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化学療法誘発性末梢神経障害の参加者の健康と機能を改善するための全身振動

2026年9月22日 更新者:Kerri Winters、OHSU Knight Cancer Institute

化学療法誘発性末梢神経障害患者の健康と機能を回復するための新しい治療的介入

This clinical trial studies how well whole body vibration works in improving the health and functioning of participants with chemotherapy-induced peripheral neuropathy. Peripheral neuropathy is a condition caused by exposure to chemotherapy drugs that may involve numbness/tingling and/or pain in the hands and feet, which can have adverse effects on daily life. Whole body vibration may cause weight loss and improve mobility and pain levels in cancer survivors who report symptoms of peripheral neuropathy.

調査の概要

詳細な説明

PRIMARY OBJECTIVES:

I. Determine the feasibility and safety of whole body vibration (WBV) in adult cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).

II. Determine the effect of WBV training on physical functioning in adult cancer survivors with CIPN.

III. Explore the effect of WBV training on symptom relief (neuropathy symptoms, pain, fatigue) and readiness to exercise in adult cancer survivors with CIPN.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (WBV): Participants complete two 10-minute WBV sessions per day, 7 days per week for 12 weeks.

GROUP II (USUAL CARE [UC]): Participants receive usual care and keep their same physical activity or dietary habits over 12 weeks.

After completion of study treatment, participants are followed up at 12 weeks.

研究の種類

介入

入学 (実際)

38

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

    • Oregon
      • Portland、Oregon、アメリカ、97239
        • OHSU Knight Cancer Institute

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:

  • Histologically confirmed cancer stage I-IIIc (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
  • Previous chemotherapy within five years of enrollment (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
  • Presence of mild-very severe CIPN symptoms (confirmed by assessment using the Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE] criteria)
  • Age 18 years or older at enrollment (confirmed by self-report on the Health History Questionnaire)

Exclusion Criteria:

  • Body weight > 275 pounds (confirmed by self-report on the Health History Questionnaire)
  • A medical condition, movement or neurological disorder, or medication use that contraindicates participation in low intensity exercise and/or WBV (confirmed by self-report on the Health History Questionnaire, and by physician clearance, if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible.)
  • Presence of any known metastases (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
  • Adjuvant treatment for cancer within previous six weeks, other than hormone blocking, targeted or immunotherapy (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)

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: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:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Usual Care (UC)

Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.

実験的:Whole body vibration (WBV)

Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.

Undergo WBV

他の名前:
  • WBV
  • 全身振動療法

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
Accrual
時間枠:Up to 12-weeks

The number of participants enrolled during the recruitment period.

Up to 12-weeks
Adherence
時間枠:Up to 12-weeks

Adherence = % of sessions attended and compliance = % of each session completed.

Up to 12-weeks
Compliance
時間枠:Up to 12-weeks

Compliance = % of each session completed.

Up to 12-weeks
Adverse events
時間枠:Weekly up to 12-weeks

An in-house survey will ask about adverse events (e.g., bone pain, nausea) that occur during the intervention. The number of discrete moderate and severe adverse events will be summed as a single variable.

Weekly up to 12-weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective physical function
時間枠:0, 12 weeks

Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

0, 12 weeks
Functional mobility
時間枠:0, 12 weeks

Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 m, turn around and return and sit in the chair.

0, 12 weeks
Functional balance-sway velocity
時間枠:0, 12 weeks

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway velocity (m/s) during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

0, 12 weeks
Functional balance-sway area
時間枠:0, 12 weeks

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway area (m2/s3) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

0, 12 weeks
Functional balance-sway amount
時間枠:0, 12 weeks

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the amount (m/s2) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

0, 12 weeks
Symptoms of chemotherapy-induced peripheral neuropathy
時間枠:0, 12 weeks

Chronic changes in symptoms will be assessed at 0 and 12 weeks using the Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx). The questionnaire consists of the 27 item FACT-G, plus 11 items that specifically measure chemotherapy-induced neuropathy symptoms and concerns. Higher scores indicate worse symptoms.

0, 12 weeks
Fatigue Visual Analog Scale
時間枠:Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks

Fatigue overall will be measured both before and after each whole body vibration session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no fatigue) to 10 (worst fatigue).

Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale
時間枠:0, 12 weeks

Chronic changes in fatigue will be assessed using the PROMIS Fatigue Scale. This instrument includes 8 items rated on a 5 point scale from "not at all" to "very much". Higher scores indicate worse fatigue.

0, 12 weeks
Pain Visual Analog Scale
時間枠:Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks

Pain in the feet will be assessed both before and after each session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no pain) to 10 (worst pain).

Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
Brief Pain Inventory
時間枠:0, 12 weeks

Chronic changes in pain will be assessed using the Brief Pain Inventory (BPI). The instrument has 2 subscales: pain severity and pain interference. Severity is determined by the average of 4 items rated from 0 (no pain) to 10 (pain as bad as you can imagine). Pain interference is determined by the average of 7 items rated from 0 (does not interfere) to 10 (completely interferes).

0, 12 weeks
Body mass index
時間枠:0, 12 weeks

Body mass index will be calculated as kg/m2.

0, 12 weeks
Exercise readiness
時間枠:1, 12 weeks

Exercise readiness will be assessed using the stage of change for exercise questionnaire. This is a categorical instrument with 5 options that indicate a person's readiness to engage in regular physical activity. Options that suggest engagement in more regular exercise are better.

1, 12 weeks
Perceived physical function
時間枠:0, 12 weeks

Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).

0, 12 weeks
Gait
時間枠:0, 12 weeks

The number of meters that participants can walk in 6-minutes will be recorded.

0, 12 weeks

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:Kerri Winters-Stone, PhD、OHSU Knight Cancer Institute

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (実際)

2019年8月5日

一次修了 (実際)

2022年12月9日

研究の完了 (実際)

2022年12月9日

試験登録日

最初に提出

2019年9月9日

QC基準を満たした最初の提出物

2019年11月17日

最初の投稿 (実際)

2019年11月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月22日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • STUDY00018342
  • STUDY00018342 (その他の識別子:OHSU Knight Cancer Institute)
  • NCI-2019-08961 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))

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?

はい

IPD プランの説明

What data in particular will be shared? All individual quantitative participant data collected during the trial, after deidentification.

What other documents will be available? None

With whom? Investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.

For what types of analyses? To achieve aims in the approved proposal.

IPD 共有時間枠

Beginning 3 months following publication. No end date.

IPD 共有アクセス基準

Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement and be approved to receive the data by the OHSU IRB.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。

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