Clinical Trial: American Ginseng in Treating Patients With Cancer-Related Fatigue

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) September 2005

Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00182780

Purpose

RATIONALE: American ginseng may help relieve cancer-related fatigue.

PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.

Condition Intervention
Fatigue
unspecified adult solid tumor, protocol specific
 Drug: ginseng
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: fatigue assessment/management
 Procedure: herbal medicine / botanical therapy
 Procedure: supportive care/therapy

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies

Study Type: Interventional
Study Design: Treatment

Official Title: Randomized Study of American Ginseng in Patients With Cancer-Related Fatigue

Further Study Details: 

OBJECTIVES:

Primary

  • Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue.

Secondary

  • Determine the toxic effects and tolerability of American ginseng in these patients.
  • Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender, baseline fatigue score (5-7 vs 8-10), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive oral American ginseng twice daily for 8 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients receive oral American ginseng as in arm I, but at a higher dose.
  • Arm III: Patients receive oral American ginseng as in arm I, but at a higher dose than arm II.
  • Arm IV: Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.

After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng on the optional continuation portion of the study for an additional 8 weeks. Patients in arm IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study.

Quality of life is assessed at baseline and then at the end of weeks 4 and 8 of both the double-blind and optional continuation portion of the study.

PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed cancer
  • Experiences cancer-related fatigue, defined as a baseline fatigue score of > 4 on a numerical analogue scale (0-10)
  • Fatigue must be present for ≥ 1 month before study entry
  • No primary brain cancer, brain metastases, or other CNS malignancy, including CNS lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Hemoglobin ≥ 11 g/dL

Hepatic

  • SGOT ≤ 1.5 times upper limit of normal (ULN)

Renal

  • Calcium ≤ 1.2 times ULN
  • Creatinine ≤ 1.2 times ULN

Cardiovascular

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No diabetes
  • No hypersensitivity to ginseng
  • No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient''''s fatigue
  • No psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

  • Not specified

Surgery

  • More than 4 weeks since prior major surgery

Other

  • More than 2 weeks since prior pharmacologic agents for the treatment of fatigue, including any of the following:
  • Psychostimulants
  • Antidepressants
  • Antidepressants used to treat conditions other than fatigue are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
  • No prior ginseng capsules for fatigue
  • Prior or concurrent ginseng-containing teas or drinks purchased at a grocery store allowed
  • No concurrent monoamine oxidase inhibitors
  • No concurrent warfarin except if used at a dose of 1 mg/day for preventing catheter clots
  • No other concurrent pharmacologic agents for fatigue

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00182780


Study chairs or principal investigators

Brent A. Bauer, MD,  Study Chair,  Mayo Clinic Cancer Center   
Charles L. Loprinzi, MD,  Mayo Clinic Cancer Center   
Teresa A. Rummans, MD,  Mayo Clinic Cancer Center   
Tait D. Shanafelt, MD,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000440907; NCCTG-N03CA
Last Updated:  September 15, 2005
Record first received:  September 15, 2005
ClinicalTrials.gov Identifier:  NCT00182780
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20



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