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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05189535
Other study ID # s2192648
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date October 3, 2021
Est. completion date September 28, 2023

Study information

Verified date January 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 28, 2023
Est. primary completion date September 18, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adult patients (18-80 years old). - Female patients. - Pathologically proved breast cancer. - Breast cancer patients who will receive adjuvant and neoadjuvant weekly paclitaxel for 12 weeks. - Eastern Cooperative Oncology Group (ECOG) performance = 2 - Adequate bone marrow function. - Adequate liver and kidney function. Exclusion Criteria: - Patients with preexisting clinical neuropathy. - Patients with diabetes mellitus. - Metastatic breast cancer. - Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics. - Patients treated with medications that increase the risk of neuropathy. - Hypersensitivity to pentoxifylline or xanthine derivatives. - Patients with recent (within 1 month) surgery, myocardial infarction (MI), intracranial or retinal bleeding or active peptic ulcer. - Patients at high risk for bleeding or taking medications that increase risk of bleeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pentoxifylline
Pentoxifylline 400 mg oral tablet twice daily for 12 weeks.
Paclitaxel
Paclitaxel I.V 80 mg/m2 weekly
Placebo
placebo

Locations

Country Name City State
Egypt Ain Shams University hospitals Cairo Abbasia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Serum tumor necrosis factor alpha (TNF-a) measuring serum level of tumor necrosis factor using ELISA kit at baseline and after 12 weeks
Other Serum malondialdehyde (MDA) measuring serum level of malondialdehyde. at baseline and after 12 weeks
Other The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT-GOG-NTX) subscale 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.
at baseline, week 1 in each cycle (cycle length is 21 days) up to 12 weeks and at week 12.
Other Time to develop neuropathy mean time to develop grade 3 or 4 neuropathy 12 weeks
Primary Incidence of Paclitaxel induced-peripheral neuropathy Number of patients reported neuropathy due to paclitaxel 12 weeks
Secondary Grade of severity of Paclitaxel induced-peripheral neuropathy in patients who developed neuropathy Severity of neuropathic symptoms will be graded using Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5) at baseline and on weekly bases for 12 weeks
Secondary Evaluation of Safety and tolerability of pentoxifylline side effects reported due to pentoxifylline will be recorded. evaluation on weekly bases for 12 weeks.
Secondary The need for dose reduction or drug discontinuation in pentoxifylline and placebo arm. number of patients who needed dose reduction or drug discontinuation due to paclitaxel induced neuropathy will be recorded. 12 weeks
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