Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

Sensory Rehabilitation in CIPN

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

Study Overview

• Status: Not yet recruiting
• Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Age Over 18
• Intervention / Treatment: Other: Explicit Sensory Retraining for the lower extremities; Other: no treatment

Detailed Description

Chemotherapy Induced Peripheral Neuropathy (CIPN) is a neurological complication of chemotherapy, affecting between 50%-90% of the patients: up to 68% within the first month after chemotherapy, 60% after 3 months, and 30% after 6 months.

Neuropathic symptoms can persist in 11% to more than 80% of individuals post chemotherapy at one to three years following treatment and around 50% even after 5 years and more.

CIPN is associated with lower self-reported physical function and Quality of Life (QoL).

The clinical picture is typically sensory, with involvement of large and small sensory fibers. Motor and autonomic involvement is less frequent.

Damage to sensory nerve fibers is typically symmetrical. Sensory loss in a 'glove and stocking type' distribution leads to 'minus' symptoms (loss of function) including numbness in hands and feet, impaired perception of light touch, hypoalgesia and impaired proprioception, temperature and vibration sensation. Paradoxically, 'plus' features (gain of function) such as paresthesia (tingling like pins and needles), dysesthesia, allodynia and hyperalgesia appear simultaneously. CIPN can be functionally debilitating including impaired balance, walking slower and shorter steps and increased falls.

Active, explicit sensory rehabilitation is efficient in promoting sensation and function in individuals with neurological conditions, such as stroke and multiple sclerosis. To the best of our knowledge although CIPN is primarily a sensory deficit there is no treatment aimed at this aspect. We aim to conduct a pilot study to explore the feasibility and clinical benefit of an active, explicit sensory rehabilitation protocol for the lower limb in individuals with chronic CIPN.

This study is a cross-over RCT evaluating the effectiveness of 3 sessions a week apart of explicit sensory retraining to the lower extremities in individuals with CIPN versus usual care. The primary outcome measures are TNAS for subjective symptoms, VAS for pain and TUG for mobility. Additional outcome measures are FABS for balance, sensory assessments - monofilaments for touch threshold, LEPT for proprioception, a home exercise log and a satisfaction questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Ofek, PT, PhD; Phone Number: +972544666412; Email: hadasbarkolofek@gmail.com
• Study Contact Backup: Name: Rotem Merose, MD; Email: rotemme@shamir.gov.il

Study Locations

• Israel
  • Rishon le Zion, Israel
    • Asaph-Harofe Shamir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
• age > 18.

Exclusion Criteria:

• Pre-chemotherapy neuropathy/ sensory impairment
• recurrent falls prior to chemotherapy (more than 2 per year)
• CNS involvement
• not ambulatory before chemotherapy
• Hebrew proficiency not meeting questionnaires' needs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: AB - early experimental treatment, later control usual care	Other: Explicit Sensory Retraining for the lower extremities; Sensory retraining of detection, discrimination, quantification of a stimuli and recognition of stimuli and objects with the leg and mainly with the foot. Top-down awareness of bottom-up sensory experience in the treatment session and in everyday life.; Other: no treatment; Usual care
Other: BA - early control usual care, later experimental treatment	Other: Explicit Sensory Retraining for the lower extremities; Sensory retraining of detection, discrimination, quantification of a stimuli and recognition of stimuli and objects with the leg and mainly with the foot. Top-down awareness of bottom-up sensory experience in the treatment session and in everyday life.; Other: no treatment; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)	TNAS -Treatment-Induced Neuropathy Assessment Scale: patient-reported outcome measure of presence and severity of CIPN. Nine 0-10 question scale. score 0-90. A higher score is for higher CIPN symptom severity.	from randomization 3 months maximum
Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)	TUG -Timed Up and Go: Balance and mobility assessment. Serves as a fall prediction screening test. Measures time taken to raise from a chair walking 3 meters and re-sit.	from randomization to maximum 3 months followup
Pain intensity: VAS - 0-100 mm visual scale	Pain intensity: VAS - 0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week	from randomization to maximum 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tactile function assessment - Semmes Weinstein Monofilaments (SWM)	Sensory threshold at the foot, as measured by Semmes Weinstein filaments.	from randomization to maximum 3 months followup
FABS - Fullerton Advanced Balance Scale	FABS - Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better.	from randomization to maximum 3 months
Proprioception of lower extremity: Lower Extremity Position Test (LEPT)	Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).	from randomization to maximum 3 months followup

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home exercise log	Amount of home exercise per minutes per day	1 minutes writing daily at home
Participant satisfaction questionnaire	Participant satisfaction questionnaire	5 minutes, at final assessment session only

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Collaborators: Zefat Academic College

Study record dates

Study Major Dates

• Study Start (Estimated): December 11, 2024
• Primary Completion (Estimated): December 11, 2024
• Study Completion (Estimated): December 11, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Neuropathic pain; Lower extremity; Chemo Induced Peripheral Neuropathy (CIPN); Sensory rehabilitation; Explicit Sensory Retraining
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: CIPN - RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No