Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Neuralgia

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Dermatologic Agents

Bone Density Conservation Agents

Pregabalin

Capsaicin

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Anti-Anxiety Agents

Application of capsaicin patches at 8% on the painful area

1 to 2 patches will be administered during the consultation. If necessary, a second application will be realized 3 months later.

Pregabalin tablets will be initiated at a dose of 50 mg / day taken in 2 doses Depending on the tolerance, the dose will be increased to 100 mg / day and then to 150 mg / day to reach a maximum dose of 600 mg / day.

An interval of 3 to 7 days must be observed between each dose increase.

Application of capsaicin patches at 8% on painful area

DENIS DUPOIRON, MD

Breast cancer is the most common cancer in women in Europe. Therefore, breast cancer has become a chronic disease and patients need to learn to live with it as well as with the adverse effects related to the disease itself or to the therapies used.

As noted in the third "Plan cancer", pain is a major criterion in the quality of life of patients treated for breast cancer.

Neuropathic pain was defined in 2011 by the international Association for the Study of Pain (I.A.S.P.) as the direct result of a lesion or disease affecting the somato-sensory system.

Surgical treatment is often the first treatment of breast cancer. It can be conservative by performing a partial mastectomy (lumpectomy or quadrantectomy) or non-preservative by total mastectomy.

Intercostobrachial neuralgia (NICB) or Post mastectomy painful Syndrome (MPRR) was first described by Wood in 1978 as "chronic pain beginning immediately or early after a mastectomy" Or a lumpectomy affecting the anterior thorax, armpit and/or arm in its upper half. These post-surgical pains are related to a lesion of the nerves in the breast area.

In particular, the intercostobrachial nerve can be severed, stretched or crushed during surgery.

Post-operative neuropathic pain in patients with breast cancer is underdiagnosed either by general practitioner or in a specialized environment.

The diagnosis of neuropathic pain is performed during examination and clinical examination. Several scales allow to detect neuropathic pain but only the DN4 is recognized to be the most specific and sensitive scale.

Patients do not always express this pain. They do not always reconcile with the surgery. Either because the pain occurs a long time after the surgery, or they find it normal to get hurt. These diagnostic difficulties cause a delay in setting up a suitable analgesic treatment.

However, neuropathic pain responds poorly to common analgesics. Diagnosis, evaluation and early management of neuropathic pain are a priority in order to avoid their chronicization, to improve the quality of life of patients with breast cancer and to enable them to return to work quickly.

We therefore assume that the diagnosis of early neuropathic pain at 2 months of surgery associated with initiation of appropriate topical treatment without the systemic effects of conventional oral treatments, would reduce the incidence of Chronic neuropathic pain 6 months after surgery.

Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery

Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer

The 11-point numerical scale (0-10) is collected at 2 months.

The 11-point numerical scale of pain is also collected at the end of treatment

Questionnaire PGIC is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

Questionnaire QLQ-C30 (quality of life questionnaire) is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

Questionnaire EQ-5D is administered to M4, M6 and at the end of treatment to measure the functional changes and quality of life changes experienced by the patient in the 2 treatment arms.

The painful area is measured from pain mapping at baseline, and after 2 months and 6 months of treatment. It is measured by the area delimited by the contours of the painful surface (centralized reading).

The tolerance of the treatments will be measured by the number of patients having at least one adverse event of grade ≥ 2 according to the classification CTCAE v5.0.

In the capsaicin arm, the number of total patches received by the patient during the 6 months will also be counted

The HAD (Hospital anxiety and despression scale) questionnaire will be collected during the screening visit

The incidence of NICBs will be measured by the number of patients included in the study (DN4 +) compared to the number of patients screened before surgery

The weight is collected after 6 months of treatment

Grünenthal GmbH

Institut Cancerologie de l'Ouest

Musculoskeletal Diseases

Neuroma

Morton Neuroma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Metatarsalgia

Foot Diseases

Joint Diseases

ALGRX 4975

Eric Diamond, D.P.M.

Subjects will have painful primary or post-operative intermetatarsal neuroma. Study drug or placebo will be injected into the space containing the neuroma. Subjects will complete weekly assessments for severity of foot pain, a brief pain inventory, and the amount of pain medication taken. Subjects will be seen for a screening visit, a treatment visit, and two follow-up visits after treatment. The last scheduled visit is one month after treatment. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Subjects will have painful primary or post-operative intermetatarsal neuroma. Each subject will be randomly allocated to receive either ALGRX 4975 or placebo in a 1:1 ratio. Study drug or placebo will be injected into the intermetatarsal space containing a painful neuroma. Subjects will complete weekly assessments for the Average Foot Pain Severity, the 7 Interference Items of the BPI, and the number of analgesic units taken. Some subjects may be followed by monthly telephone interviews to assess their level of pain over the six-month period following treatment.

Plasma concentrations will be assessed pre-dose and post dose at 5, 10, 15, 20, 30, and 45 min and at 1, 1.5, 2, 2.5, 3 and 4 hours.

Safety will be assessed at baseline and during the study with adverse events (all visits), vital signs (Visit 2 pre and post-injection and Visit 3 or at early termination), and laboratory assessments (hematology, chemistry, urinalysis) and ECG (Screening and Visit 3 or at early termination). The injection site will be examined and assessed by a 6-point scale for erythema, edema, and hemorrhage before the injection and at 1, 2 and 4 hours after the injection. A pain on injection NRS will be assessed immediately post- injection at 15, 30, and 45 minutes and 1, 2, 3, and 4 hours after study drug administration. A sensory examination of the foot will be performed before the injection and 4 hours after the injection and at the completion of the study. If a subject has injection pain, the foot may be wrapped in ice for up to 20 minutes, analgesic medication may be provided.

ALGRX 4975 in the Treatment of Patients With Morton's Neuroma

A Randomized, Double-Blind, Placebo-Controlled Trial of ALGRX 4975 in Subjects With Painful Intermetatarsal Neuroma

AlgoRx Pharmaceuticals

Cancer patients presenting neuropathic pain secondary to their anti cancer treatments will receive patch of capsaicin (qutenza) on the painful zones..

Patients suffering from neuropathic pain will receive patch of capsaicin (qutenza) on the painful zones. Three months after the first application, patients will be allowed to receive another patch if necessary. They will be able to receive one every three months. They will be followed in the study during one year after the first patch application.

Qutenza

Stéphanie Morisson, MD

In the oncology area, neuropathic pains are relatively frequent and can be induced by surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in order to reduce neuropathic pain even though using of this patch for a population of cancer patients has never been demonstrated so far in a prospective study. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Drugs for neuropathic pains are generally represented by antidepressants, anti-epileptics, opioids, lidocaine patch. However, these drugs can frequently be insufficient, and/or can lead to side effects. Qutenza (8% capsaicin patch) presents an interesting alternative.

Qutenza efficacy has been shown in five principal studies conducted on 1988 adults affected by moderate or severe neuropathic pains. All patients presented Postherpetic neuralgia, or HIV associated therapy, or painful diabetic peripheric neuropathies. These studies led to qutenza approbation in Europe and in States in 2009.

In oncology, neuropathic pains are relatively frequent and can be induced by the three big actors of the anti-cancerous therapeutic arsenal (surgery, radiotherapy, chemotherapy). In usual practice, some units are usually using qutenza, but the use of this patch for this kind of patients has not been shown in a prospective study. Advantages of this treatment are numerous, and results presented in other therapeutic area are encouraging its use in oncology.

The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

Cancer patients treated with qutenza (capsaicin patch)

Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

Percentage of responders to capsaicin at one month after the first patch application will be calculated with a relief scale completed by patients.

Maximum value of relief will be calculated for patients with relief scale completed by patients at three months after the patch application.

Correlation coefficient between maximal value of relief and time between the beginning of painful signs and first patch application.

Minimal, average, and maximal values of neuropathic pain reported on visual analog scale will be evaluated.

Capsaicin patch induced toxicities will be reported, and quoted according to CTCAE version 4.4.

Number of days of response reported by patients where patch are efficient will be reported

Number of days between the patch set and the apparition of the first effect on patients will be reported.

Number of prescribed antalgics will be reported for each patient.

Percentage of patients with an obligation to report their chemotherapy because of the pain will be calculated.

Percentage of patients who have received at least 75% of the chemotherapy prescribed will be reported.

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Cancer Pain

Pain, Intractable

phase I, single-site, non-randomized, open-label, dose-escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy

Intrathecal Resiniferatoxin

John D Heiss, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information.

People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures:

Pretreatment Visit

Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes:

* Electrocardiogram (EKG)
* Blood draw
* Urinalysis
* Neurological examinations
* Peak expiratory flow rate (PEFR)
* Eye examination
* MRI
* Urology assessment
* Pregnancy test, when appropriate
* Questionnaires to collect information on health, personality, mood, pain levels and symptoms.

  2-Day Hospitalization

Patients are hospitalized for 2 days for RTX injection and monitoring, as follows:

* RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body.
* Post-injection monitoring, including:
* Surveys about symptoms such as pain or weakness
* Neurological examinations
* Blood and CSF sampling
* EKG
* AEs

Outpatient followup

* Vitals
* Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection
* MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection
* Eye examination
* Follow-up phone calls monthly for 6 months

Pain continues to be a major problem in patients with advanced cancer. Resiniferatoxin (RTX), a potent member of the family of drugs that includes capsaicin, selectively and irreversibly destroys the neurons (or their axons) transmitting chronic pain sensation. Intrathecal injection of RTX in several animal species has demonstrated a high level of safety, specificity, and efficacy in treating severe pain. This first-in-human, dose-escalation study will investigate the intrathecal administration of RTX in cancer patients with severe pain.

PRIMARY OBJECTIVE:

To investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer.

STUDY POPULATION:

Up to 45 subjects will be accrued. Eligible subjects will be greater than or equal to 18 years of age, have a clinical and histological diagnosis of advanced malignancy, and have severe pain due to malignancy that is at or below the level of the chest and not adequately relieved by other pain control therapies.

DESIGN:

This is a single site, non-randomized, open-label, dose-escalation study using a modified Fibonacci scheme. The starting dose of RTX was 13 micrograms given as a 2 mL injection via an intra-spinal catheter over approximately 30 seconds followed by a 1 mL flush. Six subjects were dosed at this level and 3 were dosed at the 26 microgram dose level at the same volume of injectate, flush and injection time. Under the study design, RTX doses were to be increased in progressively smaller percentage increments with each dose-escalation to occur in sequential groups of 3 subjects until 1 escalation above the effective dose in 100% of subjects (ED100), completion of the 100 microgram dose level, or establishment of the maximum tolerated dose (MTD), whichever occurs first. The total duration of study participation for any subject will received a dose of 26 micrograms.

The amended RTX injection technique reduced the injection volume and increased the injection time to reduce the spread of RTX to above the T6 (sixth thoracic) vertebral level. The present technique is a 1 mL injection over 2 minutes (0.5 mL/minute) given via infusion pump, followed by flushing of the IT catheter with the minimum volume of sterile, preservative-free saline necessary to clear the internal volume of the catheter used for the injection. Three patients were treated at the new starting dose of 13 micrograms with the new injection technique. The next 3-patient cohort will received a dose of 26 micrograms. The subsequent subject dose tier will receive a dose of 44 micrograms consistent with the protocol s dose-escalation algorithm. Administering this dose will require an infusion volume of 1.76 mL of the present 25 micrograms/mL RTX formulation.

OUTCOME MEASURES:

The primary study outcome is the ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose-escalation. The primary pain variable for determining the ED100 is the daily worst pain score averaged over a 7-day period during the 3 weeks before RTX dosing and during Days 8 through 14 after dosing. The numerical rating scale (NRS), administered verbally during a daily telephone interview, will be the primary pain assessment instrument. For a given subject, the treatment will be considered effective if the subject experiences a greater than or equal to 50% reduction in the mean daily worst pain score assessed by NRS (evaluated on Study Day 15). We may also consider RTX treatment to be successful if there is greater than or equal to 50% reduction in opiate intake, measured by morphine milligram equivalents (MME) per day, even if pain levels are unchanged after RTX treatment.

Secondary outcome measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.

Safety assessments will include hematology; serum clinical chemistry tests; cerebrospinal fluid examinations; physical, neurological, and eye examinations; reporting of adverse events; electrocardiograms; and findings on magnetic resonance imaging of the spine and brain.

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer

.We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.

Dose escalation decisions are based on both effectiveness (as assessed by mean worst pain on the NRS) and DLT. The dose escalation population will include all subjects who are dosed, complete the NRS, and have the DLT assessments from baseline through Day 15. Subjects who are not evaluable for dose escalation will be replaced.

The secondary outcome variables will be summarized over time by dose cohort as appropriate for the outcome measure. Absolute and percentage change in the NRS and VAS pain scores between the pre- and post-RTX dosing assessments (baseline period and study Days 8 through 14, respectively) will also be summarized.

National Institute of Neurological Disorders and Stroke (NINDS)

Sorrento Therapeutics, Inc.

National Institute of Dental and Craniofacial Research (NIDCR)

Digestive System Diseases

Mouth and Tooth Diseases

Head and Neck Neoplasms

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Patients receive one lozenge orally of capsaicin four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.

Patients receive one lozenge orally of placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.

capsaicin

placebo

radiation therapy

Scott Okuno, MD

RATIONALE: Capsaicin lozenges may be effective treatment for mucositis caused by radiation therapy. It is not yet known whether capsaicin lozenges are more effective than no treatment for mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to study the effectiveness of capsaicin lozenges in treating patients with mucositis caused by radiation therapy.

OBJECTIVES: I. Determine the efficacy of capsaicin lozenges in terms of frequency, duration, and severity of mouth pain caused by radiation therapy to the oral cavity. II. Evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified according to dentures (yes vs no), smoking history (none vs currently vs past only), radiation therapy (primary vs postoperative adjuvant), planned radiation dose (5000-6000 cGy vs greater than 6000 cGy), planned fluoride use (yes vs no), and amount of oral mucosa in radiation field (one- to two-thirds vs greater than two-thirds). Patients receive one lozenge orally of capsaicin or placebo four times daily. Treatment begins within the first 3 days of radiation therapy and continues during and for two weeks after radiation therapy is completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery	NCT03794388	Breast Cancer P...	Capsaicin Pregabalin	18 Years -	Institut Cancerologie de l'Ouest
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma	NCT00130962	Neuroma	ALGRX 4975	18 Years -	AlgoRx Pharmaceuticals
ALGRX 4975 in the Treatment of Patients With Morton's Neuroma	NCT00130962	Neuroma	ALGRX 4975	18 Years -	AlgoRx Pharmaceuticals
Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain	NCT03317613	Neuropathic Pai...	Qutenza	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer	NCT00804154	Intractable Pai... Palliative Care	Intrathecal Res...	18 Years -	National Institutes of Health Clinical Center (CC)
Capsaicin Lozenges in Treating Patients With Mucositis Caused by Radiation Therapy	NCT00003610	Head and Neck C... Radiation Toxic...	capsaicin placebo radiation thera...	18 Years -	Alliance for Clinical Trials in Oncology
Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain	NCT03317613	Neuropathic Pai...	Qutenza	18 Years -	Centre Hospitalier Universitaire de Saint Etienne

Spots Global Cancer Trial Database for capsaicin

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

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