Clinical trial NCT03266185: Shorter Scalp Cooling Time in Paclitaxel
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasm Malignant
Breast Cancer
Ovarian Cancer
Keywords: paclitaxel-containing chemotherapy
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 52 weeks
Secondary outcomes:
measure: To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss
timeFrame: up to 52 weeks
measure: To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03
timeFrame: up to 52 weeks
measure: To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)
timeFrame: up to 52 weeks
measure: To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling
timeFrame: up to 52 weeks
measure: Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
References:
citation: 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.