American Ginseng in Treating Patients With Fatigue Caused by Cancer - Full Text View

Sponsors and Collaborators:	North Central Cancer Treatment Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00719563

Purpose

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.

Condition	Intervention	Phase
Chronic Myeloproliferative Disorders Fatigue Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: American ginseng Drug: placebo	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Fungal Infections Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

Drug Information available for: Ginseng

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Duration of response as measured by the general subscale MFSI-SF [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicities [ Designated as safety issue: Yes ]
Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI [ Designated as safety issue: No ]
Fatigue as measured by the BFI and Linear Analogue Scale Fatigue [ Designated as safety issue: No ]
Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF [ Designated as safety issue: No ]
Impact on stress/fatigue as measured by Perceived Stress Scale [ Designated as safety issue: No ]
Efficacy on fatigue in minority populations [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Impact of Wisconsin Ginseng on the expression of cortisol and cytokine in fatigued cancer survivors [ Designated as safety issue: No ]
Role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue [ Designated as safety issue: No ]
Relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.	Drug: American ginseng Given orally
Arm II: Placebo Comparator Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.	Drug: placebo Given orally

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
History of cancer-related fatigue as defined by an average score of ≥ 4 over the past 30 days on the numeric analogue scale (0 - 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)
SGOT ≤ 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 that specifically treats fatigue including, but not limited to, psychostimulants or antidepressants 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
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719563

Show 210 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Debra Barton, RN, PhD, AOCN	Mayo Clinic
Investigator:	Paul L. Schaefer, MD	North Central Cancer Treatment Group
Investigator:	Charles L. Loprinzi, MD	Mayo Clinic
Investigator:	Amit Sood, MD	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000597665, NCCTG-N07C2
Study First Received:	July 18, 2008
Last Updated:	January 10, 2009
ClinicalTrials.gov Identifier:	NCT00719563
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia

mast cell leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia

Study placed in the following topic categories:

Blast Crisis
Sezary syndrome
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Lymphoma, large-cell, immunoblastic
Lymphomatoid granulomatosis
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Lymphoma, Large-Cell, Anaplastic
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Myelodysplastic syndromes

Essential thrombocytosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Waldenstrom Macroglobulinemia
Plasmacytoma
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Disease

Immune System Diseases
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009