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

NCT05590117 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-10-21

No results posted yet for this study

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

Conditions

  • Colo-rectal Cancer
  • Neuropathy;Peripheral
  • Mucositis

Interventions

DRUG

Pentoxifylline

Pentoxifylline is a potent anti inflammatory may prevent chemotherapy induced neuropathy and mucositis and will be administered 400mg twice daily

DRUG

Placebo

placebo tablets

DRUG

FOLFOX-6 regimen

12 cycles of FOLFOX-6 regimen

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2023-10-11
Completion
2024-10-11
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590117 on ClinicalTrials.gov