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NCT03266185: COP
Shorter Scalp Cooling Time in Paclitaxel
NA trial testing Shorter PICT in Neoplasm Malignant in 91 participants. Completed in 28 August 2020.
28 August 2020
Quick facts
| Lead sponsor | Leiden University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 91 |
| Start date | 20 December 2017 |
| Primary completion | 28 August 2020 |
| Estimated completion | 28 August 2020 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Shorter PICT
Conditions studied
- Neoplasm Malignant — all drugs for Neoplasm Malignant →
- Breast Cancer — all drugs for Breast Cancer →
- Ovarian Cancer — all drugs for Ovarian Cancer →
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):
-
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
Verify or expand the search:
- PubMed search for NCT03266185
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03266185 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Leiden University Medical Center
- Last refreshed: 1 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03266185.
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