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

NCT ID: NCT04170075

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2022-12-09

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care (UC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Whole body vibration (WBV)

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%.

Group Type: EXPERIMENTAL

Whole Body Vibration

Intervention Type: BEHAVIORAL

Undergo WBV

Interventions

Whole Body Vibration

Undergo WBV

Intervention Type: BEHAVIORAL

Other Intervention Names

WBV; Whole Body Vibration Therapy

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Kerri Winters

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerri Winters-Stone, PhD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39606939 (View on PubMed)

Other Identifiers

NCI-2019-08961

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00018342

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00018342

Identifier Type: -

Identifier Source: org_study_id