breast cancer or gynaecological solid tumors L27.1
Conditions
Interventions
Group 1: Mapisal®-ointment for treatment of skin
Group 2: Placebo for treatment of skin
Sponsors
AGO Research GmbHAGO Studiengruppe
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Patients = 18 years 3. Breast cancer or gynaecological solid tumors with the need for systemic therapy 4. Systemic therapy with PLD mono or combination chemotherapy 5. Occurrence of PPE grade II or III (acc.tp CTCAE v4.03) in the previous cycle of PLD treatment which has resolved to grade 0/I at baseline evaluation 6. Planned at least 2 or more cycles with PLD 7. Women of childbearing capacity are required to have a negative serum pregnancy test or a negative urine pregnancy test before treatment and must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the 6 months after the study. If abstinence is not practiced, combination of hormonal contraceptive (either oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used 8. Patient is able to understand the content of the study and to follow the study visits
Exclusion criteria
Exclusion criteria: 1. Dermatological disease of hands and/or feet which could influence the results of the study, such as atopic dermatitis, eczema, fungal infections, psoriasis, pustulosis, viral and bacterial infections, connective tissue diseases, genodermatoses, rosacea, erythema multiforme, urticaria, epidermolysis bullosa, perniosis, vitiligo 2. Pregnant or breast feeding patients 3. Current participation or within 2 months before baseline in clinical trial with PPE treatment indication 4. Simultaneous initiation of therapy with other agents for the treatment of PPE or use of agents for the prophylaxis of PPE 5. Prior treatment with Mapisal® within 2 months before baseline 6. Allergy to any ingredients of Mapisal® or Placebo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade II/III PPE under the application of Mapisal® in comparison to placebo within the following 2 chemotherapy cycles with PLD. | — |
Secondary
| Measure | Time frame |
|---|---|
| · The feasibility of systemic therapy by PPE - Incidences of PPE - related dose reductions / interval prolongation and discontinuation of therapy during the two PLD cycles following randomization · Incidence of all PPE – grade = I during the two PLD cycles following randomization · The rate of progress and timing of onset of PPE · PRO: Between group comparisons of the 3 subscales of Skindex-16 at visit 3 before administration of chemotherapy, and longitudinally over visits 1-5 | — |
Countries
Germany
Contacts
Public ContactGabriele Elser
AGO Research GmbH, AGO Studiengruppe
Outcome results
None listed