A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients

晚期癌症患者癌症相关疲劳的联合疗法

• 批准号: 9387017
• 负责人: Sriram Yennu
• 金额: $ 20.61万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-16 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9387017
• 关键词: Adherence; Adrenal Cortex Hormones; Advanced Malignant Neoplasm; Adverse effects; Affect; Affective; Aftercare; Anorexia; Antiinflammatory Effect; Anxiety; Behavioral; C-reactive protein; Cancer Fatigue; Cancer Intervention; Cancer Patient; Chronic Disease; Clinical; Combined Modality Therapy; Data; Dexamethasone; Diagnosis; Distress; Double-Blind Method; Economics; Effectiveness; Emotional; Exercise; Fatigue; Frequencies; Funding; Goals; Inflammation; Intervention; Malignant Neoplasms; Measures; Mental Depression; Muscle function; Nausea; Oral; Pain; Pain management; Palliative Care; Patient Outcomes Assessments; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacology Study; Physical activity; Placebos; Quality of life; Randomized; Reporting; Research; Research Design; Supervision; Surrogate Markers; Survivors; Symptoms; Testing; Treatment-Related Cancer; Work; associated symptom; base; clinical care; clinically relevant; combination cancer therapy; design; effective intervention; effective therapy; experience; improved; inflammatory marker; instrument; negative affect; palliative; response; safety and feasibility; satisfaction; sleep quality; social; tool; treatment strategy

Cancer-related fatigue (CRF) is more severe and debilitating in patients with advanced cancer (ACP) than in those with early cancer or in survivors. Prior drug studies for CRF in palliative care have shown mixed results. Recent studies show that 8 mg/day dexamethasone (DEX) for one week is safe and significantly improves CRF. However, this treatment does not completely relieve CRF and therefore further studies are needed to treat this distressing symptom. Physical activity (PA) has the best evidence for treatment of CRF but its effect size is modest (0.23) in improving CRF. Hence, new treatment strategies are greatly needed. Here we propose a combination of PA with a short course of DEX with the idea that the combination would provide a more robust improvement of CRF due to anti-inflammatory effects, improvement in symptom distress, and improvement in overall well-being. Furthermore, DEX would facilitate the initiation of and adherence to the PA intervention, and thereby engage and sustain PA over a period of at least 4 weeks (the duration of the study) in a potentially synergistic manner. Objective/Hypothesis: The objective of the proposed study is to build on our prior studies to evaluate the feasibility and preliminary efficacy of the combination of physical activity and a short course of dexamethasone (hereafter abbreviated PA+ DEX) for cancer-related fatigue in advanced cancer, and will inform larger, adequately-powered effectiveness studies of PA+DEX toward a long-term goal of finding highly effective interventions for CRF. The study will test the hypothesis that, in patients with advanced cancer, the combination of dexamethasone with exercise will prove both feasible and beneficial. Specific Aims: Primary: To test the hypotheses that patients with CRF will be satisfied with the PA+ DEX intervention, have adequate rates of adherence, and that PA+ DEX will be feasible for patients with CRF. Exploratory: To test the hypothesis that PA+ DEX will be more efficacious than PA+ placebo (PA for 4 weeks plus placebo for 1 week) on CRF as measured by the Functional Assessment of Chronic Illness Therapy- Fatigue Scale (FACIT-F). To explore the effects of PA+ DEX on fatigue-related symptoms and function. Study design: Patients with a diagnosis of advanced cancer and fatigue score of ≥4/10 (Edmonton Symptom Assessment Scale) will be admitted to this study. We will use a randomized controlled design to randomly assign 70 eligible patients to receive either 8 mg/day DEX or Placebo orally for 7 days with a validated and supervised physical activity intervention for 4 weeks. Patients will complete the outlined assessments at baseline, Day 8, Day 15, Day 29, and Day 60 of the study. Feasibility, adherence, and satisfaction with the combined interventions will be assessed, and the preliminary efficacy of the combined interventions will be evaluated using the change in FACIT-F subscale scores.

晚期癌症 (ACP) 患者的癌症相关性疲劳 (CRF) 比普通癌症患者更为严重且使人衰弱。 先前针对姑息治疗中 CRF 的药物研究显示出不同的结果。 最近的研究表明，每天 8 毫克地塞米松 (DEX) 持续一周是安全的，并且可显着改善 CRF。 然而，这种治疗并不能完全缓解 CRF，因此需要进一步研究来治疗这种情况 令人痛苦的症状（PA）是治疗 CRF 的最佳证据，但其效果大小很有限。 改善 CRF 的效果有限（0.23），因此，我们非常需要新的治疗策略。 PA 与 DEX 短期课程的组合，其理念是该组合将提供更稳健的 由于抗炎作用而改善 CRF、改善症状困扰以及改善 此外，DEX 将促进 PA 干预的启动和坚持。 参与并维持 PA 至少 4 周（由此研究的持续时间） 协同方式。 目的/假设：拟议研究的目的是在我们之前的研究的基础上评估 体力活动与短疗程地塞米松相结合的可行性和初步疗效 （以下简称 PA+ DEX）用于治疗晚期癌症中与癌症相关的疲劳，并将告知更大、 对 PA+DEX 进行充分有力的有效性研究，以实现高效的长期目标 该研究将检验以下假设：在晚期癌症患者中， 地塞米松与运动的结合将被证明是可行且有益的。 具体目标： 主要：测试 CRF 患者对 PA+ DEX 满意的假设 干预，有足够的依从率，并且 PA+ DEX 对 CRF 患者是可行的。 探索性：检验 PA+ DEX 比 PA+ 安慰剂（PA 4 周）更有效的假设 加安慰剂 1 周）对 CRF 进行测量（通过慢性病治疗功能评估进行测量） 疲劳量表 (FACIT-F) 探讨 PA+ DEX 对疲劳相关症状和功能的影响。 研究设计：诊断为晚期癌症且疲劳评分≥4/10的患者（埃德蒙顿症状 评估量表）将被纳入本研究，我们将使用随机对照设计来随机分配。 70 名符合条件的患者在经过验证和监督的情况下口服 8 毫克/天 DEX 或安慰剂 7 天 患者将在第 8 天的基线时完成概述的评估。 研究的第 15 天、第 29 天和第 60 天对联合干预措施的可行性、依从性和满意度。 将进行评估，并使用变化来评估联合干预措施的初步效果 FACIT-F 子量表分数。