Clinical trial NCT06724861: Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy
Official title: Sensory Rehabilitation in CIPN
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Zefat Academic College
First posted: 2024-12-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)
timeFrame: from randomization 3 months maximum
measure: Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)
timeFrame: from randomization to maximum 3 months followup
measure: Pain intensity: VAS - 0-100 mm visual scale
timeFrame: from randomization to maximum 3 months
Secondary outcomes:
measure: Tactile function assessment - Semmes Weinstein Monofilaments (SWM)
timeFrame: from randomization to maximum 3 months followup
measure: FABS - Fullerton Advanced Balance Scale
timeFrame: from randomization to maximum 3 months
measure: Proprioception of lower extremity: Lower Extremity Position Test (LEPT)
timeFrame: from randomization to maximum 3 months followup
Other outcomes:
measure: Home exercise log
timeFrame: 1 minutes writing daily at home
measure: Participant satisfaction questionnaire
timeFrame: 5 minutes, at final assessment session only
Locations:
city: Rishon le Zion
country: Israel
facility: Asaph-Harofe Shamir Medical Center
Study officials:
References: