Shorter Scalp Cooling Time in Paclitaxel (COP)

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Breast Cancer; Neoplasm Malignant; Ovarian Cancer

Treatments: Other: Shorter PICT

Study type: Interventional

Funder types: Other

Identifiers

NCT03266185

NL61964.058.17

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 3 patient groups

45-minutes

Experimental group

Description:

45-minutes post-infusion cooling time

Treatment:

Other: Shorter PICT

20-minutes

Experimental group

Description:

20-minutes post-infusion cooling time

Treatment:

Other: Shorter PICT

No scalp cooling

No Intervention group

Description:

Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia