Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

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Breast Neoplasms

Peripheral Nervous System Diseases

Pain

Breast Diseases

Skin Diseases

Neuromuscular Diseases

All Drugs and Chemicals

Anti-Infective Agents

Antitussive Agents

Respiratory System Agents

Herbal and Botanical

Turmeric extract

Eucalyptol

Turmeric

Peppermint

Ginger

Rosemary

10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis

Placebo

Julie K Zadinsky, PhD

This study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). One-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.

Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. Current pharmacological approaches to reduce CIPN symptoms can be ineffective and cause adverse effects.

Constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-HT, AchE, and Substance P, along with antagonism of TRPA1 and TRPV1. This study will test the hypothesis that an oil blend reduces CIPN symptoms and improves quality-of-life (QOL) in breast cancer patients. The Human Response to Illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.

The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.

Participants will be seen in two separate clinic rooms. Intervention and placebo will have identical packaging and labeling with the addition of an A or B.

Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study

The following two questions are exploratory: In the past seven days, how many times have you slept through the night? In the past seven days, how many times did your pain wake you from sleep? If pain woke you from sleep, please describe your experience. If anything other than pain woke you from sleep, please list. Neither QOL questionnaire also address sleep. The answers to these questions will be integrated into QOL data.

A 22-item self-report pain intensity (over past week) peripheral neuropathy questionnaire. Each item is scored from 0 -10 (0 is no pain and 10 is the worst possible pain), a mean score is obtained, yielding a mean score between 0 and 10.

A 10 cm horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate current pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. Daily pain scores will be averaged for a weekly mean.

The QLACS consists of 47 questions in two domains (generic and cancer-specific). The questionnaire offers respondents the following choices: 1=never, 2=seldom, 3=sometimes, 4=about as often as not, 5=frequently, 6=very often, and 7=always, yielding a total score of between 0 to 350. A mean score will be used.

The QOL: CIPN20 consists of 20 questions represented by three scales: autonomic symptoms and functioning, sensory, and motor. Participants are to rate symptoms over the past week as 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Items are scored per scale as a higher score = worse, yielding a total score of between 0 and 100. A mean score will be used.

American Holistic Nurses Association

American Nurses Foundation

Ananda Apothecary

The Jojoba Company

Augusta University

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Cola

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult colon cancer patients who experienced a CIPN after adjuvant oxaliplatin-containing chemotherapy.

Dietary supplementation with "OnLife" to improve signs and symptoms of CIPN in adult breast cancer patients who experienced a CIPN after adjuvant paclitaxel regimen.

Daily dosing of dietary supplement OnLife

OnLife

Matthias Zaiss, Dr.

The objective of this observational study is to evaluate the effectiveness of the dietary supplementation "OnLife" in improving signs and symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adult patients who have finished adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer). Furthermore, patient-reported outcomes (PROs) and concomitant medication used for the treatment of neuropathic pain will be assessed.

CIPN is a common side effect of many chemotherapeutic agents and often results in dose limitation, switch to less efficacious agents or even therapy discontinuation. CIPN mainly affects sensory nerves, while motor or autonomic nerve injury is rare. Therefore, most patients with CIPN experience numbness, tingling, hyperesthesia, loss of vibratory perception, and burning pain. Due to the vulnerability of the long nerves, CIPN typically appears in a 'stocking and glove' distribution.

Chemotherapeutic agents that cause CIPN include platinum compounds (e.g., cisplatin, oxaliplatin), antitubulins (vinca alkaloids (e.g., vincristine) and taxanes (e.g., docetaxel, paclitaxel)), proteasome inhibitors (e.g., bortezomib) and immunomodulatory drugs (e.g., lenalidomide).

Platinum compounds are known to accumulate in the dorsal root ganglion (DRG) leading to cell death in sensory neurons. DRG death may account for chronic sensory neuropathy, which manifests primarily as sensory paresthesias, dysesthesias and sensory ataxia most often located in the extremities and persists between cycles. In addition, Oxaliplatin directly regulates the gating of axonal voltage-gated sodium channels, inducing an acute neurotoxicity which is characterized by peripheral nerve hyperexcitability. Symptoms, like sensitivities to touching cold items, discomfort swallowing cold liquids, throat discomfort, and muscle cramps, occur during or shortly after the infusion.

Taxanes are known to cause disruption of microtubule function and therefore microtubule-based axonal transport. In addition, they interfere with macrophage activation in both the DRG and peripheral nerve, as well as microglial activation within the spinal cord. These effects result in a distal axonopathy also referred to as the dying-back phenomenon.

The effectiveness of OnLife® in improving CIPN is based on a patented fatty acid group (FAG) that comprises palmitoylethanolamide (PEA), alpha-linolenic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), linoleic acid, oleic acid, palmitic acid, stearic acid, arachidic acid and myristic acid.

PEA, one main component of OnLife®, is an endogenous fatty acid amide belonging to the class of endocannabinoids and has been shown to have anti-inflammatory, antinociceptive, neuroprotective and anticonvulsant properties. It is synthesized in response to several inflammatory and painful disorders (e.g., intestinal inflammation and neuropathic pain) in order to counteract these pathological states. Clinical research revealed that treatment with exogenous PEA is effective and safe in various neuropathological conditions, including chronic idiopathic axonal neuropathy, diabetic neuropathy, nerve compression syndromes, as well as chemotherapy-induced neuropathic pain.

PEA exerts its analgesic and anti-inflammatory functions in the peripheral nervous system through its action on sensory neurons and on non-neuronal cells involved in inflammation, such as mast cells and macrophages. It indirectly activates cannabinoid receptor signaling by inhibiting the hydrolysis of endocannabinoids. This suppresses nociceptive behaviors and counteracts macrophage and mast cell activation, thereby reducing pain and other inflammatory symptoms. Another biological target of PEA is the nuclear peroxisome proliferator-activated receptor (PPAR)-alpha, expressed in various cells implicated in peripheral nociception, including dorsal DRG neurons and macrophages. Binding of PEA to PPAR-alpha ultimately results in reduced transcription of pro-inflammatory genes (e.g., TNF-alpha, IL-6, COX-2, iNOS) as well as repressed activity of pro-inflammatory transcription factors. In addition, there is some evidence that binding of PEA to PPAR-alpha may modulate excitability of primary sensory neurons by direct and indirect mechanisms.

The other fatty acids included in OnLife® have also been shown to have anti-inflammatory properties.

Currently, a study evaluating the efficacy and safety of OnLife® in patients with CIPN is carried out at the St. Savvas Anticancer Hospital, Athens by Dr. J. Skarlatos. First results suggest that OnLife® is reducing pain, numbness and tingle and improving heat/cold sensitivity as assessed by the physician. PRO, using the DN4 (Douleur Neuropathique 4) questionnaire, revealed a reduction of the score for diagnosing neuropathic pain during OnLife® application. Moreover, no patient showed a product-related side effect (date on file, unpublished).

Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy

An Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving Chemotherapy-induced peripherAl NeurOpathy in Patients With Colon or Breast Cancer After End of Adjuvant Therapy

Incidence of grade 0/1/2/3/4 peripheral sensory and/ or motor neuropathy according to CTCAE v4.03 after end of adjuvant oxaliplatin-containing regimen (colon cancer) or adjuvant paclitaxel regimen (breast cancer)

Questionnaire EORTC QLQ-C30 is used to determine patients' health-related quality of life.

Questionnaire EORTC QLQ-CIPN20 is used to elicit patients' experience of symptoms and functional limitations related to CIPN.

Drug treatment of neuropathic pain is observed over the time of the OnLife® application and the month after the end of OnLife® application

iOMEDICO AG

Swiss Medical Food AG

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Lymphoma

Lymphosarcoma

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, in addition to usual care.

The control group receives treatment as usual. The control group will be given the opportunity to participate in the intervention after therapy.

For the max. duration of the first in-hospital phase (3weeks), all children will receive supervised training. When children go home they will be supplied with a manual, specific exercises and the necessary training devices. Regular supervision will allow to ensure that the training is performed at maximum benefit. Each session will last for about 20 to 30 minutes in total, including a child-specific warm-up and cool-down. The children will be asked to maintain balance in a previously acquired "short-foot-position", knees slightly flexed (30°), without shoes. Training will consist of 5 playful balance exercises chosen from a standardized pool of exercises according to the child's age, with increasing difficulty in order to allow for individual, optimal progression. Each of the 5 exercises will contain of 5 repetitions for 10sec. allowing for a 20sec. rest in between each set and a 1min rest between each exercise in order to avoid neural fatigue.

Playful sensorimotor training

Fiona Streckmann, Dr.

Jeanette Greiner, Dr

Nicolas Von Der Weid

The investigators would like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients will be recruited from 7 centers (CH/D). All patients (and their guardians) scheduled to receive chemotherapy containing either a platinum derivate or vinca-alkaloid, will be asked to participate. Willing patients will then be randomized either into an intervention group or a control group. Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after therapy. Data will be assessed at 3-4 time points: Prior to chemotherapy (baseline T0), after 12 weeks (T1), after completion of therapy for children that are treated \>3 months (Tp) and after 12 months follow-up (T3). Additionally, status of Chemotherapy-induced peripheral neuropathy (CIPN) reported symptoms will be monitored twice in-between (6 weeks).

The investigators hypothesize that less children in the intervention group will develop symptoms of CIPN (TNS score) with its debilitating side-effects. Furthermore, children in the intervention group will be able to maintain relevant motor and sensory functions and their associated physical functions which will enable them to receive their planned medical therapy but also to stay on the age-appropriate motor development level, improve their quality life and enhance social reintegration after therapy.

Modern therapy has improved survival for children with cancer. However, treatment has unintended consequences. Depending on the neurotoxic agent (platinum derivates or vinca-alkaloids), 52%-100% of children develop a peripheral neuropathy. Diagnosis is underreported and its impact as potentially initial cause for many sensory and motor symptoms underestimated. The severe symptoms such as loss of sensation, numbness, pain, absent reflexes as well as loss of balance control not only delays motor development milestones such as walking, running, jumping or climbing, diminishing children's quality of life and affecting their social reintegration, but is also of high clinical relevance. Additionally, recovery is poor and there are currently no effective options to prevent or treat the symptoms of Chemotherapy-induced peripheral neuropathy (CIPN). Promising results have so far been achieved with specific exercise interventions.

The investigators would therefore like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients N=131 will be recruited from 7 centers: University Children's Hospital of Basel, the Inselspital Bern, Kantonsspital Aarau, Children Hospital for Eastern Switzerland St. Gallen, University Children Hospital Freiburg and the National Center for tumor diseases (NCT), University Children Hospital Heidelberg, Charité Berlin. All patients (and their guardians) scheduled to receive chemotherapy containing either a platinum derivate or vinca-alkaloid, will be asked to participate. Willing patients will then be randomized either into an intervention group or a control group (CG). Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after therapy. Data will be assessed at 3-4 time points: Prior to chemotherapy (baseline T0), after 12 weeks (T1), after completion of therapy for children that are treated \>3 months (Tp) and after 12 months follow-up (T3). Additionally, status of CIPN reported symptoms will be monitored twice in-between (6 weeks). The investigators hypothesize that less children in the intervention group will develop symptoms of CIPN (TNS score) with its debilitating side-effects. Furthermore, children in the intervention group will be able to maintain relevant motor and sensory functions and their associated physical functions which will enable them to receive their planned medical therapy but also to stay on the age-appropriate motor development level, improve their quality life and enhance social reintegration after therapy.

This study will follow a prospective, multicenter, two-armed, randomised, controlled, assessor-blinded trial trial (RCT with follow-up).

All assessors will be blinded and participants will only be told the result of their randomization after the baseline assessment. For the following assessments patients and guardians will be instructed prior to the assessment not to reveal the arm they are in. Assessors are instructed to converse as little as possible outside the friendly instructions. Assessors and trainers will participate in separate study meetings and cannot speak to each other regarding patient matters.

Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy

Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy - a Randomized Controlled, Multi-center Trial

data will be shared on request after completion of the study

Primary endpoint is the Ped-mTNS score. It contains a short questionnaire as well as a clinical test battery. The questionnaire is composed of three sets of questions on sensory symptoms and pain, motor function, and autonomic function, and a five- part neurologic exam. The clinical test battery contains light touch sensation, evaluated with Semmes-Weinstein-monofilaments, pin sensibility (MediPin), vibration sensibility assessed with a biothesiometer, deep tendon reflexes of Achilles and patellar tendons and muscular strength examined by a manual muscle test36, each category is rated on a likert scale from 0-4 (0 indicating no symptoms and 4 severe symptoms).

postural control - sway path on the Leonardo force plate

dorsiflexion function, assessment of foot drop with a goniometer and hand-held dynamometer

knee extension strength will be assessed with a hand-held dynamometer

lower limb power will be assessed with the countermovement jump

10m walk test / walk to run transition time

CIPN-related pain will be assessed on a child-appropriate visual analogue scale (VAS)

participation of exercise-related leisure activities

childrens' physical self concept via questionnaire

childrens quality of life via questionnaire

Insel Gruppe AG, University Hospital Bern

Kantonsspital Aarau

Ostschweizer Kinderspital

University Hospital Heidelberg

University Hospital Freiburg

Krebsforschung Schweiz, Bern, Switzerland

Clinical Trial Unit, University Hospital Basel, Switzerland

Charite University, Berlin, Germany

National Center for Tumor Diseases, Heidelberg

University of Basel

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neuralgia

Hypersensitivity

Respiratory Tract Infections

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neurologic Manifestations

Familial Cold Autoinflammatory Syndrome

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Micronutrients

Lidocaine

Leucovorin

Fluorouracil

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Intravenous infusion of D5W solution over a 130 minute period.

FOLFOX:

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.

FOLFOX:

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.

If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.

Lidocaine Hydrochloride

Dextrose 5% in water will be administered as active comparator.

Each cycle (repeated every 14 days):

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

FOLFOX regimen

Simon Haroutounian, PhD

Oxaliplatin-induced neuropathy is a major dose-limiting side effect in patients with colorectal cancer treated with the FOLFOX chemotherapy regimen. Hypersensitivity to cold is the sensory hallmark of oxaliplatin-induced neuropathy, and it can predict the development of long-term neuropathy. In this study, the investigators aim to determine whether intravenous lidocaine can prevent oxaliplatin-induced cold hypersensitivity.

Colorectal cancer is the third leading cause of cancer death in the United States, with an estimated incidence of 130.000 cases per year. Oxaliplatin is the first-line chemotherapy regimen for gastro-intestinal cancers. Despite its efficacy, oxaliplatin causes peripheral neuropathy in 72% of the treated patients. Acute oxaliplatin-induced peripheral neuropathy \[OIPN\] is the most common dose-limiting side effect of oxaliplatin and characterized by profound cold allodynia in the extremities. In about 21% of the patients acute OIPN exacerbates into chronic neuropathic pain, which is treatment resistant to currently approved drugs, pointing towards a great need to identify an effective strategy in preventing OIPN. Recent literature suggests that certain methods of assessing sensory nerve function in neuropathic pain patients may provide a prediction to an individual analgesic response; however, no placebo-controlled studies have been performed with the primary goal of identifying treatment response predictors in preventing OIPN.

In this pilot study we will both determine the tolerability and the efficacy of intravenous Lidocaine, for preventing oxaliplatin-induced cold hypersensitivity in the setting of mFOLFOX6 chemotherapy for advanced colorectal cancer.

The proposed study will be conducted in two phases. The tolerability phase is an open-label study to determine the tolerable dose regimen of IV lidocaine in patients with advanced colorectal cancer receiving oxaliplatin chemotherapy. The efficacy pilot phase is a randomized, double-blinded, controlled study comparing the outcomes between IV lidocaine versus placebo in the same setting of colorectal cancer. Consented subjects will attend a screening visit and six intervention visits, during which they will undergo sensory testing and receive intravenous lidocaine or placebo infusion. Cold hypersensitivity and spontaneous pain will be assessed at baseline, daily for 12 weeks and at follow-up visits. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the interventions lidocaine or placebo. The participants and all other study personnel will be blinded to the treatment allocation.

Tolerability phase: prospective, open-label Efficacy pilot study: randomized, parallel, double blind, placebo controlled

At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the interventions. The participants and all other study personnel will be blinded to the treatment allocation.

Lidocaine for Oxaliplatin-induced Neuropathy

Intravenous Lidocaine for Preventing Painful Oxaliplatin-induced Peripheral Neuropathy (OIPN)

IPD will be shared 6 months after publication of the results in a peer-reviewed journal, upon submission of a robust data analysis plan to the study investigators.

The intensity of cold pain and cold unpleasantness is evaluated separately, assessed daily on a 0-10 scale, upon holding a pre-cooled (\~8°C) metal cylinder for 10 seconds. the area under the curve of cold pain and cold unpleasantness vs time is calculated per chemotherapy cycle (every two weeks) and serves as a primary outcome measure.

For intervention (lidocaine+FOLFOX) and control (placebo+FOLFOX) groups, the average of cold pain AUC and cold unpleasantness AUC over 7 cycles was calculated. The average AUCs over 7 cycles were compared between study arms.

The AUC is measured as a score on a 0-10 scale multiplied by 14 days and may range between 0 and 140. Higher AUC values represent more intense cold pain/unpleasantness.

Change in CIPN (Chemotherapy-induced peripheral Neuropathy) score (on EORTC QLQ-CIPN20 tool ) from baseline to the Cycle 6 (12 weeks), and from baseline to last follow-up (34-36 weeks). EORTC QLQ-CIPN20 ranges from 0 (no symptoms) to 100 (worst symptoms). A higher score represents worse neuropathy. The changes in scores are compared between study arms.

EORTC QLQ-CIPN20 tool is a quality of life questionnaire (QLQ) from the European Organization for Research and Treatment of Cancer (EORTC) for evaluation of CIPN.

Changes in Neuropathic Pain Symptom Inventory (NPSI) descriptors of neuropathic pain over time from baseline to cycle 3(6 weeks), cycle 6 (12 weeks), and the last follow-up (34-36 weeks). The total NPSI score ranges from 0 to 100; a higher NPSI total score represents a worse neuropathy outcome. The changes in scores from baseline are compared between study arms.

The cumulative dose of oxaliplatin received over the course (up to 12 cycles) of mFOLFOX6 treatment regimen. It corresponds to the absolute summed up quantity of Oxaliplatin administered to the patient over time. There is no range for this measure. Since this is a dose-limiting neuropathy prevention study, the higher value can be interpreted as better outcome.

Washington University School of Medicine

Assistant Professor of Anesthesiology

Adverse Event: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease.

For the purposes of this protocol, all adverse events will be collected and documented on CRFs by questionnaire.

Intravenous infusion of D5W solution over a 130 minute period.

FOLFOX:

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Placebo: Dextrose 5% in water will be administered as active comparator.

FOLFOX regimen: Each cycle (repeated every 14 days):

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Placebo + FOLFOX

Intravenous infusion of lidocaine hydrochloride solution in D5W over a 130 minute period.

FOLFOX:

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Lidocaine Hydrochloride: Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.

If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study.

FOLFOX regimen: Each cycle (repeated every 14 days):

Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days.

Lidocaine + FOLFOX

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

This includes only patients who are enrolled and randomized into 2 groups.

Due to the COVID-19 pandemic, the study finished earlier than planned. The total number of patients enrolled was 26 instead of 30.

Simon Haroutounian, PhD. Associate Professor

Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient

Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.

pain AUC

unpleasantness AUC

data for 14 days following the 6th cycle was collected and analyzed.

Area Under the Curve (AUC) of Intensity of Oxaliplatin-induced Cold Pain/Unpleasantness vs Time

the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.

The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.

34-36 weeks

Patients in each group who had corresponding visit data

CIPN Score on EORTC QLQ-CIPN20

The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.

The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.

The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.

6 weeks visit

12 weeks visit

last follow-up visit

Changes in NPSI Score.

The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.

The Cumulative Dose of Oxaliplatin

Overall Study

60 minutes yoga ,twice a week for 8 weeks

60 minutes yoga practice ,twice a week for 8 weeks

yoga

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.

Therefore, the aim of this study was to evaluate the efficacy of meridian yoga for CIPN in breast cancer patients. The investigators designed a clinical randomized controlled trial in which 80 patients with CIPN were equally divided into a control group (8 weeks of general care) and a treatment group (general care plus 16 times yoga interventions for 8 weeks). The assessment time was before (vision 1) and at the completion of 8 weeks of Meridian yoga treatment (vision 2). The primary outcome was the change in scores of the neuropathic pain scale (Chinese version). The secondary outcome was to the changes of meridian energy \[Meridian Energy Analyzer (M.E.A.D.)\], Perfusion Index (PI) value of peripheral blood flow, and the changes of cortisol and IL-6 level in salivary fluid.

Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

Cortisol plays an important role in the energy metabolism, and is regarded as one of the main stress hormones.

The investigators suggest that Interleukin-6(IL-6) signaling may be an important biological mechanism associated with the persistence of painful CIPN symptoms

The investigators use the Meridian Monitoring System test to detect changes in the conductivity of the skin on the surface of the meridians, in order to judge the changes in the energy of the mWeeridians of the body.

The questionnaire explores the performance of patients with neuropathic pain and nociceptive pain in different pain types in this questionnaire, and has appropriate reliability and validity, among which, specific pain performance, for different types of pain and changes in nerve conduction examination have special performance.

This questionnaire is NPSI-T(Chinese version of neuropathic pain symptom inventory). It consists of 12 questions, all of which address pain on a scale of 0-10. Higher scores mean a worse outcome.

The investigators expected to observe changes in peripheral perfusion values to reflect the correlation between peripheral blood flow and peripheral neuropathy.

The normal value of Peripheral perfusion index(PPI) was suggested to range between 0.2 and 20%.Higher Peripheral perfusion index values reflects better peripheral tissue perfusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention	NCT03449303	Breast Cancer Peripheral Neur...	EOI Placebo	21 Years -	Augusta University
Observational STudy to Evaluate the EFfectiveness of OnLife® in Improving CIPN in Patients With Colon or Breast Cancer After End of Adj. Therapy	NCT03065478	CIPN in Adjuvan... CIPN in Adjuvan...	OnLife	18 Years -	Swiss Medical Food AG
Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy	NCT05606588	Chemotherapy-in... Pediatric Cance...	Playful sensori...	6 Years - 18 Years	University of Basel
Lidocaine for Oxaliplatin-induced Neuropathy	NCT03254394	Neuropathy, Pai... Chemotherapy-in... Colorectal Canc...	Lidocaine Hydro... Placebo FOLFOX regimen	18 Years -	Washington University School of Medicine
Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients	NCT05959811	CIPN - Chemothe... Breast Cancer	yoga	18 Years -	China Medical University Hospital
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention	NCT03449303	Breast Cancer Peripheral Neur...	EOI Placebo	21 Years -	Augusta University
Cryotherapy vs. Cryocompression for Preventing Chemotherapy-induced-peripheral-neuropathy in Women Undergoing Chemotherapy	NCT04632797	Chemotherapy-in... Chemotherapeuti... Chemotherapeuti...	Hilotherm Chemo...	18 Years - 99 Years	Medical University Innsbruck
Playful Sensorimotor Training in Pediatric Brain Tumor Patients	NCT03334162	Pediatric Cance... Pediatric Brain... Chemotherapy-in... Sensorimotor Po...	Sensorimotor tr...	6 Years - 18 Years	University of Basel
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
Chemotherapy-Induced Peripheral Neuropathy Survey	NCT01016028	Breast Cancer Colorectal Canc... Myeloma Chemotherapy-in...	Questionnaire Sensory Tests Interview	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for cipn

Every month we try and update this database with for cipn 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 cipn

Every month we try and update this database with for cipn 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 cipn 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.