The Effects of Ginseng on Cancer-Related Fatigue

NCT01375114 | Active Not Recruiting Phase 1 Results DMC

• 2 other identifiers: 2009-0854NCI-2011-01127
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if panax ginseng (commonly called ginseng) can help to control fatigue and other symptoms such as depression, anxiety, and mood changes in patients with cancer. The safety of ginseng will also be studied.

Conditions

Advanced Cancers; Solid Tumors

Keywords

Advanced Cancers; Solid Tumors; Cancer related fatigue; CRF; Panax ginseng; Placebo; Sugar pill; Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F; Quality of life; QOL; FACT-G; Hospital Anxiety and Depression Inventory; Neurocognitive function; SDMT; Global Symptom Evaluation; GSE

Outcome Measures

Primary Outcomes (1)

• Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change

  "The FACIT-F fatigue subscale was used as the primary outcome measure. There are 13 items in this fatigue subscale. Using the subscale, patients rate the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The objective was to determine whether the average improvement in FACIT-F fatigue from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value."

  Baseline and Day 29

Secondary Outcomes (4)

• Edmonton Symptom Assessment System (ESAS) Fatigue Score Change

  Baseline and Day 29

• Edmonton Symptom Assessment System (ESAS) Pain Score Change

  Baseline and Day 29

• Edmonton Symptom Assessment System (ESAS) Depression Score Change

  Baseline and Day 29

• Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change

  Baseline and Day 29

Study Arms (3)

Panax Ginseng

EXPERIMENTAL

Panax ginseng 400 mg by mouth twice a day from Day 1-29 for first 30 participants in Part 1. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.

Drug: Panax Ginseng; Behavioral: Questionnaires

Ginseng (Part 2)

EXPERIMENTAL

Panax ginseng 400 mg by mouth twice a day from Day 1-29. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.

Drug: Panax Ginseng; Behavioral: Questionnaires

Placebo (Part 2)

PLACEBO COMPARATOR

Oral placebo twice daily for 4 weeks. Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.

Dietary Supplement: Placebo; Behavioral: Questionnaires

Interventions

Panax Ginseng DRUG

400 mg by mouth twice daily from Day 1-29.

Ginseng (Part 2); Panax Ginseng

Placebo DIETARY_SUPPLEMENT

Placebo by mouth twice daily for 4 weeks.

Also known as: Sugar Pill

Placebo (Part 2)

Questionnaires BEHAVIORAL

Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.

Also known as: Surveys

Ginseng (Part 2); Panax Ginseng; Placebo (Part 2)

Eligibility Criteria

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

You may qualify if:

• All patients with a histological diagnosis of cancer.
• Rate fatigue on a numerical scale during the previous 24 hours as \>/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue).
• Describe fatigue as being present every day for most of the day for a minimum of 2 weeks.
• Memorial delirium assessment scale \</= 13.
• Are 18 years or older.
• Hemoglobin level of \>/=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level \<9g/dL will be evaluated for treatment of anemia.
• Able to understand and sign the informed consent.
• No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment).
• Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks)
• Patients should have a Zubrod \</= 2.
• All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed at least one cycle of chemotherapy or targeted therapy, or \> 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist. The PI/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents.
• Negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months. Pregnancy test to be performed no greater than 14 days prior to consent in study. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy. Women of childbearing potential need to be on or use contraception, or be abstinent during the study period. Their male partners must also use contraception (condom) or maintain abstinence. Birth controls specifications: Women who are able to become pregnant must use birth control during the study and for 30 days after the last ginseng/placebo dose. Acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide.

You may not qualify if:

• Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris).
• Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days.
• Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study.
• Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia).
• Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI).
• Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs
• Uncontrolled diabetes mellitus as defined by a random blood sugar of \>200mg/dl not being monitored by their primary care physician.
• No concurrent full dose anticoagulant therapy. \</= 1 mg/day of coumadin for preventing catheter clots allowed.
• History of hepatitis A, B and C.
• Women who are nursing.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Indena S.p.A: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yennurajalingam S, Tannir NM, Williams JL, Lu Z, Hess KR, Frisbee-Hume S, House HL, Lim ZD, Lim KH, Lopez G, Reddy A, Azhar A, Wong A, Patel SM, Kuban DA, Kaseb AO, Cohen L, Bruera E. A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer. J Natl Compr Canc Netw. 2017 Sep;15(9):1111-1120. doi: 10.6004/jnccn.2017.0149.

  PMID: 28874596 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Asian ginseng; Sugars; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Sriram Yennu, MD-Professor, Palliative Care Med
• Organization: UT MD Anderson Cancer Center

syennu@mdanderson.org

(713) 792-3938

Study Officials

• Sriram Yennurajalingam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: October 14, 2011
• Primary Completion: May 15, 2016
• Study Completion (Estimated): October 31, 2028
• Last Updated: May 4, 2026
• Results First Posted: September 22, 2023

Record last verified: 2025-10

Locations

US (1)