NCT02581059

A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib

Terminated Phase 2 Results posted Last updated 21 June 2024

What this trial tests

Phase 2 trial testing Regorafenib in Colorectal Cancer in 10 participants. Terminated before completion.

Timeline

1 April 2016

Primary endpoint
22 June 2018

22 June 2018

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 April 2016
Primary completion	22 June 2018
Estimated completion	22 June 2018
Sites	5 locations across United States

Drugs / interventions tested

• Regorafenib — full drug profile →
• Ginseng — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Palliative Medicine — all drugs for Palliative Medicine →
• Supportive Care — all drugs for Supportive Care →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Colorectal Cancer or Palliative Medicine. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Subject Fatigue Assessment--Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
  Time frame: From date of first dose until end of cycle 2 (8 weeks)
  MFSI-SF is a 30-item self-report instrument designed to measure general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor--each scored on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"). The total score is calculated by adding the general, physical, emotional, and mental subscale scores and subtracting the vigor subscale score. Thus, total scores can range fro
• Subject Fatigue Assessment--Patient-Reported Outcomes Measurement Information System (PROMIS)
  Time frame: From date of first dose until end of cycle 2 (8 weeks)
  PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each of the total raw scores were translated into T-scores for each participant using scoring tables for converting the PROMIS short form. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a

Sponsor's own description

This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent developments in the treatment of metastatic colorectal cancer.
   Loree JM, Kopetz S. · · 2017 · cited 70× · PMID 28794806 · DOI 10.1177/1758834017714997
2. Traditional Chinese Medicine and Colorectal Cancer: Implications for Drug Discovery.
   Sun Q, He M, Zhang M, Zeng S, et al · · 2021 · cited 40× · PMID 34276374 · DOI 10.3389/fphar.2021.685002