by the NCIs CTCAE v50
Correlative Objectives
To apply novel fMRI and DTI MRI protocols to characterize functional and connectome changes following SRS hypophysectomy
To study neuroanatomic and histobiochemical changes of the pituitary glandstalk after SRS hypophysectomy on post-mortem tissue
To obtain estimates of neurocognitive changes following SRS hypophysectomy in participants with refractory cancer-related pain including learning and memory Hopkins Verbal Learning Test-Revised attention WAIS-IV Digit Span Trail Making Test Part A Stroop test WAIS-IV Coding and executive function Trail Making Test Part B Controlled Oral Word Association referred to hereafter as neurocognitive battery63-66
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01986 | OTHER | NCI-CTRP Clinical Registry | None |