Pregabalin in CIPN
2019年4月25日 更新者：simon.haroutounian、Washington University School of Medicine
Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy.
Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin.
The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center.
Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled.
Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin [crossover design] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).
調査の概要
研究の種類
介入
入学 (実際)
26
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine/Barnes Jewish Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age >18
- Distal symmetric pain distribution (both feet, with or without pain in hands).
- The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
- Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
- Pain duration > 2 months.
- Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
- Able and willing to sign an IRB-approved written informed consent.
Exclusion Criteria:
- Hypersensitivity to pregabalin.
- Current treatment with pregabalin.
- Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
- History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
- Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
- Planned surgeries or radiation treatment within 10 weeks following study inclusion.
- Inability to complete pain self-report.
- Pregnancy or lactation
- Patients with seizure disorders treated with anticonvulsants
- Current participation in a trial with another investigational agent.
Concomitant medication as follows:
- Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
- Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
- Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
- Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
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：Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
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Anticonvulsant
他の名前：
Identical, matching inactive substance
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プラセボコンパレーター：Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
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Anticonvulsant
他の名前：
Identical, matching inactive substance
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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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Change in Spontaneous Pain Intensity as a Function of Baseline MPT
時間枠：Baseline to week 4
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Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment.
The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
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Baseline to week 4
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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 |
|---|---|---|
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Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
時間枠：Baseline to week 4
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Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
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Baseline to week 4
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Change in NPSI Outcomes
時間枠：Baseline to week 4
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Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
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Baseline to week 4
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Change in BPI Outcomes (SEVERITY)
時間枠：Baseline to week 4
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Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
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Baseline to week 4
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Change in Sleep Problem Index (SPI) Outcomes
時間枠：Baseline to week 4
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Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
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Baseline to week 4
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Change in BPI Outcomes (INTERFERENCE)
時間枠：baseline to week 4
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Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
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baseline to week 4
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Number of Patients With Significant Pain Reduction
時間枠：Baseline to week 4
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Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
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Baseline to week 4
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Simon Haroutounian, PhD、Washington University School of Medicine
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年4月1日
一次修了 (実際)
2018年4月2日
研究の完了 (実際)
2018年4月2日
試験登録日
最初に提出
2015年3月4日
QC基準を満たした最初の提出物
2015年3月16日
最初の投稿 (見積もり)
2015年3月20日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月14日
QC基準を満たした最後の更新が送信されました
2019年4月25日
最終確認日
2019年4月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 201501067
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