American Ginseng in Treating Patients With Fatigue Caused by Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00719563
First received: July 18, 2008
Last updated: August 10, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Fatigue
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: American ginseng
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Duration of response as measured by the general subscale MFSI-SF [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities [ Designated as safety issue: Yes ]
  • Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI [ Designated as safety issue: No ]
  • Fatigue as measured by the BFI and Linear Analogue Scale Fatigue [ Designated as safety issue: No ]
  • Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF [ Designated as safety issue: No ]
  • Impact on stress/fatigue as measured by Perceived Stress Scale [ Designated as safety issue: No ]
  • Efficacy on fatigue in minority populations [ Designated as safety issue: No ]
  • Cortisol and cytokine values in fatigued cancer survivors and relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors [ Designated as safety issue: No ]
  • Impact of Wisconsin Ginseng on the expression of cortisol and cytokine in fatigued cancer survivors [ Designated as safety issue: No ]
  • Role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue [ Designated as safety issue: No ]
  • Relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: October 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
Dietary Supplement: American ginseng
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the efficacy of American ginseng (Panax quinquefolius) as therapy for cancer-related fatigue as measured by the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF).

Secondary

  • To evaluate toxicities and tolerability of American ginseng when used for cancer-related fatigue.
  • To examine stress as a mediating variable on the effects of American ginseng on cancer-related fatigue.
  • To explore the impact of American ginseng on various dimensions of fatigue as measured by the other subscales of the MFSI-SF, functional interference as measured by the Brief Fatigue Inventory (BFI), stress as measured by the Perceived Stress Scale, and well being as measured by the Profile of Mood States (POMS), as well as the single measure of fatigue.
  • To determine clinically significant changes in fatigue scores using the global impression of change.
  • To evaluate whether there are differences in the efficacy of American ginseng for fatigue based on minority populations.

Tertiary

  • To describe cortisol and cytokine values in fatigued cancer survivors and to evaluate the relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors.
  • To evaluate whether Wisconsin Ginseng impacts the expression of cortisol and cytokine in fatigued cancer survivors.
  • To evaluate the role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue.
  • To evaluate the relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress.

OUTLINE: This is a multicenter study. Patients are stratified according to baseline fatigue score (4-7 vs 8-10), disease status of current cancer (initial diagnosis vs recurrent disease), current treatment (chemotherapy, radiation, endocrine therapy [i.e., tamoxifen or aromatase inhibitors], or other targeted therapy) ( yes vs no), duration of all prior cancer treatment in patient's lifetime (none vs ≤ 180 days vs > 180 days), and current tumor type (hematologic vs solid tumor malignancy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses until disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.

Patients are instructed to complete the Ginseng Symptom Experience Diary and the Linear Analogue Scale weekly. Patients also complete the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Profile of Mood States (POMS), and the Brief Fatigue Inventory (BFI) questionnaires at baseline and periodically during study therapy.

Patients who are not actively receiving chemotherapy or radiation therapy undergo blood and saliva sample collection at baseline and periodically during study therapy for correlative studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of histologically or cytologically proven cancer within the past 2 years

    • Currently undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or completed curative intent therapy
    • Must have completed > 1 course of chemotherapy or targeted therapy or > 1 week of radiation therapy
    • Not planning to start new or complete cancer therapy during study

      • If not currently receiving 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
  • History of cancer-related fatigue as defined by an average score of ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)

    • Experiencing fatigue for ≥ 1 month
  • No known brain metastasis or primary CNS malignancy

PATIENT CHARACTERISTICS:

  • ECOG performance score 0-2
  • Hemoglobin ≥ 11 g/dL
  • Creatinine ≤ 1.2 times upper limit of normal (ULN)
  • AST/ALT ≤ 1.5 times ULN
  • No uncontrolled hypertension (diastolic blood pressure > 100 mm Hg and systolic blood pressure > 160 mm Hg) on more than one occasion within the past 90 days
  • No pain requiring opioid pain medication
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to complete patient questionnaires alone or with assistance
  • No insomnia ≤ 4 as measure by the Linear Analogue Scale
  • No uncontrolled thyroid disorder
  • No hypersensitivity to ginseng
  • No diabetes type I or II (defined as being on oral hypoglycemics or insulin)
  • No psychiatric disorder such as severe depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia
  • No malnutrition, active infection, significant pulmonary disease, or cardiovascular disease
  • No uncontrolled nausea or vomiting, or any symptom that would preclude the patient's ability to comply with daily oral ginseng/placebo treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 4 weeks since prior major surgery including any procedure that requires general anesthetic
  • Concurrent erythropoietin agents for anemia allowed
  • No prior use of ginseng capsules for fatigue

    • Prior teas or beverages containing ginseng are allowed
  • No concurrent over-the-counter herbal/dietary supplement marketed for fatigue or energy (e.g., products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen")
  • No concurrent pharmacologic agent or nonpharmacologic interventions that specifically treats fatigue including, but not limited to, psychostimulants, antidepressants, or acupuncture except antidepressants to treat conditions other than fatigue (e.g., hot flashes) provided patient has been on a stable dose for ≥ 1 month and plans to continue for ≥ 1 month

    • Exercise is allowed
  • No concurrent chronic systemic steroids (including as part of cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone [CHOP] therapy or any regular cancer treatment) except as prophylaxis for nausea and vomiting

    • Low-dose dexamethasone allowed to prevent rash with Alimta
  • No concurrent full dose anticoagulant therapy

    • 1 mg/day of coumadin for preventing catheter clots allowed
  • No concurrent monoamine oxidase inhibitors
  • No concurrent single agent on a blinded placebo controlled treatment trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719563

  Show 326 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
Investigator: Paul L. Schaefer, MD North Central Cancer Treatment Group
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Amit Sood, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00719563     History of Changes
Other Study ID Numbers: CDR0000597665, NCCTG-N07C2
Study First Received: July 18, 2008
Last Updated: August 10, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
fatigue
unspecified adult solid tumor, protocol specific
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:
Neoplasms
Fatigue
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Myelodysplastic-Myeloproliferative Diseases
Signs and Symptoms
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on July 26, 2014