Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

NCT06724861 | Not Yet Recruiting

• 1 other identifier: CIPN - RCT
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CIPN - Chemotherapy-Induced Peripheral Neuropathy; Age Over 18; Chemotherapy-induced Peripheral Neuropathy

Keywords

Neuropathic pain; Chemo Induced Peripheral Neuropathy (CIPN); Sensory rehabilitation; Explicit Sensory Retraining; Lower extremity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Tactile function assessment - Semmes Weinstein Monofilaments (SWM)

  from randomization to maximum 3 months followup

• FABS - Fullerton Advanced Balance Scale

  from randomization to maximum 3 months

• Proprioception of lower extremity: Lower Extremity Position Test (LEPT)

  from randomization to maximum 3 months followup

Other Outcomes (2)

• Home exercise log

  1 minutes writing daily at home

• Participant satisfaction questionnaire

  5 minutes, at final assessment session only

Study Arms (2)

AB - early experimental treatment, later control usual care

OTHER

AB - early experimental treatment, later control usual care

Other: Explicit Sensory Retraining for the lower extremities; Other: no treatment

BA - early control usual care, later experimental treatment

OTHER

BA - early control usual care, later experimental treatment

Other: Explicit Sensory Retraining for the lower extremities; Other: no treatment

Interventions

Explicit Sensory Retraining for the lower extremities OTHER

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.

AB - early experimental treatment, later control usual care; BA - early control usual care, later experimental treatment

no treatment OTHER

Usual care

AB - early experimental treatment, later control usual care; BA - early control usual care, later experimental treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Zefat Academic College: collaborator

Study Sites (1)

Asaph-Harofe Shamir Medical Center

Rishon LeZiyyon, Israel

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hadas Ofek, PT, PhD

CONTACT

+972544666412; hadasbarkolofek@gmail.com

Rotem Merose, MD

CONTACT

rotemme@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not be aware of randomization and allocation. Primary investigator and statistician will receive data ready for analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: A Randomized Controlled Trial will be conducted in a within-subject cross-over design (AB BA). Full assessments will be conducted at baseline, after last treatment session. A short assessment will be conducted at the beginning of all sessions. The early intervention group (AB) will be assessed at one-month follow-up in addition. The later intervention group (BA) will be assessed at baseline, and after a month before treatment commences and immediately after last treatment

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 9, 2024
• Study Start: December 11, 2024
• Primary Completion: December 11, 2024
• Study Completion (Estimated): December 11, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

IL (1)