NCT00992706

F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer

Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer. PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

Detailed description

OBJECTIVES: * Evaluate the effects of F511 cream on the occurrence of palmar-plantar erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin hydrochloride. OUTLINE: This is a multicenter study. Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on 1, 2, or 4 weeks course schedules with at least 10 mg/m\^2 per week allowed. Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the other side hand and foot once daily (the morning) during the first week of the first pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times per week thereafter. Treatment continues throughout chemotherapy administration in the absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2 After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥ grade 2 are followed until the PPE resolves to ≤ grade 1.

Conditions

• Breast Cancer
• Palmar-plantar Erythrodysesthesia

Interventions

Type	Name	Description
DRUG	antiperspirant cream F511	Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.
DRUG	pegylated liposomal doxorubicin hydrochloride	According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-08-01
• Completion: 2012-06-01
• First posted: 2009-10-09
• Last updated: 2019-05-15

Locations

15 sites across 1 country: Switzerland