American Ginseng in Treating Patients With Cancer-Related Fatigue

Fatigue Clinical Trial

Official title:

The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182780
• Other study ID #: NCCTG-N03CA
• Secondary ID: NCI-2012-02670CD
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: October 27, 2017
• Start date: October 2005
• Est. completion date: April 2010

Study information

• Verified date: October 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: April 2010
• Est. primary completion date: September 5, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Dietary Supplement:
• American ginseng

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

References & Publications (1)

Barton DL, Soori GS, Bauer BA, Sloan JA, Johnson PA, Figueras C, Duane S, Mattar B, Liu H, Atherton PJ, Christensen B, Loprinzi CL. Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue by brief inventory at 4 and 8 weeks of treatment		at 4 and 8 weeks
Secondary	Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment		at 4 and 8 weeks
Secondary	Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment		at 4 and 8 weeks