An interventional study of Shorter PICT in Neoplasm Malignant, Breast Cancer and Ovarian Cancer, sponsored by Leiden University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Supportive care
Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients. Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in patients treated with taxanes, up to 80-90%. Previous research has shown comparable results of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an advantage for both the patient, who can spend less time in the hospital, as well for the logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes, that share similar mechanisms of action and have comparable plasma terminal half-life times, therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients as well.
Exclusion Criteria:
45-minutes post-infusion cooling time
Other: Shorter PICT
20-minutes post-infusion cooling time
Other: Shorter PICT
Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia
Shorter post-infusion cooling time
To determine the efficacy of scalp cooling in patients treated with paclitaxel-containing chemotherapy with a 45- and 20-minutes post-infusion cooling time, defined by the patient's self-determined need to wear a wig or other head covering
Time frame: up to 52 weeks
To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss
Time frame: up to 52 weeks
To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03
Time frame: up to 52 weeks
To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)
Time frame: up to 52 weeks
To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling
Time frame: up to 52 weeks
Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)
Time frame: up to 24 weeks
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center