Shorter Scalp Cooling Time in Paclitaxel (COP)

March 30, 2021 updated by: J.R. Kroep, Leiden University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: up to 52 weeks
up to 52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 20, 2017

Primary Completion (ACTUAL)

August 28, 2020

Study Completion (ACTUAL)

August 28, 2020

Study Registration Dates

First Submitted

August 26, 2017

First Submitted That Met QC Criteria

August 26, 2017

First Posted (ACTUAL)

August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 30, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL61964.058.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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