Advanced CancersPhase 1/2NCT01375114
The Effects of Ginseng on Cancer-Related Fatigue
A Phase 1/2 study testing Panax Ginseng and Questionnaires in people with Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers, Solid Tumors
- What is being tested?
- Panax Ginseng and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2011to 31 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a histological diagnosis of cancer.
- 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).
- Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.
- Memorial delirium assessment scale </= 13.
- Are 18 years or older.
- 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.
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- Able to understand and sign the informed consent.
- No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment).
- 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)
- Patients should have a Zubrod </= 2.
- 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.
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
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:
- Group 1 will take a placebo for 29 days. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. If you are assigned to this group, you may be able to take ginseng later, in the second part of the study (described below).
- Group 2 will take ginseng for 29 days, as the Part 1 group did.
You will have an equal chance of being assigned to either group. Neither you nor the study staff will know which group you are in. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Both groups in Part 2 will take ginseng or placebo by mouth, every day for 29 days. You will take it 2 times a day (morning and afternoon), 2 capsules each day.
After your Day 29 ginseng or placebo dose, if you tolerated the doses well, the study doctor may decide you can take ginseng from Days 29-57, following the same dosing schedule you had before.
Study Visits:
On Day 15 (± 3 days), Day 29 (± 3 days), Day 36 (+/- 3 days) and Day 57 (± 3 days), you will fill out questionnaires about the symptoms you may be having, such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and your overall sense of well-being. This should take about 30 minutes. You will also be asked about any side effects you may be having. You will also perform a medication review. If you cannot come to the clinic on these days, the research nurse will call and ask you the questions over the phone. The strength and stamina of your arm muscle will be measured only if you come to the clinic. It will not be measured if you are contacted over the phone. Blood (about 1 tablespoon) will be drawn for routine tests on Day 15 (± 3 days), Day 29 (± 3 days) and Day 57 (± 3 days).
The 6-minute walk test will be performed on baseline, Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days).
On Day 8 (± 3 days), Day 21 ( +/- 3 days), Day 36 (± 3 days), and Day 43 (± 3 days), the research nurse will call and ask about the symptoms and side effects you may be having. You will also perform a medication review. This should take about 30 minutes.
If you are unable to return to MD Anderson for your routine blood draw, your local doctor can draw the blood and your results will be sent to MD Anderson.
You blood will be drawn weekly if you are taking coumadin to check to see how fast your blood clots. Liver function tests will also be performed every 2 weeks if you have metastasis to your liver or are on medication such as acetaminophen statins.
Length of Participation:
If you are the among the first thirty patients you will be assigned to receive/take ginseng at the beginning of the study for a total 29 days followed by up to 28 days of ginseng, if the study doctor thinks it is in your best interest. If you are not among the first thirty patients you may receive up to 29 days of ginseng/placebo followed by up to 28 days of ginseng, if the study doctor thinks it is in your best interest. Ginseng/placebo will be stopped early if intolerable side effects occur.
If your main doctor for cancer approves, you may take ginseng after Day 57 (outside of the study) if you tolerated it well.
This is an investigational study. Ginseng is commercially available. Giving ginseng to patients with cancer and fatigue is being done for research purposes only.
Up to 158 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Solid Tumors
- Being tested
- Panax Ginseng, Placebo, Questionnaires
- Keywords
- Advanced Cancers, Solid Tumors, Cancer related fatigue, CRF, Panax ginseng, Placebo, Sugar pill, Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F, Quality of life, QOL, FACT-G, Hospital Anxiety and Depression Inventory, Neurocognitive function, SDMT, Global Symptom Evaluation, GSE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panax GinsengDrug
400 mg by mouth twice daily from Day 1-29.
PlaceboDietary supplement
Also called Sugar Pill
Placebo by mouth twice daily for 4 weeks.
QuestionnairesBehavioural
Also called Surveys
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.
| Study group | Role | What they receive |
|---|---|---|
| Panax Ginseng | Experimental | 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. Receives: Drug: Panax Ginseng; Behavioral: Questionnaires |
| Ginseng (Part 2) | Experimental | 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. Receives: Drug: Panax Ginseng; Behavioral: Questionnaires |
| Placebo (Part 2) | Placebo comparator | 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. Receives: Dietary Supplement: Placebo; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
"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."
Measured: Baseline and Day 29
Secondary outcomes (4)
Edmonton Symptom Assessment System (ESAS) Fatigue Score Change
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS fatigue was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS 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.
Measured: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Pain Score Change
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS pain was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS pain 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.
Measured: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Depression Score Change
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS depression was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS depression 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.
Measured: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS drowsiness was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS drowsiness 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.
Measured: Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study start14 Oct 2011
- Primary completion15 May 2016
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Indena S.p.A
- Responsible party
- Sponsor
- Investigators
- Sriram Yennurajalingam, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375114
- Sponsor's protocol ID
- 2009-0854
- Other IDs
- NCI-2011-01127
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2011
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Yennurajalingam S, Tannir NM, Williams JL, Lu Z, Hess KR, Frisbee-Hume S, House HL, Lim ZD, Lim KH, Lopez G, Reddy A, Azhar A, Wong A, Patel SM, Kuban DA, Kaseb AO, Cohen L, Bruera E. A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer. J Natl Compr Canc Netw. 2017 Sep;15(9):1111-1120. doi: 10.6004/jnccn.2017.0149.
PubMed 28874596
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ginseng on Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT01375114
- Acronym / sponsor ID
- 2009-0854
- Conditions
- Advanced Cancers, Solid Tumors
- Keywords
- Advanced Cancers, Solid Tumors, Cancer related fatigue, CRF, Panax ginseng, Placebo, Sugar pill, Functional Assessment of Chronic Illness Therapy-Fatigue
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Indena S.p.A
- Study start
- 14 Oct 2011 (actual)
- Primary completion
- 15 May 2016 (actual)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Posted 22 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Group 1 will take a placebo for 29 days. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. If you are assigned to this group, you may be able to take ginseng later, in the second part of the study (described below).
- Group 2 will take ginseng for 29 days, as the Part 1 group did.
You will have an equal chance of being assigned to either group. Neither you nor the study staff will know which group you are in. However, if needed for your safety, the study staff will be able to find out what you are receiving.
Both groups in Part 2 will take ginseng or placebo by mouth, every day for 29 days. You will take it 2 times a day (morning and afternoon), 2 capsules each day.
After your Day 29 ginseng or placebo dose, if you tolerated the doses well, the study doctor may decide you can take ginseng from Days 29-57, following the same dosing schedule you had before.
Study Visits:
On Day 15 (± 3 days), Day 29 (± 3 days), Day 36 (+/- 3 days) and Day 57 (± 3 days), you will fill out questionnaires about the symptoms you may be having, such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and your overall sense of well-being. This should take about 30 minutes. You will also be asked about any side effects you may be having. You will also perform a medication review. If you cannot come to the clinic on these days, the research nurse will call and ask you the questions over the phone. The strength and stamina of your arm muscle will be measured only if you come to the clinic. It will not be measured if you are contacted over the phone. Blood (about 1 tablespoon) will be drawn for routine tests on Day 15 (± 3 days), Day 29 (± 3 days) and Day 57 (± 3 days).
The 6-minute walk test will be performed on baseline, Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days).
On Day 8 (± 3 days), Day 21 ( +/- 3 days), Day 36 (± 3 days), and Day 43 (± 3 days), the research nurse will call and ask about the symptoms and side effects you may be having. You will also perform a medication review. This should take about 30 minutes.
If you are unable to return to MD Anderson for your routine blood draw, your local doctor can draw the blood and your results will be sent to MD Anderson.
You blood will be drawn weekly if you are taking coumadin to check to see how fast your blood clots. Liver function tests will also be performed every 2 weeks if you have metastasis to your liver or are on medication such as acetaminophen statins.
Length of Participation:
If you are the among the first thirty patients you will be assigned to receive/take ginseng at the beginning of the study for a total 29 days followed by up to 28 days of ginseng, if the study doctor thinks it is in your best interest. If you are not among the first thirty patients you may receive up to 29 days of ginseng/placebo followed by up to 28 days of ginseng, if the study doctor thinks it is in your best interest. Ginseng/placebo will be stopped early if intolerable side effects occur.
If your main doctor for cancer approves, you may take ginseng after Day 57 (outside of the study) if you tolerated it well.
This is an investigational study. Ginseng is commercially available. Giving ginseng to patients with cancer and fatigue is being done for research purposes only.
Up to 158 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Panax Ginseng | Experimental | Drug: Panax Ginseng, Behavioral: QuestionnairesPanax 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. |
| Ginseng (Part 2) | Experimental | Drug: Panax Ginseng, Behavioral: QuestionnairesPanax 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. |
| Placebo (Part 2) | Placebo comparator | Dietary Supplement: Placebo, Behavioral: QuestionnairesOral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- All patients with a histological diagnosis of cancer.
- 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).
- Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.
- Memorial delirium assessment scale </= 13.
- Are 18 years or older.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panax Ginseng400 mg by mouth twice daily from Day 1-29. | Drug | Ginseng (Part 2), Panax Ginseng |
| PlaceboAlso: Sugar PillPlacebo by mouth twice daily for 4 weeks. | Dietary supplement | Placebo (Part 2) |
| QuestionnairesAlso: SurveysCompletion 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. | Behavioural | Ginseng (Part 2), Panax Ginseng, Placebo (Part 2) |
Primary outcome
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
Time frame: 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."
4 secondary outcomes
Edmonton Symptom Assessment System (ESAS) Fatigue Score Change
Time frame: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Pain Score Change
Time frame: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Depression Score Change
Time frame: Baseline and Day 29
Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change
Time frame: Baseline and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28874596Yennurajalingam S, Tannir NM, Williams JL, Lu Z, Hess KR, Frisbee-Hume S, House HL, Lim ZD, Lim KH, Lopez G, Reddy A, Azhar A, Wong A, Patel SM, Kuban DA, Kaseb AO, Cohen L, Bruera E. A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer. J Natl Compr Canc Netw. 2017 Sep;15(9):1111-1120. doi: 10.6004/jnccn.2017.0149.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Yennurajalingam, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panax Ginseng and Questionnaires in people with Advanced Cancers and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change (time frame: Baseline and Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.