Get access

A randomized phase II trial of indole-3-carbinol in the treatment of vulvar intraepithelial neoplasia

Authors

  • R. NAIK,

    Corresponding author
    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author
  • S. NIXON,

    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author
  • A. LOPES,

    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author
  • K. GODFREY,

    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author
  • M.H. HATEM,

    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author
  • J.M. MONAGHAN

    1. *Northern Gynaecological Oncology Centre; and †Department of Haematology, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, United Kingdom
    Search for more papers by this author

Address correspondence and reprint requests to: Mr. Raj Naik, Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, NE9 6SX, UK.

Abstract

The aim of this study was to determine the potential therapeutic benefits of indole-3-carbinol (I3C) in the management of vulvar intraepithelial neoplasia (VIN). Women with histologically confirmed high-grade VIN were randomized to receive 200 and 400 mg/day of I3C. Symptomatology by visual analog scale and vulvoscopic appearance were assessed at recruitment, 6 weeks, 3 months, and 6 months. Tissue biopsy to determine histologic response was obtained at completion of the study period. Urine samples were obtained at each visit to determine 2-hydroxyestrone to 16-alpha-hydroxyestrone ratios. Data from 12 women were suitable for analysis. There was a significant improvement in symptomatology with the introduction of I3C (itch, P= 0.018; pain, P= 0.028). Lesion size and severity were also significantly reduced (size, P= 0.005; appearance, P= 0.046). In addition, there was a significant increase in 2-hydroxyestrone to 16-alpha-hydroxyestrone ratio following commencement of I3C, P= 0.05. However, tissue biopsy from the worst-affected vulval areas revealed no improvement in grade of VIN during the 6-month period, P= 0.317. There were no significant differences in results between those women taking 200 mg/day of I3C and those on 400 mg/day. This study has shown significant clinical improvement in symptomatology and vulvoscopic appearance of VIN with I3C therapy. Further clinical and scientific investigations are required to support these preliminary findings.

Ancillary