Prevention of Depression in Head and Neck Cancer

头颈癌抑郁症的预防

• 批准号: 9100331
• 负责人: SCOTT A IRWIN
• 金额: $ 19.03万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9100331
• 关键词: Antidepressive Agents; Anxiety; Cancer Patient; Caring; Citalopram; Comorbidity; Data; Development; Diagnosis; Disease remission; Double-Blind Method; Drops; Enrollment; Exhibits; Exploratory/Developmental Grant; Future; Goals; Head and Neck Cancer; Head and neck structure; Health; Hospice Care; Incidence; Individual; Investigation; Ketamine; Lead; Longevity; Malignant Neoplasms; Mental Depression; Methodology; National Cancer Institute; Oral; Outcome; Pain; Patients; Placebos; Population; Prevention; Prevention trial; Quality of life; Randomized; Research; Risk; Route; Safety; Selective Serotonin Reuptake Inhibitor; Serious Adverse Event; Staging; Symptoms; Testing; Time; United States National Institutes of Health; Work; anxiety symptoms; base; cancer care; cancer pain; cancer therapy; clinically significant; depression prevention; depressive symptoms; double-blind placebo controlled trial; experience; follow-up; head and neck cancer patient; high risk; hospice environment; improved; improved outcome; indicated prevention; innovation; interest; prevent; public health relevance; randomized placebo controlled trial; selective prevention; statistics; treatment group; universal prevention

 DESCRIPTION (provided by applicant): Depression as a co-morbidity is a barrier to achieving positive outcomes, improving quality of life, and delivering high-quality cancer and other care experiences. New onset depression in patients being treated for head and neck cancer is highly prevalent and leads to many negative health outcomes. Ketamine has been shown to have a rapid effect for treating depression, including in our own work in patients with cancer who were receiving hospice care. The goal of this innovative exploratory (R21) proposal is test the feasibility, safety, and tolerability of using ketamine for indicated prevention of depression in patients with head and neck cancer. We have chosen ketamine for its potential multiple positive attributes for patients with head/neck cancer: known rapid onset of action, proven efficacy in cancer pain, multiple routes of administration, ability to treat depression, and impact on co-morbid anxiety, all of which should lead to improved outcomes, including longevity and quality of life. Given the high proportion of patients with head and neck cancer who develop depression during treatment, the negative impacts that depression has on outcomes in these patients, and previous prevention trials in this population, head/neck cancer patients appear to be a good logical first choice to test ketamine's ability to prevent depression in these and other cancer patients. It is hoped that the outcomes of this proposal will lead to a definitive trial (R01 proposal) of ketamine for preventing depression in patients with head and neck cancer, with the ultimate goal of preventing depression and improving health outcomes in this, and possibly other, cancer populations. This proposal is consistent with the National Cancer Institute's research focus on co-morbidities, of which depression is likely one of the most impactful. It is also consistent with the NIH agenda of improving health outcomes. Specific Aim 1: Feasibility. To investigate the feasibility of enrolling subjects in a indicated prevention trial of oral ketamie vs placebo in patients receiving usual cancer care and treatment for stage III or IV epidermoid head/neck cancer. Hypothesis 1: At least 40 subjects will be enrolled and 80% of patients randomized will complete the trial. Specific Aim 2: Tolerability and Safety. To investigate the safety and tolerability of oral ketamine in patients receiving usual cancer care and treatment for stage III or IV epidermoid head/neck cancer. Hypothesis 2: Less than 20% of patients randomized to oral ketamine will drop-out due to adverse or serious adverse events attributed to ketamine, a proportion comparable to that in the placebo group. Exploratory Aims: Other data collected in this study will be used to explore ketamine's impact on: 1) incidence of depression, 2) anxiety symptoms, 3) pain levels, and 4) quality of life. Future Directions: This study will lay the groundwork for a larger, definitive trial (R01 proposal) of ketamine for the prevention of depression in patients with head and neck, and possibly other cancers. In the future, we may be able to explore further questions that may be of import for the prevention and/or relief of depression, suffering, and promotion of quality of life for cancer patients.

 描述（由申请人提供）：抑郁症作为一种共病，是实现积极结果、改善生活质量以及提供高质量癌症和其他护理体验的障碍。接受头颈癌治疗的患者新发抑郁症是一个障碍。氯胺酮非常普遍，并会导致许多负面的健康结果，包括在我们自己对接受临终关怀的癌症患者的研究中，这一创新探索性 (R21) 提案的目标是进行测试。这使用氯胺酮用于预防头颈癌患者抑郁症的可行性、安全性和耐受性 我们选择氯胺酮是因为它对头颈癌患者具有潜在的多重积极特性：已知起效快，对癌症有疗效。疼痛、多种给药途径、治疗抑郁症的能力以及对共病焦虑的影响，所有这些都应该会改善结果，包括寿命和生活质量，因为患有抑郁症的头颈癌患者比例很高。在治疗期间，抑郁症对治疗结果的负面影响在这些患者中，以及之前在该人群中进行的预防试验中，头颈癌患者似乎是测试氯胺酮预防这些和其他癌症患者抑郁症能力的合理首选。希望该提案的结果能够产生效果。氯胺酮用于预防头颈癌患者抑郁症的最终试验（R01 提案），最终目标是预防头颈癌患者的抑郁症并改善其健康状况。该提案与国家癌症中心一致。研究所的研究重点合并症，其中抑郁症可能是最有影响力的疾病之一，这也符合 NIH 改善健康结果的议程：调查招募受试者参加口服氯胺酮与口服氯胺酮的指示性预防试验的可行性。接受常规癌症护理和治疗的 III 期或 IV 期表皮样头/颈癌患者的安慰剂。 假设 1：将招募至少 40 名受试者，并且 80%​​ 的随机患者将完成试验。 2：耐受性和安全性。调查接受常规癌症护理和治疗的 III 期或 IV 期表皮样头/颈癌患者口服氯胺酮的安全性和耐受性。假设 2：随机接受口服氯胺酮的患者中不到 20% 的患者会出现下降。由于氯胺酮引起的不良或严重不良事件，比例与安慰剂组相当。 探索性目标：本研究中收集的其他数据将用于探索氯胺酮对以下方面的影响： 1) 抑郁症的发生率，2) 焦虑症状，3) 疼痛程度，以及 4) 未来的方向：这项研究将确定。 为氯胺酮预防头颈癌和其他癌症患者抑郁症的更大规模、明确的试验（R01 提案）奠定了基础。将来，我们也许能够探索对癌症患者可能重要的进一步问题。预防和/或缓解抑郁症、痛苦并提高癌症患者的生活质量。