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
- Conditions
- cancercarcinoma10027655
- Registration Number
- NL-OMON44353
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
* Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal of 3 planned administrations) in a dose of 80-90 mg/m2
o Paclitaxel monotherapy
o Paclitaxel in combination with carboplatin
o Paclitaxel in combination with monoclonal antibodies:
* Bevacizumab
* 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
* 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, like:
o Cold sensitivity
o Cold agglutinin disease
o Cryoglobulinaemia
o Cryofibrinogenaemia
o Cold posttraumatic dystrophy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the efficacy of scalp cooling in patients treated with<br /><br>paclitaxel-containing chemotherapy with a 45- and 20-minutes post-infusion<br /><br>cooling time, in comparison with the standard 90 minutes and no scalp cooling,<br /><br>defined by the patient*s self-determined need to wear a wig or other head<br /><br>covering</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To determine the degree of chemotherapy-induced alopecia (CIA), assessed with<br /><br>the Dean scale for assessment of hair loss<br /><br>* To determine the grade of alopecia according to NCI CTCAE toxicity version<br /><br>4.03<br /><br>* To determine the tolerance of scalp cooling, assessed by a (self-adapted)<br /><br>visual analogue scale (VAS) of 0-10, in which 0 represented *not tolerable at<br /><br>all* and 10 meant *very tolerable*<br /><br>* To determine the added value of scalp cooling for weekly paclitaxel; what is<br /><br>the incidence of severe alopecia with and without scalp cooling<br /><br>* Compare the quality of life in patients who underwent scalp cooling versus<br /><br>those who did not and in patients with hair loss despite scalp cooling versus<br /><br>those with no hair loss, assed with the chemotherapy-induced alopecia distress<br /><br>scale (CADS)</p><br>