Overview

This trial is active, not recruiting.

Conditions chronic myeloproliferative disorders, fatigue, leukemia, lymphoma, lymphoproliferative disorder, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasms, precancerous condition, unspecified adult solid tumor, protocol specific
Treatments american ginseng, placebo
Phase phase 3
Sponsor North Central Cancer Treatment Group
Collaborator National Cancer Institute (NCI)
Start date October 2008
End date September 2011
Trial size 360 participants
Trial identifier NCT00719563, CDR0000597665, NCCTG-N07C2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking double-blind
Primary purpose supportive care
Arm
(Experimental)
Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
american ginseng
Given orally
(Placebo Comparator)
Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
placebo
Given orally

Primary Outcomes

Measure
Duration of response as measured by the general subscale MFSI-SF
time frame:

Secondary Outcomes

Measure
Toxicities
time frame:
Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI
time frame:
Fatigue as measured by the BFI and Linear Analogue Scale Fatigue
time frame:
Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF
time frame:
Impact on stress/fatigue as measured by Perceived Stress Scale
time frame:
Efficacy on fatigue in minority populations
time frame:
Cortisol and cytokine values in fatigued cancer survivors and relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors
time frame:
Impact of Wisconsin Ginseng on the expression of cortisol and cytokine in fatigued cancer survivors
time frame:
Role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue
time frame:
Relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of histologically or cytologically proven cancer within the past 2 years - Currently undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or completed curative intent therapy - Must have completed > 1 course of chemotherapy or targeted therapy or > 1 week of radiation therapy - Not planning to start new or complete cancer therapy during study - If not currently receiving 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 of the initially started treatment continues through the double blind portion of the study - History of cancer-related fatigue as defined by an average score of ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10) - Experiencing fatigue for ≥ 1 month - No known brain metastasis or primary CNS malignancy PATIENT CHARACTERISTICS: - ECOG performance score 0-2 - Hemoglobin ≥ 11 g/dL - Creatinine ≤ 1.2 times upper limit of normal (ULN) - AST/ALT ≤ 1.5 times ULN - No uncontrolled hypertension (diastolic blood pressure > 100 mm Hg and systolic blood pressure > 160 mm Hg) on more than one occasion within the past 90 days - No pain requiring opioid pain medication - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to complete patient questionnaires alone or with assistance - No insomnia ≤ 4 as measure by the Linear Analogue Scale - No uncontrolled thyroid disorder - No hypersensitivity to ginseng - No diabetes type I or II (defined as being on oral hypoglycemics or insulin) - No psychiatric disorder such as severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia - No malnutrition, active infection, significant pulmonary disease, or cardiovascular disease - No uncontrolled nausea or vomiting, or any symptom that would preclude the patient's ability to comply with daily oral ginseng/placebo treatment PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since prior major surgery including any procedure that requires general anesthetic - Concurrent erythropoietin agents for anemia allowed - No prior use of ginseng capsules for fatigue - Prior teas or beverages containing ginseng are allowed - No concurrent over-the-counter herbal/dietary supplement marketed for fatigue or energy (e.g., products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen") - No concurrent pharmacologic agent or nonpharmacologic interventions that specifically treats fatigue including, but not limited to, psychostimulants, antidepressants, or acupuncture except antidepressants to treat conditions other than fatigue (e.g., hot flashes) provided patient has been on a stable dose for ≥ 1 month and plans to continue for ≥ 1 month - Exercise is allowed - No concurrent chronic systemic steroids (including as part of cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone [CHOP] therapy or any regular cancer treatment) except as prophylaxis for nausea and vomiting - Low-dose dexamethasone allowed to prevent rash with Alimta - No concurrent full dose anticoagulant therapy - 1 mg/day of coumadin for preventing catheter clots allowed - No concurrent monoamine oxidase inhibitors - No concurrent single agent on a blinded placebo controlled treatment trial

Additional Information

Official title The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study
Description OBJECTIVES: Primary - To evaluate the efficacy of American ginseng (Panax quinquefolius) as therapy for cancer-related fatigue as measured by the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). Secondary - To evaluate toxicities and tolerability of American ginseng when used for cancer-related fatigue. - To examine stress as a mediating variable on the effects of American ginseng on cancer-related fatigue. - To explore the impact of American ginseng on various dimensions of fatigue as measured by the other subscales of the MFSI-SF, functional interference as measured by the Brief Fatigue Inventory (BFI), stress as measured by the Perceived Stress Scale, and well being as measured by the Profile of Mood States (POMS), as well as the single measure of fatigue. - To determine clinically significant changes in fatigue scores using the global impression of change. - To evaluate whether there are differences in the efficacy of American ginseng for fatigue based on minority populations. Tertiary - To describe cortisol and cytokine values in fatigued cancer survivors and to evaluate the relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors. - To evaluate whether Wisconsin Ginseng impacts the expression of cortisol and cytokine in fatigued cancer survivors. - To evaluate the role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue. - To evaluate the relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress. OUTLINE: This is a multicenter study. Patients are stratified according to baseline fatigue score (4-7 vs 8-10), disease status of current cancer (initial diagnosis vs recurrent disease), current treatment (chemotherapy, radiation, endocrine therapy [i.e., tamoxifen or aromatase inhibitors], or other targeted therapy) ( yes vs no), duration of all prior cancer treatment in patient's lifetime (none vs ≤ 180 days vs > 180 days), and current tumor type (hematologic vs solid tumor malignancy). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses until disease progression or unacceptable toxicity. - Arm II: Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses. Patients are instructed to complete the Ginseng Symptom Experience Diary and the Linear Analogue Scale weekly. Patients also complete the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Profile of Mood States (POMS), and the Brief Fatigue Inventory (BFI) questionnaires at baseline and periodically during study therapy. Patients who are not actively receiving chemotherapy or radiation therapy undergo blood and saliva sample collection at baseline and periodically during study therapy for correlative studies.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).