Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2021-12-31

Brief Summary

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Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL).

The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS.

It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome.

The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.

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Detailed Description

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The research product, proposed in this study, was developed to meet the specific hydration needs of patients undergoing cancer treatment and is produced from nine main ingredients with natural moisturizing actions based on glycerin, hazelnut extract, shea butter, aloe vera, calendula, chamomile and oat extract and 2 antioxidants (vitamin E and Thoitaine), dermatologically tested and approved. The choice of the product was based, mainly, due to its natural components, whose data from previous studies were extrapolated from radiodermatitis.

Conditions

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Hand-foot Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The allocation ratio is 2:1, favouring the active treatment. In this study we are using unequal allocation ratios for a variety of reasons, including allowance for learning curves, and ethical considerations when the balance of existing evidence appears to be in favour of one intervention over the placebo.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo will be cream without the active ingredient. It will be matched in appearance, smell, consistency, and color to Extremecare topical cream. Patients will be instructed to apply the placebo cream to the hand and feet.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.

Extremecare

Extremecare is a moisturizing cream based on Thoitaine, Aloe Vera and Calendula for topical use. Patients will be instructed to apply the moisturizing cream to the hand and feet.

Group Type EXPERIMENTAL

Extremecare

Intervention Type DRUG

The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.

Interventions

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Extremecare

The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.

Intervention Type DRUG

Placebo

Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥18 years of age
* Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
* Indication of adjuvant or palliative treatment with capecitabine
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Information of the patient and signature of the informed consent form by the patient or her legal representative.

Exclusion Criteria

* Previous chemotherapy with capecitabine
* Pre-existing patients with neuropathies
* Patients with known allergic reactions to any of the ingredients of the investigational product
* Patients with dermatological conditions that affect the hands or feet
* Patients with rectal neoplasia and indication for neoadjuvant treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No