Chemotherapy-induced Peripheral NeuropathyNCT03764514
Spinal Cord Stimulation in Chemotherapy Induced Neuropathy
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Spinal Cord Stimulator
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 3 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- The patient has persistent, severe peripheral neuropathy secondary to chemotherapy
Who cannot join
- Refusal to undergo a spinal cord stimulator procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Patewood Memorial Hospital
Greenville, South Carolina, 29615
About this study
Official title: Effectiveness of Spinal Cord Stimulation As Therapy for Chemotherapy-Induced Peripheral Neuropathy: a Pilot Trial
This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.
Read the detailed description
Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.
- Being tested
- Spinal Cord Stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
Permanent Implantation
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulator - Permanent Implantation | Not described Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent Spinal Cord Stimulator Implantation
To determine the total number of patients who undergo permanent spinal cord stimulator implantation.
Measured: 2 years
Secondary outcomes (2)
Subjective Pain Assessment: Brief Pain Inventory-Short Form
Measure Pain with the Brief Pain Inventory-Short Form. The scale measures the severity of pain and the impact of pain on daily functions. The scale range includes 0-10 scales, with 0=no interference and 10=interferes completely. There is not a scoring algorithm, but "worst pain" or the average of the four severity items can be used as measures of pain severity; the average of the seven interference items can be used as a measure of pain interference.
Measured: 2 years
Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment
Measure quality of life through the use of the Pittsburgh Sleep Quality Assessment. The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (global score) indicating worse sleep quality.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start3 Dec 2018
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Smith, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764514
- Sponsor's protocol ID
- Pro00076097
- Status last verified
- Mar 2023
- First submitted
- 3 Dec 2018
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.
PubMed 19462129
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Spinal Cord Stimulation As Therapy for Chemotherapy-Induced Peripheral Neuropathy: a Pilot Trial
- ClinicalTrials.gov ID
- NCT03764514
- Acronym / sponsor ID
- Pro00076097
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 5 Dec 2018 (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 is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.
Detailed description
Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulator - Permanent Implantation | – | Device: Spinal Cord Stimulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- The patient has persistent, severe peripheral neuropathy secondary to chemotherapy
Key exclusion criteria (1 listed)
- Refusal to undergo a spinal cord stimulator procedure
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 StimulatorPermanent Implantation | Device | Spinal Cord Stimulator - Permanent Implantation |
Primary outcome
Permanent Spinal Cord Stimulator Implantation
Time frame: 2 years
To determine the total number of patients who undergo permanent spinal cord stimulator implantation.
2 secondary outcomes
Subjective Pain Assessment: Brief Pain Inventory-Short Form
Time frame: 2 years
Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 19462129Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
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. This study is not recruiting at the moment.
Joshua Smith, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Peripheral Neuropathy, run by Prisma Health-Upstate at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent Spinal Cord Stimulator Implantation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764514, which also lists 1 linked publication.
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 24 Sep 2024.