Shorter Scalp Cooling Time in Paclitaxel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2020-08-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasm Malignant Breast Cancer Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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45-minutes

45-minutes post-infusion cooling time

Group Type EXPERIMENTAL

Shorter PICT

Intervention Type OTHER

Shorter post-infusion cooling time

20-minutes

20-minutes post-infusion cooling time

Group Type EXPERIMENTAL

Shorter PICT

Intervention Type OTHER

Shorter post-infusion cooling time

No scalp cooling

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shorter PICT

Shorter post-infusion cooling time

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No