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Pentoxifylline

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alpha-Tocopherol

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Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.

Trental

Nathalie Johnson, MD

The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.

This is a single center, 18-month study in which 30 women will receive Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months. Subjects will begin the treatment regimen within four weeks after completion of radiation treatment and will remain on the study drugs for six months. Following completion of active treatment, all subjects will enter the twelve-month observational phase of the trial in which they will be evaluated for changes in breast tissue using the following objective tools: Bakers Grade Assessment, Visual Analog Scale (VAS), implant revision or loss, breast photographs, adverse event assessment and the Quality of Life tool (SF-12).

Prevention of Capsular Contracture Using Trental and Vitamin E

A Single Center, Prospective Treatment Trial to Assess Prophylactic Use of Trental (Pentoxifylline) and Vitamin E to Prevent Capsular Contracture After Implant Reconstruction in Patients Requiring Adjuvant Radiation Therapy

Legacy Health System

Principal Investigator

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and pentoxifylline 400 mg twice daily for the paclitaxel treatment period.

Patients will receive paclitaxel 80 mg/m2 once per week for 12 weeks and placebo twice daily for the paclitaxel treatment period..

Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.

Placebo

The aim of this study is to evaluate the effect of pentoxifylline 400 mg twice daily administration on the prevention of paclitaxel-Induced peripheral neuropathy in breast cancer patients.

Paclitaxel induced peripheral neuropathy (PIPN) starts early during therapy and may worsen even after cessation and affect mainly sensory neurons. The symptoms of neuropathy include pain, tingling, cold-sensitivity and numbness that typically presents in a stocking glove distribution. The pathogenesis of PIPN may be attributed to drug accumulation in dorsal root ganglia causing increase in inflammatory cytokines, immune mediators and dysregulation of calcium subunits which in turn increases pain. It also causes oxidative stress in sensory axons leading to axon demyelination, increased sensitization to signal transduction, release of pro-inflammatory mediators and activation of apoptosis.

Many animal studies and clinical trials have shown pentoxifylline to have a significant anti-inflammatory and antioxidant effect. It also preserved nerve conduction velocity and ameliorated mechanical hyperalgesia. Pentoxifylline showed a prominent reduction in neuropathic pain in diabetic patients. These effects were mainly due to the ability of pentoxifylline to reduce TNF-α and MDA levels. So, pentoxifylline is a drug of interest due to its ability to ameliorate neuro-inflammation and oxidative stress which play a critical role in PIPN pathogenesis.

A prospective, randomized, placebo controlled

"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

"Evaluation of the Effect of Pentoxifylline on the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"

measuring serum level of tumor necrosis factor using ELISA kit

measuring serum level of malondialdehyde.

evaluating the functional difficulties and quality of life related to paclitaxel induced neuropathic symptoms.

score range from (0-44) where lower score indicates more sever symptoms according to the FACT-GOG-NTX scoring guideline.

mean time to develop grade 3 or 4 neuropathy

Number of patients reported neuropathy due to paclitaxel

Severity of neuropathic symptoms will be graded using Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)

side effects reported due to pentoxifylline will be recorded.

number of patients who needed dose reduction or drug discontinuation due to paclitaxel induced neuropathy will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prevention of Capsular Contracture Using Trental and Vitamin E	NCT01082003	Capsular Contra...	Trental	18 Years -	Legacy Health System
"Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients"	NCT05189535	Breast Cancer F... Peripheral Neur...	Pentoxifylline Paclitaxel Placebo	18 Years - 80 Years	Ain Shams University
Prevention of Capsular Contracture Using Trental and Vitamin E	NCT01082003	Capsular Contra...	Trental	18 Years -	Legacy Health System

Spots Global Cancer Trial Database for trental

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

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