EVALUATION OF OVARIAN PAIN AND QUALITY OF LIFE

卵巢疼痛和生活质量的评估

• 批准号: 5207646
• 负责人: Russell K Portenoy
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5207646
• 关键词: analgesics; anticholinergic agent; 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患病率， 那些患有持续性疾病的人，并注意到存在一种陈规定型观念， 疼痛综合征，预示着大多数患者的疾病发作。 在 本申请，我们提出的研究，评估新的管理 这些主要症状的每一个策略，并试图确定 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 阿片类药物可能无法令人满意的挑战性问题 疗法 尽管缺乏来自对照研究的数据， 现在经验性地使用药物作为这种情况下的辅助镇痛剂。 本方案的研究1是一个安慰剂对照的平行组， 东莨菪碱和格隆溴铵的重复给药比较，两种 市售抗胆碱能药物可能存在差异 由于血脑屏障的可变渗透率的影响。 癌症- 相关的疲劳也从未被研究过，尽管 其非常高的患病率。 我们提出了两个对照试验， 第一个评估精神刺激药物的安全性和有效性 对于这种情况。 研究2是一项安慰剂对照、重复给药、 精神兴奋剂哌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、平行组比较 哌醋甲酯和新型精神兴奋剂匹莫林 后者 药物在卵巢癌人群中可能特别有用， 咀嚼制剂的可用性和副作用特征， 可能比其他兴奋剂更好。 鉴于高流行率和 疼痛和心理困扰对卵巢癌的不良影响 因此，需要采取新的办法， 这些问题 在研究4中，我们提出了一项随机试验， 评估预期电话筛查计划的效用， 旨在识别和提供早期干预， 患有活动性卵巢癌的患者，疼痛未缓解，或 加剧了心理压力 最后，我们建议复制和 进一步明确了我们之前的发现， 可能预示着疾病的发病， 主要治疗 研究5是一项前瞻性纵向调查， 亚群，这将额外提供有关 疼痛监测作为改善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意义 对卵巢癌患者支持性护理的意义。