Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Related Information
Registry Information

Alternate Title

American Ginseng in Treating Patients With Cancer-Related Fatigue

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Closed	18 and over	NCI	NCCTG-N03CA NCT00182780, N03CA

Special Category: NCI Web site featured trial

Objectives

Primary

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

Secondary

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

Entry 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

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

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)

Expected Enrollment

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

Outcomes

Fatigue by brief inventory at 4 and 8 weeks of treatment

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

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.

Barton DL, Soori GS, Bauer BA, et al.: Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Support Care Cancer : , 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Brent Bauer, MD, Protocol chair		Ph: 507-284-2511 Email: bauer.brent@mayo.edu
Charles Loprinzi, MD, Protocol co-chair		Ph: 507-284-2511 Email: cloprinzi@mayo.edu
Teresa Rummans, MD, Protocol co-chair		Ph: 507-284-2511
Tait Shanafelt, MD, Protocol co-chair		Ph: 507-284-2511
Patricia Johnson, MD, PhD, Protocol co-chair		Ph: 217-383-3010

Related Information

Featured trial article

Registry Information
Official Title		The Use of American Ginseng (panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
Trial Start Date		2005-10-21
Registered in ClinicalTrials.gov		NCT00182780
Date Submitted to PDQ		2005-07-13
Information Last Verified		2006-07-26
NCI Grant/Contract Number		CA025224