Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer

• Status: Enrolling by invitation
• Trial end date: 2024-10-11

Summary

This study aims to:

• Evaluate the possible protective effect of pentoxifylline against oxaliplatin induced peripheral neuropathy and chemotherapy induced mucositis in patients with stage II and stage III colorectal cancer.

This study will be a randomized placebo controlled parallel study.48 patients with colorectal cancer will be randomized to 2 groups:

Group I (control group; n=24) which will receive 12 cycles of FOLFOX-6 regimen plus placebo tablets twice daily. Group II (Pentoxiphylline group; n=24) which will receive FOLFOX-6 regimen in addition to pentoxifylline 400 mg twice daily.

Blood sample collection and biochemical assessment:

• Malondialdehyde (MDA) as oxidative stress marker (colorimetry).

• Tumor necrosis factor alfa (TNF-α) as pro inflammatory marker (ELISA).

• Neurotensin (NT) as a potential marker for neuropathic pain (ELISA).

• Citrulline as a biomarker for mucositis (ELISA).

Clinical assessment of oxaliplatin induced neuropathy will be done through:

The assessment of the severity of neuropathic pain through "Brief Pain Inventory-Short Form" at baseline and by the end of every two chemotherapy cycles.

The implication of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5, 2017) for grading of neuropathy every 2 cycles. The use of Neurotoxicity- 12 item questionnaire score (Ntx-12) from the validated Functional Assessment of Cancer Therapy/Gynecologic Oncology Group at baseline and by the end of every two chemotherapy cycles).

Mucositis will be assessed at baseline and by the end of every two chemotherapy cycles through the use of common terminology criteria for adverse events "CTCAE, version 5.00, 2017

• Phase: Early Phase 1

Details

• Lead Sponsor: Tanta University
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin; Pentoxifylline