Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01127 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indena S.p.A | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panax Ginseng | Drug | 400 mg by mouth twice daily from Day 1-29. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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." | Baseline and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sriram Yennurajalingam, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28874596 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
A total of 165 patient were enrolled for this protocol. In Phase-l part of the study, 30 pt received Panax Ginseng and 2 patients withdrew consent. For Phase-II part of study, out of 133 participants, 127 participants were randomized. 6 participants were not randomized for this study for various reasons (participant withdrew n=3, withdrawn at oncologist's request n=1 and due to comorbidities n=2).
Patients were recruited from the outpatient clinics for palliative care, pain management, internal medicine, and oncology at MD Anderson Cancer Center in Houston, Texas who have been diagnosed with cancer and currently undergoing outpatient chemotherapy at the cancer center, and experiencing Cancer Related Fatigue (CRF) with an average intensity of ≥4/10 on the Edmonton Symptom Assessment Scale (ESAS scale, 0-10) during the 24 hours prior to study enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase-I Panax Ginseng (Single Group) | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days |
| FG001 | Phase-II Blinded Panax Ginseng | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days |
| FG002 | Phase-ll Blinded Placebo | Took similar appearance colored Placebo capsule twice daily by mouth for 29 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase-I Panax Ginseng (Single Group) | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days |
| BG001 | Phase-II Blinded Panax Ginseng | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Those who completed 29 days of trials | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 29 |
|
Baseline up to 57 days
Adverse events that were reported by the patient
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase-I Panax Ginseng (Single Group) | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sriram Yennu, MD-Professor, Palliative Care Med | UT MD Anderson Cancer Center | (713) 792-3938 | syennu@mdanderson.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2020 | Nov 1, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| D000073893 | Sugars |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Placebo by mouth twice daily for 4 weeks. |
|
|
| Questionnaires | Behavioral | 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. |
|
|
| 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. | 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. | 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. | Baseline and Day 29 |
| Patient Changed Mind |
|
| Pruritus |
|
| Restlessness |
|
| Diarrhea |
|
| Pt enrolled in another clinical trial |
|
| Nausea |
|
| Increased AST/ALT |
|
| Vaginal Hemorrhage |
|
| Family problem |
|
| Protocol Violation |
|
| BG002 | Phase-ll Blinded Placebo | Took similar appearance colored Placebo capsule twice daily by mouth for 29 days |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Phase-II Blinded Panax Ginseng | Took one capsule (400mg) twice daily for 29 days |
| OG002 | Phase-ll Blinded Placebo | Took similar appearance colored capsule twice daily for 29 days |
|
|
|
| Secondary | 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. | Those who completed 29 days of trials | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 29 |
|
|
|
|
| Secondary | 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. | Those who completed 29 days of trials | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 29 |
|
|
|
|
| Secondary | 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. | Those who completed 29 days of trials | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 29 |
|
|
|
|
| Secondary | 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. | Those who completed 29 days of trials | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 29 |
|
|
|
|
| 1 |
| 30 |
| 3 |
| 30 |
| 4 |
| 30 |
| EG001 | Phase-II Blinded Panax Ginseng | Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days | 1 | 63 | 2 | 63 | 6 | 63 |
| EG002 | Phase-ll Blinded Placebo | Took similar appearance colored Placebo capsule twice daily by mouth for 29 days | 0 | 64 | 1 | 64 | 5 | 64 |
| EG003 | Open Label Extension | One capsule 400mg by mouth twice a day for 29 days | 0 | 102 | 0 | 102 | 9 | 102 |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorder (Other) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| White Blood Cell disorder | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and Infestations | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombotic Thrombocytopenic purpura | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Breast Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| General disorders (other) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Akathisia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Increased ALT | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Increased AST | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Delirium | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017531 |
| Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |