Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy

OHSU Knight Cancer Institute38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Accrual

The number of participants enrolled during the recruitment period.

Time frame: Up to 12-weeks

Adherence

Adherence = % of sessions attended and compliance = % of each session completed.

Time frame: Up to 12-weeks

Compliance

Compliance = % of each session completed.

Time frame: Up to 12-weeks

Adverse events

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.

Time frame: Weekly up to 12-weeks

Secondary Outcomes

Objective physical function

Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.

Time frame: 0, 12 weeks

Functional mobility

Functional mobility will be measured by the Timed Up and Go (TUG) test which measures the time that it takes a person to rise from a chair, walk 7 m, turn around and return and sit in the chair.

Time frame: 0, 12 weeks

Functional balance-sway velocity

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway velocity (m/s) during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Time frame: 0, 12 weeks

Functional balance-sway area

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the sway area (m2/s3) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Time frame: 0, 12 weeks

Functional balance-sway amount

Functional balance will be measured by postural sway which evaluates how well a person can maintain their equilibrium during quiet standing. Will conduct a standard 30-second postural sway test to measure the amount (m/s2) of sway during quiet standing with feet together and eyes closed using lightweight, inertial wireless sensors worn on the trunk.

Time frame: 0, 12 weeks

Symptoms of chemotherapy-induced peripheral neuropathy

Chronic changes in symptoms will be assessed at 0 and 12 weeks using the Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (FACT/GOG-Ntx). The questionnaire consists of the 27 item FACT-G, plus 11 items that specifically measure chemotherapy-induced neuropathy symptoms and concerns. Higher scores indicate worse symptoms.

Time frame: 0, 12 weeks

Fatigue Visual Analog Scale

Fatigue overall will be measured both before and after each whole body vibration session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no fatigue) to 10 (worst fatigue).

Time frame: 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

Chronic changes in fatigue will be assessed using the PROMIS Fatigue Scale. This instrument includes 8 items rated on a 5 point scale from "not at all" to "very much". Higher scores indicate worse fatigue.

Time frame: 0, 12 weeks

Pain Visual Analog Scale

Pain in the feet will be assessed both before and after each session using a visual analog scale to identify any acute symptom relief from training. The scale ranges from 0 (no pain) to 10 (worst pain).

Time frame: Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks

Brief Pain Inventory

Chronic changes in pain will be assessed using the Brief Pain Inventory (BPI). The instrument has 2 subscales: pain severity and pain interference. Severity is determined by the average of 4 items rated from 0 (no pain) to 10 (pain as bad as you can imagine). Pain interference is determined by the average of 7 items rated from 0 (does not interfere) to 10 (completely interferes).

Time frame: 0, 12 weeks

Body mass index

Body mass index will be calculated as kg/m2.

Time frame: 0, 12 weeks

Exercise readiness

Exercise readiness will be assessed using the stage of change for exercise questionnaire. This is a categorical instrument with 5 options that indicate a person's readiness to engage in regular physical activity. Options that suggest engagement in more regular exercise are better.

Time frame: 1, 12 weeks

Perceived physical function

Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).

Time frame: 0, 12 weeks

Gait

The number of meters that participants can walk in 6-minutes will be recorded.

Time frame: 0, 12 weeks

Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced Peripheral Neuropathy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes