Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned

Status Recruiting

Clinical Trial Summary

Phase IIa clinical trial will be conducted with patients requiring in-label paclitaxel-chemotherapy due to ovarian or breast cancer. The efficacy of a 12-week telmisartan treatment, starting one week before planned paclitaxel-administration to prevent PIPNP (paclitaxel-induced peripheral neuropathic pain) will be assessed by measurement of occurrence of clinical symptoms of PIPNP as well as lipid profiles

Clinical Trial Description

Paclitaxel is a cytostatic drug that is widely used for the first-line treatment of breast- and ovarian cancer and causes neuropathic pain in up to 87% of treated patients Treating mice with telmisartan causes a strong reduction of PIPNP, thus indicating that telmisartan may be a promising pharmacological treatment option for PIPNP in patients. It is proposed that telmisartan reduces the inflammatory component of PIPNP. Telmisartan has a good risk profile, low occurrence of side effects and is generally well tolerated in patients.These collective characteristics make it a suitable, already approved and appropriate substance for combination therapy with paclitaxel. Therefore, telmisartan is a promising candidate to potentially prevent PIPNP in patients whose safety profile is well known due to preclinical and clinical trials for the indication of hypertension and coronary heart disease. Moreover, due to its mechanisms it might as well reduce symptoms of PIPNP sufficiently without severe side effects. To validate these observations clinically, this phase IIa clinical trial will be conducted with breast and ovarian cancer patients requiring in-label paclitaxel-chemotherapy. The efficacy of a 12-week telmisartan treatment initiated before the first administration of paclitaxel to prevent PIPNP will be assessed. Moreover, beside lipid profiles, quantitative sensoric testing of pain characteristics in focus on biomarker detection and development that may be useful for a precision medicine approach will be assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05322889
Study type	Interventional
Source	Fraunhofer Institute for Molecular Biology and Applied Ecology
Contact	Christin Jonetzko
Phone	00 49 69 6301 80231
Email	christin.jonetzko@itmp.fraunhofer.de
Status	Recruiting
Phase	Phase 2
Start date	April 9, 2020
Completion date	June 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04699734` - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy	N/A
Recruiting	`NCT06019325` - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy	N/A
Completed	`NCT05235191` - Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies	Phase 3
Completed	`NCT05845177` - Persistent Pain After Hip Replacement
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT05949554` - Electroencephalographic (EEG) Profils for Patients on Intravenous Ketamine.
Withdrawn	`NCT05052645` - Ear Acupuncture for Neuropathic Pain	N/A
Completed	`NCT02824588` - Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain	N/A
Completed	`NCT02866396` - Impact of Pregabalin in Chronic Users vs. a Perioperative Limited Prescription on Oxycodone Requirement
Completed	`NCT02930551` - Neuromas as the Cause of Pain	N/A
Active, not recruiting	`NCT02560545` - Cannabinoids Effects on the Pain Modulation System	N/A
Enrolling by invitation	`NCT02485795` - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management	N/A
Completed	`NCT02099890` - The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury	Phase 3
Not yet recruiting	`NCT02246517` - The Effect of N2O on Chronic Neuropathic Pain Patients	Phase 0
Completed	`NCT01946555` - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain	N/A
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Completed	`NCT01718821` - Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients	N/A
Completed	`NCT01669967` - The Role of Intravenous (IV) Lidocaine in the Management of Chronic Neuropathic Pain of Peripheral Nerve Origin	N/A
Completed	`NCT01207596` - Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain	Phase 4
Completed	`NCT01201317` - A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prevention of Paclitaxel-induced Neuropathic Pain in Patients With Planned Paclitaxel Chemotherapy (PrevTel) — PrevTel

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms