Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K07CA221931 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and severe side-effect of taxane chemotherapy, often used to treat breast cancer. Unfortunately there are very limited treatments for CIPN. This is a phase II randomized controlled trial to test the preliminary efficacy of exercise vs. nutrition education on CIPN, to systematically investigate the potential roles of inflammation and interoception, and to obtain data with a more accurate effect size to inform a future study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Exercise for Cancer Patients (EXCAP©®) involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program. |
|
| Nutrition Education | Active Comparator | Nutrition education 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 |
|---|---|---|
| Patient-reported sensory symptoms of chemotherapy-induced peripheral neuropathy (CIPN) | CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). | Time point 2 (approximately 6 weeks), controlling for baseline value |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory loss | Finger tactile sensitivity | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline |
| Numbness and tingling | Patient-reported severity of numbness/tingling (0-10). A larger value reflects more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). |
| Measure | Description | Time Frame |
|---|---|---|
| Musculoskeletal function | Leg strength via isokinetic dynamometer test | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline |
| Cardiovascular function | Distance walked in six-minute walk test |
Inclusion criteria (subjects must…)
Exclusion criteria (subjects must not…)
Additional exclusion criteria only for patients performing the MRI scanning (40 of 80 enrolled subjects)
1. Subjects must not have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, chest expander from breast reconstruction, etc.-note that most port-a-caths are safe for MRI scanning)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States | ||
| University of Rochester Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15911236 | Background | Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14. |
Not provided
Not provided
Interested researchers may contact the study PI with requests for collaboration.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Assessor and investigator will be masked of Arms to the extent possible (i.e., for some outcomes e.g., biomarkers but not others e.g. symptom tests).
| Nutrition Education |
| Behavioral |
12 weeks of implementing eating tips and tracking food. |
|
| Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline |
| Sensory, motor, and autonomic symptoms of CIPN | CIPN-20 total score (Postma et al 2005). The score includes 20 questions, each rated 1-4, and the score ranges from 20-80 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks) or time point 4 (approx. 24 weeks), controlling for baseline |
| Patient-reported sensory symptoms of CIPN | CIPN-20 sensory subscale (Postma et al 2005). The subscale includes 9 questions, each rated 1-4, and the score ranges from 9-36 with larger values reflecting more severe (worse) symptoms of chemotherapy-induced peripheral neuropathy (CIPN). | Time point 3 (approx. 12 weeks) or time point 4 (approx. 25 weeks), controlling for baseline |
| Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline |
| Neuropsychological function | Brain connectivity via functional magnetic resonance imaging | Time point 2 (approx. 6 weeks), controlling for baseline |
| Immunological function | Inflammatory cytokine concentration via ELISA (IL-6, IL-10, etc.) | Time point 2 (approx. 6 weeks) or time point 3 (approx. 12 weeks), controlling for baseline |
| Rochester |
| New York |
| 14642 |
| United States |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |