High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy
High-concentration Capsaicin Patch for the Prevention of Paclitaxel-induced Peripheral Neuropathy- a Prospective, Double-blind, Randomized, Placebo-controlled Trial
This research study is for participants who are receiving paclitaxel infusion as part of their cancer treatment. The purpose of this study is to test the effectiveness of the Food and Drug Administration (FDA) approved high-concentration (8%) capsaicin patch (HCCP) in prevention of taxane-induced peripheral neuropathy (nerve pain in hands and/or feet). Participants will be randomized, like flipping a coin, into one of four groups. Group one will receive the HCCP on one hand and one foot 60 minutes prior to each infusion. Group two will receive the HCCP on one hand and one foot 30 minutes prior to each infusion. Group three will receive a placebo patch on one hand and one foot containing a very low concentration of capsaicin (0.025%) for 60 minutes prior to infusion. Group four will receive a placebo patch on one hand and one foot for 30 minutes prior to infusion. Participants will have an equal chance of being placed in each of the four groups.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, serious side effect of drugs used to treat cancer, such as taxanes. CIPN affects up to 80% of people receiving chemotherapy cancer treatment, and the incidence of CIPN is expected to increase as cancer survival increases. CIPN can cause sensory loss, neuropathic (nerve-related) pain, gait instability (problems with balance), and fine motor impairment. These symptoms can often continue for years after treatment is completed. These symptoms may also cause doctors to lower or stop chemotherapy, which may affect the outcomes of cancer treatment. CIPN is a leading cause of poor quality of life for millions of cancer survivors.
Despite how common and serious CIPN is, there are no FDA-approved preventive therapies for CIPN. The high-concentration capsaicin patch (HCCP, 8%) is an FDA-approved topical therapy for peripheral neuropathic pain that acts by prolonged activation and reversible "defunctionalization" of nerve cells called Transient Receptor Potential Vanilloid 1 (TRPV1)-expressing sensory neurons. TRPV1 plays an important role in how pain is felt by acting as a receptor on sensory neurons. This means that it detects and relays painful stimuli to the central nervous system. Damaging TRPV1 by using the topical HCCP patch leads to temporary relief without permanent nerve injury or systemic side effects. HCCP has demonstrated clinical efficacy in treating established CIPN; however, its use as a preventive intervention has not been reported. Preclinical and translational data indicate that early modulation of TRPV1-calcium signaling may prevent maladaptive neuronal hyperexcitability and epigenetic changes that underlie chronic neuropathy. Thus, repurposing HCCP to preemptively modulate this pathway represents a novel, mechanism-based opportunity to prevent CIPN before irreversible neurodegeneration occurs.
This project directly addresses a high-impact unmet need by testing whether pretreatment with HCCP reduces the incidence and severity of CIPN. By integrating a randomized, placebo-controlled clinical trial with multimodal neurophysiological, participant-reported, and molecular assessments, this work will generate rigorous clinical and mechanistic evidence supporting a scalable, non-invasive, and rapidly translatable prevention strategy. If successful, these findings will shift the CIPN management paradigm from reactive symptom control to proactive prevention, improving treatment adherence, functional outcomes, and survivorship quality.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究連絡先
研究連絡先
- 名前：Jijun Xu, MD, PhD
- 電話番号：(216) 444-4080
- メール：Xuj3@ccf.org
研究連絡先のバックアップ
- 名前：Heather Rogers
- 電話番号：(216) 444-1292
- メール：ROGERSH3@ccf.org
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
-
コンタクト：
- Jijun Xu, MD, PhD
- 電話番号：216-444-4080
- メール：Xuj3@ccf.org
-
主任研究者：
- Jijun Xu, MD, PhD
-
-
参加基準
適格基準
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:
- Adult participants (ages 18-65 years old)
- Eligible participants must have intact skin in the areas to be treated (hands and feet)
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Participants with pre-existing peripheral neuropathy, concurrent use of other neurotoxic medications, palliative-intent chemotherapy, pregnancy, inability to provide informed consent or participate in follow-up visits, or any contraindications listed in the HCCP Summary of Product Characteristics (SmPC)8 will be excluded.
- Pregnant or breastfeeding women are excluded from this study because Paclitaxel is a chemotherapy agent with the potential for teratogenic or abortifacient effects.
- HIV-positive participants will not be excluded unless the participant has an established peripheral neuropathy related to HIV or its treatment. HIV testing is not required for 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
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：HCCP 30-minute application
The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. |
|
実験的：HCCP 60-minute application
The 8% High Concentration Capsaicin Patch (HCCP) patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
Participants will receive 8% HCCP patch. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. |
|
プラセボコンパレーター：Placebo 30-minute application
This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 30 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
Participants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. |
|
プラセボコンパレーター：Placebo 60-minute application
This arm will receive a matched placebo patch containing 0.025% capsaicin. The patch will be administered in an outpatient setting one week prior to the initiation of standard of care chemotherapy. The patch will be administered either on the hand or foot. It will be applied for 60 minutes. If the participant is expected to receive standard of care chemotherapy at Week 12, then they will receive a second HCCP patch on Week 11. |
Participants will receive the placebo patch containing 0.025% capsaicin. It will be administered on the hand or foot for either 30 or 60 minutes, depending on which arm the participant is in. It will be administered at baseline (Week 0), just prior to starting standard of care chemotherapy. It will be administered again on Week 11, as long as the participant is expected to receive standard of care chemotherapy on Week 12. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in taxane-induced peripheral neuropathy due to HCCP patch
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
Change in taxane-induced peripheral neuropathy is measured by the incidence of grade ≥2 neuropathy (Common Terminology Criteria for Adverse Events, CTCAE v5.0). |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in FACT-GOG-Ntx scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) is a 13-item questionnaire that asks participants to rank symptoms of daily function on a 5-point Likert scale from Not at all (0) to Very much (4). Higher scores indicate greater quality of life. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in PROMIS Pain Interference scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire is a 8-item questionnaire that assesses the daily impacts of pain. Each item is answered on a 5-point Likert scale from Not at all (1) to Very much (5). Higher scores indicate greater pain interference. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in PROMIS Physical Function scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire is a 8-item questionnaire that assesses daily physical functioning. Four questions are answered on a 5-point Likert scale from Without any difficulty (5) to Unable to do (1), and the other 4 questions answered on a 5-point Likert scale from Not at all (5) to Cannot do (1). Higher scores indicate greater physical functioning. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in PROMIS Sleep Disturbance scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance questionnaire is a 8-item questionnaire that assesses sleep disturbance. One question asks participants to ran their sleep quality on a 5-point scale from "Very poor" to "Very good." Seven questions are answered on a 5-point Likert scale from Not at all (5) to Very much (1). Higher scores indicate worse sleep disturbance. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in EQ-5D-5L scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The EuroQol 5-Dimension, 5-Level (EQ-5D-5L) questionnaire has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels that the participant can choose from: no problems, slight problems, moderate problems, severe problems and extreme problems. These numbers are combined for a 5-digit number that describes the participant's health status. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in Patient Global Impression of Change (PGIC) scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
Patient Global Impression of Change (PGIC) questionnaire contains one question that asks the participant to rank their overall health status on a 7-point Likert scale from (1) Very much improved to (7) Very much worse. Higher scores indicate worse health status. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in EORTC QLQ-CIPN20 scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20-Item Scale (EORTC QLQ-CIPN20) questionnaire is a 20-item questionnaire that assess symptoms of chemotherapy-induced peripheral neuropathy (CIPN). Participants answer questions on a 4-point Likert scale from Not at all (1) to Very much (4). Higher scores indicate greater symptoms of CIPN. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Change in Numeric Rating Scale for pain (NRS) scores
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The Numeric Rating Scale (NRS) for pain is a one-item question that asks participants to rank their pain on a scale of 0 to 10 from None (0) to Severe (10). Higher rankings indicate more severe pain. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Time-to-onset of paclitaxel-induced peripheral neuropathy (PIPN)
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
Time-to-onset of PIPN will be measured as the days from start of treatment (Week 1) to the first reported day of PIPN. This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Cumulative paclitaxel dose
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
Cumulative paclitaxel dose will be measured as the amount of paclitaxel a participant receives in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
|
Dose reductions or delays due to neuropathy
時間枠：Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
The number of instances of dose reductions or delays due to neuropathy will be measured as the incidence in total (from Week 0 and up to Week 52). This question will be asked at Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52. |
Baseline (Day 0), Week 1, Week 4, Week 12, Week 24, Week 52
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Jijun Xu, MD, PhD、Case Comprehensive Cancer Center, Cleveland Clinic
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- CASE10Z26
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
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。