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Shorter Scalp Cooling Time in Paclitaxel (COP)

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ClinicalTrials.gov Identifier: NCT03266185
Recruitment Status : Recruiting
First Posted : August 30, 2017
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, 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.

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Breast Cancer Ovarian Cancer Other: Shorter PICT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 : December 20, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266185


Contacts
Contact: Rieneke Lugtenberg, MD +31715298408 r.t.lugtenberg@lumc.nl
Contact: Judith Kroep, MD, PHD +31715263464 j.r.kroep@lumc.nl

Locations
Netherlands
LUMC Recruiting
Leiden, Netherlands
Contact: Rieneke Lugtenberg, M.D.    +31712898408    r.t.lugtenberg@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center

Responsible Party: J.R. Kroep, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03266185     History of Changes
Other Study ID Numbers: NL61964.058.17
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by J.R. Kroep, Leiden University Medical Center:
paclitaxel-containing chemotherapy

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action