Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine: TACX Care Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Extremecare (Drug)
结局指标
主要结局
Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.
时间窗: Up to 15 weeks
Number of Patients who developed Hand-foot Syndrome (HFS) by Toxicity Grade. The incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 for all patients assigned who received at least 1 cycle of capecitabine. Investigators assess and fill the grading into the case report form every visit.
次要结局
- Incidence of cessation of capecitabine therapy(Up to 15 weeks)
- Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.(Up to 15 weeks)
- Changes in the signs of hand-foot syndrome(Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days))
- Quality of Life as Measured by Dermatology Life Quality Index (DLQI)(Up to 15 weeks)
研究者
Flavia Viecili Tarcha
Principal Investigator
Instituto Brasileiro de Controle do Cancer