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American Ginseng in Treating Patients With Fatigue Caused by Cancer

Phase 3
Completed
Conditions
Fatigue
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic/Myeloproliferative Neoplasms
Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Unspecified Adult Solid Tumor, Protocol Specific
Precancerous Condition
Interventions
Registration Number
NCT00719563
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
364
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm IAmerican ginsengPatients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
Arm IIplaceboPatients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.
Primary Outcome Measures
NameTimeMethod
Change From Baseline to Week 4 in the General Subscale of the MFSI-SFBaseline and week 4

Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of FatigueBaseline and Week 4

Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMSBaseline and Week 4

Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)Baseline and Week 4

PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of FatigueBaseline and Week 8

Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMSBaseline and week 8

Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)Baseline and Week 8

PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

Number of Treatment Related Grade 2 to 3 Adverse Events >=1% IncidenceWeek 1 to Week 8

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SFBaseline and Week 4

Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3Baseline and Week 8

Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SFBaseline and week 8

Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3Baseline and Week 4

Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority PopulationsBaseline and Week 4

Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Trial Locations

Locations (322)

Mayo Clinic Scottsdale

🇺🇸

Scottsdale, Arizona, United States

Aurora Presbyterian Hospital

🇺🇸

Aurora, Colorado, United States

Boulder Community Hospital

🇺🇸

Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital

🇺🇸

Colorado Springs, Colorado, United States

St. Anthony Central Hospital

🇺🇸

Denver, Colorado, United States

Porter Adventist Hospital

🇺🇸

Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center

🇺🇸

Denver, Colorado, United States

St. Joseph Hospital

🇺🇸

Denver, Colorado, United States

Rose Medical Center

🇺🇸

Denver, Colorado, United States

CCOP - Colorado Cancer Research Program

🇺🇸

Denver, Colorado, United States

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Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States

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