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NCT03266185: COP

Shorter Scalp Cooling Time in Paclitaxel

Completed NA Last updated 1 April 2021
What this trial tests

NA trial testing Shorter PICT in Neoplasm Malignant in 91 participants. Completed in 28 August 2020.

Timeline
20 December 2017
Primary endpoint
28 August 2020
28 August 2020

Quick facts

Lead sponsorLeiden University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment91
Start date20 December 2017
Primary completion28 August 2020
Estimated completion28 August 2020
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Neoplasm Malignant or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparable effectiveness of 45- and 20-min post-infusion scalp cooling time in preventing paclitaxel-induced alopecia - a randomized controlled trial.
    Lugtenberg RT, van den Hurk CJG, Smorenburg CH, Mosch L, et al · · 2022 · cited 3× · PMID 35501515 · DOI 10.1007/s00520-022-07090-7

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Other recruiting trials for Neoplasm Malignant

Currently open trials in the same condition.

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Data sources for this page

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