Clinical trial NCT04170075: Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy
Official title: A Novel Therapeutic Intervention to Restore Health and Functioning in Persons With Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2019-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Accrual
timeFrame: Up to 12-weeks
measure: Adherence
timeFrame: Up to 12-weeks
measure: Compliance
timeFrame: Up to 12-weeks
measure: Adverse events
timeFrame: Weekly up to 12-weeks
Secondary outcomes:
measure: Objective physical function
timeFrame: 0, 12 weeks
measure: Functional mobility
timeFrame: 0, 12 weeks
measure: Functional balance-sway velocity
timeFrame: 0, 12 weeks
measure: Functional balance-sway area
timeFrame: 0, 12 weeks
measure: Functional balance-sway amount
timeFrame: 0, 12 weeks
measure: Symptoms of chemotherapy-induced peripheral neuropathy
timeFrame: 0, 12 weeks
measure: Fatigue Visual Analog Scale
timeFrame: Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale
timeFrame: 0, 12 weeks
measure: Pain Visual Analog Scale
timeFrame: Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
measure: Brief Pain Inventory
timeFrame: 0, 12 weeks
measure: Body mass index
timeFrame: 0, 12 weeks
measure: Exercise readiness
timeFrame: 1, 12 weeks
measure: Perceived physical function
timeFrame: 0, 12 weeks
measure: Gait
timeFrame: 0, 12 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
References: