Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

Not Applicable

Not yet recruiting

• Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy; Age Over 18; Chemotherapy-induced Peripheral Neuropathy

• Registration Number: NCT06724861
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

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 Timeline

• Study First Submitted: 2024-11-21
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2024-12-11
• Primary Completion: 2024-12-11
• Study Completion: 2026-12-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)	from randomization 3 months maximum	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.
Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)	from randomization to maximum 3 months followup	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.
Pain intensity: VAS - 0-100 mm visual scale	from randomization to maximum 3 months	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

Secondary Outcome Measures

Name	Time	Method
Tactile function assessment - Semmes Weinstein Monofilaments (SWM)	from randomization to maximum 3 months followup	Sensory threshold at the foot, as measured by Semmes Weinstein filaments.
FABS - Fullerton Advanced Balance Scale	from randomization to maximum 3 months	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.
Proprioception of lower extremity: Lower Extremity Position Test (LEPT)	from randomization to maximum 3 months followup	Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).

Trial Locations

Locations (1)

Asaph-Harofe Shamir Medical Center; 🇮🇱 Rishon le Zion, Israel