Clinical trial · Interventional

American Ginseng in Treating Patients With Cancer-Related Fatigue

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

NCT00182780CI-TRIAL-00030140completedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Fatigue	—	UNRESOLVED	—
Unspecified Adult Solid Tumor, Protocol Specific	Adult Solid Neoplasm	ALIAS	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
American ginseng	Dietary Supplement	—	UNRESOLVED
Placebo	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (4)

type
EXPERIMENTAL
label
Arm I - American ginseng (low dose)
description
Patients receive oral American ginseng 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.
interventionNames
1. Dietary Supplement: American ginseng
type
EXPERIMENTAL
label
Arm II - American ginseng (mid-dose)
description
Patients receive oral American ginseng at the mid-dose 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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTBarton 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-finding evaluation: NCCTG trial N03CA. Support Care Cancer. 2010 Feb;18(2):179-87. doi: 10.1007/s00520-009-0642-2. Epub 2009 May 6. PMID 19415341