American Ginseng in Treating Patients With Cancer-Related Fatigue

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00182780
First received: September 15, 2005
Last updated: April 21, 2010
Last verified: July 2006
  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
Dietary Supplement: American ginseng

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fatigue by brief inventory at 4 and 8 weeks of treatment

Secondary Outcome Measures:
  • Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
  • Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment

Estimated Enrollment: 280
Study Start Date: October 2005
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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 (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (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, every 2 weeks during treatment, and at the end of treatment.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  • No uncontrolled hypertension (i.e., diastolic blood pressure [BP] > 100 mm Hg and/or systolic BP > 160)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No diabetes, defined as receiving oral hypoglycemics or insulin
  • No hypersensitivity to ginseng
  • No uncontrolled pain, hypothyroidism, or insomnia that is considered to be the primary cause of patient's fatigue
  • Not currently under the care of a psychiatrist for documented psychiatric disorder (e.g., severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Concurrent epoetin alfa for treatment of anemia allowed

Chemotherapy

  • Concurrent chemotherapy allowed except CHOP therapy

Endocrine therapy

  • No concurrent chronic systemic steroids

Radiotherapy

  • Not specified

Surgery

  • More than 4 weeks since prior major surgery

Other

  • No prior ginseng capsules for fatigue

    • Prior ginseng-containing teas or drinks purchased at a grocery store allowed
  • No concurrent pharmacologic agents for the treatment of fatigue, including any of the following:

    • Psychostimulants
    • Antidepressants

      • Antidepressants used to treat conditions other than fatigue (e.g., hot flashes) are allowed provided the patient has been on a stable dose for ≥ 1 month and plans to continue antidepressant for ≥ 1 month
  • No concurrent monoamine oxidase inhibitors
  • No concurrent full anticoagulation doses of warfarin or heparin

    • A dose of 1 mg/day for preventing catheter clots allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182780

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Brent A. Bauer, MD Mayo Clinic
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Teresa A. Rummans, MD Mayo Clinic
Investigator: Tait D. Shanafelt, MD Mayo Clinic
Investigator: Patricia A. Johnson, MD, PhD Carle Cancer Center at Carle Foundation Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00182780     History of Changes
Other Study ID Numbers: CDR0000440907, NCCTG-N03CA
Study First Received: September 15, 2005
Last Updated: April 21, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
fatigue
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014