Shorter Scalp Cooling Time in Paclitaxel

NCT03266185CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Leiden University Medical Center

Enrollment

91

Start Date

2017-12-20

Completion Date

2020-08-28

Study Type

INTERVENTIONAL

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

Interventions

Shorter PICT

Conditions

Neoplasm MalignantBreast CancerOvarian Cancer

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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

Time frame: up to 52 weeks

Secondary Outcomes

To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss

Time frame: up to 52 weeks

To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03

Time frame: up to 52 weeks

To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)

Time frame: 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

Time frame: up to 52 weeks

Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)

Time frame: up to 24 weeks

Locations

LUMC, Leiden, Netherlands