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

NCT04170075 | Completed DMC

• 2 other identifiers: STUDY00018342NCI-2019-08961
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Accrual

  The number of participants enrolled during the recruitment period.

  Up to 12-weeks

• Adherence

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

  Up to 12-weeks

• Compliance

  Compliance = % of each session completed.

  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.

  Weekly up to 12-weeks

Secondary Outcomes (14)

• Objective physical function

  0, 12 weeks

• Functional mobility

  0, 12 weeks

• Functional balance-sway velocity

  0, 12 weeks

• Functional balance-sway area

  0, 12 weeks

• Functional balance-sway amount

  0, 12 weeks

Study Arms (2)

Usual Care (UC)

NO INTERVENTION

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.

Whole body vibration (WBV)

EXPERIMENTAL

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%.

Behavioral: Whole Body Vibration

Interventions

Whole Body Vibration BEHAVIORAL

Undergo WBV

Also known as: WBV, Whole Body Vibration Therapy

Whole body vibration (WBV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kerri Winters-Stone, PhD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: November 20, 2019
• Study Start: August 5, 2019
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months following publication. No end date.
• 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.

Locations

US (1)