Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in general subscale of the Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
研究概览
简要总结
This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may decrease fatigue in people who were treated for cancer.
详细描述
PRIMARY OBJECTIVES:
I. To assess the efficacy of ginseng on decreasing cancer-related fatigue (CRF) in post-treatment cancer survivors as measured by Multidimensional Fatigue Symptom Inventory MFSI-Short Form (SF) at 28 and 56 days compared to placebo-controlled group.
SECONDARY OBJECTIVES:
I. To assess the acceptability and feasibility of ginseng as therapy for CRF in posttreatment cancer survivors.
II. To evaluate toxicities and tolerability associated with 2,000 mg per day of North American ginseng extract AFX-2 (panax quinquefolius) when used for cancer-related fatigue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Histologic or cytologic proven breast cancer or colon cancer (stage I, II or III)
- •Treated with chemotherapy and surgery
- •Treatment has been completed (except hormone therapy) for >= 90 days prior to registration
- •No known evidence of disease
- •Men or women with a history of CRF as defined by a score >= 4 on the numeric analogue scale (0 ? 10) (Eligibility Question Fatigue Scale)
- •Presence of CRF >= 30 days prior to registration
- •Hemoglobin >= 11.0 g/dL obtained =< 180 days prior to registration
- •Serum glutamic-oxaloacetic transaminase (SGOT) =< 1.5 x upper limit of normal (ULN) obtained =< 180 days prior to registration
- •Creatinine =< 1.2 X ULN obtained =< 180 days prior to registration
- •Ability to complete questionnaire(s) in English by themselves or with assistance
- •Provide written informed consent
- •Willing to return to enrolling institution for follow-up of the study and optional crossover (if applicable)
- •Willing to provide blood samples for correlative research purposes
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •CROSSOVER RE-REGISTRATION - INCLUSION CRITERIA
- •Treatment cannot begin prior to re-registering to the crossover phase and will ideally begin =< 7 days after registration for the crossover phase
排除标准
- •Hypersensitivity to ginseng
- •Use of ginseng capsules for fatigue, within the last 12 months
- •Uncontrolled hypertension >= 2 times as noted in medical history (diastolic blood pressure > 100, systolic > 160) =< 90 days prior to registration
- •Currently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for >= 30 days prior to registration and plans to continue for >= 30 days after registration; erythropoietin agents to treat anemia are allowed
- •Known brain metastasis or primary central nervous system (CNS) malignancy
- •Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days)
- •Diabetes (defined by being on oral hypoglycemics or insulin)
- •Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia; (defined per medical history)
- •Major surgery =< 28 days prior to registration
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential who are unwilling to employ adequate contraception
- •Treatable causes of fatigue have not been ruled out, at least by history and exam criteria, by the treating provider, such as uncontrolled pain, hypothyroidism, or insomnia; NOTE: if these are considered to be the primary cause for the patient?s fatigue then the patient is not eligible for this trial
- •Patients with pain requiring opioid pain medication; NOTE: over the counter analgesics such as Tylenol or ibuprofen are allowed
- •New use of Ambien and/or other benzodiazepines =< 30 days prior to registration
- •New use of sleep aids including melatonin =< 30 days prior to registration
- •Use of full anticoagulant doses of coumadin or heparin (exception: 1 mg/day of coumadin for preventing catheter clots is allowed)
- •Use of monoamine oxidase inhibitors (MAOI) inhibitors
- •Patients scoring greater than 4 on a 0 to 10 scale with regard to sleep troubles or pain
- •Patients planning to start any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study
- •Patients with malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician 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, high doses of caffeine, guarana, or anything called an ?adaptogen?)
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •History of myocardial infarction =< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmia
研究组 & 干预措施
Group I (North American ginseng extract AFX-2)
Patients receive North American ginseng extract AFX-2 PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Group I (North American ginseng extract AFX-2)
Patients receive North American ginseng extract AFX-2 PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
干预措施: American Ginseng (Drug)
Group I (North American ginseng extract AFX-2)
Patients receive North American ginseng extract AFX-2 PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses 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 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. At the end of course 2, patients may optionally crossover to Group I to receive ginseng for an additional 28 days.
干预措施: Laboratory Biomarker Analysis (Other)
GROUP II (placebo)
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. At the end of course 2, patients may optionally crossover to Group I to receive ginseng for an additional 28 days.
干预措施: Placebo (Other)
GROUP II (placebo)
Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. At the end of course 2, patients may optionally crossover to Group I to receive ginseng for an additional 28 days.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in general subscale of the Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
时间窗: Baseline up to day 56
Will be evaluated by taking the change from baseline in the general subscale of the MFSI-SF and comparing the two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used. Graphical procedures will include stream plots of individual patient scores and plots of average values over time for each treatment group. Supplemental tests on endpoints (paired t-test for continuous/ordinal data; McNemar?s test for binary data; and Bowker?s test for categorical data) will be utilized to deter
次要结局
- Change in MFSI-SF emotional subscale(Baseline up to day 56)
- Change in MFSI-SF general subscale(Baseline up to day 56)
- Change in MFSI-SF mental subscale(Baseline up to day 56)
- Change in MFSI-SF physical subscale(Baseline up to day 56)
- Change in MFSI-SF vigor subscale(Baseline up to day 56)
- Change in the single item numeric analogue fatigue question(Baseline up to day 56)
- Fatigue as measured by the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) score(At day 28)
- Fatigue as measured by the NIH PROMIS score(At day 56)
- Incidence of adverse events as reported by the patient in a Ginseng Symptom Experience Diary(Up to day 56)
- Perceived treatment efficacy as measured by the Subject Global Impression of Change(At 8 weeks)