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乏（CRF）比晚期癌症（ACP）患者更严重， 早期癌症患者或幸存者。先前的药物研究CRF姑息治疗显示了混合的结果。 最近的研究表明，地塞米松（DEX）8 mg/天一周是安全的，并显着改善CRF。 然而，这种治疗并不能完全缓解CRF，因此需要进一步的研究来治疗这种情况。 痛苦的症状体力活动（PA）是治疗慢性肾衰竭的最佳证据，但其效果大小为 对CRF的改善作用不大（0.23）。因此，非常需要新的治疗策略。在这里，我们提出一个 PA与短期DEX的组合，其想法是该组合将提供更稳健的 由于抗炎作用而改善CRF，改善症状痛苦，改善 整体福祉。此外，DEX将促进PA干预的启动和依从性， 因此，在至少4周（研究持续时间）的时间内， 协同方式。 目的/假设：拟议研究的目的是在我们先前研究的基础上评估 体力活动与短期地塞米松联合应用的可行性及初步疗效 （以下简称PA+ DEX）用于晚期癌症中的癌症相关疲劳，并将告知更大， PA+DEX的充分有效性研究，以实现发现高效的长期目标 CRF的干预措施。这项研究将检验一个假设，即在晚期癌症患者中， 地塞米松与运动相结合将证明是可行的和有益的。 具体目的：主要目的：检验CRF患者对PA+ DEX满意的假设 PA+ DEX对CRF患者是可行的。 探索性：检验PA+ DEX比PA+安慰剂更有效的假设（PA治疗4周 加安慰剂1周），通过慢性疾病治疗的功能评估进行测量- 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（埃德蒙顿症状）的患者 评估量表）将被纳入本研究。我们将采用随机对照设计， 70名合格患者接受8 mg/天DEX或安慰剂口服7天， 进行为期4周的体力活动干预。患者将在基线、第8天、 研究第15天、第29天和第60天。联合干预的可行性、依从性和满意度 将进行评估，并将使用变化评估联合干预措施的初步疗效 FACIT-F子量表评分。