Shorter Scalp Cooling Time in Paclitaxel

Leiden University Medical Center91 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neoplasm Malignant Breast Cancer Ovarian Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

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

Shorter Scalp Cooling Time in Paclitaxel

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes