The Effects of Ginseng on Cancer-Related Fatigue
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
研究概览
简要总结
The goal of this clinical research study is to learn if panax ginseng (commonly called ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood changes in patients with cancer. The safety of ginseng will also be studied.
详细描述
The Study Supplement:
Ginseng is an herbal supplement that may affect people's energy level, especially during times of fatigue or stress. Many people have used ginseng, but its level of effectiveness and safety has not been clearly studied. In this study, researchers will use questionnaires and other tests to study how ginseng may affect cancer-related fatigue.
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will be assigned to a dose of the study drug(s), depending on when you join the study. The first 30 participants will take part in Part 1 of the study. Participants in Part 1 will take ginseng by mouth, in capsule form, every day for 29 days. You will take it 2 times a day (morning and afternoon), and will swallow a total of 2 capsules each day.
If you enroll on this study after the first 30 participants, you will take part in Part 2 of the study. Participants in Part 2 will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •1. All patients with a histological diagnosis of cancer.
- •2. Rate fatigue on a numerical scale during the previous 24 hours as \>/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue).
- •3. Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.
- •4. Memorial delirium assessment scale \/=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level \<9g/dL will be evaluated for treatment of anemia.
- •7. Able to understand and sign the informed consent.
- •8. No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment).
- •9. Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks)
- •10. Patients should have a Zubrod \ 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist. The PI/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents.
- •12. Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy. Women of childbearing potential need to be on or use contraception, or be abstinent during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth controls specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide.
排除标准
- •Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris).
- •Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days.
- •Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- •Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia).
- •Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI).
- •Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs
- •Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician.
- •No concurrent full dose anticoagulant therapy. </= 1 mg/day of coumadin for preventing catheter clots allowed.
- •History of hepatitis A, B and C.
- •Women who are nursing.
研究组 & 干预措施
Panax Ginseng
Panax ginseng 400 mg by mouth twice a day from Day 1-29 for first 30 participants in Part 1. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Questionnaires (Behavioral)
Ginseng (Part 2)
Panax ginseng 400 mg by mouth twice a day from Day 1-29. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Panax Ginseng (Drug)
Panax Ginseng
Panax ginseng 400 mg by mouth twice a day from Day 1-29 for first 30 participants in Part 1. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Panax Ginseng (Drug)
Placebo (Part 2)
Oral placebo twice daily for 4 weeks. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Questionnaires (Behavioral)
Ginseng (Part 2)
Panax ginseng 400 mg by mouth twice a day from Day 1-29. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Questionnaires (Behavioral)
Placebo (Part 2)
Oral placebo twice daily for 4 weeks. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
时间窗: Baseline and Day 29
"The FACIT-F fatigue subscale was used as the primary outcome measure. There are 13 items in this fatigue subscale. Using the subscale, patients rate the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The objective was to determine whether the average improvement in FACIT-F fatigue from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value."
次要结局
- Edmonton Symptom Assessment System (ESAS) Fatigue Score Change(Baseline and Day 29)
- Edmonton Symptom Assessment System (ESAS) Pain Score Change(Baseline and Day 29)
- Edmonton Symptom Assessment System (ESAS) Depression Score Change(Baseline and Day 29)
- Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change(Baseline and Day 29)