Clinical trial · Interventional
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
- 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)
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
Conditions
Conditions (2)
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ethyol (Amifostine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
- measure
- To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
Secondary outcomes (1)
- measure
- Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Age \> 18 * Patient receiving radiation therapy or combined modality therapy to treat malignancy. * No evidence of distant metastatic disease. * Granulocyte count (segs \& bands) \> 2000/mm3 and platelet count \> 100,000/mm3 * Serum creatinine \<2.0mg/dL * Total bilirubin \<2.0mg%, SGOT \< times the upper limit of normal. * Patients may not be entered on investigational therapeutic trials. * Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures. Exclusion Criteria: * Life expectancy of \<6 months * Patients receiving only chemotherapy to treat malignancy. * Patients who have been treated with any investigational drugs \<4 weeks prior to study entry. * General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent. * Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study. * Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.
References
Publications (0)
Data not yet available