American Ginseng, cpr 700 mg (500 mg of Panax Quinquefolius 5%): 1 cpr twice a day orally for 3 months

Placebo: 1 cpr twice a day orally for 3 months

Cancer Related Fatigue

Breast Cancer Female

American Ginseng

Placebo

Oncology Department, Perugia Hospital

American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

American Ginseng (Panax Quinquefolius) for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients Submitted to Adjuvant Chemotherapy After Surgery. A Study of NICSO (Network Italiano Cure di Supporto in Oncologia).

Incidence will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).

Intensity will be evaluated through the Numeric Rating Scale (NRS). NRS is a linear numeric scale, from 0 = no fatigue to 10 = the worst possible fatigue. A NRS value ≥ 4 indicates the presence of a signficative fatigue (moderate-severe fatigue).moderate-severe fatigue.

QoL will be evaluated through validated instruments: the Brief Fatigue Inventory (BFI) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30), Italian version.

Fausto Roila

Medical doctor

Network Italiano Cure di Supporto in Oncologia

Azienda Ospedaliera di Perugia

Associazione Umbra per la lotta Contro il Cancro

Avanti Tutta Onlus

Randomized, double-blind, placebo-controlled

Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.

Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.

Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Ginseng

Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Total

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Menopausal status

Time since current cancer diagnosis

More than one primary cancer

Type of cancer

Currently receiving treatment

Current endocrine therapy

Sleep aids

If taking sleep aids, how frequent?

Exercising regularly

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.

Change From Baseline to Week 4 in the General Subscale of the MFSI-SF

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.

Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..

Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence

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 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF

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 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue

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 Vigor/Activity and Fatigue-inertia as Measured by POMS

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 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)

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 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF

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 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue

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 Vigor/Activity and Fatigue-inertia as Measured by POMS

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.

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

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).

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

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).

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

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

Overall Study

Debra L. Barton, RN, PhD, AOCN, FAAN

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

American ginseng

placebo

Mayo Clinic Scottsdale

Aurora Presbyterian Hospital

Boulder Community Hospital

Penrose Cancer Center at Penrose Hospital

St. Anthony Central Hospital

Porter Adventist Hospital

Presbyterian - St. Luke's Medical Center

St. Joseph Hospital

Rose Medical Center

CCOP - Colorado Cancer Research Program

Swedish Medical Center

Poudre Valley Hospital

Front Range Cancer Specialists

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Sky Ridge Medical Center

Hope Cancer Care Center at Longmont United Hospital

St. Mary - Corwin Regional Medical Center

North Suburban Medical Center

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

University of Florida Shands Cancer Center

Mayo Clinic - Jacksonville

MBCCOP - Medical College of Georgia Cancer Center

Kapiolani Medical Center at Pali Momi

Cancer Research Center of Hawaii

MBCCOP - Hawaii

OnCare Hawaii, Incorporated - Lusitana

Queen's Cancer Institute at Queen's Medical Center

Straub Clinic and Hospital, Incorporated

Hawaii Medical Center - East

OnCare Hawaii, Incorporated - Kuakini

Kapiolani Medical Center for Women and Children

Tripler Army Medical Center

Kauai Medical Clinic

Maui Memorial Medical Center

Pacific Cancer Institute - Maui

Rush-Copley Cancer Care Center

Illinois CancerCare - Bloomington

St. Joseph Medical Center

Graham Hospital

Illinois CancerCare - Canton

Illinois CancerCare - Carthage

Memorial Hospital

Eureka Community Hospital

Illinois CancerCare - Eureka

Galesburg Clinic, PC

Galesburg Cottage Hospital

Illinois CancerCare - Galesburg

Illinois CancerCare - Havana

Mason District Hospital

Illinois CancerCare - Kewanee Clinic

Illinois CancerCare - Macomb

McDonough District Hospital

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Illinois CancerCare - Monmouth

OSF Holy Family Medical Center

BroMenn Regional Medical Center

Community Cancer Center

Illinois CancerCare - Community Cancer Center

Community Hospital of Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Cancer Treatment Center at Pekin Hospital

Illinois CancerCare - Pekin

Proctor Hospital

CCOP - Illinois Oncology Research Association

Oncology Hematology Associates of Central Illinois, PC - Peoria

Methodist Medical Center of Illinois

OSF St. Francis Medical Center

Illinois CancerCare - Peru

Illinois Valley Community Hospital

Illinois CancerCare - Princeton

Perry Memorial Hospital

Illinois CancerCare - Spring Valley

CCOP - Carle Cancer Center

St. Francis Hospital and Health Centers - Beech Grove Campus

Elkhart Clinic, LLC

Michiana Hematology-Oncology, PC - Elkhart

Elkhart General Hospital

Howard Community Hospital

Center for Cancer Therapy at LaPorte Hospital and Health Services

Michiana Hematology-Oncology, PC - South Bend

Saint Joseph Regional Medical Center

Michiana Hematology Oncology PC - Plymouth

Reid Hospital & Health Care Services

CCOP - Northern Indiana CR Consortium

Memorial Hospital of South Bend

South Bend Clinic

Michiana Hematology Oncology PC - La Porte

McFarland Clinic, PC

Cedar Rapids Oncology Associates

Mercy Regional Cancer Center at Mercy Medical Center

Medical Oncology and Hematology Associates - West Des Moines

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

John Stoddard Cancer Center at Iowa Lutheran Hospital

McCreery Cancer Center at Ottumwa Regional

American Ginseng in Treating Patients With Fatigue Caused by Cancer

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

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

four, 250mg tablets daily 5-14 days prior to surgery

Breast Cancer

American Ginseng root

Simmons Cancer Institute-SIU School of Medicine

A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

panax stipuleanatus/breast neoplasms

American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

American Ginseng in Treating Patients With Fatigue Caused by Cancer

A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

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