Efficacy of Ginseng for Patients on Regorafenib

NCT02581059 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB00035502HCRN GI14-191
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colorectal Cancer; Palliative Medicine; Supportive Care

Keywords

Regorafenib; American Ginseng; Fatigue

Outcome Measures

Primary Outcomes (2)

• Subject Fatigue Assessment--Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)

  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 from -24 to 96 where higher scores indicate more of the cancer-related fatigue (meaning higher scores represent worse fatigue). A minimally clinically important improvement (or worsening) in the MFSI-Short Form is for changes of more than 4.5 points. T-score value of 36 indicates the population mean with a standard deviation of 34.93.

  From date of first dose until end of cycle 2 (8 weeks)

• Subject Fatigue Assessment--Patient-Reported Outcomes Measurement Information System (PROMIS)

  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 person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For this instrument all questions were negatively worded (i.e., How fatigued were you on average?) therefore a higher T-score represents having more fatigue. Thus, a T-score of 60 is one SD

  From date of first dose until end of cycle 2 (8 weeks)

Secondary Outcomes (8)

• Subject Compliance

  Cycle 1 From date of first dose until day 15

• Subject Compliance

  Cycle 2 From date of first dose until day 15

• Subject Compliance

  Cycle 1 From day16 until day 22

• Subject Compliance

  Cycle 2 From day 16 until day 22

• Characterize Adverse Events (AE)

  From date of first dose until end of cycle 2 (8 weeks)

Study Arms (2)

Regorafenib + Ginseng

EXPERIMENTAL

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles).

Drug: Regorafenib; Dietary Supplement: Ginseng

Regorafenib Only

ACTIVE COMPARATOR

Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles.

Drug: Regorafenib

Interventions

Regorafenib DRUG

All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles.

Also known as: Stivarga

Regorafenib + Ginseng; Regorafenib Only

Ginseng DIETARY_SUPPLEMENT

Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles.

Also known as: Panax quinquefolius

Regorafenib + Ginseng

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Age ≥ 18 years at the time of consent.
• Life expectancy of at least 12 weeks (3 months) as determined by the treating physician.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
• Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
• Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
• All subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.
• Must be able to swallow and retain oral medication.
• Subject must be deemed a suitable candidate for regorafenib as per their treating physician.

You may not qualify if:

• Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
• Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
• Prior treatment with regorafenib.
• Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• Congestive heart failure \> New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management).
• Evidence or history of bleeding diathesis or coagulopathy.
• Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration.
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration.
• Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)\].
• Subjects with pheochromocytoma.
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• Ongoing infection \> Grade 2 NCI-CTCAE v4.0.
• Metastatic brain or meningeal tumors (symptomatic or asymptomatic).
• Major surgical procedure or significant traumatic injury, as defined by the site investigator, within 28 days before study registration.
• Renal failure requiring hemo- or peritoneal dialysis

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Bayer: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (5)

Indiana Univeristy Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

IU Health Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

Altantic Health System

Morristown, New Jersey, 07960, United States

Location

Comprehensive Cancer Center at Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Related Links

• Hoosier Cancer Research Network Website

MeSH Terms

Conditions

Colorectal Neoplasms; Fatigue

Interventions

regorafenib; Asian ginseng

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Annesha Majumdar
• Organization: Hoosier Cancer Research Network

amajumdar@hoosiercancer.org

3179212050

Study Officials

• Rodwige J. Desnoyers, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 20, 2015
• Study Start: April 1, 2016
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)