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Cancer SurvivorEarly Phase 1NCT03407716

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

A Early Phase 1 study testing American Ginseng, Laboratory Biomarker Analysis and Questionnaire Administration in people with Cancer Survivor and Stage I Breast Cancer AJCC v7, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
American Ginseng, Laboratory Biomarker Analysis and Questionnaire Administration
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteUnited States
Study dates
1 Mar 2019to 22 Feb 2021
Phase
Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • CROSSOVER RE-REGISTRATION - INCLUSION CRITERIA
  • Treatment cannot begin prior to re-registering to the crossover phase and will ideally begin =< 7 days after registration for the crossover phase

Who cannot join

  • 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)
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  • 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
  • New use of Ambien and/or other benzodiazepines =< 30 days prior to registration
  • New use of sleep aids including melatonin =< 30 days prior to registration
  • Use of full anticoagulant doses of coumadin or heparin (exception: 1 mg/day of coumadin for preventing catheter clots is allowed)
  • Use of monoamine oxidase inhibitors (MAOI) inhibitors
  • Patients scoring greater than 4 on a 0 to 10 scale with regard to sleep troubles or pain
  • Patients planning to start any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study
  • Patients with malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician as they could impact fatigue
  • Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, high doses of caffeine, guarana, or anything called an ?adaptogen?)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • History of myocardial infarction =< 180 days prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors: A Randomized Controlled Pilot Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the efficacy of ginseng on decreasing cancer-related fatigue (CRF) in post-treatment cancer survivors as measured by Multidimensional Fatigue Symptom Inventory MFSI-Short Form (SF) at 28 and 56 days compared to placebo-controlled group.

SECONDARY OBJECTIVES:

  1. To assess the acceptability and feasibility of ginseng as therapy for CRF in posttreatment cancer survivors.

II. To evaluate toxicities and tolerability associated with 2,000 mg per day of North American ginseng extract AFX-2 (panax quinquefolius) when used for cancer-related fatigue.

III. To explore the impact of ginseng on secondary endpoints, various dimensions of fatigue as measured by the other subscales of the MFSI-SF, Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form, as well as the single measure of fatigue (captured on Fatigue Linear Analogue Scale).

IV. To determine clinically significant changes in fatigue scores per the various measures of fatigue using the global impression of change.

TERTIARY OBJECTIVES:

  1. To explore the relationship between ginseng therapy, inflammation biomarker adiponectin, and post-treatment cancer survivors? fatigue.

OUTLINE: Patients are randomized into 1 of 2 groups.

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

GROUP II: 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.

After completion of study, patients are followed up at day 28 and 56.

Being tested
American Ginseng, Laboratory Biomarker Analysis, Placebo, Questionnaire Administration
Medical subject headings
Breast Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • American GinsengDrug

    Also called ginseng, Ginseng Root, Panax quinquifolius

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Questionnaire AdministrationOther

    Correlative studies

Study groups in NCT03407716
Study groupRoleWhat they receive
Group I (North American ginseng extract AFX-2)ExperimentalPatients 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.
Receives: Drug: American Ginseng; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration
GROUP II (placebo)Placebo comparatorPatients 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.
Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline up to day 56

Secondary outcomes (11)

  1. Change in MFSI-SF emotional subscale

    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

    Measured: Baseline up to day 56

  2. Change in MFSI-SF general subscale

    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

    Measured: Baseline up to day 56

  3. Change in MFSI-SF mental subscale

    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

    Measured: Baseline up to day 56

  4. Change in MFSI-SF physical subscale

    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

    Measured: Baseline up to day 56

  5. Change in MFSI-SF vigor subscale

    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

    Measured: Baseline up to day 56

  6. Change in the single item numeric analogue fatigue question

    Analysis will involve a t-test and Wilcoxon rank sum procedures (as appropriate).

    Measured: Baseline up to day 56

  7. Fatigue as measured by the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) score

    Analysis will involve a t-test and Wilcoxon rank sum procedures (as appropriate).

    Measured: At day 28

  8. Fatigue as measured by the NIH PROMIS score

    Analysis will involve a t-test and Wilcoxon rank sum procedures (as appropriate).

    Measured: At day 56

  9. Incidence of adverse events as reported by the patient in a Ginseng Symptom Experience Diary

    Any other possible side effects are recorded in the diary and assessed through nurse phone calls using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity as measured by the CTCAE version 4.0 for each randomized arm separately. Toxicity data and other incidence rate-based endpoints will be compared across treatment groups using chi-square testing. Binomial confidence intervals for toxicity incidence rates will be constructed for each treatment group. The Gins

    Measured: Up to day 56

  10. Perceived treatment efficacy as measured by the Subject Global Impression of Change

    Analysis will involve a t-test and Wilcoxon rank sum procedures (as appropriate). Descriptive statistics will be used to summarize the Global Impression of Change.

    Measured: At 4 weeks

  11. Perceived treatment efficacy as measured by the Subject Global Impression of Change

    Analysis will involve a t-test and Wilcoxon rank sum procedures (as appropriate). Descriptive statistics will be used to summarize the Global Impression of Change.

    Measured: At 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study start1 Mar 2019
  3. Primary completion13 May 2020
  4. Study completion22 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03407716
Sponsor's protocol ID
MC16C2
Other IDs
NCI-2017-02494, MC16C2
Status last verified
Mar 2022
First submitted
12 Jan 2018
Last updated
5 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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