CIPN - Chemotherapy-Induced Peripheral NeuropathyNCT06724861
Sensory Rehabilitation in Chemo Induced Peripheral Neuropathy
A study testing Explicit Sensory Retraining for the lower extremities and no treatment in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Age Over 18, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Age Over 18, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Explicit Sensory Retraining for the lower extremities and no treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Apr 2025to 11 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
- age > 18.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rotem Merose, MD contact
Israel1 site, 1 recruiting
- Recruiting
Shamir Medical center
Tzrifin
Hadas Ofek, MD, 972-544666412, hadasbarkolofek@gmail.com
Nicole Asraf, MD, 972544699403, nicoleas000@gmail.com
About this study
Official title: Sensory Rehabilitation in 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.
Read the 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.
- Conditions
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Age Over 18, Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Explicit Sensory Retraining for the lower extremities, no treatment
- Keywords
- Neuropathic pain, Chemo Induced Peripheral Neuropathy (CIPN), Sensory rehabilitation, Explicit Sensory Retraining, Lower extremity
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Explicit Sensory Retraining for the lower extremitiesOther
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 treatmentOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| AB - early experimental treatment, later control usual care | Other | AB - early experimental treatment, later control usual care Receives: Other: Explicit Sensory Retraining for the lower extremities; Other: no treatment |
| BA - early control usual care, later experimental treatment | Other | BA - early control usual care, later experimental treatment Receives: Other: Explicit Sensory Retraining for the lower extremities; Other: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS)
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.
Measured: from randomization 3 months maximum
Functional - Balance and mobility outcome measure - Timed Up and Go test (TUG)
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.
Measured: from randomization to maximum 3 months followup
Pain intensity: VAS - 0-100 mm visual scale
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
Measured: from randomization to maximum 3 months
Secondary outcomes (3)
Tactile function assessment - Semmes Weinstein Monofilaments (SWM)
Sensory threshold at the foot, as measured by Semmes Weinstein filaments.
Measured: from randomization to maximum 3 months followup
FABS - Fullerton Advanced Balance Scale
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.
Measured: from randomization to maximum 3 months
Proprioception of lower extremity: Lower Extremity Position Test (LEPT)
Proprioception of lower extremity as measured by Lower Extremity Position Test (LEPT).
Measured: from randomization to maximum 3 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start8 Apr 2025
- Primary completion11 Dec 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Zefat Academic College
- Responsible party
- Principal investigator, Rotem Merose, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724861
- Sponsor's protocol ID
- CIPN - RCT
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Rehabilitation in CIPN
- ClinicalTrials.gov ID
- NCT06724861
- Acronym / sponsor ID
- CIPN - RCT
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Zefat Academic College
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 11 Dec 2027 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| AB - early experimental treatment, later control usual care | Other | Other: Explicit Sensory Retraining for the lower extremities, Other: no treatmentAB - early experimental treatment, later control usual care |
| BA - early control usual care, later experimental treatment | Other | Other: Explicit Sensory Retraining for the lower extremities, Other: no treatmentBA - early control usual care, later experimental treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CIPN by self-report (present or absent) > 3 months after last chemotherapy treatment
- age > 18.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Explicit Sensory Retraining for the lower extremitiesSensory 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 | AB - early experimental treatment, later control usual care, BA - early control usual care, later experimental treatment |
| no treatmentUsual care | Other | AB - early experimental treatment, later control usual care, BA - early control usual care, later experimental treatment |
Primary outcome
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.
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.
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rotem Merose, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Explicit Sensory Retraining for the lower extremities and no treatment in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Age Over 18, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadas Ofek, PT, PhD (+972544666412, hadasbarkolofek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient self-Report Outcome Measure - Treatment-Induced Neuropathy Assessment Scale (TNAS) (time frame: from randomization 3 months maximum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.