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Completed

NCT Number: NCT03266185

Shorter Scalp Cooling Time in Paclitaxel

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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Key information

Conditions

Neoplasm Malignant Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LUMC

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shorter PICT

Other

Shorter post-infusion cooling time

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03

    Time frame: up to 52 weeks

  3. To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)

    Time frame: up to 52 weeks

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study 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

Acronym: COP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2017
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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