Ice Plant Intensive Cream for the Prevention of Hand-Foot Syndrome in Breast Cancer: Pilot Randomized Controlled Trial (WIn-HFS)

University Hospital Tuebingen

Status

Completed

Conditions

Breast Cancer

Hand-Foot Syndrome

Treatments

Other: Ice Plant Intensive Cream plus Standard Care

Other: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT05755646

S00748-NIM

Details and patient eligibility

About

The present pilot study investigates the feasibility of a prospective larger confirmatory study on the efficacy of Dr. Hauschka Med Ice Plant Intensive Cream for the prevention of hand-foot syndrome in patients with breast carcinoma undergoing therapy with doxorubicin and / or docetaxel.

Enrollment

36 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Breast cancer patients
Therapy with Doxorubicin and/or Docetaxel
Karnofsky performance status scale > 80
Informed consent

Exclusion criteria

Patients with previous skin disease and/or polyneuropathy
Intolerance or allergic reaction on at least one ingredient of Ice Plant Intensive Cream
Already receiving chemotherapy
Usage of Ice Plant Intensive Cream before trial
Severe physical or psychological illness due to which the patient is not able to participate in the study
Lack of German language skills

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

36 participants in 2 patient groups

Ice Plant Intensive Cream plus Standard Care

Experimental group

Description:

This group receives a 30-minute nursing consultation on the standard treatment and on the use of the Ice Plant Intensive Cream for the prevention of hand-foot syndrome.

Treatment:

Other: Ice Plant Intensive Cream plus Standard Care

Standard Care

Active Comparator group

Description:

This group receives a 30-minute nursing consultation on the standard treatment for the prevention of hand-foot syndrome.

Treatment:

Other: Standard Care