American Ginseng in Treating Patients With Fatigue Caused by Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00719563
• Date of registration: 18/07/2008
• Primary sponsor: North Central Cancer Treatment Group
• Public title: American Ginseng in Treating Patients With Fatigue Caused by Cancer
• Scientific title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study
• Date of first enrolment: October 2008
• Target sample size: 360
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00719563
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Countries of recruitment

United States

Contacts

• Name: Amit Sood, MD
• Affiliation: Mayo Clinic

• Name: Charles L. Loprinzi, MD
• Affiliation: Mayo Clinic

• Name: Debra Barton, RN, PhD, AOCN, FAAN
• Affiliation: Mayo Clinic

• Name: Paul L. Schaefer, MD
• Affiliation: North Central Cancer Treatment Group

Key inclusion & exclusion 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

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Dietary Supplement: American ginseng

Other: placebo

Primary Outcome(s)

Duration of response as measured by the general subscale MFSI-SF [Time Frame: No]

Secondary Outcome(s)

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: No]

Efficacy on fatigue in minority populations [Time Frame: No]

Fatigue as measured by the BFI and Linear Analogue Scale Fatigue [Time Frame: No]

Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF [Time Frame: No]

Impact of Wisconsin Ginseng on the expression of cortisol and cytokine in fatigued cancer survivors [Time Frame: No]

Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI [Time Frame: No]

Impact on stress/fatigue as measured by Perceived Stress Scale [Time Frame: No]

Relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress [Time Frame: No]

Role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue [Time Frame: No]

Toxicities [Time Frame: Yes]

Secondary ID(s)

CDR0000597665

NCCTG-N07C2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)