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Randomized Controlled Trial
. 2022 Aug;30(8):6641-6648.
doi: 10.1007/s00520-022-07090-7. Epub 2022 May 2.

Comparable effectiveness of 45- and 20-min post-infusion scalp cooling time in preventing paclitaxel-induced alopecia - a randomized controlled trial

Affiliations
Randomized Controlled Trial

Comparable effectiveness of 45- and 20-min post-infusion scalp cooling time in preventing paclitaxel-induced alopecia - a randomized controlled trial

Rieneke T Lugtenberg et al. Support Care Cancer. 2022 Aug.

Abstract

Purpose: Scalp cooling can prevent chemotherapy-induced alopecia (CIA). Previously, the post-infusion cooling time (PICT) could be successfully reduced in docetaxel-treated patients from 90 to 45 and 20 min. Therefore, it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well.

Methods: Patients treated with weekly paclitaxel were included in this multi-centre trial and randomly assigned to a PICT of 45 or 20 min. The results were compared to a standard PICT of 90 min, derived from prospective collected data from the Dutch Scalp Cooling Registry. The primary endpoint was the percentage of patients who decide to not wear a wig or head covering. Secondary endpoints were the degree of CIA assessed with the Dean scale for assessment of hair loss; alopecia graded according to NCI CTC toxicity version 4.03 (CTCAE4.03); tolerance of scalp cooling and perceived distress of CIA.

Results: Ninety-one patients were enrolled in this study; 74 patients were evaluable for hair loss. Hair preservation was successful in 27 patients (75%) with a PICT of 45 min and in 31 patients (82%) with a PICT of 20 min. There was no difference in success rate with the standard PICT of 90 min (85%, p = 0.29). Similar success rates were seen when using the Dean scale and CTCAE assessment, with no differences between groups (p = 0.12 and p = 0.38).

Conclusions: A 20 min PICT is as effective as 45 and 90 min to prevent weekly paclitaxel-induced alopecia and should be the new standard of care.

Trial register: ClinicalTrials.gov Identifier: NCT03266185.

Keywords: Alopecia; Chemotherapy-induced alopecia distress scale (CADS); Paclitaxel; Randomized controlled trial; Scalp cooling.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow diagram. PICT, post-infusion cooling time
Fig. 2
Fig. 2
Severity of CIA distress measured with the CADS questionnaire. A Differences between 45- and 20-min PICT. B Differences between successful and not successful scalp cooling. CIA, Chemotherapy-induced alopecia; CADS, chemotherapy-induced alopecia distress scale; PICT, post-infusion cooling time

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