CIPN - Chemotherapy-Induced Peripheral NeuropathyAge Over 18Chemotherapy-induced Peripheral Neuropathy
Investigational drug(s) / intervention(s)
Explicit Sensory Retraining for the lower extremitiesno treatment
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.
no treatment: Usual care
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Shamir Medical center
Tzrifin
Israel
Recruiting
More Assaf-Harofeh Medical Center trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.