Phase 3
Completed N=341
American Ginseng in Treating Patients With Fatigue Caused by Cancer
Source: ClinicalTrials.gov NCT00719563 ↗Enrolled (actual)
341
Serious AEs
1.8%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline to Week 4 in the General Subscale of the MFSI-SF — 14.4; 8.2 units on a scale — p=0.0737
Summary
RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.
PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 4 in the General Subscale of the MFSI-SF |
14.4; 8.2 | 0.0737 |
| SECONDARY Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence |
5; 3; 2; 2; 9; 10 | — |
| SECONDARY Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF |
1.6; -0.4; 2.0; 0.6; 0.5; 0.5 | — |
| SECONDARY Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue |
11.9; 9.9; 11.8; 7.9; 11.8; 9.7 | — |
| SECONDARY Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS |
5.0; 3.9; 14.5; 7.7 | — |
| SECONDARY Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS) |
-3.1; -3.2 | — |
| SECONDARY Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF |
20; 10.3; 3.0; -1.7; 2.8; 3.4 | — |
| SECONDARY Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue |
16.4; 11.5; 17.6; 8.1; 16.6; 10.0 | — |
| SECONDARY Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS |
8.2; 6.4; 18.6; 10.2 | — |
| SECONDARY Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS) |
-5.2; -4.7 | — |
| SECONDARY Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3 |
38.8; 29.2; 12.2; 5.7; 8.9; 2.6 | — |
| SECONDARY Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3 |
35.7; 30.6; 7.6; 3.8; 5.3; 5.3 | — |
| SECONDARY Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations |
— | — |
Eligibility Criteria
- Required characteristics
- ≥ 18 years of age
- Men or women with a history of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)
- The presence of fatigue ≥ 1 month prior to randomization
- ECOG performance score 0, 1, or 2
- Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma, undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or those having completed curative intent therapy who were diagnosed within the past 2 years
- Note: If a patient is receiving treatment for their disease such as chemotherapy, targeted therapies, immunotherapy or radiation therapy then, the patient must have completed ≥ 1 cycle of chemotherapy, targeted therapy, or ≥ 1 week of radiation treatment.
- Laboratory values obtained prior to randomization:
- Hgb ≥ 11 (must be obtained ≤ 30 days; patients must not be transfused ≤ 30 days to meet this criterion)
- Creatinine ≤ 1.2 x UNL (must be obtained ≤ 180 days prior to randomization)
- AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (must be obtained ≤ 180 days prior to randomization)
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Ability to complete patient questionnaires alone or with assistance
- Controlled:
- Pain (≤ 4 on Linear Analogue Scale)
- Insomnia (≤ 4 on Linear Analogue Scale)
- Willingness to provide blood/saliva samples for correlative studies.
- Note: These samples are only required for those not receiving active treatment for their disease. Active treatment is defined as chemotherapy, radiation therapy, or immunotherapy, not anti-hormone therapy such as tamoxifen, aromatase inhibitors or leuprolide.
- Contraindications
- Hypersensitivity to ginseng
- Prior use of ginseng capsules for fatigue in the past year
- Note: Prior use of teas or drinks containing ginseng is allowed, however, patients will be asked to avoid these beverages while on the study.
- Uncontrolled hypertension on more than one occasion (diastolic blood pressure > 100, systolic > 160) measured ≤ 90 days prior to randomization
- Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc.
- Note: Antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for ≥ 1 month and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.
- Known brain metastasis or primary CNS malignancy
- Chronic systemic steroid use (including CHOP therapy or as part of any regular cancer treatment, however, steroids used as prophylaxis for nausea and vomiting are allowed) to prevent rash with Alimta, low dose dexamethasone will be allowed.
- Diabetes Type I or II (defined by being on oral hypoglycemics or insulin).
- Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history).
- ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetic
- Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- Pain requiring opioid pain medication, however, over the counter analgesics such as Tylenol or ibuprofen are allowed.
- Use of full dose of anticoagulant therapy (Exception: 1 mg/day of Coumadin for preventing catheter clots is allowed).
- Use of MAO inhibitors.
- Planning to start or complete any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study. Note: If not currently getting treatment, no chemotherapy agents ≤ 21 days prior to randomization. Combination treatment regimens that have components ending at different times are allowed, as long as any part
Data sourced from ClinicalTrials.gov (NCT00719563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.