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This is a feasibility pilot study to initiate a research program to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the hands and feet).
This is a feasibility pilot study to help obtain external funding for a larger study to assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is a dose-limiting and painful side effect of chemotherapy for which there are no established treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The investigators will acquire data on CIPN via patient reports and clinical assessments as well as general pain and hypothetical mechanistic factors that may help explain how exercise may treat CIPN; these factors include measures of musculoskeletal, cardiovascular, neuropsychological, and immunological function. The primary outcomes are related to the feasibility of identifying, recruiting, and obtaining complete data from research participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. |
|
| Nutrition Education Control | Active Comparator | Nutrition education (control) involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXCAP Exercise | Behavioral | 12 weeks of at-home walking and resistance exercise |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients screened who are eligible | Number of patients eligible divided by number of patients screened | 12 weeks |
| Percent of patients eligible who are consented | Number of patients consented divided by number of patients approached | 12 weeks |
| Percent of patients consented who complete the exercise intervention | Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm | 12 weeks |
| Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy | Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39304604 | Derived | Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Support Care Cancer. 2024 Sep 21;32(10):677. doi: 10.1007/s00520-024-08855-y. | |
| 38559210 |
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Interested researchers may contact the study PI with requests for collaboration.
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| Nutrition Education Control |
| Behavioral |
12 weeks of implementing eating tips |
|
| Kleckner IR, Manuweera T, Lin PJ, Chung KH, Kleckner AS, Gewandter JS, Culakova E, Tivarus ME, Dunne RF, Loh KP, Mohile NA, Kesler SR, Mustian KM. Pilot trial testing the effects of exercise on chemotherapy-induced peripheral neurotoxicity (CIPN) and the interoceptive brain system. Res Sq [Preprint]. 2024 Mar 13:rs.3.rs-4022351. doi: 10.21203/rs.3.rs-4022351/v1. |