1% Topical Pimecrolimus Cream for the Prevention of Rash Associated With the Use of the EGFR Antagonist, Cetuximab
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.
研究概览
简要总结
When cancer patients are treated with the drug cetuximab they very often develop a rash. Usually it appears on their face and back and other parts of the body. The rash looks like acne and is treated with skin creams or antibiotics most of the time. The rash can become very painful and cause patients to stop using cetuximab to treat their cancer, even if cetuximab was helping fight their cancer.
Cetuximab is known to be a good drug to help treat cancer. This study will help us learn about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel) to see if it will help prevent the rash or keep the rash from getting worse. The investigators also want to see how the rash affects patients and their quality of life.
Participants will be in this study for about four weeks if their rash does not get worse. They will need to apply the study cream and placebo two times daily and answer quality of life questionnaires during this study. Participants will also be seen by a dermatologist and have pictures taken of their rash.
详细描述
Adult patients who are being treated with cetuximab for a malignancy will be offered the chance to take part in the study. Patients must provide written informed consent in order to participate in the study (including consent to clinical photographs).
The area of skin to be treated with investigational cream will be the face. Baseline photographs will be taken of the selected area of bilateral face.
Patients will be requested to apply a thin layer of the investigational cream twice daily to one half of face at the same time they are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. Patients will be provided the sufficient investigational cream free of charge for the duration of study. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator. The dermatologist and study investigators will remain blinded to the side to which the investigational cream was applied. In this manner, patients will serve as their own controls. Patients are free to use oral tetracyclines if recommended by their primary oncologists. Patients on the trial, however, cannot use another rash treatment with the exception of moisturizing agents.
Patients participating in the study will be instructed to apply a moisturizing cream, lotion, or ointment of their choice to the face three times a day. Moisturizers should be applied to the skin after, not before, the investigational cream application. Patients should not wet the treated area of skin for one hour after applying investigational cream, otherwise it could be washed off. The investigational cream should not be applied at or near the eyes. Patients on study will be instructed to minimize sun exposure and to avoid exposure to artificial sunlight. Patients should apply sunscreen to when exposed to sunlight, after the investigational cream has been completely absorbed into the skin.
Patients will be given a copy of the Dermatology Life Quality Index (DLQI) questionnaire and asked to complete it on all study visits. Patients will be given help to complete the questionnaire if needed. The questionnaire and its interpretation are listed in the appendix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Patient is starting treatment with cetuximab at the WVU Cancer Center
- •Patient has advanced (unresectable or metastatic) malignancy
- •Patient is expected to remain on cetuximab treatment for at least 2 weeks after enrollment on study.
- •Patients should be 18 years or older
- •Patients should not have a known contraindication to topical pimecrolimus therapy
- •Patients should have given written informed consent
- •Sexually active men and women of child bearing potential agree to use an effective method of contraception during study participation and for three months afterwards.
- •Negative pregnancy test for woman of child bearing potential
排除标准
- •Known allergy to topical pimecrolimus.
- •Patients with active or recent (within one month) infection in face
- •Psoriasis, eczema or others skin conditions not related to cetuximab involving face
- •Pregnant or nursing women
研究组 & 干预措施
Pimecrolimus on Left vs. Placebo on Right
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
干预措施: Pimecrolimus (Drug)
Pimecrolimus on Left vs. Placebo on Right
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
干预措施: Placebo (Drug)
Pimecrolimus on Right vs. Placebo on Left
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
干预措施: Pimecrolimus (Drug)
Pimecrolimus on Right vs. Placebo on Left
Patients will apply a thin layer of the Pimecrolimus cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.
时间窗: 2 weeks
To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.
次要结局
未报告次要终点