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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA256154 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-11456 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC19075 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-19075 | Other Identifier | DCP | |
| URCC-19075 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (EXCAP, tactile sensitivity test, counseling) | Experimental | 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. |
|
| Arm 2 (usual care, tactile sensitivity test) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-induced peripheral neuropathy (CIPN) symptom severity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of exercise on the severity of CIPN symptoms | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian R Kleckner | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente-Fresno | Fresno | California | 93720 | United States | ||
| Contra Costa Regional Medical Center |
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| Exercise Counseling | Other | Meet with certified exercise instructor |
|
| Exercise Intervention | Other | Participate in the EXCAP program |
|
| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Neuropathy Assessment | Other | Undergo tactile sensitivity test |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 6 weeks post randomization |
| Effects of exercise on tactile sensitivity | 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 | 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 |
| Martinez |
| California |
| 94553-3156 |
| United States |
| Kaiser Permanente-Roseville | Roseville | California | 95661 | United States |
| Kaiser Permanente Downtown Commons | Sacramento | California | 95814 | United States |
| Kaiser Permanente-South Sacramento | Sacramento | California | 95823 | United States |
| Kaiser Permanente-Santa Teresa-San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente San Leandro | San Leandro | California | 94577 | United States |
| Kaiser San Rafael-Gallinas | San Rafael | California | 94903 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente-South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente-Vallejo | Vallejo | California | 94589 | United States |
| Kaiser Permanente-Walnut Creek | Walnut Creek | California | 94596 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| Boulder Community Foothills Hospital | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| Rocky Mountain Cancer Centers - Centennial | Centennial | Colorado | 80112 | United States |
| The Women's Imaging Center | Denver | Colorado | 80209 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers-Rose | Denver | Colorado | 80220 | United States |
| Rocky Mountain Cancer Centers - Swedish | Englewood | Colorado | 80113 | United States |
| The Melanoma and Skin Cancer Institute | Englewood | Colorado | 80113 | United States |
| Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado | 80501 | United States |
| Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | 80260 | United States |
| Beebe South Coastal Health Campus | Millville | Delaware | 19967 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Medical Oncology Hematology Consultants PA | Newark | Delaware | 19713 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Carle at The Riverfront | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | 52402 | United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| Christiana Care - Union Hospital | Elkton | Maryland | 21921 | United States |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | United States |
| Trinity Health Medical Center - Brighton | Brighton | Michigan | 48114 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | United States |
| Trinity Health Medical Center - Canton | Canton | Michigan | 48188 | United States |
| Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | United States |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | United States |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| CaroMont Regional Medical Center | Gastonia | North Carolina | 28054 | United States |
| CaroMont Health - Lincoln Cancer Center | Lincolnton | North Carolina | 28092 | United States |
| FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| Nash UNC HealthCare | Rocky Mount | North Carolina | 27804 | United States |
| Strecker Cancer Center-Belpre | Belpre | Ohio | 45714 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Saint Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Prisma Health Cancer Institute - Easley | Easley | South Carolina | 29640 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Chesapeake Regional Medical Center | Chesapeake | Virginia | 23320 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | 54303 | United States |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D009682 | Magnetic Resonance Spectroscopy |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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