Clinical trial · Interventional
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
- 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)
RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer. PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Neurotoxicity | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
Secondary outcomes (1)
- measure
- Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Prior therapy with platinum-based chemotherapy regimen for a malignancy * Treatment with other agents, including paclitaxel, allowed * Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy * Must have persisted and be stable for 3-36 months after completion of chemotherapy * Duration of neuropathy no more than 3 years * No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease) PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-3 Life expectancy * At least 6 months Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2.0 mg/dL Renal * Creatinine no greater than 2.0 mg/dL * Calcium at least lower limit of normal Cardiovascular * No hypotension * No history of cerebrovascular accident Other * No other significant comorbid medical conditions that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No concurrent chemotherapy * No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 24 hours since prior antihypertensive medications * No prior amifostine * Prior treatment on a GOG treatment protocol allowed * No concurrent monoamine oxidase inhibitors * No concurrent neurotoxic agents during and for at least 6 months after study entry
References
Publications (0)
Data not yet available