Shorter Scalp Cooling Time in Paclitaxel

Not Applicable

Completed

• Conditions: Ovarian Cancer; Breast Cancer; Neoplasm Malignant
• Interventions: Other: Shorter PICT

• Registration Number: NCT03266185
• Lead Sponsor: Leiden University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-26
• Study First Submitted QC: 2017-08-26
• Study First Posted: 2017-08-30
• Study Start: 2017-12-20
• Primary Completion: 2020-08-28
• Study Completion: 2020-08-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
45-minutes	Shorter PICT	45-minutes post-infusion cooling time
20-minutes	Shorter PICT	20-minutes post-infusion cooling time

Primary Outcome Measures

Name	Time	Method
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	up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling	up to 52 weeks
To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss	up to 52 weeks
To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)	up to 52 weeks
To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03	up to 52 weeks
Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)	up to 24 weeks

Trial Locations

Locations (1)

LUMC; 🇳🇱 Leiden, Netherlands