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NCT Number: NCT06724861

Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asaph-Harofe Shamir Medical Center

Rishon LeZiyyon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

No treatment

Other

Usual care

Primary outcomes

  1. Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)

    Time frame: 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.

  2. Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)

    Time frame: 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.

  3. Pain intensity: VAS - 0-100 mm visual scale

    Time frame: 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 outcomes

  1. Tactile function assessment - Semmes Weinstein Monofilaments (SWM)

    Time frame: from randomization to maximum 3 months followup

    Sensory threshold at the foot, as measured by Semmes Weinstein filaments.

  2. FABS - Fullerton Advanced Balance Scale

    Time frame: 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.

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

    Time frame: from randomization to maximum 3 months followup

    Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).

Other outcomes

  1. Home exercise log

    Time frame: 1 minutes writing daily at home

    Amount of home exercise per minutes per day

  2. Participant satisfaction questionnaire

    Time frame: 5 minutes, at final assessment session only

    Participant satisfaction questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Hadas Ofek, PT, PhD

CONTACT

[email protected]

+972544666412

Rotem Merose, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assaf-Harofeh Medical Center

Other Gov

Collaborators

  • Zefat Academic College

Registry information

Official study title

Sensory Rehabilitation in CIPN

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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