Trial · NCT00719563

American Ginseng in Treating Patients With Fatigue Caused by Cancer

NCT00719563, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2014-08-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. American Ginseng in Treating Patients With Fatigue Caused by Cancer. Trials, record NCT00719563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00719563

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: American Ginseng in Treating Patients With Fatigue Caused by Cancer
NCT number: NCT00719563
Status: Completed
Phases: Phase 3
Enrollment: 364 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: 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
Interventions: American ginseng, placebo
First posted: 2008-07-21
Last updated: 2017-02-09
Results first posted: 2014-08-06

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 4 in the General Subscale of the MFSI-SF	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.
Secondary	Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	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.
Secondary	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	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.
Secondary	Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue	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.
Secondary	Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS	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.
Secondary	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.
Secondary	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	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.
Secondary	Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue	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.
Secondary	Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS	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.
Secondary	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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 4 in the General Subscale of the MFSI-SF	Baseline and week 4	Includes all participants who completed both baseline and week 4 assessments.	units on a scale	MEAN
SECONDARY	Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Week 1 to Week 8	Includes all participants that reported at least one value after baseline.	participants	NUMBER
SECONDARY	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	Baseline and Week 4	Includes all participants who completed both baseline and week 4 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue	Baseline and Week 4	Includes all participants who completed both baseline and week 4 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS	Baseline and Week 4	Includes all participants who completed both baseline and week 4 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)	Baseline and Week 4	Includes all participants who completed both baseline and week 4 assessments.	units on a scale	MEAN
SECONDARY	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	Baseline and week 8	Includes all participants who completed both baseline and week 8 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue	Baseline and Week 8	Includes all participants who completed both baseline and week 8 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS	Baseline and week 8	Includes all participants who completed both baseline and week 8 assessments.	units on a scale	MEAN
SECONDARY	Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)	Baseline and Week 8	Includes all participants who completed both baseline and week 8 assessments.	units on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group88

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 4 in the General Subscale of the MFSI-SF	Ginseng		14.4	Standard Deviation 27.1	units on a scale
Change From Baseline to Week 4 in the General Subscale of the MFSI-SF	Placebo		8.2	Standard Deviation 24.8	units on a scale
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Ginseng	Grade 2 Nausea	5		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Placebo	Grade 2 Nausea	3		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Ginseng	Grade 2 Vomiting	2		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Placebo	Grade 2 Vomiting	2		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Ginseng	Grade 2 Insomnia	9		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Placebo	Grade 2 Insomnia	10		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Ginseng	Grade 3 Insomnia	1		participants
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence	Placebo	Grade 3 Insomnia	1		participants

1 to 10 of 88Source ClinicalTrials.gov

See all 88 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ginseng	171
Overall Study	STARTED	Placebo	170
Overall Study	COMPLETED	Ginseng	133
Overall Study	COMPLETED	Placebo	128
Overall Study	NOT COMPLETED	Ginseng	38
Overall Study	NOT COMPLETED	Placebo	42

Source ClinicalTrials.gov

Adverse events102

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hemoglobin decreased	Blood and lymphatic system disorders	Ginseng	2	168	3
other	Hemoglobin decreased	Blood and lymphatic system disorders	Placebo	0	169	0
other	Left ventricular failure	Cardiac disorders	Ginseng	0	168	0
other	Left ventricular failure	Cardiac disorders	Placebo	1	169	1
other	Palpitations	Cardiac disorders	Ginseng	1	168	1
other	Palpitations	Cardiac disorders	Placebo	0	169	0
other	Sinus tachycardia	Cardiac disorders	Ginseng	1	168	1
other	Sinus tachycardia	Cardiac disorders	Placebo	0	169	0
other	Tinnitus	Ear and labyrinth disorders	Ginseng	1	168	4
other	Tinnitus	Ear and labyrinth disorders	Placebo	0	169	0

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ginseng
Total, all-cause mortality	Placebo
Total, other adverse events	Ginseng	115	168
Total, other adverse events	Placebo	112	169
Total, serious adverse events	Ginseng	1	168
Total, serious adverse events	Placebo	5	169

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ginseng vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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