化学療法による末梢神経障害に対する運動の効果のテスト (CIPN)
化学療法誘発性末梢神経障害（CIPN）を治療するための運動の多施設無作為対照第II相試験
This phase II trial studies whether using exercise is better than the usual approach for treating chemotherapy-induced peripheral neuropathy (CIPN). CIPN occurs when chemotherapy damages the nerves communicating between the brain, spinal cord, and the rest of the body. The usual approach for treating CIPN is treatment with drugs that help reduce symptoms of other types of neuropathy (for example, from diabetes). However, these drugs do not treat all symptoms of CIPN. Exercise may help to reduce CIPN symptoms.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. Assess the preliminary efficacy of exercise versus (vs.) standard care for treating CIPN (via patient-reported CIPN-20 total score).
SECONDARY OBJECTIVES:
I. Assess the preliminary efficacy of exercise vs. standard care on individual symptoms of CIPN (via CIPN Symptom Inventory; i.e., numbness, tingling, burning/shooting pain, and cramping in the hands and feet).
II. Assess the preliminary efficacy of exercise vs. standard care on a clinical test of CIPN symptoms (via the tactile sensitivity in the fingers and toes).
III. Assess the effects of exercise vs. standard care on two possible CIPN mechanisms, namely interoception (via Multidimensional Assessment of Interoceptive Awareness version 2 [MAIA-2] questionnaire).
EXPLORATORY OBJECTIVES:
I. Assess the effects of exercise vs. standard care on other common symptoms related to cancer, chemotherapy, and CIPN, including:
Ia. Daily Diary of symptoms of CIPN. Ib. An array of cancer and treatment symptoms (MD Anderson Symptom Inventory; MDASI).
Ic. Anxiety and depression (hospital anxiety and depression scale; HADS). Id. Pain catastrophizing (pain catastrophizing scale; PCS). Ie. Cognitive impairment (Functional Assessment of Cancer Therapy-Cognitive [FACT-Cog]).
If. Fatigue (brief fatigue inventory; BFI). Ig. Quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM 1 (EXERCISE): Participants undergo the exercise for cancer patients (EXCAP) intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5.
ARM 2 (CONTROL): Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes.
Participants may optionally undergo magnetic resonance imaging (MRI) on study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Fresno、California、アメリカ、93720
- Kaiser Permanente-Fresno
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Martinez、California、アメリカ、94553-3156
- Contra Costa Regional Medical Center
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Roseville、California、アメリカ、95661
- Kaiser Permanente-Roseville
-
Sacramento、California、アメリカ、95814
- Kaiser Permanente Downtown Commons
-
Sacramento、California、アメリカ、95823
- Kaiser Permanente-South Sacramento
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San Jose、California、アメリカ、95119
- Kaiser Permanente-Santa Teresa-San Jose
-
San Leandro、California、アメリカ、94577
- Kaiser Permanente San Leandro
-
San Rafael、California、アメリカ、94903
- Kaiser San Rafael-Gallinas
-
Santa Clara、California、アメリカ、95051
- Kaiser Permanente Medical Center - Santa Clara
-
South San Francisco、California、アメリカ、94080
- Kaiser Permanente-South San Francisco
-
Vallejo、California、アメリカ、94589
- Kaiser Permanente-Vallejo
-
Walnut Creek、California、アメリカ、94596
- Kaiser Permanente-Walnut Creek
-
-
Colorado
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Aurora、Colorado、アメリカ、80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder、Colorado、アメリカ、80303
- Boulder Community Foothills Hospital
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Boulder、Colorado、アメリカ、80304
- Rocky Mountain Cancer Centers-Boulder
-
Centennial、Colorado、アメリカ、80112
- Rocky Mountain Cancer Centers - Centennial
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Denver、Colorado、アメリカ、80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver、Colorado、アメリカ、80220
- Rocky Mountain Cancer Centers-Rose
-
Denver、Colorado、アメリカ、80218
- Colorado Blood Cancer Institute
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Denver、Colorado、アメリカ、80209
- The Women's Imaging Center
-
Englewood、Colorado、アメリカ、80113
- Rocky Mountain Cancer Centers - Swedish
-
Englewood、Colorado、アメリカ、80113
- The Melanoma and Skin Cancer Institute
-
Lakewood、Colorado、アメリカ、80228
- Rocky Mountain Cancer Centers-Lakewood
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Littleton、Colorado、アメリカ、80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree、Colorado、アメリカ、80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont、Colorado、アメリカ、80501
- Rocky Mountain Cancer Centers-Longmont
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Thornton、Colorado、アメリカ、80260
- Rocky Mountain Cancer Centers-Thornton
-
-
Delaware
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Millville、Delaware、アメリカ、19967
- Beebe South Coastal Health Campus
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Newark、Delaware、アメリカ、19713
- Helen F Graham Cancer Center
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Newark、Delaware、アメリカ、19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach、Delaware、アメリカ、19971
- Beebe Health Campus
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
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Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
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Hawaii
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Honolulu、Hawaii、アメリカ、96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu、Hawaii、アメリカ、96813
- Straub Clinic and Hospital
-
Honolulu、Hawaii、アメリカ、96813
- University of Hawaii Cancer Center
-
Honolulu、Hawaii、アメリカ、96826
- Kapiolani Medical Center for Women and Children
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‘Aiea、Hawaii、アメリカ、96701
- Hawaii Cancer Care - Westridge
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‘Aiea、Hawaii、アメリカ、96701
- Pali Momi Medical Center
-
-
Illinois
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Carterville、Illinois、アメリカ、62918
- SIH Cancer Institute
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Centralia、Illinois、アメリカ、62801
- Centralia Oncology Clinic
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Danville、Illinois、アメリカ、61832
- Carle at The Riverfront
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Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Decatur、Illinois、アメリカ、62526
- Cancer Care Specialists of Illinois - Decatur
-
Effingham、Illinois、アメリカ、62401
- Crossroads Cancer Center
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O'Fallon、Illinois、アメリカ、62269
- Cancer Care Center of O'Fallon
-
Urbana、Illinois、アメリカ、61801
- Carle Cancer Center
-
-
Iowa
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Cedar Rapids、Iowa、アメリカ、52403
- Oncology Associates at Mercy Medical Center
-
Cedar Rapids、Iowa、アメリカ、52402
- Physicians' Clinic of Iowa PC
-
Des Moines、Iowa、アメリカ、50314
- Mercy Medical Center - Des Moines
-
-
Maryland
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Elkton、Maryland、アメリカ、21921
- Christiana Care - Union Hospital
-
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Michigan
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Ann Arbor、Michigan、アメリカ、48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brighton、Michigan、アメリカ、48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Brighton、Michigan、アメリカ、48114
- Trinity Health Medical Center - Brighton
-
Canton、Michigan、アメリカ、48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Canton、Michigan、アメリカ、48188
- Trinity Health Medical Center - Canton
-
Chelsea、Michigan、アメリカ、48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Chelsea、Michigan、アメリカ、48118
- Chelsea Hospital
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Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Lansing、Michigan、アメリカ、48912
- University of Michigan Health - Sparrow Lansing
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Livonia、Michigan、アメリカ、48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Ypsilanti、Michigan、アメリカ、48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Minnesota
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Coon Rapids、Minnesota、アメリカ、55433
- Mercy Hospital
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Fridley、Minnesota、アメリカ、55432
- Unity Hospital
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Minneapolis、Minnesota、アメリカ、55407
- Abbott-Northwestern Hospital
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Saint Louis Park、Minnesota、アメリカ、55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
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Waconia、Minnesota、アメリカ、55387
- Ridgeview Medical Center
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Willmar、Minnesota、アメリカ、56201
- Rice Memorial Hospital
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Missouri
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Osage Beach、Missouri、アメリカ、65065
- Lake Regional Hospital
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St Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
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North Carolina
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Gastonia、North Carolina、アメリカ、28054
- CaroMont Regional Medical Center
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Lincolnton、North Carolina、アメリカ、28092
- CaroMont Health - Lincoln Cancer Center
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Pinehurst、North Carolina、アメリカ、28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Rocky Mount、North Carolina、アメリカ、27804
- Nash UNC HealthCare
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Ohio
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Belpre、Ohio、アメリカ、45714
- Strecker Cancer Center-Belpre
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Lancaster、Ohio、アメリカ、43130
- Fairfield Medical Center
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Lima、Ohio、アメリカ、45801
- Saint Rita's Medical Center
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Marietta、Ohio、アメリカ、45750
- Marietta Memorial Hospital
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Newark、Ohio、アメリカ、43055
- Licking Memorial Hospital
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Portsmouth、Ohio、アメリカ、45662
- Southern Ohio Medical Center
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Zanesville、Ohio、アメリカ、43701
- Genesis Healthcare System Cancer Care Center
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South Carolina
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Boiling Springs、South Carolina、アメリカ、29316
- Prisma Health Cancer Institute - Spartanburg
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Easley、South Carolina、アメリカ、29640
- Prisma Health Cancer Institute - Easley
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Greenville、South Carolina、アメリカ、29605
- Prisma Health Cancer Institute - Faris
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Greenville、South Carolina、アメリカ、29615
- Prisma Health Cancer Institute - Eastside
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Greenville、South Carolina、アメリカ、29605
- Prisma Health Cancer Institute - Butternut
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Greer、South Carolina、アメリカ、29650
- Prisma Health Cancer Institute - Greer
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Seneca、South Carolina、アメリカ、29672
- Prisma Health Cancer Institute - Seneca
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Virginia
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Chesapeake、Virginia、アメリカ、23320
- Chesapeake Regional Medical Center
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Wisconsin
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Green Bay、Wisconsin、アメリカ、54301
- Saint Vincent Hospital Cancer Center Green Bay
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Green Bay、Wisconsin、アメリカ、54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
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Sturgeon Bay、Wisconsin、アメリカ、54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
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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
説明
Inclusion Criteria:
- Have a diagnosis of cancer
- Have received neurotoxic chemotherapy within the past nine months (could still be on chemotherapy or have already completed chemotherapy; i.e., taxane-, platinum-, vinca alkaloid-, epothilone-, or proteasome inhibitor-based chemotherapy
- Report one or more symptoms of CIPN at a level of >= 4 on the CIPN symptom inventory on the Screening Form
- Have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Have at least six months life expectancy
- Be at least 18 years of age
- Be able to read and understand English
- Be able to provide written informed consent
Exclusion Criteria:
- Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking and progressive resistance exercise program, according to the participant's physician (e.g., oncologist, primary care) or physician's designee
- Be identified as in the active or maintenance stage of exercise behavior per the Exercise Stages of Change Question on the Screening Form
- Have planned surgery or radiation treatment during the course of the study (hormonal and biologic therapy is allowed)
- Have contraindications for MRI scanning, per the MRI safety screening procedures of the MRI facility to be utilized for this participant
- Are pregnant of have plans to become pregnant during the course of the study. Documentation of pregnancy and use of contraception can be obtained from the medical record.
- Have a current or prior cancer in the central nervous system (spine, brainstem, brain) as this would interfere with assessments of brain functional connectivity.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm 1 (EXCAP, tactile sensitivity test, counseling)
Participants undergo the EXCAP intervention consisting of a home-based, self-directed, individually tailored progressive walking and resistance program for up to 6 weeks. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. In addition, participants meet with a certified exercise instructor over 45 minutes at baseline and 2 additional booster meetings over 15-30 minutes during weeks 2 and 3 or weeks 4 and 5. Participants may optionally undergo MRI on study. |
Undergo MRI
他の名前：
Ancillary studies Meet with certified exercise instructor Participate in the EXCAP program Undergo tactile sensitivity test
他の名前：
|
|
アクティブコンパレータ：Arm 2 (usual care, tactile sensitivity test)
Participants receive usual care for 6 weeks. At the end of the study, participants may receive the exercise kit and complete the EXCAP program as in Arm 1. Participants also undergo a tactile sensitivity test at baseline and after completion of EXCAP over 15-25 minutes. Participants may optionally undergo MRI on study. |
Undergo MRI
他の名前：
Ancillary studies Meet with certified exercise instructor Participate in the EXCAP program Undergo tactile sensitivity test
他の名前：
Receive standard of care
他の名前：
|
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 |
|---|---|---|
|
Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity
時間枠：Week 6 post randomization
|
Will estimate the effects of exercise versus usual care on CIPN using analysis of covariance (ANCOVA). Will be measured by the mean European Organization for Research and Treatment of Cancer-CIPN20. The model will include CIPN-20 at Week 6 as the outcome, treatment group (exercise vs. usual care) as the independent variable of interest and the pre-intervention CIPN-20 score as a covariate. |
Week 6 post randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effects of exercise on the severity of CIPN symptoms
時間枠：Up to 6 weeks post randomization
|
We will estimate the effects of exercise vs. usual care on CIPN symptoms (i.e., hot/burning or sharp/shooting pain in the hands or feet, numbness or tingling in the hands or feet) collected from the daily symptom inventory (0-10 severity) using analysis of covariance (ANCOVA). The model will include the average of daily symptom inventory for each CIPN symptom at post-intervention as the outcome, controlling for the average of daily symptom inventory for each CIPN symptom at pre-intervention. |
Up to 6 weeks post randomization
|
|
Effects of exercise on tactile sensitivity
時間枠：Up to 6 weeks post randomization
|
We will estimate the effects of exercise vs. usual care on tactile sensitivity in the fingers and toes, assessed via an established touch test procedure with a set of monofilaments, using analysis of covariance (ANCOVA). The model will include the tactile sensitivity score at post-intervention as the outcome, controlling for the pre-intervention score. |
Up to 6 weeks post randomization
|
|
Effect of exercise on interoception
時間枠：Up to 6 weeks post randomization
|
We will estimate the effects of exercise vs. usual care on interoception, measured via the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), using analysis of covariance (ANCOVA). The model will include the MAIA-2 total score at post-intervention as the outcome, controlling for the pre-intervention MAIA-2 total score. |
Up to 6 weeks post randomization
|
協力者と研究者
捜査官
- 主任研究者：Ian R Kleckner、University of Rochester NCORP Research Base
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- URCC19075
- UG1CA189961 (米国 NIH グラント/契約)
- URCC19075 (その他の識別子：University of Rochester NCORP Research Base)
- NCI-2020-11456 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- URCC-19075 (その他の識別子：CTEP)
- R21CA256154 (米国 NIH グラント/契約)
- URCC-19075 (その他の識別子：DCP)
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。