Clinical trial NCT00182780: American Ginseng in Treating Patients With Cancer-Related Fatigue
Official title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue
unspecified adult solid tumor, protocol specific
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-16
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Fatigue by brief inventory at 4 and 8 weeks of treatment
timeFrame: at 4 and 8 weeks
Secondary outcomes:
measure: Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
timeFrame: at 4 and 8 weeks
measure: Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment
timeFrame: at 4 and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Brent A. Bauer, MD
role: STUDY_CHAIR
References:
citation: 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-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.