Breast Neoplasms, Hand-Foot Syndrome, Skin Cream
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial with two arms, involving a total of 78 participants equally distributed into two groups.
Experimental group: 39 women with breast cancer
J01.516.213.249
Sponsors
Universidade Federal de São João del-Rei
Hospital São João de Deus Fundação Geraldo Corrêa
Eligibility
Sex/Gender
Female
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Women; aged between 18 and 59 years; taking oral capecitabine (Xeloda®); who agree to participate in the study after reading the Informed Consent Form (FICF); who present a medical referral for participation in the proposed protocol; who do not report previous allergic reactions to cosmetics; who present mental conditions suitable for participation in the study, as assessed using the Mini Mental Scale
Exclusion criteria
Exclusion criteria: Patients diagnosed with breast cancer who do not use oral capecitabine (Xeloda®); Clinical condition that makes it unsafe to participate in a group setting (e.g., severe neutropenia); Report allergy to the use of cosmetics; Patients who use capecitabine (Xeloda®) concomitantly with radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the incidence and severity of hand-foot syndrome in cancer patients undergoing capecitabine-based chemotherapy. The assessment will be performed based on clinical scales that have already been validated at regular intervals throughout the treatment. The reduction in the severity of hand-foot syndrome in the intervention group that will use the specific moisturizing cosmetic will be compared to the control group that uses the control moisturizing cosmetic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include the improvement in the quality of life of patients assessed by standardized questionnaires applied at regular intervals; the comparison of the time of onset of hand-foot syndrome between the two groups; the assessment of adherence to treatment with specific moisturizing cosmetic or control moisturizing cosmetic; and the prevention of the need to reduce the dose or interrupt treatment with capecitabine due to toxicity | — |
Countries
Brazil
Contacts
Public ContactMariana;Ana Carolina Pereira;de Oliveira
Universidade Federal de São João del-Rei;Hospital São João de Deus Fundação Geraldo Corrêa
Outcome results
None listed