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Pentoxifylline Role Against Chemotherapy-induced Neuropathy

B

Beni-Suef University

Status

Completed

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Drug: Pentoxifylline

Study type

Interventional

Funder types

Other

Identifiers

NCT06562998
FMBSUREC/07072024

Details and patient eligibility

About

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.

Enrollment

72 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients> 18 years old.
  • Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
  • Adequate liver and kidney function.

Exclusion criteria

  • Children less than 18 years old.
  • Evidence of physical diseases or major surgery.
  • Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
  • 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 retinal bleeding or active peptic ulcer.
  • Patients at high risk for bleeding or taking medications that increase risk of bleeding.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups, including a placebo group

PTX group
Active Comparator group
Description:
paclitaxel based regimens plus Pentoxifylline 400mg twice daily for 12weeks.
Treatment:
Drug: Pentoxifylline
Control group
Placebo Comparator group
Description:
include those assigned for Taxol-based chemotherapy without intervention for 12 weeks
Treatment:
Drug: Pentoxifylline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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