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

Instituto Brasileiro de Controle do Cancer

Status and phase: Unknown; Phase 2

Conditions: Hand-foot Syndrome

Treatments: Drug: Placebo; Drug: Extremecare

Study type: Interventional

Funder types: Other

Identifiers

NCT04833998

01629018.1.0000.0072

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Extremecare

Experimental group

Description:

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.

Treatment:

Drug: Extremecare