EVALUATION OF OVARIAN PAIN AND QUALITY OF LIFE

卵巢疼痛和生活质量的评估

• 批准号: 6237131
• 负责人: Russell K Portenoy
• 金额: $ 15.34万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-01 至 1998-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6237131
• 关键词: analgesics; anticholinergic agent; behavioral /social science research tag; cancer complication; cancer pain; central nervous system stimulants; clinical trials; fatigue; female; human subject; human therapy evaluation; interview; longitudinal human study; methylphenidate; neoplasm /cancer chemotherapy; neoplasm /cancer palliative treatment; neoplasm /cancer remission /regression; ovary neoplasms; oxazolidone; patient care management; psychological stressor; quality of life; quaternary ammonium compound; scopolamine; syndrome; women's health

During our previous study of patients with ovarian cancer, we observed a high prevalence of pain, fatigue, and psychological distress among those with persistent disease and noted the existence of a stereotypical pain syndrome that heralded disease onset in a majority of patients. In this application, we propose studies that evaluate novel management strategies for each of these major symptoms and attempt to determine the importance of this newly described pain syndrome. The abdominal pain associated with malignant bowel obstruction is a challenging problem that may not respond satisfactorily to opioid therapy. Despite a lack of data from controlled studies, anticholinergic drugs are now used empirically as adjuvant analgesics in this setting. Study 1 of this proposal is a placebo-controlled, parallel-group, repeated-dose comparison of scopolamine and glycopyrrolate, two commercially available anticholinergic drugs that may differ in side effects due to variable penetrance of the blood-brain barrier. Cancer- related fatigue also never been studied in controlled fashion, despite its very high prevalence. We propose two controlled trials that will be the first to evaluate the safety and efficacy of psychostimulated drugs for this condition. Study 2 is a placebo-controlled, repeated-dose, parallel-group efficacy trial of the psychostimulant methylphenidate; and Study 3 is a placebo-controlled, repeated-dose, parallel-group comparison of methylphenidate and the novel psychostimulant pemoline. The latter drug may be particularly useful in the ovarian cancer population due to the availability of a chewable formulation and a side-effect profile that may be better than other stimulants. Given the high prevalence and adverse impact of pain and psychological distress in the ovarian cancer population, new approaches are needed for the long-term management of these problems. In the Study 4, we proposed a randomized trial that will evaluate the utility of a prospective telephone screening program, which has been designed to identify and provide early intervention for those patients with active ovarian cancer who experience unrelieved pain or heightened psychological distress. Finally, we propose to replicate and further define our previous findings that a stereotypical pain syndrome may herald the onset of disease in those who achieve remission following primary therapy. Study 5 is a prospective longitudinal survey of this subpopulation, which will additionally provide information about the potential of pain monitoring as a means of improving early diagnosis. The information acquired through these studies will have important implications for the supportive care of patients with ovarian cancer.

在我们之前对卵巢癌患者的研究中，我们观察到 疼痛、疲劳和心理困扰的高发人群 那些患有持续性疾病的人并注意到存在一种刻板印象 在大多数患者中预示疾病发作的疼痛综合症。在……里面 在这一应用中，我们提出了评估小说管理的研究 针对每个主要症状的策略，并尝试确定 这种新描述的疼痛综合征的重要性。 与恶性肠梗阻相关的腹痛是一种 可能对阿片类药物反应不令人满意的挑战性问题 心理治疗。尽管缺乏来自对照研究的数据，但抗胆碱能 在这种情况下，药物现在被经验地用作辅助止痛剂。 这项建议的研究1是安慰剂对照的平行组， 东莨菪碱和甘草次酸重复给药剂量比较 商业上可用的抗胆碱能药物，可能有不同的侧面 由于血脑屏障的不同透过率而产生的影响。癌症-- 相关的疲劳也从未在受控方式下进行研究，尽管 它的患病率很高。我们建议进行两项对照试验， 第一次评估精神刺激药物的安全性和有效性 在这种情况下。研究2是一项安慰剂对照的重复给药， 精神刺激剂哌醋甲酯的平行组疗效试验； 研究3是一项安慰剂对照、重复给药、平行分组比较。 醋酸甲酯和新型精神刺激剂佩莫林。后者 药物在卵巢癌人群中可能特别有用，因为 一种咀嚼制剂的可用性和副作用概况 可能比其他兴奋剂更好。考虑到高流行率和 疼痛和心理困扰对卵巢癌患者的不良影响 对于人口来说，需要新的方法来长期管理 这些问题。在研究4中，我们提出了一项随机试验，将 评估预期电话筛查计划的效用， 旨在识别并为这些患者提供早期干预 活动期卵巢癌患者疼痛未缓解或 更严重的心理困扰。最后，我们建议复制和 进一步说明我们之前的发现是一种刻板印象的疼痛综合症 可能预示着在以下情况下获得缓解的人疾病的发病 初级治疗。研究5是对此进行的前瞻性纵向调查。 子群体，它还将提供有关 疼痛监测作为提高早期诊断的一种手段的潜力。 通过这些研究获得的信息将具有重要的 对卵巢癌患者支持性护理的启示。