Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Palmo planar erythrodysesthesia grade
研究概览
简要总结
A cytotoxic complication caused by chemotherapy is hand-foot syndrome, also known as palmar-plantar erythrodysesthesia (PPE). The mechanism is not yet clear, but it is thought that the chemotherapeutic agent generates cytotoxicity on the acral epidermis. Clinically it manifests as erythema and edema on the palms of the hands and feet, dry and scaly skin, accompanied by a sensation of tightness and pain. Extreme cases present blisters and ulcerations that may require hospitalization. It can also be accompanied by paresthesias. The main objective will be to evaluate if photobiomodulation is effective in reducing PPE induced by Capecitabine and 5-Fluorouracil chemotherapy.
It will be a 4 week treatment, with 2 groups: G1 - Moisturizing cream and Photobiomodulation; G2: Moisturizing cream and photobiomodulation sham.
详细描述
Methodology: randomized, controlled, double-blind, single-center clinical trial. The study population (40 participants) will be divided into two groups - Group 1: moisturizer plus LED (light emitting diode) treatment and Group 2: moisturizer plus LED sham treatment. For the application of LED light, Antares (ibramed) with P2 LED cluster (630 nm) will be applied twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks.
The Palmar-plantar Erythrodysesthesia (PPE) degree is the main outcome while the secondary outcomes are the data referring to the chemotherapy treatment plan (Chemotherapy dose, need of reducing drug dose or interrupting the treatment) and also the quality of life by using Hand-foot syndrome (HSF) questionnaire - HSF-14 and dermatology Life Questionnaire Index (DLQI). PPE grade and chemotherapy plan will be measured prior to the start of treatment with photobiomodulation, in the middle and at the end of it. Quality of life questionnaires (HFS-14 - Hand-foot syndrome and DLQI - dermatology Life Questionnaire Index) will be applied at the beginning and at the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age,
- •hospitalized or outpatients,
- •with oncological pathology (confirmed by anatomo-pathological or cytological diagnosis)
- •undergoing chemotherapy treatment (oral capecitabine and 5-Fluorouracil in continuous infusion, following the treatment plans protocolized by the institution: Xelox Bevacizumab, Capecitabine, Capecitabine + Radiotherapy, Folfoxiri, Xeliri-Bevacizumab, Folfox4-Bevacizumab , Docetaxel-CDDP-5-Fluorouracil (Colony Stimulating Factors), mFolfirinox q/14 days, Flot.)
- •who develop hand-foot syndrome of greater or equal toxicity to 1 on the CTC scale NCI v. 5.0 and on Saif scale. Et al. for dark skin
排除标准
- •Patients with palmo-plantar skin comorbidities,
- •autoimmune comorbidities,
- •amputated limbs,
- •systemic infection,
- •localized or regional limb infection,
- •respiratory isolation,
- •contact isolation
- •insulin-requiring diabetics.
结局指标
主要结局
Palmo planar erythrodysesthesia grade
时间窗: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
3 Epp grades were stablished by CTC NCI being: Grade 1 - Minimal palmoplantar skin changes, without pain (erythema, edema, hyperkeratosis),; grade 2 - Skin changes (scaling, blisters, fissures, edema, hyperkeratosis) with pain, limiting instrumental activities; grade 3 - Severe skin changes (scaling, blisters, fissures, edema, hyperkeratosis, bleeding), with pain..
次要结局
- Need of interrupting chemotherapy(Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28))
- Questionnaire(Follow up (day 60))
- Peripheral Sensory Neuropathy World Health Organization (WHO) Scale(Before treatment ( Day 0) and the end of the treatment (Day 28))
- DLQI(Before treatment ( Day 0) and the end of the treatment (Day 28))
- Need of reducting chemotherapy dose(Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28))
- HSF-14(Before treatment (Day 0) and at the end of the treatment (Day 28))
- Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale(Before treatment ( Day 0) and the end of the treatment (Day 28))
- Chemotherapy dose(Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28))
研究者
Christiane Pavani
Clinical Professor
University of Nove de Julho