IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of IL-2 Treatments Tolerated
研究概览
简要总结
This study will determine the effectiveness of an antidepressant in preventing or reducing depressive symptoms in people with melanoma who are receiving Interleukin-2 (IL-2) treatment.
详细描述
Melanoma is the most serious type of skin cancer, affecting nearly 54,000 people in the United States each year. Melanomas often develop in pre-existing moles or as new moles on the body. If left untreated, the cancerous cells can spread throughout the body. Fortunately, melanoma can be cured if a person is diagnosed and treated early. Typical treatments include surgery, amputation, chemotherapy, and immunotherapy. Interleukin-2 (IL-2) treatment, a type of immunotherapy, uses the body's immune system to slow or stop the spread of cancer cells to other parts of the body. However, IL-2 treatment is typically associated with severe side effects, including depression, fatigue, and difficulty thinking. This study will evaluate whether escitalopram, an antidepressant, can help improve treatment-related depressive symptoms, reduce stress hormone levels, and increase the number of treatment cycles among people with metastatic melanoma who are receiving IL-2 treatment.
Participation in this double-blind study will last up to 18 weeks and will include 5 to 14 study visits. Participants will complete four 1-week cycles of IL-2 treatment over a 12-week period. Two weeks prior to starting IL-2 treatment, participants will undergo a psychiatric interview; a computerized thinking test; questionnaires; and blood, urine, and saliva collection. Participants will also be randomly assigned to start receiving either escitalopram or placebo for the entire duration of the study. The dosage of escitalopram or placebo will vary depending on the symptom severity of each participant. Immediately prior to IL-2 treatment, participants will undergo preliminary IL-2 procedures, which will include a medical history review, physical exam, and blood collection. These same procedures will occur every day that the participant is in the hospital for IL-2 treatment. Participants will stay in the hospital when receiving all four IL-2 treatment cycles. During these hospital stays, participants will complete repeat questionnaires and computerized tasks. Blood collection will occur at selected times as well. A follow-up visit will occur 4 weeks after the final treatment dose of IL-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cancer and beginning Interleukin (IL)-2 treatment
- •Willing to use an effective form of birth control throughout the study if sexually active
排除标准
- •Diagnosed with major depression or experiencing significant depressive symptoms or a Hamilton Rating Scale-Depression score of 18 or higher
- •Brain metastases, history of a brain injury, or seizure disorders
- •Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for substance abuse or dependence within 3 months of study entry
- •Suicidal, psychotic, or received psychiatric hospitalization within 12 months of study entry
- •Past or current history of schizophrenia or bipolar disorder
- •Pregnant or planning on becoming pregnant within 1 to 2 years
- •Evidence of untreated or poorly controlled infectious, hormone, heart, blood, kidney, liver, or neurological disease
- •Use of antidepressants, glucocorticoids, guanethidine, centrally acting alpha-antagonists, beta-blockers, or anticonvulsants
- •Clinically significant eye abnormalities
- •A score lower than 28 on the Mini Mental Status Exam (MMSE)
- •Prior history of severe adverse events associated with escitalopram or other selective serotonin reuptake inhibitor (SSRI) antidepressants
- •Diagnosed with type 1 or type 2 diabetes
- •Any condition that might make the participant unsuitable for enrollment or that could interfere with study participation
研究组 & 干预措施
Escitalopram
Participants will receive escitalopram and IL-2 treatment
干预措施: IL-2 (Drug)
Escitalopram
Participants will receive escitalopram and IL-2 treatment
干预措施: Escitalopram (Drug)
Placebo
Participants will receive placebo and IL-2 treatment
干预措施: Placebo (Drug)
Placebo
Participants will receive placebo and IL-2 treatment
干预措施: IL-2 (Drug)
结局指标
主要结局
Number of IL-2 Treatments Tolerated
时间窗: Cycle 4 (up to 12 weeks of IL-2 treatment)
The mean number of IL-2 doses tolerated (out of the possible 60 total doses) are presented for each study arm. The standard high dose regimen of IL-2 includes 15 doses per cycle. The dose of IL-2 is reduced, or treatment is stopped entirely, if the side effects become severe. This analysis includes the total number of doses taken at the end of Cycle 4, by all participants who began the trial, regardless of how many cycles each participant completed.
次要结局
- Hamilton Depression Rating Scale (HAM-D) Score(Screening and Cycles 1 - 4 (up to 14 weeks))
- Genetic Polymorphisms(Screening and After Cycle 4 (up to 14 weeks))
- Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)(Screening and Cycles 1 - 4 (up to 14 weeks))
- Plasma Concentrations of Interleukin 6 (IL-6)(Screening and Cycles 1 - 4 (up to 14 weeks))
- Plasma Concentrations of Cortisol(Screening and Cycles 1 - 4 (up to 14 weeks))