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Completed

NCT Number: NCT02039635

Korean Red Ginseng in Treating Patients With Fatigue Caused by Chemotherapy for Colorectal Cancer

Korean Red Ginseng may improve fatigue in healthy subject. It is not yet known whether Korean Red Ginseng is effective compared with a placebo in chemotherapy.

The purpose of this study is to determine whether Korean Red Ginseng is effective in the treatment of the fatigue from colorectal cancer with chemotherapy.(modified FOLFOX-6)

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea Ginseng Corporation

Shinseongdong, Daejeon, 305-805, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20 years and older
  • Person who agreed to participate in this study and signed voluntarily on the written informed consent form
  • Person who is confirmed as colorectal cancer through histological and image diagnosis and scheduled for adjuvant or palliative therapy with mFOLFOX-6 regimen
  • Fertile patients with negative pregnancy test confirmed and who has agreed to use effective contraception
  • Person who is able to fully communicate with the physician about his/her fatigue status and is able to completely fill out the questionnaires
  • Life expectancy more than 6 months
  • Performance status of ECOG grade 0~1
  • Hb ≥ 9g/dL
  • Person with moderate liver function (AST, ALT ≤ 2.5 × ULN)
  • Person with moderate renal function (Cr ≤ 1.5 × ULN)

Exclusion criteria

  • Pregnant or nursing women
  • Primary brain cancer, brain metastases or other CNS malignancy, including CNS lymphoma
  • No controlled pain despite the use if analgesics.
  • Person showing hypothyroidism despite the hormone treatment
  • Person with insomnia despite an appropriate treatment
  • No controlled hypertension (DBP >100mmHg or SBP >160mmHg)
  • Person who has experience of hypersensitivity to the trial drug (ginseng) components
  • Person with autoimmune disorders (Multiple sclerosis, Lupus, rheumarthritis etc.)
  • Person who is alcoholic dependent or has psychiatric disorder
  • Person who has cognitive or psychiatric problems
  • Person who has an experience of chemotherapy agents use 6 months before a screening visit
  • Person who had a surgery 2 weeks before a screening visit
  • Person who had taken herbal medicinal product (including Chinese medicine) 4 weeks before the screening visit
  • Person who has medical status that is judged to affect the result or who is judged as inappropriate for the study by the physician

Treatment and study plan

Korean Red Ginseng

Dietary Supplement

Given Orally

Placebo

Dietary Supplement

Given Orally

Primary outcomes

  1. Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake trial drugs up to 16 weeks

    Time frame: From Baseline up to 16 weeks

Secondary outcomes

  1. Area Under Curve (AUC) of Brief Fatigue Index (BFI) on the intake of trial drugs up to 8 weeks

    Time frame: From Baseline up to 8 weeks

  2. Change in Functional Assessment of Chronic Illness Therapy-Fatigue Trial Outcome Index (FACIT-F TOI) after 8 and 16 weeks of trial drug intake

    Time frame: Baseline, 8 and 16 weeks

  3. Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) total score after 8 and 16 weeks of trial drug in take

    Time frame: Baseline, 8 and 16 weeks

  4. The percentage of subjects whom the Functional Assessment of Cancer Therapy-General (FACT-G) score decreased more than 20 scores after 8 and 16 weeks of trial drug intake

    Time frame: Baseline, 8 and 16 weeks

  5. Change in blood cytokine (IL-1, IL-6, TNF-alpha) level after 16 weeks of trial drug intake

    Time frame: Baseline, 16 weeks

  6. Change in blood cortisol level after 16 weeks of trial drug intake

    Time frame: Baseline, 16 weeks

  7. Perceived Stress Scale (PSS) change after 16 weeks of trial drug intake

    Time frame: Baseline, 16 weeks

  8. adverse events

    Time frame: Baseline, 8 and 16 weeks

    • Voluntary reports of adverse events and collected reports of adverse events (agitation, anxiety, headache, insomnia, vomiting)
    • Laboratory and physical test
    • ECOG performance
    • ECG

Other outcomes

  1. Tumor response after 8 and 16 weeks of trial drug intake

    Time frame: Baseline, 8 and 16 weeks

  2. Progressive-free survival (PFS)

    Time frame: up to 16 weeks

  3. Change in blood cytokine(IL-2, IL-8, IL-10) level after 16 weeks of trial drug intake

    Time frame: Baseline, 16 weeks

Sponsors and collaborators

Lead sponsor

Korea Ginseng Corporation

Industry

Registry information

Official study title

A Study of Korean Red Ginseng for Evaluation of Improvement of Cancer-related Fatigue in Patients With Colorectal Cancer With Chemotherapy: A Randomized, Double-blind, Placebo-Controlled, Parallel, Multicenter Trial

Acronym: KRG

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 17, 2014
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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