Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy.

NCT06313359 | Recruiting

• 1 other identifier: FY2024-125
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. Investigators are also interested to see if the participants have any difficulty with doing two activities at the same time, such as walking and texting.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Fall risk

  Fall risk will be assessed using the Timed Up and Go (TUG)-Test. For the TUG, the participant will be asked to stand up from a chair, walk 3 m and touch a line on the floor, walk back to the chair and sit down. Timing of the test will begin when the tester gives the command "go" and will be stopped when the participant made contact with the chair as they sat down.

  5 minutes

• Quality of life- in cancer patients

  Participants in the cancer related peripheral neuropathy group will complete the Functional Assessment of Cancer Therapy- General (FACT-G ) to assess self-reported quality of life. The FACT-G uses a 5-point Likert scale, with higher numbers indicating a better health state.

  5 minutes

Secondary Outcomes (10)

• Trail Making Test (TMT) Parts A & B

  5 minutes

• Single Task- Working Memory

  3 minutes

• Single Task- Visual Attention Cognitive Task

  3 minutes

• Protective Sensation

  5 minutes

• Grip Strength

  5 minutes

Study Arms (2)

Cancer treatment induced peripheral neuropathy

Individuals with a history of non CNS cancer with cancer treatment induced peripheral neuropathy symptoms.

Control group

Age and gender matched individuals without peripheral neuropathy symptoms.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non CNS Cancer population with neuropathy symptoms related to cancer treatments.

You may qualify if:

• Experimental group
• Individuals 18 years and older
• diagnosed with non- CNS cancer who underwent treatment and presents with peripheral neuropathy symptoms.
• Control group
• age (+/- one year) and gender matched individuals
• no diagnosed peripheral neuropathy
• No diagnosed cognitive symptoms.

You may not qualify if:

• Unable to follow two step commands.
• Unable to ambulate x 50 feet independently without use of an assistive device.
• Unable to use a phone to send text messages.
• Diagnosis of diabetic peripheral neuropathy
• Diagnosis of CNS cancer.
• Unable to speak/understand English

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (7)

• Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.

  PMID: 28486769 BACKGROUND

• Small GH, Brough LG, Neptune RR. The influence of cognitive load on balance control during steady-state walking. J Biomech. 2021 Jun 9;122:110466. doi: 10.1016/j.jbiomech.2021.110466. Epub 2021 Apr 23.

  PMID: 33962328 BACKGROUND

• Mounier NM, Abdel-Maged AE, Wahdan SA, Gad AM, Azab SS. Chemotherapy-induced cognitive impairment (CICI): An overview of etiology and pathogenesis. Life Sci. 2020 Oct 1;258:118071. doi: 10.1016/j.lfs.2020.118071. Epub 2020 Jul 14.

  PMID: 32673664 BACKGROUND

• Montero-Odasso M, Sarquis-Adamson Y, Kamkar N, Pieruccini-Faria F, Bray N, Cullen S, Mahon J, Titus J, Camicioli R, Borrie MJ, Bherer L, Speechley M. Dual-task gait speed assessments with an electronic walkway and a stopwatch in older adults. A reliability study. Exp Gerontol. 2020 Dec;142:111102. doi: 10.1016/j.exger.2020.111102. Epub 2020 Oct 2.

  PMID: 33017671 BACKGROUND

• Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410.

  PMID: 31617564 BACKGROUND

• Komatsu H, Yagasaki K, Komatsu Y, Yamauchi H, Yamauchi T, Shimokawa T, Doorenbos AZ. Falls and Functional Impairments in Breast Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):253-260. doi: 10.4103/apjon.apjon_7_19.

  PMID: 31259221 BACKGROUND

• Autissier E. Chemotherapy-Induced Peripheral Neuropathy: Association With Increased Risk of Falls and Injuries. Clin J Oncol Nurs. 2019 Aug 1;23(4):405-410. doi: 10.1188/19.CJON.405-410.

  PMID: 31322611 BACKGROUND

Study Officials

• Priya Karakkattil, PhD

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

• Asha Vas, PhD

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priya Karakkattil

CONTACT

12148625624; Pkarakkattil@twu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: March 30, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2024-10

Locations

US (1)