Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Multidimensional Fatigue Inventory (MFI) score
研究概览
简要总结
Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer survivors. CRF can persist for months or years after cancer therapy is completed and has a negative impact on all areas of mental and physical function. Treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Massage therapy is one of the fastest growing complementary therapies. A recently completed study in breast cancer survivors with CRF found that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement in quality of life. This study investigates the effects of massage therapy on CRF among prostate cancer survivors. The study will evaluate whether SMT improves quality of life, depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced fatigue beyond self report at the treatment visits, the researchers will implement continuous, real-time monitoring of physiologic and psychological signs and symptoms, throughout the treatment period. This study will improve care for CRF and other hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune modulation as a potential mechanism of action.
This study is a randomized clinical trial to test the efficacy of Swedish massage therapy (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. The primary outcome is the Multidimensional Fatigue Inventory (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life, depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of Symptom Severity (AMoSS) ratings.
详细描述
Fatigue is the most common, and one of the most devastating symptoms among patients with cancer. According to the National Comprehensive Cancer Network (NCCN), cancer-related fatigue (CRF) is "a distressing, persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity". Fatigue occurs across the spectrum of cancer types and treatments. CRF has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF has been rated as more troublesome and to have a greater negative impact on quality of life than other cancer-related symptoms such as pain, depression, and nausea. CRF can persist for months or years after cancer therapy is completed.
Meaningful, evidence-based treatment options for CRF are limited. Over 50% of patients with cancer have used a complementary and alternative medicine (CAM) approach for symptom management and quality of life. One of the widely employed CAM interventions is massage therapy. Most of the studies investigating massage for patients with cancer focus on depression, anxiety, or pain as the outcomes of interest. A previous investigation of breast cancer survivors reported decreases in mood symptoms and an improvement in fatigue, however, CRF was not the primary outcome measure. This randomized clinical trial will test the efficacy of Swedish massage therapy (SMT) vs. an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. Participants will receive weekly treatments for 6 weeks.
The aims of the study are as follows:
Aim 1: To conduct a feasibility study to determine whether a 6-week SMT intervention can decrease CRF among prostate cancer survivors who have received radiation therapy and have CRF.
Aim 2: To determine whether the hypothesized decrease in CRF is due to SMT modulating the immune system of subjects with CRF. The researchers hypothesize that SMT will decrease plasma concentrations of IL-6 (a pro-inflammatory cytokine) more than LT and that the decrease in plasma IL-6 will mediate the decrease in fatigue as assessed with the MFI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate cancer
- •At least 2 months after the end of radiation therapy
- •Brief Fatigue Inventory (BFI) score of >25
- •Satisfactory results of screening safety labs, serum testosterone test and drug test
- •Ability to understand study procedures and to comply with them for the entire length of the study
排除标准
- •Inability to lay supine for one hour at a time, given the nature of the massage intervention
- •Actively suicidal or homicidal
- •Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 microUnits per milliliter (mcU/mL)), uncontrolled pain, or medical problems associated with fatigue, including: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and poorly controlled sleep apnea
- •Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment. Those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
- •Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
- •Unable to comply with the protocol for any reason
- •Use of non-steroidal anti-inflammatory drugs; aspirin use is allowed but must be tracked
- •Illicit drug use
- •Shift work
- •Currently dieting
- •Excessive, regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
- •Have used massage as a therapeutic modality (medical or psychological) at any point for the treatment of medical conditions
- •Have massages on a regular basis, defined as receiving 4 or more massages per year for the last 5 years
- •Currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem
- •Unable to read and understand the informed consent document because of language difficulties
- •Inability or unwillingness to give written informed consent
研究组 & 干预措施
Swedish Massage Therapy
Participants in this arm will receive Swedish massage, which is the most commonly offered and best-known type of massage.
干预措施: Swedish Massage Therapy (Other)
Light Touch Intervention
Participants in this arm will receive light touch only.
干预措施: Light Touch Intervention (Other)
结局指标
主要结局
Change in Multidimensional Fatigue Inventory (MFI) score
时间窗: Baseline, Week 6
Multidimensional Fatigue Inventory (MFI) is a brief (20-item) self-report instrument that assesses 5 dimensions (subscales) of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Respondents indicate their level of agreement with fatigue related statements on a 5 point scale ranging from "Yes, that is true" = 1 to "No that is not true" = 5. Possible scores for each subscale range from 4 (no fatigue) to 20 (maximum fatigue). The primary outcome measure for this study will be the total of four MFI subscales (general fatigue, physical fatigue, reduced activity, and reduced motivation).
次要结局
- Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) score(Baseline, Week 6)
- Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale score(Baseline, Week 6)
- Change in step count(Baseline, Week 6)
- Change in Automated Monitoring of Symptom Severity (AMoSS) survey score(Baseline, Week 6)
- Change in Patient-Reported Outcome Measurement System (PROMIS) Fatigue Scale score(Baseline, Week 6)
- Change in Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q) score(Baseline, Week 6)
- Change in circadian variation of activity(Baseline, Week 6)
- Change in plasma IL-6(Baseline, Week 6)
- Change in sleep duration(Baseline, Week 6)
- Change in sleep latency(Baseline, Week 6)
研究者
Mark H. Rapaport
Professor
Emory University