Chemotherapy-induced Peripheral NeuropathyNCT03687970
A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
A study testing Brief Pain Inventory, Hospital Anxiety and Depression Scale and Neuropathic Pain Symptom Inventory in people with Chemotherapy-induced Peripheral Neuropathy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators propose that using the Diode Laser fiber type Selective Stimulator (DLss) in patients with chemotherapy-induced peripheral neuropathy (CIPN) will allow for the assessment of changes in small-fiber pain thresholds, to identify differences between subjects who received chemotherapy and developed… 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?
- Brief Pain Inventory, Hospital Anxiety and Depression Scale and Neuropathic Pain Symptom Inventory
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2018to 17 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Group A: Painful CIPN group
- Age >18
- Distal symmetric pain distribution (both feet, with or without pain in hands).
- The pain appeared during or up to 12 weeks after treatment with oxaliplatin, cisplatin, paclitaxel, docetaxel or any combination of these.
- Score of 4 or more on Douleur Neuropathique 4 (DN4) neuropathic pain questionnaire
- Pain duration > 2 months.
Show all 13Show fewer
- Patient report of average daily pain intensity in the last week ≥3 on 0-10 Numerical Rating Scale (NRS).
- Able and willing to sign an Institutional Review Board (IRB)-approved written informed consent.
- Group B: Control group:
- Age >18
- History of cancer diagnosis, previously treated with at least 8 infusions of chemotherapy regimen that included oxaliplatin or at least 6 infusions of chemotherapy regimen that included cisplatin, paclitaxel, docetaxel, or any combination of these.
- No ongoing pain in distal symmetric distribution (subjects with symptoms and signs such as mild numbness, or vibration sensation loss are eligible to be included in the control group).
- Able and willing to sign an IRB-approved written informed consent. * Subjects in the control group will be matched by the type of previous chemotherapy to the subjects in the Painful CIPN group. An additional attempt will be made to match controls by sex, age, cancer diagnosis, and cumulative neurotoxic chemotherapy dose.
Who cannot join
- History of pre-existing painful distal symmetric polyneuropathy prior to chemotherapy.
- Alternative etiology exists for the distal painful symptoms.
- Current or previous treatment with a vinca alkaloid (e.g. vincristine, vinblastine), bortezomib, or another agent which may cause major peripheral neurotoxicity.
- Pregnant
- Concomitant medication as follows:
- Patients receiving chronic daily opioids, topical lidocaine or topical capsaicin will be excluded.
- Patients receiving as needed (PRN) analgesics, including acetaminophen, NSAIDs or short-acting opioids, will be required not to take them 48h before testing, at for at least five half-lives of the specific analgesic, at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN): a Feasibility Study
The investigators propose that using the Diode Laser fiber type Selective Stimulator (DLss) in patients with chemotherapy-induced peripheral neuropathy (CIPN) will allow for the assessment of changes in small-fiber pain thresholds, to identify differences between subjects who received chemotherapy and developed painful CIPN, compared to subjects who received similar chemotherapy but did not develop painful CIPN (control group).
Additionally, the investigators would like to investigate whether the response to DLss correlates with pain severity in patients with persistent painful neuropathy.
The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If the investigators' initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.
Read the detailed description
Painful chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, occurring in more than 60% of patients at some point during the course of cancer treatment with commonly used drugs such as taxanes and platinum compounds. It potentially may result in severely diminished quality of life and dose reduction or/and treatment delay, which may ultimately impact survival.
The mechanisms by which chemotherapy-induced nerve damage ultimately leads to pain are poorly understood, because virtually no structural or functional differences in nerve fibers between painless and painful peripheral neuropathy have been identified. As a result, there is no reliable way to predict which patients will develop persistent painful chemotherapy-induced peripheral neuropathy.
The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If our initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.
In this other interventional study, we will test the utility of the Diode Laser fiber type Selective Stimulator (DLss) to identify sensory changes that are unique to patients with painful chemotherapy induced peripheral neuropathy (CIPN) vs. controls.
Painful symptoms of CIPN develop in patients with differential nerve damage to Aδ vs C-type peripheral nerve fibers. We hypothesize that Aδ:C fiber threshold ratio, as measured by the DLss, will be different between patients with painful CIPN compared to control patients who received a similar regimen of chemotherapy, but did not develop painful CIPN. The confirmation of hypothesis may lead to a novel approach for early detection of CIPN.
Subjects: 20 evaluable patients with painful CIPN following treatment with oxaliplatin, cisplatin, paclitaxel, docetaxel (or any combination of above) will be included in painful CIPN group, and 20 controls matched by the type of chemotherapy received, who did not develop painful CIPN.
The study procedure will include a one-time visit for sensory assessments including:
- Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS);
- Assessment of pain symptoms on Neuropathic pain Symptom Inventory (NPSI) and Brief Pain Inventory (BPI).
- Assessment of mood on hospital anxiety and depression scale (HADS)
- Quantitative sensory testing (QST): thermal detection and pain thresholds, mechanical detection threshold, temporal summation (TS), and conditioned pain modulation (CPM).
The primary outcome is the comparison of Aδ:C fiber threshold ratio between patients who have developed painful CIPN, and the control subjects.
In secondary analyses, we will generate Spearman correlation coefficient between the "Aδ:C fiber threshold ratio" and the severity of painful CIPN on NPSI scale.
- Being tested
- Brief Pain Inventory, Hospital Anxiety and Depression Scale, Neuropathic Pain Symptom Inventory, Diode Laser fiber type Selective Stimulator, Quantitative sensory testing
- Keywords
- CIPN, Neuropathic pain, DLss, Peripheral neuropathy
- Medical subject headings
- Neuralgia, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Pain InventoryOther
Also called BPI
-A self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity (4 items which generate the PAIN SEVERITY score), list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life (7 items which generate the PAIN INTERFERENCE score) on a 10 point scale.
Hospital Anxiety and Depression ScaleOther
Also called HADS
- 14 item scale with even of the items relating to anxiety and seven relating to depression
- Each item on the questionnaire is scored from 0-3 and this means that a patient can score between 0 and 21 for either anxiety or depression
Neuropathic Pain Symptom InventoryOther
Also called NPSI
-The NPSI questionnaire utilized in this study includes eight parameters (i.e., burning pain, squeezing pain, pressure pain, electric shock pain, stabbing pain, tingling pain, pins and needles pain and allodynia [pain provoked by light touch]). Each of the parameters includes recall of the past 24 hours
Diode Laser fiber type Selective StimulatorProcedure or surgery
Also called DLss
-Each patient will have an A and C fiber stimulation. Stimulation will be performed on the dorsum of the foot using stimulation previously published parameters to elicit "burning pain," which is from activation of C-fibers and "pinprick" pain from A-fibers
Quantitative sensory testingProcedure or surgery
Also called QST
- Quantitative sensory testing will be performed on the dorsal mid-foot and the ipsilateral shoulder will serve as control area
- Cold and warm detection thresholds, cold and heat pain thresholds, mechanical detection thresholds, and wind-up ratio
Conditioned pain modulation efficiencyProcedure or surgery
Also called CPM
-Immersion of a hand up to the wrist to a thermostat-controlled water bath maintained at 12 degrees Celsius, and the application of a heat stimulus on the contralateral forearm.
Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)Other
-The subjects are asked to rate the intensity of their current pain on a 0-10 scale - 0 denoting "no pain" and 10 denoting "worst imaginable pain".
| Study group | Role | What they receive |
|---|---|---|
| Group A: Painful CIPN Group | Experimental | -Performed at baseline: NPSI, BPI, HADS, Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS), QST, CPM, and DLss Receives: Other: Brief Pain Inventory; Other: Hospital Anxiety and Depression Scale; Other: Neuropathic Pain Symptom Inventory; Procedure: Diode Laser fiber type Selective Stimulator; Procedure: Quantitative sensory testing; Procedure: Conditioned pain modulation efficiency; Other: Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS) |
| Group B: Control Group | Active comparator | -Performed at baseline: NPSI, BPI, HADS, Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS), QST, CPM, and DLss Receives: Other: Brief Pain Inventory; Other: Hospital Anxiety and Depression Scale; Other: Neuropathic Pain Symptom Inventory; Procedure: Diode Laser fiber type Selective Stimulator; Procedure: Quantitative sensory testing; Procedure: Conditioned pain modulation efficiency; Other: Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aδ:C Fiber Detection Threshold Ratio
Comparison of the Aδ:C fiber detection threshold ratio (as measured by the DLss) between patients with painful neuropathy and patients who did not develop painful neuropathy following similar cancer chemotherapy
Measured: At the time of the DLss (day 1)
Secondary outcomes (2)
The Aδ:C Pain Threshold Ratio
Aδ:C pain threshold shows Aδ fiber threshold divided by C fiber threshold measured by DLss detection and pain threshold protocols.
Measured: At the time of the DLss (day 1)
The Severity of Neuropathy on NPSI Scale.
The severity of painful CIPN on Neuropathic Pain Symptom Inventory (NPSI) scale.
Increased NPSI (0-100) score indicates more severe neuropathic pain.
Measured: At the time of the DLss (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start17 Sep 2018
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Lasmed LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Simon Haroutounian, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687970
- Sponsor's protocol ID
- 201807162
- Other IDs
- 1R43CA206796-01A1
- Status last verified
- Apr 2021
- First submitted
- 25 Sep 2018
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the recent proposal from the International Committee of Medical Journal Editors, patient-level data will be made available within 6 months after publication of the primary manuscript. Data will be provided to researchers who submit a methodologically sound research proposal including a protocol and statistical analysis plan. No patient-identifying fields (including dates) will be included in the shared dataset. Certain technical data related to the intellectual property rights of LasMed LLC may not be available for sharing.
Publications
Nemenov MI, Alaverdyan H, Burk C, Roles K, Frey K, Yan Y, Kazinets G, Haroutounian S. Characterization of Patients With and Without Painful Peripheral Neuropathy After Receiving Neurotoxic Chemotherapy: Traditional Quantitative Sensory Testing vs C-Fiber and Adelta-Fiber Selective Diode Laser Stimulation. J Pain. 2022 May;23(5):796-809. doi: 10.1016/j.jpain.2021.11.011. Epub 2021 Dec 9.
PubMed 34896646
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method for Identifying Sensory Changes in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN): a Feasibility Study
- ClinicalTrials.gov ID
- NCT03687970
- Acronym / sponsor ID
- 201807162
- Keywords
- CIPN, Neuropathic pain, DLss, Peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Lasmed LLC, National Cancer Institute (NCI)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose that using the Diode Laser fiber type Selective Stimulator (DLss) in patients with chemotherapy-induced peripheral neuropathy (CIPN) will allow for the assessment of changes in small-fiber pain thresholds, to identify differences between subjects who received chemotherapy and developed painful CIPN, compared to subjects who received similar chemotherapy but did not develop painful CIPN (control group).
Additionally, the investigators would like to investigate whether the response to DLss correlates with pain severity in patients with persistent painful neuropathy.
The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If the investigators' initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.
Detailed description
Painful chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy, occurring in more than 60% of patients at some point during the course of cancer treatment with commonly used drugs such as taxanes and platinum compounds. It potentially may result in severely diminished quality of life and dose reduction or/and treatment delay, which may ultimately impact survival.
The mechanisms by which chemotherapy-induced nerve damage ultimately leads to pain are poorly understood, because virtually no structural or functional differences in nerve fibers between painless and painful peripheral neuropathy have been identified. As a result, there is no reliable way to predict which patients will develop persistent painful chemotherapy-induced peripheral neuropathy.
The ultimate goal of this study is to develop a non-invasive, bedside quantitative test that is specific for painful CIPN. If our initial hypothesis is confirmed, the next step would be to design a prospective longitudinal study and assess changes in DLss early after initiation of chemotherapy, to determine whether this approach can help identify early predictive parameters of painful CIPN.
In this other interventional study, we will test the utility of the Diode Laser fiber type Selective Stimulator (DLss) to identify sensory changes that are unique to patients with painful chemotherapy induced peripheral neuropathy (CIPN) vs. controls.
Painful symptoms of CIPN develop in patients with differential nerve damage to Aδ vs C-type peripheral nerve fibers. We hypothesize that Aδ:C fiber threshold ratio, as measured by the DLss, will be different between patients with painful CIPN compared to control patients who received a similar regimen of chemotherapy, but did not develop painful CIPN. The confirmation of hypothesis may lead to a novel approach for early detection of CIPN.
Subjects: 20 evaluable patients with painful CIPN following treatment with oxaliplatin, cisplatin, paclitaxel, docetaxel (or any combination of above) will be included in painful CIPN group, and 20 controls matched by the type of chemotherapy received, who did not develop painful CIPN.
The study procedure will include a one-time visit for sensory assessments including:
- Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS);
- Assessment of pain symptoms on Neuropathic pain Symptom Inventory (NPSI) and Brief Pain Inventory (BPI).
- Assessment of mood on hospital anxiety and depression scale (HADS)
- Quantitative sensory testing (QST): thermal detection and pain thresholds, mechanical detection threshold, temporal summation (TS), and conditioned pain modulation (CPM).
The primary outcome is the comparison of Aδ:C fiber threshold ratio between patients who have developed painful CIPN, and the control subjects.
In secondary analyses, we will generate Spearman correlation coefficient between the "Aδ:C fiber threshold ratio" and the severity of painful CIPN on NPSI scale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Painful CIPN Group | Experimental | Other: Brief Pain Inventory, Other: Hospital Anxiety and Depression Scale, Other: Neuropathic Pain Symptom Inventory, Procedure: Diode Laser fiber type Selective Stimulator, Procedure: Quantitative sensory testing, Procedure: Conditioned pain modulation efficiency, Other: Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)-Performed at baseline: NPSI, BPI, HADS, Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS), QST, CPM, and DLss |
| Group B: Control Group | Active comparator | Other: Brief Pain Inventory, Other: Hospital Anxiety and Depression Scale, Other: Neuropathic Pain Symptom Inventory, Procedure: Diode Laser fiber type Selective Stimulator, Procedure: Quantitative sensory testing, Procedure: Conditioned pain modulation efficiency, Other: Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)-Performed at baseline: NPSI, BPI, HADS, Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS), QST, CPM, and DLss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Group A: Painful CIPN group
- Age >18
- Distal symmetric pain distribution (both feet, with or without pain in hands).
- The pain appeared during or up to 12 weeks after treatment with oxaliplatin, cisplatin, paclitaxel, docetaxel or any combination of these.
- Score of 4 or more on Douleur Neuropathique 4 (DN4) neuropathic pain questionnaire
Key exclusion criteria (7 listed)
- History of pre-existing painful distal symmetric polyneuropathy prior to chemotherapy.
- Alternative etiology exists for the distal painful symptoms.
- Current or previous treatment with a vinca alkaloid (e.g. vincristine, vinblastine), bortezomib, or another agent which may cause major peripheral neurotoxicity.
- Pregnant
- Concomitant medication as follows:
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 |
|---|---|---|
| Brief Pain InventoryAlso: BPI-A self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity (4 items which generate the PAIN SEVERITY score), list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life (7 items which generate the PAIN INTERFERENCE score) on a 10 point scale. | Other | Group A: Painful CIPN Group, Group B: Control Group |
| Hospital Anxiety and Depression ScaleAlso: HADS* 14 item scale with even of the items relating to anxiety and seven relating to depression * Each item on the questionnaire is scored from 0-3 and this means that a patient can score between 0 and 21 for either anxiety or depression | Other | Group A: Painful CIPN Group, Group B: Control Group |
| Neuropathic Pain Symptom InventoryAlso: NPSI-The NPSI questionnaire utilized in this study includes eight parameters (i.e., burning pain, squeezing pain, pressure pain, electric shock pain, stabbing pain, tingling pain, pins and needles pain and allodynia [pain provoked by light touch]). Each of the parameters includes recall of the past 24 hours | Other | Group A: Painful CIPN Group, Group B: Control Group |
| Diode Laser fiber type Selective StimulatorAlso: DLss-Each patient will have an A and C fiber stimulation. Stimulation will be performed on the dorsum of the foot using stimulation previously published parameters to elicit "burning pain," which is from activation of C-fibers and "pinprick" pain from A-fibers | Procedure or surgery | Group A: Painful CIPN Group, Group B: Control Group |
| Quantitative sensory testingAlso: QST* Quantitative sensory testing will be performed on the dorsal mid-foot and the ipsilateral shoulder will serve as control area * Cold and warm detection thresholds, cold and heat pain thresholds, mechanical detection thresholds, and wind-up ratio | Procedure or surgery | Group A: Painful CIPN Group, Group B: Control Group |
| Conditioned pain modulation efficiencyAlso: CPM-Immersion of a hand up to the wrist to a thermostat-controlled water bath maintained at 12 degrees Celsius, and the application of a heat stimulus on the contralateral forearm. | Procedure or surgery | Group A: Painful CIPN Group, Group B: Control Group |
| Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)-The subjects are asked to rate the intensity of their current pain on a 0-10 scale - 0 denoting "no pain" and 10 denoting "worst imaginable pain". | Other | Group A: Painful CIPN Group, Group B: Control Group |
Primary outcome
Aδ:C Fiber Detection Threshold Ratio
Time frame: At the time of the DLss (day 1)
Comparison of the Aδ:C fiber detection threshold ratio (as measured by the DLss) between patients with painful neuropathy and patients who did not develop painful neuropathy following similar cancer chemotherapy
2 secondary outcomes
The Aδ:C Pain Threshold Ratio
Time frame: At the time of the DLss (day 1)
The Severity of Neuropathy on NPSI Scale.
Time frame: At the time of the DLss (day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34896646Nemenov MI, Alaverdyan H, Burk C, Roles K, Frey K, Yan Y, Kazinets G, Haroutounian S. Characterization of Patients With and Without Painful Peripheral Neuropathy After Receiving Neurotoxic Chemotherapy: Traditional Quantitative Sensory Testing vs C-Fiber and Adelta-Fiber Selective Diode Laser Stimulation. J Pain. 2022 May;23(5):796-809. doi: 10.1016/j.jpain.2021.11.011. Epub 2021 Dec 9.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In accordance with the recent proposal from the International Committee of Medical Journal Editors, patient-level data will be made available within 6 months after publication of the primary manuscript. Data will be provided to researchers who submit a methodologically sound research proposal including a protocol and statistical analysis plan. No patient-identifying fields (including dates) will be included in the shared dataset. Certain technical data related to the intellectual property rights of LasMed LLC may not be available for sharing.
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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. This study is not recruiting at the moment.
Simon Haroutounian, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Pain Inventory, Hospital Anxiety and Depression Scale and Neuropathic Pain Symptom Inventory in people with Chemotherapy-induced Peripheral Neuropathy, run by Washington University School of Medicine 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 13 inclusion and 7 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 19 May 2021. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Aδ:C Fiber Detection Threshold Ratio (time frame: At the time of the DLss (day 1)). 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 NCT03687970, 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 19 May 2021.