A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Palmar-plantar erythrodysesthesia (PPE) resolution
研究概览
简要总结
This is a single-centre, phase II, three-arm, randomised controlled trial to evaluate the efficacy and safety of a cosmetic moisturising cream containing palm-oil-derived vitamin E concentrate or a similar moisturising cream without the vitamin E concentrate in addition to urea-based cream, or urea-based cream alone (1:1:1) in patients who are receiving capecitabine-based cancer therapy and develop capecitabine-associated PPE of NCI-CTCAE grade 1.
详细描述
In this study, cancer patients from Sarawak General Hospital who are receiving capecitabine-based therapy and develop PPE of NCI-CTCAE grade 1 will be recruited and randomised 1:1:1 to three study arms. The participants who are randomised to treatment arms will receive moisturising creams with or without palm-oil-derived vitamin E concentrate, in addition to urea-based cream for external application on palms and soles. Participants who are randomised to the control arm will be required to use urea-based cream only.
Both patients and investigators will be blinded to the investigational cream assignment i.e., double-blind. However, blinding will not be applicable to the use of urea cream i.e., open-label. The patients will need to use the cream(s) at least two times a day for nine to eighteen weeks or equivalent to three to six treatment cycles of capecitabine. At week-9, the patients who are planned to continue capecitabine therapy and do not develop PPE of grade 2/3 will continue to receive the study treatments for additional nine weeks or equivalent to three treatment cycles of capecitabine (extended period).
The patients will be assessed for their PPE grading, symptoms, dermatological quality of life, pain score, and adverse events at the end of each capecitabine treatment cycle at the clinic.
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, Investigator)
盲法说明
The use of the investigational creams, i.e. moisturising creams with or without vitamin E concentrate will be double-blinded. Both creams will be the same in colour, texture, packaging, and labelling. The patients, investigators, and blinded study personnel will blinded the patients' assignment of the investigational creams. On the other hand, the use of urea cream will be open-labelled.
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
- •18 years old and above
- •Able to give written consent freely
- •Receiving capecitabine at least 1 dose, as monotherapy or in combination therapy
- •Receiving urea-based cream
- •Developed PPE of NCI-CTCAE grade 1
- •Have at least three cycles of chemotherapy to complete
- •Life expectancy ≥ 6 months
排除标准
- •Unable to understand the information sheet and informed consent form
- •Allergy history towards vitamin E and its isoforms or any components of the investigational products
- •Unable to tolerate urea-based products
- •Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
- •PPE complicated with infection
- •Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions
- •Receiving long-term topical or systemic steroid treatment (except as part of pre-or post-medications of chemotherapy regime)
- •Pregnant or lactating mother
- •Participating in another interventional trial
- •Refuses to interrupt his/her usual care
- •Anticipated inability to follow-up
结局指标
主要结局
Palmar-plantar erythrodysesthesia (PPE) resolution
时间窗: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Number of participants who have resolved PPE (NCI-CTCAE grade 1 to 0)
次要结局
- Time-to-PPE resolution(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Overall adverse events(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Palmar-plantar erythrodysesthesia (PPE) worsening(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Time-to-PPE worsening(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Pain score (numerical scale of 1 to 10)(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Dermatology-related adverse events(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
- Dermatology Life Quality Index (0 - 30)(At Day 22, Day 43, Day 64, and Day 127 of cream treatment)
研究者
Voon Pei Jye
Medical Oncologist
Sarawak General Hospital