The Palliative Radiotherapy And Inflammation Study - PRAIS (PRAIS)
The Palliative Radiotherapy And Inflammation Study: Palliative Radiotherapy of Bone Metastasis. Classification, Inflammatory Biomarkers, and Longitudinal Clinical Follow-up
Radiation therapy (RT) is one of the primary treatments for bone cancer pain due to metastatic cancer disease. About 6 of 10 patients obtain pain relief from RT. There are no established predictors that can be used to select patients that respond to RT. This raises the need to identify potential clinical characteristics and biomarkers that may better select patients for RT. A similar argument can be stated for the development of cachexia; there are currently no predictors that can identify patients who will develop cachexia later in the cancer disease trajectory. Cancer symptoms can be related to inflammation. Both pain, cachexia and depression are associated with inflammation in experimental and preclinical studies . Still, the clinical data on the relationship between inflammation and pain or cachexia are sparse. This is especially true for longitudinal follow-up studies.
This study will include 1000 adult patients in a multicenter, multinational longitudinal observation study of patients who receive radiation therapy for bone cancer pain. Demographic data, clinical variables, genetic biomarkers and inflammatory substances will be assessed before start of RT. The primary analysis in the study is to identify potential predictors for pain relief from RT. During follow up the study will also explore for predictors for development of cachexia and which inflammatory substances that are associated with changes in pain intensity, depression and development of cachexia.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Oslo、ノルウェー
- Dept of Oncology, Oslo Universitetssykehus
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Trondheim、ノルウェー、7006
- Dept of Oncology, St Olavs Hospital
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Ålesund、ノルウェー
- Dept of Oncology, Ålesund sjukehus
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
- Verified cancer diagnosis (based on radiological, histological, cytological or operative evidence). Those with hematological malignancies are also eligible.
- Bone metastasis verified either by bone x-ray, bone scan, computer tomography (CT) or magnetic resonance imaging (MRI)
- Patients that are about to undergo radiotherapy with palliative intent for painful bone metastasis
- Radiotherapy should be administered within one week after baseline observations are obtained
- Age ≥18 years
- Patient is able to comply with trial procedures.
Exclusion criteria:
- Pathological fracture in long bones (e.g femora or humeral shaft fractures)
- Patients not consenting to participate in the study
- On-going RT or RT administered within the last 4 weeks
- Patients who are not able to follow the trial procedures
- Previous participation in this study
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Radiation therapy for bone cancer pain
The group includes all cancer diagnoses, and different fractions of RT planned.
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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 response
時間枠：3 - 8 weeks
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Complete response implies a numeric rate scale (NRS) worst pain of zero at the treated site on an 11-point rating scale, with no concomitant increase in analgesic intake. Partial response is defined as either i) pain reduction of two or more at the treated site on the 11-point NRS worst pain rating scale together with no increase in analgesic intake, or ii) reduction in analgesic intake of at least 25 per cent from baseline without an increase in pain score at the treated site. An "intermediate response" category represents any response other than complete or partial response or pain progression |
3 - 8 weeks
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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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Cachexia
時間枠：1 year
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Cachexia defined as a) Weight loss >5% over past 6 months (in absence of simple starvation); or b) body mass index (BMI) <20 and any degree of weight loss >2%; or c) Appendicular skeletal muscle index consistent with sarcopenia (males <7・26 kg/m2; females <5・45 kg/m2) and any degree of weight loss >2%
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1 year
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Depression
時間枠：1 year
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Depression symptoms last 2 weeks scored i patient Health Questionnaire (PHQ) - 9.
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1 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Inflammatory Biomarkers
時間枠：1 year
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Change in inflammatory biomarkers during longitudinal follow-up in relation to change in pain, depression and cachexia.
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1 year
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協力者と研究者
協力者
捜査官
- スタディディレクター：Pål Klepstad, phd md、Norwegian University of Science and Technology
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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。