NCT05590117

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

Status unknown EARLY_PHASE1 Last updated 21 October 2022

What this trial tests

EARLY_PHASE1 trial testing Pentoxifylline in Colo-rectal Cancer in 48 participants. Status unknown.

Timeline

11 October 2022

Primary endpoint
11 October 2023

11 October 2024

Quick facts

Lead sponsor	Tanta University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	48
Start date	11 October 2022
Primary completion	11 October 2023
Estimated completion	11 October 2024
Sites	1 location across Egypt

Drugs / interventions tested

• Pentoxifylline — full drug profile →
• Placebo
• FOLFOX-6 regimen — full drug profile →

Conditions studied

• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• Neuropathy;Peripheral — all drugs for Neuropathy;Peripheral →
• Mucositis — all drugs for Mucositis →

Sponsor

Tanta University

Who can join

18 and older, any sex, with Colo-rectal Cancer or Neuropathy;Peripheral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Colorectal Cancer at the Crossroads: The Good, the Bad, and the Future of Platinum-Based Drugs.
   Kee JX, Yau JNN, Kumar Muthuramalingam RP, Wang X, et al · · 2025 · cited 6× · PMID 40985211 · DOI 10.1021/acs.chemrev.5c00041