Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 45-minutes | Experimental | 45-minutes post-infusion cooling time |
|
| 20-minutes | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shorter PICT | Other | Shorter post-infusion cooling time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss | up to 52 weeks | |
| To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03 | up to 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LUMC | Leiden | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501515 | Derived | Lugtenberg RT, van den Hurk CJG, Smorenburg CH, Mosch L, Houtsma D, Deursen MAGDH, Kaptein AA, Gelderblom H, Kroep JR. Comparable effectiveness of 45- and 20-min post-infusion scalp cooling time in preventing paclitaxel-induced alopecia - a randomized controlled trial. Support Care Cancer. 2022 Aug;30(8):6641-6648. doi: 10.1007/s00520-022-07090-7. Epub 2022 May 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS) | 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 | up to 52 weeks |
| Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS) | up to 24 weeks |
| D004701 |
| Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |