American Ginseng in Treating Patients With Fatigue Caused by Cancer

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.

PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

1. Required characteristics

• ≥ 18 years of age

• Men or women with a history of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)

• The presence of fatigue ≥ 1 month prior to randomization

• ECOG performance score 0, 1, or 2

• Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma, undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or those having completed curative intent therapy who were diagnosed within the past 2 years

• Note: If a patient is receiving treatment for their disease such as chemotherapy, targeted therapies, immunotherapy or radiation therapy then, the patient must have completed ≥ 1 cycle of chemotherapy, targeted therapy, or ≥ 1 week of radiation treatment.

• Laboratory values obtained prior to randomization:

• Hgb ≥ 11 (must be obtained ≤ 30 days; patients must not be transfused ≤ 30 days to meet this criterion)

• Creatinine ≤ 1.2 x UNL (must be obtained ≤ 180 days prior to randomization)

• AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (must be obtained ≤ 180 days prior to randomization)

• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

• Ability to complete patient questionnaires alone or with assistance

• Controlled:

• Pain (≤ 4 on Linear Analogue Scale)

• Insomnia (≤ 4 on Linear Analogue Scale)

• Willingness to provide blood/saliva samples for correlative studies.

• Note: These samples are only required for those not receiving active treatment for their disease. Active treatment is defined as chemotherapy, radiation therapy, or immunotherapy, not anti-hormone therapy such as tamoxifen, aromatase inhibitors or leuprolide.

2. Contraindications

• Hypersensitivity to ginseng

• Prior use of ginseng capsules for fatigue in the past year

• Note: Prior use of teas or drinks containing ginseng is allowed, however, patients will be asked to avoid these beverages while on the study.

• Uncontrolled hypertension on more than one occasion (diastolic blood pressure > 100, systolic > 160) measured ≤ 90 days prior to randomization

• Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc.

• Note: Antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for ≥ 1 month and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.

• Known brain metastasis or primary CNS malignancy

• Chronic systemic steroid use (including CHOP therapy or as part of any regular cancer treatment, however, steroids used as prophylaxis for nausea and vomiting are allowed) to prevent rash with Alimta, low dose dexamethasone will be allowed.

• Diabetes Type I or II (defined by being on oral hypoglycemics or insulin).

• Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history).

• ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetic

• Any of the following:

• Pregnant women

• Nursing women

• Women of childbearing potential who are unwilling to employ adequate contraception

• Pain requiring opioid pain medication, however, over the counter analgesics such as Tylenol or ibuprofen are allowed.

• Use of full dose of anticoagulant therapy (Exception: 1 mg/day of Coumadin for preventing catheter clots is allowed).

• Use of MAO inhibitors.

• Planning to start or complete any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study. Note: If not currently getting treatment, no chemotherapy agents ≤ 21 days prior to randomization. Combination treatment regimens that have components ending at different times are allowed, as long as any part of the initially started treatment continues through the double blind portion of the study.

• Malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician, as they could impact fatigue.

• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen").

• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral ginseng/placebo treatment.

• Uncontrolled thyroid disorder.

• Currently receiving single agent on blinded placebo controlled treatment trials.