Effect on Fatigue of Light (Lux) Therapy in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Assessment of change of Tiredness: PIPER Score
研究概览
简要总结
Fatigue is a symptom most commonly associated with the diagnosis of cancer. Fatigue often appears before the diagnosis of cancer, is increasing during treatment with chemotherapy and persists for years after treatment in more than 35% of patients. Fatigue is the earliest and most important symptom described by cancer patients. Its prevalence in cancer chemotherapy patients is between 70 and 100%. Fatigue is more common to cancer patients and to the general population or other types of patients. Typically described as a lack of energy associated with mental disorders, fatigue related to cancer can be extremely debilitating. The causes are many, mainly including the cancer itself, side effects due to treatment, sleeplessness due to pain, anxiety or depression. The cancer-related fatigue has a negative and significant direct impact on all aspects of the patient's quality of life, especially the physical, social and behavioral. Despite the availability of certain treatments and the advanced biomedical research, fatigue remains an inevitable consequence of cancer and its treatment.
The therapeutic use of natural light in medicine dates back to the late nineteenth century. Its remarkable effect on the stimulation of the immune system and fight against infections caused the development of the first therapy techniques (also called luxthérapie) awarded in 1903 by the Nobel Prize in medicine and physiology. Light plays a fundamental role in the regulation of circadian rhythms and homeostatic. The mechanism of action passes through a path "non-visual" involving melanopsin ganglion cells located in the retina. Activation of the pineal gland (epiphysis) by melanopsin cells allows transduce information "shadow and light" in melatonin synthesis from serotonin. Today, the effectiveness of the therapy is well established for treating fatigue-related disorders such as chronic fatigue, seasonal depression or seasonal or non-certain sleep disorders and in which the melatonin metabolism is disturbed. Light therapy, by its mechanism of action, allows reprogramming "of the biological clock and improved synchronization of circadian rhythms.
详细描述
Hypotheses
Some studies have shown an inverse relationship between cancer-related fatigue and the time of exposure to natural light for cancer patients. This association suggests the existence of a vicious circle of side effects of chemotherapy (physical fatigue and moral), itself causing a decrease in outdoor activity and therefore a reduction of the light exposure time natural. This results in a strengthening of the initial patient's state of fatigue. In an interesting way, vitamin D synthesized in large part due to light plays a cancer protective role], especially in the prevention and treatment of pancreatic cancer for example. Furthermore and paradoxical way, the disruption of circadian rhythms is correlated to the development and tumor progression in vitro, in vivo tumor growth and incidence of cancer in humans.
Notoriously, the direct effect of light therapy on cancer-related fatigue has been little discussed in the literature. Data obtained from a small sample of patients indicate that light therapy improves quality of life by reducing fatigue in patients with breast cancer during chemotherapy. To date, There are no data on the effects of light therapy on cancer-related fatigue in general, patients treated with chemotherapy.
The purpose of this pilot study is to evaluate the role of light therapy on cancer-related fatigue in patients during the 6 months following initiation of first-line chemotherapy.
Primary objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Cancer histologically or cytologically confirmed (regardless of type)
- •Patient eligible for first-line chemotherapy
- •Life expectancy> 3 months
- •WHO PS ≤ 2
- •Age ≥ 18 years
- •Informed consent signed and dated
- •Affiliation to a social security scheme
排除标准
- •Macular degeneration
- •Diabetic retinopathy
- •untreated cataract
- •Patient treated with vitamin D
- •Psychiatric disorders (bipolar disorder, paranoia, schizophrenia)
- •For patients with other comorbidities may indicate against-the practice of therapy: application specialist opinion (ophthalmologist or psychiatrist)
结局指标
主要结局
Assessment of change of Tiredness: PIPER Score
时间窗: Day 1, week 12, week 24 and week 28
Tiredness: PIPER Score (main variable) (22 items targeted in 4 dimensions: behavioral tiredness / intensity, emotional, sensory and cognitive / mood)
次要结局
- Assessment of change of Health General condition WHO SCORE(Day 1, week 12, week 24 and week 28)
- Assessment of change of slumber(Day 1, week 12, week 24 and week 28)
- Assessment of change of Pain SCORE(Day 1, week 12, week 24 and week 28)
- Assessment of change of Quality of life (EORTC-QLQ-C30 SCORE)(Day 1, week 12, week 24 and week 28)
- Assessment of change of Depression Scale(Day 1, week 12, week 24 and week 28)