Clinical TrialID 966

Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors

NCT03407716

Cancer Survivor|Stage I Breast Cancer AJCC v7|Stage I Colon Cancer AJCC v6 and v7|Stage IA Breast Cancer AJCC v7|Stage IB Breast Cancer AJCC v7|Stage II Breast Cancer AJCC v6 and v7|Stage II Colon Cancer AJCC v7|Stage II

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Record Fields

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Clinical Trial Id
966
Evidence Id
966
Core Evidence Id
966
Source Clinical Trial Id
947
Herb2 Clinical Trial Id
HBCT000947
Nct Id
NCT03407716
Title
Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors
Status
Completed
Phase
Early_Phase 1
Study Result
No
Study Condition
Cancer Survivor|Stage I Breast Cancer AJCC v7|Stage I Colon Cancer AJCC v6 and v7|Stage IA Breast Cancer AJCC v7|Stage IB Breast Cancer AJCC v7|Stage II Breast Cancer AJCC v6 and v7|Stage II Colon Cancer AJCC v7|Stage IIA Breast Cancer AJCC v6 and v7|Stage IIA Colon Cancer AJCC v7|Stage IIB Breast Cancer AJCC v6 and v7|Stage IIB Colon Cancer AJCC v7|Stage IIC Colon Cancer AJCC v7|Stage III Breast Cancer AJCC v7|Stage III Colon Cancer AJCC v7|Stage IIIA Breast Cancer AJCC v7|Stage IIIA Colon Cancer AJCC v7|Stage IIIB Breast Cancer AJCC v7|Stage IIIB Colon Cancer AJCC v7|Stage IIIC Breast Cancer AJCC v7|Stage IIIC Colon Cancer AJCC v7
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Intervention
DRUG: American Ginseng|OTHER: Laboratory Biomarker Analysis|OTHER: Placebo|OTHER: Questionnaire Administration
Intervention Allocation
Randomized
Intervention Model
Crossover
Intervention Mask
Double
Intervention Purpose
Supportive_Care
Gender
All
Age
Adult, Older_Adult
Enrollment
2
Outcome Measure
Change in general subscale of the Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF), Will be evaluated by taking the change from baseline in the general subscale of the MFSI-SF and comparing the two arms by a two-sample, two-sided t-test. If there is evidence of non-normality (via Shapiro-Wilk testing), a non-parametric procedure such as Wilcoxon rank sum will be used. Graphical procedures will include stream plots of individual patient scores and plots of average values over time for each treatment group. Supplemental tests on endpoints (paired t-test for continuous/ordinal data; McNemar?s test for binary data; and Bowker?s test for categorical data) will be utilized to deter, Baseline up to day 56
Sponsor Collaborator
Mayo Clinic|National Cancer Institute (NCI)
Funded By
OTHER
Location
Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States
Other Id
MC16C2|NCI-2017-02494|MC16C2
Start Date
2019-03-01
Primary Completion Date
2020-05-13
Completion Date
2021-02-22
First Posted
2018-01-23
Results First Posted
Last Update Posted
2023-01-05
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03407716
Title Cn
Title En
Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors
Bilingual Status
semi_complete