Chemotherapy-induced Peripheral NeuropathyPhase 4NCT06596200
Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
A Phase 4 study testing Spinal Cord Stimulation Implant in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Maryland St. Joseph Medical Center.
Trial summary
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Spinal Cord Stimulation Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 15 Nov 2026
- Phase
- Phase 4
- 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 as diagnosed by Oncology and/or neurology
- Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
- Pain severity greater than 4 out of 10 on a numeric rating scale of pain
- Pain chronicity greater than 6 months after the cessation of chemotherapy
- Failure of medical therapy, which must have included duloxetine
- Age 18 or greater
Who cannot join
- Platelet count less than 100k/mm3
- Spinal anatomy precluding placement of the SCS leads between T6 and T11
- Active infection
- Estimated Lifespan less than 1 year
- Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.
- Being tested
- Spinal Cord Stimulation Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation ImplantDevice
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - SCS | Experimental | Patients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant. Receives: Device: Spinal Cord Stimulation Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
-- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.
Measured: 1 year
Secondary outcomes (6)
- - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.
CIPN20 is a 20-item patient questionnaire with items scored 1 to 4. Scores vary from 20 to 80, with higher scores indicating more prevalent neuropathy symptoms.
Measured: 1 year
- Pain interference in daily life will be quantified via the brief pain inventory (BPI).
BPI includes reported pain severity (NRS) and a 7-item questionnaire assessing pain interference with each item scored 0-10 with higher scores indicating worsened pain interference.
Measured: 1 year
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).
The mTCNS is a clinician administered exam with 11 items scored 0-3. A normal score is 0 with higher scores indicating worsened neuropathy on physical exam, up to a maximum of 33.
Measured: 1 year
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).
PGIC is a 7 point scale rating their impression (1-"very much improved", 2-"much improved", 3-"minimally improved", 4-"no change", 5-"minimally worse", 6-"much worse", 7-"very much worse").
Measured: 1 year
- Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.
Measured: 1 year
- Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland St. Joseph Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596200
- Sponsor's protocol ID
- 00110894
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents
- ClinicalTrials.gov ID
- NCT06596200
- Acronym / sponsor ID
- 00110894
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Maryland St. Joseph Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 19 Sep 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.
Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - SCS | Experimental | Device: Spinal Cord Stimulation ImplantPatients who are eligible will receive a trial implant for a 3-7 day trial period. If there is at least 50% pain relief in the trial period, the patients will receive the permanent SCS implant and will be followed for 1 year post permanent implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- CIPN as diagnosed by Oncology and/or neurology
- Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
- Pain severity greater than 4 out of 10 on a numeric rating scale of pain
- Pain chronicity greater than 6 months after the cessation of chemotherapy
- Failure of medical therapy, which must have included duloxetine
Key exclusion criteria (5 listed)
- Platelet count less than 100k/mm3
- Spinal anatomy precluding placement of the SCS leads between T6 and T11
- Active infection
- Estimated Lifespan less than 1 year
- Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months
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 |
|---|---|---|
| Spinal Cord Stimulation ImplantSpinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord | Device | Intervention Group - SCS |
Primary outcome
-- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.
Time frame: 1 year
6 secondary outcomes
- - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.
Time frame: 1 year
- Pain interference in daily life will be quantified via the brief pain inventory (BPI).
Time frame: 1 year
- Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).
Time frame: 1 year
- The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).
Time frame: 1 year
- Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.
Time frame: 1 year
- Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.
Time frame: 1 year
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal Cord Stimulation Implant in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Maryland St. Joseph Medical Center.
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 6 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aja Janyavula, MD, MPH (4104275459, UMSJMCtrials@umm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
-- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant. (time frame: 1 year). 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 19 Sep 2024.