Age Over 18, Chemotherapy-induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy
Conditions
Keywords
Neuropathic pain, Chemo Induced Peripheral Neuropathy (CIPN), Sensory rehabilitation, Explicit Sensory Retraining, Lower extremity
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.
Interventions
OTHERExplicit 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.
OTHERno treatment
Usual care
Sponsors
Assaf-Harofeh Medical Center
Zefat Academic College
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The outcome assessor will not be aware of randomization and allocation. Primary investigator and statistician will receive data ready for analysis.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Israel
Contacts
CONTACTHadas Ofek, PT, PhD
CONTACTRotem Merose, MD
Outcome results
None listed