Phase II clinical trial
The aim of this trial is to compare the degree of efficacy, safety and tolerability of CG 428 cutaneous solution versus placebo on prevention of chemotherapy induced alopecia (CIA) in female patients with metastatic cancer treated with selected regimens inducing alopecia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
40
The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours
The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours
CHUV Lausanne
Lausanne, Switzerland
Rate of hair loss at different time points based of on Olsen's Visual Analog Scale (OVAS) and using the Severity of Alopecia Tool score (SALT score)
Physical examination of the scalp: skin AEs, hair status (alopecia graded according to CTCAE v.4.03.)
Time frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
Rate of grade 2 alopecia according to CTCAE v. 4.03.
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Time to reach grade 2 alopecia during chemotherapyaccording to CTCAE v. 4.03. .
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Time to recover to grade 1 and grade 0 according to CTCAE v. 4.03 after the last dose of the selected chemotherapy
CTCAE v. 4.03 : Common Toxicity Criteria for Adverse Event (skin toxicity)
Time frame: Every 3 weeks for 24 weeks.
Percent of hair loss according to OVAS (Olsen's visual analog scale) at different time points after the end of the chemotherapy.
Olsen's visual analog scale : visual aid for estimating percentage scalp hair loss.
Time frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
Adverse events based on the CTCAE 4.03.
Time frame: Every 3 to 8 weeks (variable). The following investigations will be performed every 3 to 4 weeks during the study treatment
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Patient's subjective assessment through questionnaire
Time frame: Every 3 weeks for 24 weeks.