Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women With Breast Cancer Receiving Adjuvant Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Percent of patients developing modified Radiation Therapy Oncology Group(RTOG) Visual Assessment Score Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer
研究概览
简要总结
To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.
详细描述
Rationale
Radiation dermatitis is a common problem in a significant proportion of breast cancer patients. In addition, radiation dermatitis is a quantifiable complication which is relatively easily observed and graded according to modified Radiation Therapy Oncology Group (RTOG) criteria for toxicity. Radiation dermatitis is thought to be related to abrasion that degrades the keratinized skin surface. This results in decreased ability of skin stem cells to regenerate which leads to moist desquamation. A barrier film could potentially form a protective scaffold for new skin growth and repair. Cavilon No Sting Barrier Film (BF) has been shown in randomized trials involving post-mastectomy radiation patients to reduce the duration and frequency of radiation-induced moist desquamation. However, this treatment has not been studied in the statistically more prevalent situation of an intact breast. Therefore, we propose to investigate Cavilon to reduce side-effects of radiation treatment in intact breast cancer patients treated with conservative surgery and adjuvant radiation therapy.
2.0 STUDY OBJECTIVES 2.1 Primary Objectives To evaluate effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer. The grading of dermatitis will be obtained according to modified RTOG scale for visual assessment of radiation-induced skin erythema. This is attached as Appendix A. In addition, Skin Toxicity Assessment Tool (STAT) will also be used by the patient and physician validated against the quality of life tools and toxicity tools. This is attached as Appendix B.
2.2 Secondary Objectives Quality of Life The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be used to measure overall quality of life. Quality of life has been considered an important contributor to overall performance status and outcome. Quality of life consists of multiple components (e.g. physical, social, and psychological aspects, etc.). Improved quality of life translates into better outcomes, especially in the context of palliation. Global quality of life was found to be significantly associated with survival in a general population of cancer patients in Canada . In fact, many clinical trials in palliative care include improved quality of life for cancer patients as a primary outcome. The EORTC Quality of Life Questionnaire (QLQ-C30) was developed in Europe and is frequently used to measure quality of life and its related components . The EORTC QLQ C-30 is attached in appendix C.
Time to develop radiation dermatitis On each follow up visit, all patients will be assessed for development of any grade of radiation dermatitis. The time to develop grade I, II and or grade III radiation dermatitis will be calculated from the date of first dose of radiation therapy delivered to the date of visit at which the grade of dermatitis is observed. Time to additional treatment, i.e. over-the-counter or prescription interventions, will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
within patient randomization. One half of breast received Cavilon and other receives standard of care treatment. Care provider is blinded as to portion receiving treatment.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients between 18 and 80 years of age at the time of enrollment
- •Histopathologically or cytologically confirmed diagnosis of breast cancer
- •Completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection
- •Signed and dated ethics-approved informed consent form prior to any study procedures
- •Ability to comply with the requirements of the study
- •Scheduled adjuvant radiation therapy treatment
排除标准
- •Clinical or radiological evidence of local recurrence or metastatic disease
- •Previous history of radiation therapy to ipsilateral axilla and/or breast area
- •Planned boost of radiation Dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting
- •Any significant history or concurrent disease which, in the judgment of the Investigator would make the patient inappropriate for entry to this study
- •History of contraindications of radiation such as scleroderma
研究组 & 干预措施
3M Cavilon No Sting Barrier Film
Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.
干预措施: 3M Cavilon No Sting Barrier Film (Device)
Standard preparations
Standard treatment
干预措施: Standard Preparation (Drug)
结局指标
主要结局
Percent of patients developing modified Radiation Therapy Oncology Group(RTOG) Visual Assessment Score Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer
时间窗: 3 1/2 - 5 weeks of radiation treatment.
modified RTOG Visual Assessment Score
次要结局
- Time to develop modified Radiation Therapy Oncology Group Visual Assessment Score Grade I, II, and/or Grade III radiation dermatitis(3 1/2 - 5 weeks of radiation treatment.)
- Absolute cost of barrier film and standard treatment care(3 1/2 - 5 weeks)
研究者
Michael Lock
Principal Investigator
Lawson Health Research Institute