Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Explicit Sensory Retraining for the lower extremities, no treatment.
- Who it may be relevant to
- Registry conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy, Age Over 18, Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sensory Rehabilitation in CIPN
Overview
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.
Interventions
- 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
Primary outcome measures
- Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS) [Time frame: from randomization 3 months maximum]
- Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG) [Time frame: from randomization to maximum 3 months followup]
- Pain intensity: VAS - 0-100 mm visual scale [Time frame: from randomization to maximum 3 months]
Secondary outcome measures (3)
- Tactile function assessment - Semmes Weinstein Monofilaments (SWM) [Time frame: from randomization to maximum 3 months followup]
- FABS - Fullerton Advanced Balance Scale [Time frame: from randomization to maximum 3 months]
- Proprioception of lower extremity: Lower Extremity Position Test (LEPT) [Time frame: from randomization to maximum 3 months followup]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Asaph-Harofe Shamir Medical Center — Rishon LeZiyyon
Identifiers
NCT: NCT06724861 · CIPN - RCT