Clinical trial · Interventional
The Impact of Pentoxifylline and Vitamin E on Radiotherapy-induced Toxicity in Head & Neck Cancer Patients
The Impact of Pentoxifylline and Vitamin E on The Incidence and Severity of Radiotherapy- Induced Oral Mucositis and Dysphagia in Patients With Head and Neck Cancer
NCT02397486CI-TRIAL-00041933completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pentoxifylline | Drug | — | UNRESOLVED |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Vitamin E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] . Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.
- interventionNames
- Drug: Pentoxifylline
- Drug: Vitamin E
- Drug: Cisplatin
- Radiation: Radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Platinum based concurrent chemoradiotherapy \[cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks\] .
- interventionNames
- Drug: Cisplatin
- Radiation: Radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients * Measurable disease * Patients with squamous cell carcinoma of the head and neck eligible for treatment with concurrent chemo- radiotherapy * Able to understand and willing to sign a written informed consent document Exclusion Criteria: * Pregnant or lactating women, since imaging cannot be done in this setting. * Patients treated with vitamin E and/ or pentoxifylline for any other indication * Patients with recent cerebral and/or retinal hemorrhage * Patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine. * Patients treated with oral anticoagulants. * Absolute neutrophil count ≤1.5×109/L * Platelets ≤100×109/L * AST ≥ 2.5 X institutional upper limit normal (ULN) * Serum creatinine ≥ 1.5 mg% for males \& 1.4 mg% for females * Serum bilirubin ≥ 1.5X institutional upper limit normal (ULN)
References
Publications (1)
- RESULTSayed R, El Wakeel L, Saad AS, Kelany M, El-Hamamsy M. Pentoxifylline and vitamin E reduce the severity of radiotherapy-induced oral mucositis and dysphagia in head and neck cancer patients: a randomized, controlled study. Med Oncol. 2019 Nov 21;37(1):8. doi: 10.1007/s12032-019-1334-5. PMID 31748905