COP: Shorter Scalp Cooling Time in Paclitaxel

Sponsor

Leiden University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03266185

Collaborator

(none)

Enrollment

Location

Arms

32.3

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Malignant Breast Cancer Ovarian Cancer	Other: Shorter PICT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Dec 20, 2017

Actual Primary Completion Date :

Aug 28, 2020

Actual Study Completion Date :

Aug 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 45-minutes 45-minutes post-infusion cooling time	Other: Shorter PICT Shorter post-infusion cooling time
Experimental: 20-minutes 20-minutes post-infusion cooling time	Other: Shorter PICT Shorter post-infusion cooling time
No Intervention: No scalp cooling Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia

Arm

Intervention/Treatment

Experimental: 45-minutes

45-minutes post-infusion cooling time

Other: Shorter PICT

Shorter post-infusion cooling time

Experimental: 20-minutes

20-minutes post-infusion cooling time

Other: Shorter PICT

Shorter post-infusion cooling time

No Intervention: No scalp cooling

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

Outcome Measures

Primary Outcome Measures

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

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 grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03 [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 added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LUMC	Leiden		Netherlands

Sponsors and Collaborators

Leiden University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

J.R. Kroep, MD, PhD, Leiden University Medical Center

ClinicalTrials.gov Identifier:

NCT03266185

Other Study ID Numbers:

NL61964.058.17

First Posted:

Aug 30, 2017

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by J.R. Kroep, MD, PhD, Leiden University Medical Center

paclitaxel-containing chemotherapy

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Apr 1, 2021