Wounds and Injuries

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Neoplasms

Rare Diseases

Peripheral Nervous System Diseases

Pain

Peripheral Nerve Injuries

Neuroma

Neuralgia

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neuromuscular Diseases

Neurologic Manifestations

Chronic Graft Versus Host Disease

Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device

Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Axoguard Nerve Cap®

Ray A Rivera, MD

Kyle Icke, PhD

Ian Valerio, MD

Brendan MacKay, MD

This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.

Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Nerve end size as measured by MRI or CT scan prior to required secondary TMR or RPNI procedure recorded in cubic millimeters (mm3).

Explanted tissue will be cut into thin slices, affixed to microscope slides, and stained with Hematoxylin and Eosin (H\&E), Masson's Trichrome (MT) and Neurofilament 200 (NF200) to allow for histological evaluation of axonal swirling, nerve cap remodeling, and overall tissue response.

The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.

The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".

Final VAS score will be collected either just prior to TMR or RPNI procedure or 12- months post op if subject will not undergo the secondary TMR or RPNI procedure

The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The pain related measures include domains evaluating fatigue, pain intensity, pain interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measured where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue).

Final PROMIS® Pain Related Measure will be collected either just prior to TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure.

In this study, the Work Productivity and Activity Impairment (WPAI:SHP) questionnaire is an instrument to measure impairments in both paid work and unpaid work (leisure/regular activities) due nerve injury post-surgical intervention. It measures (1) absenteeism (work time missed), (2) presenteeism (impairment at work / reduced on-the-job effectiveness), (3) work productivity loss (overall work impairment / absenteeism plus presenteeism), as well as the (4) impairments in unpaid activity because of nerve injury post-surgical intervention during the past seven days. Scores for these 4 measures are expressed as impairment percentages with higher percentage scores indicating greater impairment in than lower percentage scores.

Final WPAI:SHP will be collected either at the office visit following the TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure

The BAM-ULA is a 10-item observational measure of activity performance. The 10 items are as follows: tuck a shirt in pants, lift a 20-lb bag, open a water bottle, remove a wallet from back pocket, replace the wallet in back pocket, take a gallon of water from the refrigerator and place on the counter (lift gallon jug), pour water from a gallon jug, brush or comb hair, use a fork, and open a door with knob. Items are scored with either a 0 (cannot complete all subtasks) or 1 (can complete all subtasks). Lower scores area associated with greater impairment of activity performance and higher scores are associated with less impairment of activity performance.

An observational test used to evaluate functional mobility in terms of postural stability, gait, stride length, and sway. Patients wear their regular footwear and can use a walking aid. They are asked to sit in a chair, stand up from that chair, walk to a line on the floor (10 ft. away) at their normal pace, turn around, walk back to the chair at a normal pace, and sit down again.

A performance measure used evaluate functional mobility and gait. It assesses walking speed in meters per second over 10-meter distance.

Quantity and class of pain medication use for subjects who were implanted with the Axoguard Nerve Cap® will be captured during the following visits: Screening (baseline), 2-weeks, 1, 3, 6, 9, 12, and 15 months post-op for comparison to baseline.

Axogen Corporation

Skin and Connective Tissue Diseases

Breast Neoplasms

Antipyretics

Analgesics

All Drugs and Chemicals

Acetaminophen

Inclusion criteria: unilateral breast cancer surgery with Axillary lymph node dissection (ALND) during the last year and a half. Exclusion criteria: bilateral breast cancer, ipsilateral shoulder pathology, neuropathy.

Procedure: ULNT 1 and EMG recording.

Inclusion criteria: unilateral breast cancer surgery with Sentinel Lymph Node Biopsy (SLNB) during the last year and a half. Exclusion criteria: bilateral breast cancer, ipsilateral shoulder pathology, neuropathy.

Procedure: ULNT 1 and EMG recording

Matched by age and dominant arm to each case. Exclusion criteria: current painful conditions involving their neck or dominant upper-extremity, and chronic pain conditions or use of pain relievers.

Procedure: ULNT 1 and EMG recording.

While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.

ULNT 1 and EMG recording

María Torres-Lacomba, Doctor

Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test for the median nerve, called upper limb neurodynamic test 1 (ULNT1). Design: A matched case-control observational study. Objective: to check the increased upper limb mechanosensitivity by shoulder range of motion (ROM) during ULNT1 and to determine, for the first time, the evoked electromyographic (EMG) muscle activity. Participants: 62 cases who underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital, Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity, breast cancer, pain, EMG, shoulder ROM, median nerve.

Upper limb neural mechanosensitivity is a painful disturbance that breast cancer patients often undergo following axillary surgery. It is assessed by the upper limb neurodynamic test for the median nerve, called upper limb neurodynamic test 1 (ULNT1).A neural provocation test is a sequence of movements designed to assess the mechanics and physiology of part of the nervous system by elongating the length of the nerve bedding and by increasing the pressure in and around the peripheral nerve .The most reliable test to assess the upper limb neural mechanosensitivity is the neural provocation test for the median nerve, called upper limb neurodynamic test 1 (ULNT1). This test consists of depressing shoulder girdle in a neutral position, shoulder abduction and lateral rotation, elbow extension, forearm supination and wrist extension. Cervical contralateral lateral flexion may be included to further increase the loading of the brachial plexus and, as a sensitizing maneuver, to differentiate structurally between neural and non-neural involvement. The ULNT1 is considered as positive when symptoms are reproduced on affected upper limb, or side-to-side differences in ROM, or symptoms modified by lateral neck side-bending. Likewise, It is also necessary to assess the EMG activity of the involved muscles to verify the early and increased protective muscle response suggested throughout the neural strain performance.

It is also necessary to assess the EMG activity of the involved muscles to verify the early and increased protective muscle response suggested throughout the neural strain performance. Design: A matched case-control observational study. Objective: to check the increased upper limb mechanosensitivity by shoulder ROM during ULNT1 and to determine, for the first time, the evoked EMG muscle activity. Participants: 62 cases who underwent breast cancer surgery and 64 matched control women. Setting: Torrejon Hospital, Physical Therapy Department, Madrid (Spain). Intervention: To record EMG muscle activity during ULNT1 performance and to measure shoulder ROM. Key outcomes: mechanosensitivity, breast cancer, pain, EMG, shoulder ROM, median nerve.

EMG at Performing ULTN 1 in Breast Cancer Patients

Evoked EMG Muscle Activity at Performing ULTN 1 in Breast Cancer Patients

Intensity of the evoked muscle activity from biceps brachii and triceps brachii muscles by EMG recording

degrees of range of motion of three movements: shoulder abduction, shoulder external rotation and elbow flexion.

University of Alcala

PhD student

Antineoplastic Agents

Micronutrients

Hematinics

Vitamins

Vinorelbine

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Vincristine

Cisplatin

Oxaliplatin

Vitamin B 6

Pyridoxal

Pyridoxine

Vitamin B Complex

Vitamin B 12

Hydroxocobalamin

Taxane

Vinca Alkaloids

Folic Acid

Tubulin Modulators

Antimitotic Agents

Trace Elements

Vitamin B6

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Folate

Vitamin B9

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

Multivitamin (MV)

Multivitamin (containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12), plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6

Patients are treated per standard of care according to the choice of the treating physician with heavy metals (cisplatin, oxaliplatin), taxanes (paclitaxel, docetaxel), or vinca alkaloids (vincristine, vinorelbine)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; vincristine, 8-16; vinorelbine, 360-480; cisplatin, 240-400; oxaliplatin, 400-800; abraxane, 1200-1800

Chemotherapy

Zoneddy Dayao, MD

Many types of chemotherapy may cause nerve damage as a side effect. This neurotoxicity can manifest as peripheral sensory neuropathy (characterized by numbness, tingling, or pain). The goal of this study is to determine the efficacy of the combination of vitamin B6 and B12 in preventing chemotherapy induced neuropathy.

Neuropathy can be a significant side effect of chemotherapy using platinum compounds, taxanes, and vinca alkaloids. There is clinical and preclinical data that vitamin B6 and B12 may alleviate neuropathy in experimentally induced neuropathy in animal models, or clinical neuropathy such as diabetic neuropathy. This is a randomized phase III study of the use of multivitamins with or without vitamin B6 and B12 to prevent or relieve neuropathic toxicity from chemotherapy in patients receiving chemotherapy. Patients will be stratified by type of chemotherapy agent (3 groups), presence or absence of neuropathy at baseline, and randomized to receive placebo or vitamin B6/B12 supplementation.

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients

A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported.

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients.

New Mexico Cancer Care Alliance

Since vitamin B6 and B12 are food supplements with only rare toxic effects, no toxicity will be recorded. Only serious adverse (SAE) will be reported, whether or not related to these vitamins.

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Cumulative doses (in mg/m2) are:

paclitaxel, 700; docetaxel, 300; vincristine, 16; navelbine, 480; cisplatin, 300; oxaliplatin, 400

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The number of completed surveys decreased as time went on for each group of patients. This resulted in small numbers of patients to analyze, especially in Group 3 (Vinca Alkaloids), since there weren't many patients in this group to begin with.

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Taxane Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400

Taxane Group: MV + Vitamin B12 + Vitamin B6

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Cumulative doses for chemotherapy (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Heavy Metals Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Cumulative doses for chemotherapy (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Vinca Alkaloids Group: Multivitamin (MV) Arm

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm

Of the 92 and 97 patients in the MV arm and MV + Vit.B12 + VitB6 arm, 84 and 86 patients, respectively, in the Group 1 (Taxanes) completed the FACT-Tax questionnaire at baseline and the analysis is presented here. This also applies to 48 and 45 patients in Group 2 (Heavy Metals) and 10 and 12 patients in Group 3 (Vincas)

Neurotoxicity Assessment at Baseline

Multivitamin, plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

cisplatin, 240-400; oxaliplatin, 400-800

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

vincristine, 8-16; vinorelbine, 360-480

Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 72 \& 80 patients, respectively, in the Group 1 (Taxanes) both completed 2 cycles of treatment and completed the FACT-Tax questionnaire at cycle 2, and the analysis is presented here. The same applies to 27 \& 25 patients in Group 2 (Heavy Metals) and 9 \& 10 patients in Group 3 (Vinca)

Neurotoxicity Assessment at Cycle 2

Multivitamin (MV) plus Vitamin B6 tablets and Vitamin B12 injections

Multivitamin + Vitamin B12 + Vitamin B6: As in Arm 1, one multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts).

The patient will also take the following, starting on the first day of chemotherapy:

1. pyridoxine 50 mg three times per day, orally and continue for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)
2. Vitamin B12 one mg injected intramuscularly, every 3 or 4 weeks, depending on the timing of the chemotherapy for 4 doses.

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, 240-400; abraxane, 1200-1800

Of the 92 \& 97 patients in the MV and MV + Vit.B12 + VitB6 arms, 57 \& 65 patients, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemotherapy and completed the FACT-Tax questionnaire at cycle 4, and the analysis is presented here. The same applies to 28 \& 21 patients in Group 2 (Heavy Metals) and 6 \& 9 patients in Group 3 (Vinca)

Neurotoxicity Assessment at Cycle 4

Multivitamin only

Multivitamin (MV): Multivitamins containing no more than 10 mg of pyridoxine and/or 10 micrograms of Vitamin B12 will be given to the patients on this arm.

1 multivitamin pill will be taken orally, daily starting on the first day of chemotherapy and continuing for no more than 30 days past the cumulative chemotherapy dose (until the next cycle starts)

Ranges of cumulative doses (in mg/m2) are:

paclitaxel, 700-960; docetaxel, abraxane, 1200-1800

Of the 92 \& 97 patients in the Multivitamin (MV) and MV + Vit.B12 + VitB6 arms, 54 \& 62, respectively, in Group 1 (Taxanes) completed both 4 cycles of chemo and the FACT-Tax questionnaire at baseline and cycle 4; analysis is presented here. The same applies to 28 \& 20 patients in Group 2 (Heavy Metals) and 5 \& 9 patients in Group 3 (Vinca)

Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Overall Study

The study participants will include 250 cancer survivors who have completed neurotoxic agent containing chemotherapy at least three months prior and have persistent moderate to severe Chemotherapy-Induced Peripheral Neuropathy/CIPN pain randomized to one of two study arms.

Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).

Electroacupuncture

Sham Acupuncture

Jun Mao, MD, MSCE

Wanqing Zhi, MD, PhD

Electroacupuncture (referred to as EA) may be an effective treatment for Chemotherapy-Induced Peripheral Neuropathy/CIPN pain. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body with the goal of promoting health and well-being. EA involves adding a very small amount of electricity through the acupuncture needles (electrical stimulation). Researchers have found that EA can increase the effects of regular acupuncture, and it is particularly helpful for treating different kinds of pain. The purpose of this study is to learn if EA can improve CIPN pain in cancer survivors, and if it is effective against other CIPN-related symptoms.

Randomization will occur before the baseline assessments are administered. Once the patient is randomized, the acupuncturists will look up the patient's group assignment and provide the appropriate treatment. The study team and patients will be blinded to which acupuncture group the patient was assigned. The acupuncturists and one clinical research coordinator will be the only ones unblinded. The clinical research coordinator will be unblinded in order to assist acupuncturists to confirm randomization. This clinical research coordinator will not be the primary research coordinator in the study and will not have direct contact with the patient. The rest of the study coinvestigators and staff will remain blinded.

The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

A Randomized Phase III Clinical Trial of Acupuncture for Chemotherapy-induced Peripheral Neuropathy Treatment (ACT)

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form (BPI-SF)

The primary outcome will be the patient's rating of his/her average pain in the past 24 hours. All participants will fill out the Brief Pain Inventory-Short Form

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends	NCT04865679	Symptomatic Neu... Amputation Chronic Nerve P...	Axoguard Nerve ...	18 Years - 80 Years	Axogen Corporation
EMG at Performing ULTN 1 in Breast Cancer Patients	NCT02599467	Physiotherapy	ULNT 1 and EMG ...	40 Years - 75 Years	University of Alcala
EMG at Performing ULTN 1 in Breast Cancer Patients	NCT02599467	Physiotherapy	ULNT 1 and EMG ...	40 Years - 75 Years	University of Alcala
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends	NCT04865679	Symptomatic Neu... Amputation Chronic Nerve P...	Axoguard Nerve ...	18 Years - 80 Years	Axogen Corporation
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients	NCT00659269	Cancer	Multivitamin (M... Multivitamin + ... Chemotherapy	18 Years -	New Mexico Cancer Care Alliance
The Effect of Electroacupuncture on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)	NCT04917796	Chemotherapy-in... Nerve Pain	Electroacupunct... Sham Acupunctur...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for nerve pain

Every month we try and update this database with for nerve pain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nerve pain

Every month we try and update this database with for nerve pain cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nerve pain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.