RAD ONC FREEDOM Oncology Pain (FREEDOM)
Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
연구 개요
상세 설명
Refractory pain is one of the most debilitating challenges in oncology patients, particularly at the end of life. Over 60% of cancer patients experience pain, with 30% of these patients becoming refractory to opioid pain medication. Interventional techniques such as nerve blocks and pain pumps only transiently relieve pain and are often not viable for advanced cancer patients. In patients with diffuse metastatic disease with less than 3-6 months survival, there is a pressing need for a rapid and thorough relief of pain sensation.
Recently, using highly focused radiation delivered to very unique targets in the brain, patients can have marked reduction in perceived pain. There are centers in the brain dubbed as gateways of pain, including the pituitary hypophysis1 and the centromedian and parafascicular complexes2, with some preliminary data also involving the anterior cingulum. Ablation or neuromodulation of these targets with focused high doses of radiation have been shown in small series to provide pain relief in ~3.5 days with a 50% reduction of perceived pain.
The investigators propose to conduct a study in medically refractory cancer pain patients utilizing radiosurgery to ablate the pituitary hypophysis, as well as neuromodulate the centromedian and parafascicular complexes within the thalami - the so-called “triple target.†3 This involves treating the pituitary hypophysis and thalamus to a dose of 90 Gy. These patients will have previously failed to achieve adequate pain control with opioid pain regimens and interventional approaches. This trial will involve a multidisciplinary approach involving radiation oncology, neurosurgery, palliative care, and medical oncology colleagues across UCLA.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: CHRISTY PALODICHUK
- 전화번호: +1 310-794-2971
- 이메일: cpalodichuk@mednet.ucla.edu
연구 연락처 백업
- 이름: William Delery
- 전화번호: 310-825-5111
- 이메일: WDelery@mednet.ucla.edu
연구 장소
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California
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Los Angeles, California, 미국, 90095
- 모병
- UCLA / Jonsson Comprehensive Cancer Center
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연락하다:
- CHRISTY PALODICHUK
- 전화번호: +1 310-794-2971
- 이메일: cpalodichuk@mednet.ucla.edu
-
연락하다:
- William Delery
- 전화번호: 310-825-5111
- 이메일: WDelery@mednet.ucla.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female ≥ 18 years of age on day of SRS treatment.
- Documentation of insufficiently controlled mixed, complex cancer pain based on Brief Pain Inventory (BPI) >8/10 despite optimization of opioid regimen
- Not eligible for or willing to undergo further pain-relieving interventions
- Written informed consent (and assent when applicable) obtained from patient or patient's legal representative and ability for patient to comply with the study requirements and agree to undergo the study's SRS treatment plan.
Exclusion Criteria:
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Claustrophobia or inability to life flat
- Inability to undergo routine imaging studies
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Current history of intracranial malignancy or brain metastasis
- Any prior intracranial irradiation
- Previous history of craniotomy, deep brain stimulation (DBS) or laser interstitial themal therapy (LITT).
- Presence of intracranial hardware such as leads for DBS or any other material that may interfere with safe treatment.
- Any comorbidity or condition which would limit full compliance with the protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Treatment
intracranial functional stereotactic radiosurgery (FnSRS) to the centromedian-parafasciular complex bilaterally, and the hypophysis.
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intracranial functional stereotactic radiosurgery (FnSRS) to the triple target: centromedian-parafasciular complex bilaterally, and the hypophysis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain Inventory
기간: - Baseline: Daily measurements on three separate days prior to treatment (Day -7 +/- 3 days, Day -3 +/- 1 day, Day -2 +/- 1 day)- Post-baseline: Days +1, 2, 3, 4, 7, 14, 21, 28
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For each patient, investigator will measure the Brief Pain Inventory (BPI) (score range: 0-10) at the following days.
Higher score indicates greater pain perception.
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- Baseline: Daily measurements on three separate days prior to treatment (Day -7 +/- 3 days, Day -3 +/- 1 day, Day -2 +/- 1 day)- Post-baseline: Days +1, 2, 3, 4, 7, 14, 21, 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Opioid Usage Quantification
기간: o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
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(1) To describe opioid daily consumption pre- and post-treatment
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o Pre-study (screening visit) and Baseline (Day-7, Day-3, & Day-2)o Days +1, 2, 3, 4, 7, 14, 21, 28
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functional stereotactic radiosurgery (FnSRS) treatment side effects
기간: 28 days post treatment
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To characterize the side effect profile of FnSRS for treatment of intracranial triple targets
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28 days post treatment
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Pain anxiety symptom scale (PASS-20)
기간: Baseline visit (Day -7) Day +28 after treatment.
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To evaluate the changes in neuropsychiatric metrics, quality of life and executive function after FnSRS for modulation of intracranial triple targets.
Assesses fear, avoidance, and anxiety related to pain.
(0-5, 0=Never, 5=Always); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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17-item Hamilton Depression Rating Scale:
기간: Baseline visit (Day -7) Day +28 after treatment.
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Evaluates the severity of depressive symptoms.
(0-4, 0=Absent, 4=Very Severe); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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Hamilton Anxiety Rating Scale
기간: Baseline visit (Day -7) Day +28 after treatment.
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Measures the severity of anxiety symptoms.
(0-4, 0=Not Present, 4=Very Severe); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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Pittsburgh Sleep Quality Index
기간: Baseline visit (Day -7) Day +28 after treatment.
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Assesses sleep quality and disturbances over a one-month period.
(0-3, 0=Not During the past month, 3=Three or more times a week); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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Social disability screening schedule/WHO disability assessment schedule
기간: Baseline visit (Day -7) Day +28 after treatment.
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Measures social functioning and disability in various life domains.
(0-4, 0=None, 4=Extreme or Cannot Do); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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Activity of Daily Living Scale
기간: Baseline visit (Day -7) Day +28 after treatment.
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Evaluates the ability to perform basic self-care and everyday activities.
(0-3 or NA, 0=Appropriate, 3=Cannot do by self alone at all; Not Applicable); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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36-item Short Form-Health Survey/RAND-36
기간: Baseline visit (Day -7) Day +28 after treatment.
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Assesses health-related quality of life across multiple dimensions, including physical, mental, and social well-being.
(0=2, 0=No, not limited at all; 2=Yes, Limited a lot); higher scores indicate a worse assessment.
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Baseline visit (Day -7) Day +28 after treatment.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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