Phase III Study of Ginseng for Cancer Related Fatigue
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Change in fatigue
研究概览
简要总结
This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.
详细描述
PRIMARY OBJECTIVE:
I. To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks.
SECONDARY OBJECTIVES:
I. To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4, the Global Impression of Change at week 4 and 8, and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at week 4 and 8.
II. To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate (on a 0 to 10 scale) their toxicities experienced while on study.
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 (Participant, Investigator)
盲法说明
Research staff, other than pharmacy, are blinded, and will dispense product to the patient. Option to unblind: At the end of treatment, if, in the judgment of patient or patient's attending clinician, it would be helpful for the future of patient's clinical care, the code may be broken.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Has received or is receiving treatment for a solid-organ malignancy (not hematologic)
- •History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet
- •Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
- •Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet
- •Life expectancy ≥ 6 months
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration)
- •Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration)
- •Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration)
- •No clinical suspicion of hypothyroidism within 180 days prior to registration [if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) < 5 milli-international units per liter (mIU/L) is required]
- •Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed consent
排除标准
- •Any known hypersensitivity to ginseng
- •Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed
- •Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)
- •Use of erythropoietic agents ≤ 6 months
- •Uncontrolled hypertension on more than three occasions (diastolic blood pressure ≥ 100, systolic ≥ 160) measured ≤ 180 days prior to randomization
- •Surgery that required general anesthetic ≤ 30 days prior to randomization
- •Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), as they could impact fatigue
- •Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, guarana, or anything called an "adaptogen")
- •Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor
- •Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)
研究组 & 干预措施
Group I (Western ginseng)
Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: American Ginseng (Dietary Supplement)
Group I (Western ginseng)
Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Group II (placebo)
Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo Administration (Drug)
Group II (placebo)
Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in fatigue
时间窗: Baseline to 8 weeks
Will be measured by the Linear Analog Scale for Fatigue, a single-item questionnaire rating fatigue over the pats week on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be.
次要结局
- Change in fatigue(Baseline, 4 and 8 weeks)
- Percentage of patients who perceive moderate to very much better fatigue(At 8 weeks)
- Incidence of adverse events(Up to 8 weeks)