Manon M C Komen1, Wim P M Breed2, Carolien H Smorenburg3, Tjeerd van der Ploeg4, S H Goey5, Jacobus J M van der Hoeven6, Johan W R Nortier6, Corina J G van den Hurk7. 1. Department of Internal Medicine and Medical Oncology, Medical Centre Alkmaar, PO Box 501, 1800, AM, Alkmaar, The Netherlands. manon.komen@mca.nl. 2. Give Hair a Chance Foundation, Research Department, Knowledge Institute Scalp Cooling, PO Box 231, 5600, AE, Eindhoven, The Netherlands. 3. Department of Medical Oncology, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, CX, Amsterdam, The Netherlands. 4. Science Department, Medical Centre Alkmaar, PO Box 501, 1800, AM, Alkmaar, The Netherlands. 5. Department of Internal Medicine, Twee Steden ziekenhuis, Dr. Deelenlaan 5, 5042, AD, Tilburg, The Netherlands. 6. Department of Medical Oncology, Leiden University Medical Centre, PO Box 9600, 2300, RC, Leiden, The Netherlands. 7. Research Department, The Netherlands Comprehensive Cancer Organisation, PO Box 231, 5600, AE, Eindhoven, The Netherlands.
Abstract
PURPOSE: For patients, chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of treatment. Scalp cooling can prevent or minimise CIA; the results may depend on the duration of cooling. Since a previous study on post-infusion cooling time in patients treated withdocetaxel chemotherapy found no difference between 90 and 45 min, we investigated whether hair-preserving results could be maintained with a shorter post-infusion cooling time. METHODS: In this prospective, multi-centre randomised study, 134 patients who started treatment with docetaxel 75-100 mg/m(2) in a 3-weekly schedule were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 45 or 20 min. The primary end point was the need for a wig or other head covering as assessed by the patient. A visual analogue scale (VAS) with a range from 0 (not tolerable) to 10 (very tolerable) was used to measure tolerance. RESULTS: Scalp cooling results were similar for 45- and 20-min post-infusion cooling times. Thirty-three out of 45 patients (73 %) treated with 20 min of post-infusion cooling did not need a form of head covering, compared with 41 out of 52 patients (79 %) treated with 45 min of post-infusion cooling (p = 0.5). The procedure was well tolerated (mean visual analogue score 8.3). Six patients stopped due to intolerance during the first treatment cycle. CONCLUSIONS: A 20-min post-infusion cooling time is effective and tolerable for patients treated with scalp cooling to prevent docetaxel-induced alopecia. TRIAL REGISTRATION: Trialregister.nl Identifier, NTR 1856.
RCT Entities:
PURPOSE: For patients, chemotherapy-induced alopecia (CIA) is one of the most distressing side effects of treatment. Scalp cooling can prevent or minimise CIA; the results may depend on the duration of cooling. Since a previous study on post-infusion cooling time in patients treated with docetaxel chemotherapy found no difference between 90 and 45 min, we investigated whether hair-preserving results could be maintained with a shorter post-infusion cooling time. METHODS: In this prospective, multi-centre randomised study, 134 patients who started treatment with docetaxel 75-100 mg/m(2) in a 3-weekly schedule were randomly assigned in a 1:1 ratio to a post-infusion cooling time of 45 or 20 min. The primary end point was the need for a wig or other head covering as assessed by the patient. A visual analogue scale (VAS) with a range from 0 (not tolerable) to 10 (very tolerable) was used to measure tolerance. RESULTS:Scalp cooling results were similar for 45- and 20-min post-infusion cooling times. Thirty-three out of 45 patients (73 %) treated with 20 min of post-infusion cooling did not need a form of head covering, compared with 41 out of 52 patients (79 %) treated with 45 min of post-infusion cooling (p = 0.5). The procedure was well tolerated (mean visual analogue score 8.3). Six patients stopped due to intolerance during the first treatment cycle. CONCLUSIONS: A 20-min post-infusion cooling time is effective and tolerable for patients treated with scalp cooling to prevent docetaxel-induced alopecia. TRIAL REGISTRATION: Trialregister.nl Identifier, NTR 1856.
Entities:
Keywords:
Alopecia; Chemotherapy; Docetaxel; Scalp cooling; Side effects
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