NCT03407716

Brief Summary

This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may decrease fatigue in people who were treated for cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

January 5, 2023

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

January 12, 2018

Last Update Submit

January 3, 2023

Conditions

Cancer SurvivorStage I Breast Cancer AJCC v7Stage I Colon Cancer AJCC v6 and v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage II Colon Cancer AJCC v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIA Colon Cancer AJCC v7Stage IIB Breast Cancer AJCC v6 and v7Stage IIB Colon Cancer AJCC v7Stage IIC Colon Cancer AJCC v7Stage III Breast Cancer AJCC v7Stage III Colon Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIA Colon Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIB Colon Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Stage IIIC Colon Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (11)

  • Change in MFSI-SF emotional subscale

    Baseline up to day 56

  • Change in MFSI-SF general subscale

    Baseline up to day 56

  • Change in MFSI-SF mental subscale

    Baseline up to day 56

  • Change in MFSI-SF physical subscale

    Baseline up to day 56

  • Change in MFSI-SF vigor subscale

    Baseline up to day 56

  • +6 more secondary outcomes

Other Outcomes (1)

  • Change in inflammation biomarkers (adiponectin, cortisol, IL-6)

    Baseline up to day 84

Study Arms (2)

Group I (North American ginseng extract AFX-2)

EXPERIMENTAL

Patients receive North American ginseng extract AFX-2 PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: American GinsengOther: Laboratory Biomarker AnalysisOther: Questionnaire Administration

GROUP II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. At the end of course 2, patients may optionally crossover to Group I to receive ginseng for an additional 28 days.

Other: Laboratory Biomarker AnalysisOther: PlaceboOther: Questionnaire Administration

Interventions

American GinsengDRUG

Given PO

Also known as: ginseng, Ginseng Root, Panax quinquifolius
Group I (North American ginseng extract AFX-2)
Laboratory Biomarker AnalysisOTHER

Correlative studies

GROUP II (placebo)Group I (North American ginseng extract AFX-2)
PlaceboOTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy
GROUP II (placebo)
Questionnaire AdministrationOTHER

Correlative studies

GROUP II (placebo)Group I (North American ginseng extract AFX-2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic proven breast cancer or colon cancer (stage I, II or III)
  • Treated with chemotherapy and surgery
  • Treatment has been completed (except hormone therapy) for \>= 90 days prior to registration
  • No known evidence of disease
  • Men or women with a history of CRF as defined by a score \>= 4 on the numeric analogue scale (0 ? 10) (Eligibility Question Fatigue Scale)
  • Presence of CRF \>= 30 days prior to registration
  • Hemoglobin \>= 11.0 g/dL obtained =\< 180 days prior to registration
  • Serum glutamic-oxaloacetic transaminase (SGOT) =\< 1.5 x upper limit of normal (ULN) obtained =\< 180 days prior to registration
  • Creatinine =\< 1.2 X ULN obtained =\< 180 days prior to registration
  • Ability to complete questionnaire(s) in English by themselves or with assistance
  • Provide written informed consent
  • Willing to return to enrolling institution for follow-up of the study and optional crossover (if applicable)
  • Willing to provide blood samples for correlative research purposes
  • Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
  • Treatment cannot begin prior to re-registering to the crossover phase and will ideally begin =\< 7 days after registration for the crossover phase

You may not qualify if:

  • Hypersensitivity to ginseng
  • Use of ginseng capsules for fatigue, within the last 12 months
  • Uncontrolled hypertension \>= 2 times as noted in medical history (diastolic blood pressure \> 100, systolic \> 160) =\< 90 days prior to registration
  • Currently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for \>= 30 days prior to registration and plans to continue for \>= 30 days after registration; erythropoietin agents to treat anemia are allowed
  • Known brain metastasis or primary central nervous system (CNS) malignancy
  • Chronic oral or intravenous systemic steroid use (defined as being used on a regular basis or who have a problem that has required ongoing use of steroids in the last 180 days for greater than 7 days)
  • Diabetes (defined by being on oral hypoglycemics or insulin)
  • Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia; (defined per medical history)
  • Major surgery =\< 28 days prior to registration
  • Any of the following:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception
  • Treatable causes of fatigue have not been ruled out, at least by history and exam criteria, by the treating provider, such as uncontrolled pain, hypothyroidism, or insomnia; NOTE: if these are considered to be the primary cause for the patient?s fatigue then the patient is not eligible for this trial
  • Patients with pain requiring opioid pain medication; NOTE: over the counter analgesics such as Tylenol or ibuprofen are allowed
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColonic Neoplasms

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Noel Arring

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

March 1, 2019

Primary Completion

May 13, 2020

Study Completion

February 22, 2021

Last Updated

January 5, 2023

Record last verified: 2022-03

Locations

US(1)