A Novel Therapeutic Intervention to Restore Health and Functioning in Persons With Chemotherapy-Induced Peripheral Neuropathy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This clinical trial studies how well whole body vibration works in improving the health and functioning of participants with chemotherapy-induced peripheral neuropathy. Peripheral neuropathy is a condition caused by exposure to chemotherapy drugs that may involve numbness/tingling and/or pain in the hands and feet, which can have adverse effects on daily life. Whole body vibration may cause weight loss and improve mobility and pain levels in cancer survivors who report symptoms of peripheral neuropathy.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the feasibility and safety of whole body vibration (WBV) in adult cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). II. Determine the effect of WBV training on physical functioning in adult cancer survivors with CIPN. III. Explore the effect of WBV training on symptom relief (neuropathy symptoms, pain, fatigue) and readiness to exercise in adult cancer survivors with CIPN. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (WBV): Participants complete two 10-minute WBV sessions per day, 7 days per week for 12 weeks. GROUP II (USUAL CARE \[UC\]): Participants receive usual care and keep their same physical activity or dietary habits over 12 weeks. After completion of study treatment, participants are followed up at 12 weeks.
Investigators
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed cancer stage I-IIIc (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Previous chemotherapy within five years of enrollment (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Presence of mild-very severe CIPN symptoms (confirmed by assessment using the Patient-Reported Outcomes \[PRO\]-Common Terminology Criteria for Adverse Events \[CTCAE\] criteria)
- •Age 18 years or older at enrollment (confirmed by self-report on the Health History Questionnaire)
Exclusion Criteria
- •Body weight \> 275 pounds (confirmed by self-report on the Health History Questionnaire)
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in low intensity exercise and/or WBV (confirmed by self-report on the Health History Questionnaire, and by physician clearance, if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible.)
- •Presence of any known metastases (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
- •Adjuvant treatment for cancer within previous six weeks, other than hormone blocking, targeted or immunotherapy (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)
Outcomes
Primary Outcomes
Adverse events
Time Frame: Weekly up to 12-weeks
An in-house survey will ask about adverse events (e.g., bone pain, nausea) that occur during the intervention. The number of discrete moderate and severe adverse events will be summed as a single variable.
Accrual
Time Frame: Up to 12-weeks
The number of participants enrolled during the recruitment period.
Adherence
Time Frame: Up to 12-weeks
Adherence = % of sessions attended and compliance = % of each session completed.
Compliance
Time Frame: Up to 12-weeks
Compliance = % of each session completed.
Secondary Outcomes
- Functional balance-sway amount(0, 12 weeks)
- Symptoms of chemotherapy-induced peripheral neuropathy(0, 12 weeks)
- Body mass index(0, 12 weeks)
- Functional balance-sway velocity(0, 12 weeks)
- Objective physical function(0, 12 weeks)
- Functional mobility(0, 12 weeks)
- Fatigue Visual Analog Scale(Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks)
- Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale(0, 12 weeks)
- Perceived physical function(0, 12 weeks)
- Exercise readiness(1, 12 weeks)
- Functional balance-sway area(0, 12 weeks)
- Brief Pain Inventory(0, 12 weeks)
- Pain Visual Analog Scale(Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks)
- Gait(0, 12 weeks)