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

Primary Purpose

Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Body Vibration
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (UC)

Whole body vibration (WBV)

Arm Description

Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.

Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.

Outcomes

Primary Outcome Measures

Accrual
The number of participants enrolled during the recruitment period.
Adherence
Adherence = % of sessions attended and compliance = % of each session completed.
Compliance
Compliance = % of each session completed.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.
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).
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).
Body mass index
Body mass index will be calculated as kg/m2.
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.
Perceived physical function
Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).
Gait
The number of meters that participants can walk in 6-minutes will be recorded.

Full Information

First Posted
September 9, 2019
Last Updated
August 29, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04170075
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (UC)
Arm Type
No Intervention
Arm Description
Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.
Arm Title
Whole body vibration (WBV)
Arm Type
Experimental
Arm Description
Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.
Intervention Type
Behavioral
Intervention Name(s)
Whole Body Vibration
Other Intervention Name(s)
WBV, Whole Body Vibration Therapy
Intervention Description
Undergo WBV
Primary Outcome Measure Information:
Title
Accrual
Description
The number of participants enrolled during the recruitment period.
Time Frame
Up to 12-weeks
Title
Adherence
Description
Adherence = % of sessions attended and compliance = % of each session completed.
Time Frame
Up to 12-weeks
Title
Compliance
Description
Compliance = % of each session completed.
Time Frame
Up to 12-weeks
Title
Adverse events
Description
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 Outcome Measure Information:
Title
Objective physical function
Description
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
Title
Functional mobility
Description
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
Title
Functional balance-sway velocity
Description
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
Title
Functional balance-sway area
Description
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
Title
Functional balance-sway amount
Description
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
Title
Symptoms of chemotherapy-induced peripheral neuropathy
Description
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
Title
Fatigue Visual Analog Scale
Description
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
Title
Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale
Description
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
Title
Pain Visual Analog Scale
Description
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
Title
Brief Pain Inventory
Description
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
Title
Body mass index
Description
Body mass index will be calculated as kg/m2.
Time Frame
0, 12 weeks
Title
Exercise readiness
Description
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
Title
Perceived physical function
Description
Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).
Time Frame
0, 12 weeks
Title
Gait
Description
The number of meters that participants can walk in 6-minutes will be recorded.
Time Frame
0, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone, PhD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
What data in particular will be shared? All individual quantitative participant data collected during the trial, after deidentification. What other documents will be available? None With whom? Investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed. For what types of analyses? To achieve aims in the approved proposal.
IPD Sharing Time Frame
Beginning 3 months following publication. No end date.
IPD Sharing Access Criteria
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement and be approved to receive the data by the OHSU IRB.

Learn more about this trial

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

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