ナブパクリタキセル誘発性末梢神経障害の改善における高気圧酸素療法の有効性と安全性
ハイパーバリック酸素療法によるナブパクリタキセル誘発性末梢神経障害改善の有効性と安全性：無作為化臨床試験
The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Kun Wang, PhD
- 電話番号：+8615989223200
- メール：gzwangkun@126.com
研究連絡先のバックアップ
- 名前：Yingcong Lin, Master of Medicine
- 電話番号：+8618666885689
- メール：18666885689@163.com
研究場所
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510080
- 募集
- Guangdong Provincial People's Hospital
-
コンタクト：
- Kun Wang
-
コンタクト：
- Wang Kun PhD, Doctor
- 電話番号：15989223200
- メール：gzwangkun@126.com
-
Guangzhou、Guangdong、中国
- 募集
- Guangdong Provincial People's Hospital
-
コンタクト：
- Yingcong Lin, master of medicine
- 電話番号：+86 18666885689
- メール：18666885689@163.com
-
コンタクト：
- Kun Wang, PhD
- 電話番号：+8613922118086
- メール：gzwangkun@126.com
-
-
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
説明
Inclusion Criteria:
- aged ≥ 18 years and ≤ 75 years, female
- early-stage breast cancer or locally advanced breast cancer
- Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel
- The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10.
- The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
Exclusion Criteria:
- Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.
- Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.
- Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).
- Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.
- Karnofsky Performance Status score < 80
- Patients with any other conditions that the investigator deems unsuitable for participation in the 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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：HBOT group
hyperbaric oxygen intervention：Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA) |
|
他の：Control group
Standard care |
Standard care |
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 |
|---|---|---|
|
EORTC QLQ-CIPN20 subscales
時間枠：baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
|
Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NCI-CTCAE 5.0
時間枠：baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4 |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
|
EORTC QLQ-C30
時間枠：baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
|
BPI-SF
時間枠：baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
|
Nerve Conduction Velocity
時間枠：baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve. |
baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended
|
協力者と研究者
捜査官
- 主任研究者：Kun Wang、Guangdong Provincial People's Hospital
研究記録日
主要日程の研究
研究開始 (推定)
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
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
- KY2026-046-02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。