毎日のハンドヘルド振動療法
化学療法誘発性末梢神経障害（CIPN）の治療のための毎日のハンドヘルド振動療法：パイロット研究
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.
調査の概要
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：Lacy Slayton
- 電話番号：(317) 278-6718
- メール：lslayton@iu.edu
研究連絡先のバックアップ
- 名前：Cheri West, RN
- 電話番号：317-278-3021
- メール：chawest@iu.edu
研究場所
-
-
Indiana
-
Avon、Indiana、アメリカ、46123
- 募集
- Indiana University Health West
-
コンタクト：
- Cheri West
- 電話番号：317-278-3021
- メール：chawestr@iu.edu
-
Indianapolis、Indiana、アメリカ、46202
- 募集
- Indiana University Melvin & Bren Simon Cancer Center
-
コンタクト：
- Cheri West
- 電話番号：317-278-3021
- メール：chawest@iu.edu
-
Indianapolis、Indiana、アメリカ、46202
- 募集
- IU Health Joe & Shelly Schwarz Cancer Center
-
コンタクト：
- Cheri West
- 電話番号：317-278-3021
- メール：chawest@iu.edu
-
-
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:
- 18 years or older at enrollment
- Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Have completed chemotherapy ≥ 60 days prior to enrollment
- Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m)
- Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy
- If solid tumor cancer, must have non-metastatic cancer
- Agree to return to clinic for required study related measurements at specified intervals
Exclusion Criteria:
- Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
- Known diagnosis of diabetes mellitus.
- Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
- Will be receiving concurrent radiation of the upper-extremity
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 |
|---|---|
|
実験的：Vibration Therapy
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks. |
vibration therapy using hand held vibration device |
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 |
|---|---|---|
|
募集の実現可能性 - スクリーニング後に研究への参加に同意した患者の割合
時間枠：募集期間（研究開始後最長5年間）
|
募集期間（研究開始後最長5年間）
|
|
|
Feasibility of compliance- percentage of vibration therapy sessions completed
時間枠：4 weeks
|
Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned. |
4 weeks
|
|
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
時間枠：4 weeks
|
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form |
4 weeks
|
|
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
時間枠：baseline, week 1, week 2, week 3, week 4
|
CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms |
baseline, week 1, week 2, week 3, week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in CIPN Severity via the CIPN20 questionnaire scores
時間枠：baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
|
Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum) |
baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
|
|
Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale
時間枠：baseline, week 4, week 8
|
Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life |
baseline, week 4, week 8
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Erin Newton, MD、Indiana University
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。