Clinical Trial: American Ginseng in Treating Patients With Fatigue Caused by Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

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 Summary:

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 f
    Sponsor: Alliance for Clinical Trials in Oncology

    Current Primary Outcome: Change From Baseline to Week 4 in the General Subscale of the MFSI-SF [ Time Frame: Baseline 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.


    Original Primary Outcome: Duration of response as measured by the general subscale MFSI-SF

    Current Secondary Outcome:

    • Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence [ Time Frame: Week 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-SF [ Time Frame: Baseline 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.
    • Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue [ Time Frame: Baseline 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 POMS [ Time Frame: Baseline 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) [ Time Frame: 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 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF [ Time Frame: Baseline 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.
    • Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue [ Time Frame: Baseline 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 POMS [ Time Frame: Baseline 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) [ Time Frame: Baselin

      Original Secondary Outcome:

      • Toxicities
      • Impact on physical, mental, and emotional states and vigor as measured by other subscales of the MFSI-SF and BFI
      • Fatigue as measured by the BFI and Linear Analogue Scale Fatigue
      • Fatigue-inertia, vigor-activity, tension-anxiety, anger-hostility, and confusion-bewilderment as measured by POMS and subscales of the MFSI-SF
      • Impact on stress/fatigue as measured by Perceived Stress Scale
      • Efficacy on fatigue in minority populations


      Information By: Alliance for Clinical Trials in Oncology

      Dates:
      Date Received: July 18, 2008
      Date Started: October 2008
      Date Completion:
      Last Updated: December 19, 2016
      Last Verified: December 2016