Clinical trial NCT04833998: Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine
Official title: Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine: TACX Care Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hand-foot Syndrome
Keywords: Hand-foot Syndrome
Palmoplantar Erythrodysesthesia
Acral Erythema
Capecitabine
Moisturizing cream
Lead sponsor: Instituto Brasileiro de Controle do Cancer
Sponsor class: OTHER
Collaborators: name: Wecare Comércio de Cosméticos
First posted: 2021-04-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Changes in the signs of hand-foot syndrome
timeFrame: Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)
measure: Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
timeFrame: Up to 15 weeks
measure: Quality of Life as Measured by Dermatology Life Quality Index (DLQI)
timeFrame: Up to 15 weeks
measure: Incidence of cessation of capecitabine therapy
timeFrame: Up to 15 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: IBCC Oncologia
Study officials:
References: