Multi-Center Randomized Controlled Phase II Trial of Exercise to Treat Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Status: Active_not_recruiting
Location: See all (93) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Kaiser Permanente-Fresno
Fresno
Contra Costa Regional Medical Center
Martinez
Kaiser Permanente-Roseville
Roseville
Kaiser Permanente Downtown Commons
Sacramento
Kaiser Permanente-South Sacramento
Sacramento
Kaiser Permanente-Santa Teresa-San Jose
San Jose
Kaiser Permanente San Leandro
San Leandro
Kaiser San Rafael-Gallinas
San Rafael
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Kaiser Permanente-South San Francisco
South San Francisco
Kaiser Permanente-Vallejo
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
Boulder Community Foothills Hospital
Boulder
Rocky Mountain Cancer Centers-Boulder
Boulder
Rocky Mountain Cancer Centers - Centennial
Centennial
Colorado Blood Cancer Institute
Denver
Rocky Mountain Cancer Centers-Midtown
Denver
Rocky Mountain Cancer Centers-Rose
Denver
The Women's Imaging Center
Denver
Rocky Mountain Cancer Centers - Swedish
Englewood
The Melanoma and Skin Cancer Institute
Englewood
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Rocky Mountain Cancer Centers-Littleton
Littleton
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
Rocky Mountain Cancer Centers-Longmont
Longmont
Rocky Mountain Cancer Centers-Thornton
Thornton
Washington, D.c.
MedStar Georgetown University Hospital
Washington D.c.
MedStar Washington Hospital Center
Washington D.c.
Delaware
Beebe South Coastal Health Campus
Millville
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Beebe Health Campus
Rehoboth Beach
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Straub Clinic and Hospital
Honolulu
University of Hawaii Cancer Center
Honolulu
Iowa
Oncology Associates at Mercy Medical Center
Cedar Rapids
Physicians' Clinic of Iowa PC
Cedar Rapids
Mercy Medical Center - Des Moines
Des Moines
Illinois
SIH Cancer Institute
Carterville
Centralia Oncology Clinic
Centralia
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Cancer Care Center of O'Fallon
O'fallon
Carle Cancer Center
Urbana
Maryland
Christiana Care - Union Hospital
Elkton
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton
Trinity Health Medical Center - Brighton
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton
Trinity Health Medical Center - Canton
Canton
Chelsea Hospital
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids
University of Michigan Health - Sparrow Lansing
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti
Minnesota
Mercy Hospital
Coon Rapids
Unity Hospital
Fridley
Abbott-Northwestern Hospital
Minneapolis
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
Ridgeview Medical Center
Waconia
Rice Memorial Hospital
Willmar
Missouri
Lake Regional Hospital
Osage Beach
Missouri Baptist Medical Center
St Louis
North Carolina
CaroMont Regional Medical Center
Gastonia
CaroMont Health - Lincoln Cancer Center
Lincolnton
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst
Nash UNC HealthCare
Rocky Mount
Ohio
Strecker Cancer Center-Belpre
Belpre
Fairfield Medical Center
Lancaster
Saint Rita's Medical Center
Lima
Marietta Memorial Hospital
Marietta
Licking Memorial Hospital
Newark
Southern Ohio Medical Center
Portsmouth
Genesis Healthcare System Cancer Care Center
Zanesville
South Carolina
Prisma Health Cancer Institute - Spartanburg
Boiling Springs
Prisma Health Cancer Institute - Easley
Easley
Prisma Health Cancer Institute - Butternut
Greenville
Prisma Health Cancer Institute - Eastside
Greenville
Prisma Health Cancer Institute - Faris
Greenville
Prisma Health Cancer Institute - Greer
Greer
Prisma Health Cancer Institute - Seneca
Seneca
Virginia
Chesapeake Regional Medical Center
Chesapeake
Wisconsin
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
Time Frame
Start Date: 2022-02-25
Completion Date: 2026-02-01
Participants
Target number of participants: 133
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Rochester NCORP Research Base
Collaborators: National Cancer Institute (NCI)