Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer (NCT00058071) | Clinical Trial Compass
CompletedPhase 3
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
United States100 participantsStarted 2003-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 conc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks