Prospective, Multi-centre Trial to Evaluate Effectiveness of 45-min and 20-min Post-infusion Cooling Time for Patients Treated With Scalp Cooling to Prevent Paclitaxel-induced Alopecia
| Registry | NCT03266185, acronym COP |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 91 (Actual) |
| Sponsor | Leiden University Medical Center (Other) |
| Conditions | Neoplasm Malignant, Breast Cancer, Ovarian Cancer |
| Interventions | Shorter PICT (Other) |
| Dates | start 2017-12-20, primary completion 2020-08-28, completion 2020-08-28, first posted 2017-08-30, last updated 2021-04-01 |
| Locations | 1 site in Netherlands |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 45-minutes | Experimental | Other: Shorter PICT | 45-minutes post-infusion cooling time |
| 20-minutes | Experimental | Other: Shorter PICT | 20-minutes post-infusion cooling time |
| No scalp cooling | No intervention | Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal 3 planned administrations) in a dose of 80-90 mg/m2 Paclitaxel monotherapy, Paclitaxel in combination with carboplatin, Paclitaxel in combination with monoclonal antibodies: Bevacizumab or Trastuzumab * Age ≥ 18 years * WHO performance status 0-2 * Survival expectation must be > 3 months * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * Treatment with paclitaxel in sequential schemes with other alopecia inducing agents such as paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel monotherapy after 5-fluouracil, epirubicin, cyclophosphamide (FEC) treatment * Alopecia before the start of the study * Rare cold-related disorders: Cold sensitivity, Cold agglutinin disease, Cryoglobulinaemia, Cryofibrinogenaemia, Cold posttraumatic dystrophy
| Facility | City | Country | Status |
|---|---|---|---|
| LUMC | Leiden | Netherlands |