Treatment of Palmar-Plantar Erythrodysesthesia (PPE) in gynecologic oncology with Mapisal® - an interventional, prospective, randomized, double-blind, placebo-controlled intergroup trial of the AGO and NOGGO Study Group - AGO-PRO 2

AGO Research GmbHAGO Studiengruppe0 个研究点目标入组 15 人开始时间: 2017年2月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•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

发起方

AGO Research GmbHAGO Studiengruppe