American Ginseng in Treating Patients With Cancer-Related Fatigue

NCT00182780 | Completed

• 3 other identifiers: NCCTG-N03CANCI-2012-02670CDR0000440907
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

fatigue; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Fatigue by brief inventory at 4 and 8 weeks of treatment

  at 4 and 8 weeks

Secondary Outcomes (2)

• Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment

  at 4 and 8 weeks

• Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment

  at 4 and 8 weeks

Study Arms (4)

Arm I - American ginseng (low dose)

EXPERIMENTAL

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.

Dietary Supplement: American ginseng

Arm II - American ginseng (mid-dose)

EXPERIMENTAL

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.

Dietary Supplement: American ginseng

Arm III - American ginseng (high-dose)

EXPERIMENTAL

Patients receive oral American ginseng at the high 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.

Dietary Supplement: American ginseng

Arm IV - Placebo

OTHER

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.

Other: Placebo

Interventions

American ginseng DIETARY_SUPPLEMENT

Arm I - American ginseng (low dose); Arm II - American ginseng (mid-dose); Arm III - American ginseng (high-dose)

Placebo OTHER

Arm IV - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related 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-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 RESULT

MeSH Terms

Conditions

Fatigue

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brent A. Bauer, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2005
• Primary Completion: September 5, 2006
• Study Completion: April 1, 2010
• Last Updated: October 31, 2017

Record last verified: 2017-10