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Trial Title:
Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain
NCT ID:
NCT06287515
Condition:
Hypophysectomy
Conditions: Official terms:
Cancer Pain
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Stereotactic Radiosurgery
Description:
Given by Radiation Therapy
Arm group label:
SRS hypophysectomy
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 (n=20
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 form.57
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 form.57
To obtain estimates of the change after SRS hypophysectomy in participants with
refractory cancer-related pain in the interference scale of the BPI short form.57
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 pain.60
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 pain.61
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 PAL).59 To obtain estimates of neurologic toxicity
related to SRS measured by the NCI's CTCAE v5.0.
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 gland/stalk 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 battery".63-66
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old on the day of signing informed consent and willing and able to
sign a written informed consent.
- English fluency in order to complete PROs and neurocognitive assessment
- Pathologic or cytologic confirmation of malignancy.
- Poorly controlled intractable nociceptive or mixed pain limiting function or quality
of life. Participants must have exhausted or not a candidate for standard of care
pain control measures such as opioids, injections/ablations, conventional radiation
therapy, or surgical intervention with a curative intent and pain limiting function
that affects the participants quality of life in the judgment of the treating
physician. Refractory status will require at least consultation and two follow-up
visits with pain specialists (pain management or supportive care).
- ECOG performance status of 0-3.
- Life expectancy is greater than 4 weeks and less than 1 year in the treating
physician's judgment.
Exclusion Criteria:
- Participants with prior cranial or head/neck radiation where cumulative
organ-at-risk dose constraints cannot be achieved (see section 4.2).
- Inability to have an MRI of the brain for reasons such as a non-compatible
bioimplant that could be displaced during MRI, shrapnel embedded (such as from war
wounds), metal workers, and machinists (potential for metallic fragments in or near
the eyes).
- Expressions of pain due to depression, delirium or addictive behavior
- Participants who are pregnant.
- Known psychiatric or substance abuse disorders that would interfere with cooperation
with the requirements of the study in the judgment of the Investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Chenyang Wang, MD
Phone:
832-710-1570
Email:
cwang23@mdanderson.org
Investigator:
Last name:
Chenyang Wang, MD
Email:
Principal Investigator
Start date:
August 31, 2024
Completion date:
July 1, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06287515
http://www.mdanderson.org
