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Herbal Supplement
Ginseng for Cancer-Related Fatigue
Phase 2
Waitlist Available
Led By Sriram Yennurajalingam, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
No concurrent use of chronic systemic steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 29
Awards & highlights
Study Summary
This trial will study whether ginseng can help relieve fatigue and other symptoms in cancer patients.
Who is the study for?
This trial is for adults with cancer who feel very tired every day, have a certain level of physical ability (Zubrod ≤ 2), and rate their fatigue at least 4 out of 10. They must not be severely anemic, use chronic steroids, or have uncontrolled diabetes. Pregnant women can't join; others must agree to use birth control.Check my eligibility
What is being tested?
Researchers are testing if ginseng can reduce cancer-related fatigue and improve mood symptoms like depression and anxiety. Participants will either receive ginseng or a placebo while also completing questionnaires about their symptoms.See study design
What are the potential side effects?
Possible side effects from ginseng may include sleep problems, digestive issues, headaches, and possible interactions with other medications. Specific risks might depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am not taking long-term steroids.
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I can handle my personal care and am up more than 50% of my waking hours.
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I have felt extremely tired every day for at least 2 weeks.
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I am not pregnant.
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I have felt very tired, rating my fatigue at 4 or higher in the last day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 29
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
Secondary outcome measures
Edmonton Symptom Assessment System (ESAS) Depression Score Change
Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change
Edmonton Symptom Assessment System (ESAS) Fatigue Score Change
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Panax GinsengExperimental Treatment2 Interventions
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.
Group II: Ginseng (Part 2)Experimental Treatment2 Interventions
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.
Group III: Placebo (Part 2)Placebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Panax Ginseng
2002
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,637 Total Patients Enrolled
Indena S.p.AIndustry Sponsor
9 Previous Clinical Trials
457 Total Patients Enrolled
Sriram Yennurajalingam, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
458 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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