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

Malignant Solid Neoplasm Clinical Trial

Official title:

A Novel Therapeutic Intervention to Restore Health and Functioning in Persons With Chemotherapy-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04170075
• Other study ID #: STUDY00018342
• Secondary ID: NCI-2019-08961ST
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: December 9, 2022

Study information

• Verified date: August 2023
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 9, 2022
• Est. primary completion date: December 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Peripheral Nervous System Diseases

Intervention

Behavioral:
• Whole Body Vibration
Undergo WBV

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual	The number of participants enrolled during the recruitment period.	Up to 12-weeks
Primary	Adherence	Adherence = % of sessions attended and compliance = % of each session completed.	Up to 12-weeks
Primary	Compliance	Compliance = % of each session completed.	Up to 12-weeks
Primary	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	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.	0, 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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).	Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
Secondary	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.	0, 12 weeks
Secondary	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).	Before and after every whole body vibration session, up to 2 times per day, 7 days per week, for 12 weeks
Secondary	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).	0, 12 weeks
Secondary	Body mass index	Body mass index will be calculated as kg/m2.	0, 12 weeks
Secondary	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.	1, 12 weeks
Secondary	Perceived physical function	Perceived physical function will be measured by self-report using the Late-Life Function and Disability Instrument (LLFDI).	0, 12 weeks
Secondary	Gait	The number of meters that participants can walk in 6-minutes will be recorded.	0, 12 weeks