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
- Conditions
- breast cancer or gynaecological solid tumorsL27.1Localized skin eruption due to drugs and medicaments
- Registration Number
- DRKS00011255
- Lead Sponsor
- AGO Research GmbHAGO Studiengruppe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 15
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of grade II/III PPE under the application of Mapisal® in comparison to placebo within the following 2 chemotherapy<br>cycles with PLD.
- Secondary Outcome Measures
Name Time Method · The feasibility of systemic therapy by PPE<br> - Incidences of PPE - related dose reductions / interval prolongation and discontinuation of therapy during the two PLD cycles following randomization<br>· Incidence of all PPE – grade = I during the two PLD cycles following randomization<br>· The rate of progress and timing of onset of PPE<br>· PRO: Between group comparisons of the 3 subscales of Skindex-16 at visit 3 before administration of chemotherapy, and longitudinally over visits 1-5