Chemotherapy-induced Peripheral NeuropathyNCT03272919
Chemotherapy Induced Peripheral Neuropathy (CIPN)
A study testing Arm 1: Investigational INF and Arm 2: standardized muscle stretching and strength in people with Chemotherapy-induced Peripheral Neuropathy, run by Loma Linda University at 1 site in United States.
Trial summary
Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of chemotherapy having a negative impact on the quality of life for cancer survivors due to numbness, decreased sensation, pain (of various intensities in the extremities), gait/balance problems, and difficulty with fine motor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Arm 1: Investigational INF and Arm 2: standardized muscle stretching and strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 25 May 2022
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed stages I to III breast cancer patients with any biomarker status (ER, PR and HER) receiving treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel).
- Chemotherapy naive patients with gynecologic cancers including ovarian, uterine, and cervical cancer planning to receive definitive number of platinum-based compounds (carboplatin or cisplatin) and/or taxanes (docetaxel and paclitaxel) chemotherapy.
- Planned to receive a minimum of 4 cycles of treatment with either of the offending chemotherapy agents (a cycle of weekly paclitaxel is considered 3 doses).
- Women aged ≥ 18 years at signing of informed consent
- No pre-existing peripheral neuropathy (WPPN)
- ECOG status 0 or 1
Show all 9Show fewer
- Able to provide written, informed consent to participate in the study and follow the study procedures.
- Cannot participate in another non-medical intervention/therapy for peripheral neuropathy
- Cannot receive more than 3 weeks of treatment with implicating chemotherapy prior to start of study assigned therapy.
Who cannot join
- Male
- Preexisting peripheral neuropathy.
- Previous exposure to any of the implicated chemotherapy agents within the last 5 years (platinum-based compounds, vinca alkaloids and/or taxanes) that could potentially cause peripheral neuropathy
- Evidence of significant medical illness, or psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study.
- Stage IV or metastatic breast cancer
- Any physical or neurological disability that would preclude patients from participating in physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda Medical Center
Loma Linda, California, 92354
About this study
Official title: Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of chemotherapy having a negative impact on the quality of life for cancer survivors due to numbness, decreased sensation, pain (of various intensities in the extremities), gait/balance problems, and difficulty with fine motor skills of the hands and fingers.To date, there are no preventive modalities to mitigate CIPN development.When CIPN becomes intolerable, optimal doses of chemotherapy have to be reduced or discontinued, which may affect a patient's overall survival. Intraneural facilitation (INF) is a technique developed by physical therapists at Loma Linda University after careful study of the structure, pathophysiology and biomechanics of peripheral nerves. The focus of INF is restoration of circulation to an ischemic nerve. INF has been offered to subjects receiving treatment at LLUCC with anecdotal success. The purpose of this study is to evaluate INF as a treatment modality under the rigor of scientific inquiry to determine its effectiveness as a viable treatment option for breast cancer patients with CIPN.
Read the detailed description
STUDY OUTLINE: This is a single institution study. Patients with newly diagnosed breast cancer stages I to III with any biomarker status (ER, PR and HER), without preexisting peripheral neuropathy planning to receive treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel) and chemotherapy naive patients with gynecologic cancers including ovarian, uterine, and cervical cancer planning to receive definitive number of platinum-based compounds (carboplatin or cisplatin) and/or taxanes (docetaxel and paclitaxel) chemotherapy are potential study patients.
Subjects will be randomized into one of two treatment arms within 3 weeks of starting the offending chemotherapy agents after fulfilling the other study eligibility requirements. Arm 1 (investigational) will receive INF twice a week for six weeks by the same treating physical therapist (physical therapist #1). Arm 2 (control) will receive a standardized program of muscle stretching and strengthening exercises twice a week for 6 weeks under the supervision of treating physical therapist #1. Actual treatment time for both modalities is approximately 45 minutes. Measurements used to detect the presence and degree of peripheral neuropathy will be administered by the same assessment physical therapist (physical therapist #2) at baseline and at the end of weeks 3, 6, and 3 months post last physical therapy treatment. Assessment tools are: ultrasound imaging on the popliteal and posterior tibia artery, the 20-item Pain Quality Assessment Scale (PQAS, specifically addresses neuropathological symptomatology), the National Comprehensive Cancer Network (NCCN) Distress thermometer (DT), and the Michigan Neuropathy Screening Instrument (MNSI) will be assessed and recorded along with treatment adherence. Treating physician will be recording National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) neuropathy score and performance status at routine intervals during and after chemotherapy.
Objectives
Primary objective
- To compare the degree of neuropathy and distress between Arm 1 receiving INF therapy compared to Arm 2 receiving usual care of muscle stretching and strengthening exercises based on standardized measurements (PQAS, MNSI, NCCN DT, and AE assessment).
Secondary objectives
- To compare the Ultrasound measurements of peak systolic velocity, volume flow and pulsatility of popliteal and posterior tibia artery between the two treatment arms for assessing differences in vascular perfusion.
- To compare the rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between Arm 1 receiving INF therapy compared to Arm 2 receiving standardized program of muscle stretching and strengthening exercises.
- To compare subject acceptability, burden and satisfaction with the assigned physical therapy modality between the two arms based on patient satisfaction questionnaire administered at the end of treatment.
- Being tested
- Arm 1: Investigational INF, Arm 2: standardized muscle stretching and strength
- Keywords
- Breast Cancer, Peripheral neuropathy, Taxol, carboplatin
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Investigational INFOther
INF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.
Arm 2: standardized muscle stretching and strengthOther
subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Investigational INF | Experimental | Intraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow. Receives: Other: Arm 1: Investigational INF |
| Arm 2: Standardized muscle stretching and strengthen | Other | subjects will receive a standardized program of muscle stretching and strengthening exercise twice a week for six weeks under the supervision of treating physical therapist Receives: Other: Arm 2: standardized muscle stretching and strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score.
The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.
Measured: upto 3 months post completion of assigned treatment
Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT
Study participants self report distress based on National Comprehensive Cancer Network's Distress Thermometer (DT) measures distress on a scale of 0 = no distress, 10=extreme distress.
Measured: upto 3 months post completion of assigned treatment
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on MSNI scores
The MSNI is a physical screening instrument of the lower legs and feet for the assessment of neuropathy using visual inspection, vibration sensation, ankle reflexes and monofilament testing producing a score of 0 being normal and 10 meaning significant neuropathy as measured by the assessing physical therapist
Measured: upto 3 months post completion of assigned treatment
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on CTCAE grading
The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician
Measured: upto 3 months post completion of assigned treatment
Secondary outcomes (4)
Measure the peak systolic velocity on ultrasound imaging in the popliteal and posterior tibia artery in the two arms.
Ultrasound imaging will be administered before and after treatment on the measurement days for subjects in both Arm 1 and Arm 2
Measured: upto 3 months post completion of assigned treatment
Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group
The completion and premature discontinuation rates due to peripheral neuropathy for each subject will be counted for each Arm.
Measured: upto 3 months post completion of assigned treatment
Measure the rate of dose reductions in chemotherapy due to peripheral neuropathy by treatment group
The dose reductions in chemotherapy due to peripheral neuropathy for each subject will be measured for each Arm.
Measured: upto 3 months post completion of assigned treatment
Questionnaire to survey patients on acceptability, satisfaction and burden of treatment
A written survey of 10 questions regarding subject acceptance, burden and satisfaction will be administered to each subject in both Arms at the end of treatment.
Measured: upto 3 months post completion of assigned treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start28 Sep 2017
- Primary completion25 May 2022
- Study completion25 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayathri Nagaraj, Loma Linda University
- Investigators
- Gayathri Nagaraj, MD, Principal investigator, Loma Linda University Medical CenterEllen D'Errico, PHD, Principal investigator, Loma Linda University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272919
- Sponsor's protocol ID
- 5170197
- Status last verified
- May 2023
- First submitted
- 8 Aug 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hankins J, Bussell M, Gharibvand L, Jeon WJ, Castillo DR, D'Errico E, Nagaraj G. A Novel Approach of Intraneural Facilitation Versus Standard Physical Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251413222. doi: 10.1177/15347354251413222. Epub 2026 Mar 16.
PubMed 41840756
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study of Intraneural Facilitation for Managing Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03272919
- Acronym / sponsor ID
- 5170197
- Keywords
- Breast Cancer, Peripheral neuropathy, Taxol, carboplatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 6 Sep 2017 (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.
Chemotherapy induced peripheral neuropathy (CIPN) is a common side effect of many forms of chemotherapy having a negative impact on the quality of life for cancer survivors due to numbness, decreased sensation, pain (of various intensities in the extremities), gait/balance problems, and difficulty with fine motor skills of the hands and fingers.To date, there are no preventive modalities to mitigate CIPN development.When CIPN becomes intolerable, optimal doses of chemotherapy have to be reduced or discontinued, which may affect a patient's overall survival. Intraneural facilitation (INF) is a technique developed by physical therapists at Loma Linda University after careful study of the structure, pathophysiology and biomechanics of peripheral nerves. The focus of INF is restoration of circulation to an ischemic nerve. INF has been offered to subjects receiving treatment at LLUCC with anecdotal success. The purpose of this study is to evaluate INF as a treatment modality under the rigor of scientific inquiry to determine its effectiveness as a viable treatment option for breast cancer patients with CIPN.
Detailed description
STUDY OUTLINE: This is a single institution study. Patients with newly diagnosed breast cancer stages I to III with any biomarker status (ER, PR and HER), without preexisting peripheral neuropathy planning to receive treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel) and chemotherapy naive patients with gynecologic cancers including ovarian, uterine, and cervical cancer planning to receive definitive number of platinum-based compounds (carboplatin or cisplatin) and/or taxanes (docetaxel and paclitaxel) chemotherapy are potential study patients.
Subjects will be randomized into one of two treatment arms within 3 weeks of starting the offending chemotherapy agents after fulfilling the other study eligibility requirements. Arm 1 (investigational) will receive INF twice a week for six weeks by the same treating physical therapist (physical therapist #1). Arm 2 (control) will receive a standardized program of muscle stretching and strengthening exercises twice a week for 6 weeks under the supervision of treating physical therapist #1. Actual treatment time for both modalities is approximately 45 minutes. Measurements used to detect the presence and degree of peripheral neuropathy will be administered by the same assessment physical therapist (physical therapist #2) at baseline and at the end of weeks 3, 6, and 3 months post last physical therapy treatment. Assessment tools are: ultrasound imaging on the popliteal and posterior tibia artery, the 20-item Pain Quality Assessment Scale (PQAS, specifically addresses neuropathological symptomatology), the National Comprehensive Cancer Network (NCCN) Distress thermometer (DT), and the Michigan Neuropathy Screening Instrument (MNSI) will be assessed and recorded along with treatment adherence. Treating physician will be recording National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) neuropathy score and performance status at routine intervals during and after chemotherapy.
Objectives
Primary objective
- To compare the degree of neuropathy and distress between Arm 1 receiving INF therapy compared to Arm 2 receiving usual care of muscle stretching and strengthening exercises based on standardized measurements (PQAS, MNSI, NCCN DT, and AE assessment).
Secondary objectives
- To compare the Ultrasound measurements of peak systolic velocity, volume flow and pulsatility of popliteal and posterior tibia artery between the two treatment arms for assessing differences in vascular perfusion.
- To compare the rate of any dose reductions and premature chemotherapy discontinuation rates due to peripheral neuropathy between Arm 1 receiving INF therapy compared to Arm 2 receiving standardized program of muscle stretching and strengthening exercises.
- To compare subject acceptability, burden and satisfaction with the assigned physical therapy modality between the two arms based on patient satisfaction questionnaire administered at the end of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Investigational INF | Experimental | Other: Arm 1: Investigational INFIntraneural Facilitation (INF) treatment is an effective way to restore blood flow to damaged nerves as neuropathy is strongly impacted by reduced blood flow. |
| Arm 2: Standardized muscle stretching and strengthen | Other | Other: Arm 2: standardized muscle stretching and strengthsubjects will receive a standardized program of muscle stretching and strengthening exercise twice a week for six weeks under the supervision of treating physical therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed stages I to III breast cancer patients with any biomarker status (ER, PR and HER) receiving treatment with platinum-based compounds (Carboplatin and Cisplatin) and/or taxanes (Docetaxel and Paclitaxel).
- Chemotherapy naive patients with gynecologic cancers including ovarian, uterine, and cervical cancer planning to receive definitive number of platinum-based compounds (carboplatin or cisplatin) and/or taxanes (docetaxel and paclitaxel) chemotherapy.
- Planned to receive a minimum of 4 cycles of treatment with either of the offending chemotherapy agents (a cycle of weekly paclitaxel is considered 3 doses).
- Women aged ≥ 18 years at signing of informed consent
- No pre-existing peripheral neuropathy (WPPN)
Key exclusion criteria (6 listed)
- Male
- Preexisting peripheral neuropathy.
- Previous exposure to any of the implicated chemotherapy agents within the last 5 years (platinum-based compounds, vinca alkaloids and/or taxanes) that could potentially cause peripheral neuropathy
- Evidence of significant medical illness, or psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study.
- Stage IV or metastatic breast cancer
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 |
|---|---|---|
| Arm 1: Investigational INFINF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain. | Other | Arm 1: Investigational INF |
| Arm 2: standardized muscle stretching and strengthsubjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist. | Other | Arm 2: Standardized muscle stretching and strengthen |
Primary outcome
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score.
Time frame: upto 3 months post completion of assigned treatment
The 20 item PQAS measures self reported aspects of nociceptive and neuropathic pain (intensity, sensation, depth, location) on a scale of 0 to 10.
Descriptive Statistics to measure the degree of distress in the two arms based on NCCN- DT
Time frame: upto 3 months post completion of assigned treatment
Study participants self report distress based on National Comprehensive Cancer Network's Distress Thermometer (DT) measures distress on a scale of 0 = no distress, 10=extreme distress.
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on MSNI scores
Time frame: upto 3 months post completion of assigned treatment
The MSNI is a physical screening instrument of the lower legs and feet for the assessment of neuropathy using visual inspection, vibration sensation, ankle reflexes and monofilament testing producing a score of 0 being normal and 10 meaning significant neuropathy as measured by the assessing physical therapist
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on CTCAE grading
Time frame: upto 3 months post completion of assigned treatment
The CTCAE measures peripheral sensory neuropathy on a scale of 1=asymptomatic to 5=death as measured by the treating physician
4 secondary outcomes
Measure the peak systolic velocity on ultrasound imaging in the popliteal and posterior tibia artery in the two arms.
Time frame: upto 3 months post completion of assigned treatment
Measure the rate of premature chemotherapy discontinuation due to peripheral neuropathy by treatment group
Time frame: upto 3 months post completion of assigned treatment
Measure the rate of dose reductions in chemotherapy due to peripheral neuropathy by treatment group
Time frame: upto 3 months post completion of assigned treatment
Questionnaire to survey patients on acceptability, satisfaction and burden of treatment
Time frame: upto 3 months post completion of assigned treatment.
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 10 May 2023.
- Derived from this study: PubMed 41840756Hankins J, Bussell M, Gharibvand L, Jeon WJ, Castillo DR, D'Errico E, Nagaraj G. A Novel Approach of Intraneural Facilitation Versus Standard Physical Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251413222. doi: 10.1177/15347354251413222. Epub 2026 Mar 16.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Not yet recruitingPhase 2
Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
Breast Cancer, Peripheral Neuropathy Due to Chemotherapy
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Not yet recruiting
AYUrvedic Foot Massage for Symtoms of Taxane-induced Peripheral nEuroPathy
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Active, not recruitingPhase 2
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel
Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy
Recruiting
Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm
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.
Gayathri Nagaraj, MD principal investigator
Loma Linda University Medical Center
Ellen D'Errico, PHD principal investigator
Loma Linda University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Investigational INF and Arm 2: standardized muscle stretching and strength in people with Chemotherapy-induced Peripheral Neuropathy, run by Loma Linda University 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 9 inclusion and 6 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 10 May 2023. 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?
Descriptive Statistics to measure the degree of peripheral neuropathy in the two arms based on the PQAS score. (time frame: upto 3 months post completion of assigned treatment). The study lists 4 primary outcomes in all. 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 NCT03272919, 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 10 May 2023.