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

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 - COP

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44353

Enrollment

Registered

2017-12-19

Start date

2018-01-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer carcinoma

Interventions

Paclitaxel

Randomisation between a 45- and 20-minutes post-infusion cooling time

Chemotherapy-induced alopecia

Post-infusion cooling time

Scalp cooling

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal of 3 planned administrations) in a dose of 80-90 mg/m2 o Paclitaxel monotherapy o Paclitaxel in combination with carboplatin o Paclitaxel in combination with monoclonal antibodies: * Bevacizumab * 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

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, like: o Cold sensitivity o Cold agglutinin disease o Cryoglobulinaemia o Cryofibrinogenaemia o Cold posttraumatic dystrophy

Design outcomes

Primary

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, in comparison with the standard 90 minutes and no scalp cooling, defined by the patient*s self-determined need to wear a wig or other head covering	—

Secondary

Measure	Time frame
* To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the Dean scale for assessment of hair loss * To determine the grade of alopecia according to NCI CTCAE toxicity version 4.03 * To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS) of 0-10, in which 0 represented not tolerable at all and 10 meant very tolerable * To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling * Compare the quality of life in patients who underwent scalp cooling versus those who did not and in patients with hair loss despite scalp cooling versus those with no hair loss, assed with the chemotherapy-induced alopecia distress scale (CADS)	—

Measure

Time frame

* To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the Dean scale for assessment of hair loss * To determine the grade of alopecia according to NCI CTCAE toxicity version 4.03 * To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS) of 0-10, in which 0 represented *not tolerable at all* and 10 meant *very tolerable* * To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling * Compare the quality of life in patients who underwent scalp cooling versus those who did not and in patients with hair loss despite scalp cooling versus those with no hair loss, assed with the chemotherapy-induced alopecia distress scale (CADS)

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)