Daniel C Betticher1, Geoffrey Delmore, Urs Breitenstein, Sandro Anchisi, Beatrice Zimmerli-Schwab, Andreas Müller, Roger von Moos, Anne Marguerite Hügli-Dayer, Hubert Schefer, Sereina Bodenmann, Vera Bühler, Ralph R Trueb
1Clinics of Medical Oncology, HFR Fribourg Cantonal Hospital, Fribourg, Switzerland.
The aim of this trial was to investigate two options of scalp cooling treatments and assess the tolerance and efficacy. This study was a nonrandomised, prospective, controlled study on 238 patients across 27 facilities in Switzerland. Data were collected at the screening visit, treatment visits and at an end of study visit. Hair loss was graded against the World Health Organisation’s (WHO) scale for alopecia (0 = no hair loss; 1 = mild; 2 = pronounced; 3 = total, reversible alopecia, 4 = total, irreversible alopecia). The scalp cooling patients were also asked to complete an additional questionnaire including questions about tolerance, side effects, hair loss, hair regrowth and general impression of treatment.
Method of scalp cooling: Paxman Scalp Cooler (PSC-2) (PAX) or a cold cap (CC). The treatment was deemed a success if the patient did not need to wear a wig at the end of treatment.
Drug regimens: docetaxel 55-60mg/day on weekly basis or 135- 140mg/day on three-weekly basis. Patient tolerability was measured on a visual analogue scale of 1-10 where 0 was intolerable and 10 was very tolerable.
All patients received docetaxel palliative, first-line chemotherapy for a solid tumour. 238 patients took part in the trial (128 – PAX, 71 – CC, 39 – no cooling). The cooling protocol was amended during the study. September 2009: the post-infusion cooling time for both the CC and PAX groups was reduced from 90 to 45 minutes due to new research (van den Hurk et al., 2012a). September 2010: inclusion criteria were updated to include patients with metastases treated with docetaxel-based regimens.
No significant difference was found for hair retention between the CC and PAX groups. The patients being treated on a weekly basis with docetaxel showed a lower incidence of CIA than patients treated on a three-weekly basis.
93.7% of patients rated their scalp cooling treatment as reasonably well or better when using the Paxman Scalp Cooler. 8 patients from the scalp cooled groups reported adverse events; most prominently, a cold sensation.
30 patients (13%) discontinued scalp cooling after cycle 1. Limitations: This study was open and unrandomized therefore patients could have been biased when choosing their method of treatment. The grading of alopecia against the WHO scale is subjective, as is the choice to wear a wig. The protocol used in this trial is now slightly outdated as the protocol for scalp cooling recommended by Paxman has been updated to a longer pre-cooling time (30 minutes) and shorter post cooling time (20 minutes).
