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NCT02397486
The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients
Phase 2 trial testing Pentoxifylline in Head and Neck Neoplasms in 60 participants. Completed in 30 June 2018.
30 June 2018
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 2 May 2015 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Pentoxifylline — full drug profile →
- Vitamin E (VITAMIN E) — full drug profile →
- Cisplatin (cisplatin) — full drug profile →
- Radiation therapy — full drug profile →
Conditions studied
- Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
Sponsor
Ain Shams University
Who can join
18 and older, any sex, with Head and Neck Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine whether pentoxifylline and vitamin E are effective in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Radiation-Induced Oral Mucositis.
Maria OM, Eliopoulos N, Muanza T. · · 2017 · cited 253× · PMID 28589080 · DOI 10.3389/fonc.2017.00089 -
New Frontiers in the Pathobiology and Treatment of Cancer Regimen-Related Mucosal Injury.
Cinausero M, Aprile G, Ermacora P, Basile D, et al · · 2017 · cited 164× · PMID 28642709 · DOI 10.3389/fphar.2017.00354 -
Antioxidant Therapy in Cancer: Rationale and Progress.
Luo M, Zhou L, Huang Z, Li B, et al · · 2022 · cited 109× · PMID 35740025 · DOI 10.3390/antiox11061128 -
Oral Mucositis: An Update on Innate Immunity and New Interventional Targets.
Chen C, Zhang Q, Yu W, Chang B, et al · · 2020 · cited 44× · PMID 32479139 · DOI 10.1177/0022034520925421 -
Clinically Evaluated Cancer Drugs Inhibiting Redox Signaling.
Kirkpatrick DL, Powis G. · · 2017 · cited 38× · PMID 26983373 · DOI 10.1089/ars.2016.6633 -
Utilization of redox modulating small molecules that selectively act as pro-oxidants in cancer cells to open a therapeutic window for improving cancer therapy.
Petronek MS, Stolwijk JM, Murray SD, Steinbach EJ, et al · · 2021 · cited 29× · PMID 33485837 · DOI 10.1016/j.redox.2021.101864 -
Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study.
Sayed R, El Wakeel L, Saad AS, Kelany M, et al · · 2019 · cited 29× · PMID 31748905 · DOI 10.1007/s12032-019-1334-5 -
Utilization of Vitamin E Analogs to Protect Normal Tissues While Enhancing Antitumor Effects.
Aykin-Burns N, Pathak R, Boerma M, Kim T, et al · · 2019 · cited 11× · PMID 30573184 · DOI 10.1016/j.semradonc.2018.10.008
Verify or expand the search:
- PubMed search for NCT02397486
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Head and Neck Neoplasms
Currently open trials in the same condition.
- NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
- NCT06912087 — Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC · Phase 1 · recruiting
- NCT06998069 — Head and Neck Cancer Study Project in the Geriatric Population · Phase 3 · recruiting
- NCT07158164 — DPYD Pharmacogenomics and Fluoropyrimidine (FP) Dose-Adjustment · Phase 4 · recruiting
- NCT06303180 — NIDCD Otolaryngology Clinical Protocol Biospecimen Bank · recruiting
Other Ain Shams University trials
Trials by the same sponsor.
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- NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
- NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02397486 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 26 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02397486.
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