The Effects of Ginseng on Cancer-Related Fatigue

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Indena S.p.A

Criteria

Inclusion Criteria:

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

5. Are 18 years or older.

6. Hemoglobin level of >/=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

11. All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed at least one cycle of chemotherapy or targeted therapy, or > 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.

Exclusion Criteria:

1. Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris).

2. Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days.

3. Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.

4. Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia).

5. Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI).

6. Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs

7. Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician.

8. No concurrent full dose anticoagulant therapy.catheter clots allowed.

9. History of hepatitis A, B and C.

10. Women who are nursing.