Shorter Scalp Cooling Time in Paclitaxel

Breast Cancer Clinical Trial

— COP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266185
• Other study ID #: NL61964.058.17
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: August 28, 2020

Study information

• Verified date: March 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 28, 2020
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Neoplasm Malignant
• Neoplasms
• Ovarian Cancer

Intervention

Other:
• Shorter PICT
Shorter post-infusion cooling time

Locations

Country	Name	City	State
Netherlands	LUMC	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss		up to 52 weeks
Secondary	To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03		up to 52 weeks
Secondary	To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)		up to 52 weeks
Secondary	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
Secondary	Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)		up to 24 weeks