RAD ONC FREEDOM Oncology Pain (FREEDOM)
Functional Radiosurgery for Easing or Eliminating Debilitating Oncologic Morbidity (FREEDOM)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：CHRISTY PALODICHUK
- 電話番号：+1 310-794-2971
- メール：cpalodichuk@mednet.ucla.edu
研究連絡先のバックアップ
- 名前：William Delery
- 電話番号：310-825-5111
- メール：WDelery@mednet.ucla.edu
研究場所
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California
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Los Angeles、California、アメリカ、90095
- 募集
- UCLA / Jonsson Comprehensive Cancer Center
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コンタクト：
- CHRISTY PALODICHUK
- 電話番号：+1 310-794-2971
- メール：cpalodichuk@mednet.ucla.edu
-
コンタクト：
- William Delery
- 電話番号：310-825-5111
- メール：WDelery@mednet.ucla.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Inventory
時間枠：- 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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Opioid Usage Quantification
時間枠：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
時間枠：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)
時間枠：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:
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。