Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin f… (NCT00245050) | Clinical Trial Compass
CompletedPhase 3
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
United States34 participantsStarted 2004-04
Plain-language summary
RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.
PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic breast cancer, or advanced endometrial cancer.
Who can participate
Sex
FEMALE
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:
* Diagnosis of 1 of the following:
* Recurrent ovarian, fallopian tube, or peritoneal cavity cancer
* Metastatic breast cancer
* Advanced endometrial cancer
* Planning to receive chemotherapy with doxorubicin HCl liposome at a dose of 40 mg/m\^2
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Not specified
Menopausal status:
* Not specified
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* AST and ALT ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* Bilirubin normal
Renal
* Creatinine ≤ 2.0 mg/dL
Cardiovascular
* Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
* No history of cardiac disease
* No New York Heart Association class II-IV heart disease
* No clinical evidence of congestive heart failure
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No active infection requiring antibiotics
* No history of hypersensitivity reaction attributed to a conventional formulation of doxorubicin HCl or doxorubicin HCl liposome and any of its components
* No other invasive malignancy within the past 5 years except nonmelanoma or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or …
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
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Timeframe: Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.