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Clinical 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Cancer Survivor
  • Colonic Neoplasms
  • 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

NCT number NCT03407716
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Early Phase 1
Start date March 1, 2019
Completion date February 22, 2021

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