Clinical trial NCT03407716: Ginseng in Decreasing Cancer-Related Fatigue After Treatment in Cancer Survivors
Official title: Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-01-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in general subscale of the Multidimensional Fatigue Symptom Inventory- Short Form (MFSI-SF)
timeFrame: Baseline up to day 56
Secondary outcomes:
measure: Change in MFSI-SF emotional subscale
timeFrame: Baseline up to day 56
measure: Change in MFSI-SF general subscale
timeFrame: Baseline up to day 56
measure: Change in MFSI-SF mental subscale
timeFrame: Baseline up to day 56
measure: Change in MFSI-SF physical subscale
timeFrame: Baseline up to day 56
measure: Change in MFSI-SF vigor subscale
timeFrame: Baseline up to day 56
measure: Change in the single item numeric analogue fatigue question
timeFrame: Baseline up to day 56
measure: Fatigue as measured by the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) score
timeFrame: At day 28
measure: Fatigue as measured by the NIH PROMIS score
timeFrame: At day 56
measure: Incidence of adverse events as reported by the patient in a Ginseng Symptom Experience Diary
timeFrame: Up to day 56
measure: Perceived treatment efficacy as measured by the Subject Global Impression of Change
timeFrame: At 4 weeks
measure: Perceived treatment efficacy as measured by the Subject Global Impression of Change
timeFrame: At 8 weeks
Other outcomes:
measure: Change in inflammation biomarkers (adiponectin, cortisol, IL-6)
timeFrame: Baseline up to day 84
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Noel Arring
role: PRINCIPAL_INVESTIGATOR
References: