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DOI Link

Study Purpose

To evaluate the effectiveness of oral pyridoxine as prophylactic therapy for Palmar-Plantar Erythrodysesthesia (PPE)

Intervention Characteristics/Basic Study Process

The first 15 patients were treated without prophylaxis with oral pyridoxine. The following 20 patients were given oral pyridoxine 300 mg per day for 56 days.

Sample Characteristics

  • N = 35
  • KEY DISEASE CHARACTERISTICS: Patients with locally advanced breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Receiving pegylated liposomal doxorubicin (PLD) (15 mg/m2 biweekly for four administrations) and paclitaxel (80 mg/m2 weekly for eight administrations) as neoadjuvant chemotherapy

Setting

  • LOCATION: Oncology unit at S. Salvatore Hospital in Pesaro, Italy

Study Design

  • Phase II study
    • Started in 2004

Measurement Instruments/Methods

  • Article discussed grade 1, grade 2, and grade 3 PPE

Results

In group 1, 33% developed PPE—one patient developed grade 3, and four patients developed grade 2 PPE. In group 2, 40% developed PPE—three patients developed grade 3, and five patients developed grade 2 PPE.

Conclusions

Prophylactic use of vitamin B6 may not be useful with biweekly administrations at low dose (15–20 mg/m2) because of low frequency of PPE documented with this particular schedule.

Limitations

  • Small sample size
  • No randomization of patients
  • Low doses of PLD
  • Inadequate description of measurement tool/method to grade PPE symptoms; reliability and validity unclear