Wisconsin Ginseng for Cancer Fatigue

Recruiting at 14 trial locations

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Must not be taking: Psychostimulants, Antidepressants, Antidiabetics, Warfarin

Disqualifiers: Hypersensitivity to ginseng, Uncontrolled hypertension, Severe depression, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

Will I have to stop taking my current medications?

The trial requires you to stop using any other medications specifically for treating fatigue, like certain psychostimulants or antidepressants, unless the antidepressants are for other conditions and have been stable for at least 30 days. You also cannot use any herbal supplements for fatigue or certain other medications like antidiabetic drugs, warfarin, or monoamine oxidase inhibitors.

Is Wisconsin Ginseng safe for humans?

Studies on American ginseng (Panax quinquefolius), also known as Wisconsin Ginseng, have included evaluations of its safety, particularly in trials for cancer-related fatigue. These studies suggest that it is generally safe for human use, although specific safety data from these trials should be consulted for detailed information. ^{1 2 3 4 5}

How is Wisconsin Ginseng different from other treatments for cancer-related fatigue?

Wisconsin Ginseng (American Ginseng) is unique because it is a natural herbal treatment being studied for its potential to improve cancer-related fatigue, which is a common and distressing symptom for cancer patients. Unlike other treatments, it is being evaluated for its safety and effectiveness in a randomized, double-blind trial, offering a potential alternative to limited existing options. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Wisconsin Ginseng for cancer fatigue?

Research shows that American ginseng (Panax quinquefolius), which is the same as Wisconsin Ginseng, has been studied in trials and found to potentially help with cancer-related fatigue, a common and distressing symptom for cancer patients. ^{1 2 3 5 7}

Who Is on the Research Team?

Daniel S. Childs, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for cancer patients experiencing significant fatigue, which affects their daily life and treatment process. Participants should be currently dealing with cancer-related tiredness to qualify.

Inclusion Criteria

Provide informed consent

Life expectancy ≥ 6 months

Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration)

Exclusion Criteria

My doctor plans to change my cancer treatment soon.

Any known hypersensitivity to ginseng

Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Western ginseng or placebo orally twice daily for 8 weeks

8 weeks

Regular monitoring visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wisconsin Ginseng

Trial Overview The study is testing whether Wisconsin ginseng can help reduce fatigue in cancer patients compared to a placebo (a substance with no active drug). Patients will also fill out questionnaires about their fatigue levels.

How Is the Trial Designed?

Group I: Group I (Western ginseng) Experimental Treatment 2 Interventions

Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Group II (placebo) Placebo Group 2 Interventions

Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a pilot trial involving 290 cancer patients, American ginseng doses of 1,000 and 2,000 mg/day showed promising trends in reducing cancer-related fatigue compared to placebo, particularly in vitality and activity interference measures.

The study found that patients taking ginseng reported greater satisfaction and perceived benefits without significant differences in toxicity compared to those on placebo, suggesting that ginseng may be a safe option for managing fatigue in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Barton, DL., Soori, GS., Bauer, BA., et al.[2021]

In a phase III trial involving 364 cancer survivors, American ginseng (2000mg daily) significantly reduced cancer-related fatigue (CRF) after 8 weeks compared to a placebo, with a notable change score of 20 versus 10.3 (P = .003).

The treatment was well-tolerated, showing no significant differences in toxicities between the ginseng and placebo groups, indicating it is a safe option for managing CRF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. Barton, DL., Liu, H., Dakhil, SR., et al.[2022]

In a randomized double-blind trial involving 438 colorectal cancer patients, Korean red ginseng (KRG) significantly improved cancer-related fatigue (CRF) over 16 weeks compared to a placebo, particularly enhancing mood and walking ability.

While KRG was associated with a higher incidence of neutropenia, the overall rate of adverse events was similar to the placebo group, indicating that KRG can be safely combined with mFOLFOX-6 chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial. Kim, JW., Han, SW., Cho, JY., et al.[2020]

In a preliminary study involving 30 patients with cancer-related fatigue (CRF), high-dose Panax ginseng (800 mg daily for 29 days) was found to be safe, with no severe adverse events reported.

The study showed that 87% of patients experienced significant improvements in fatigue levels, as measured by the FACIT-F scale, and also reported better overall well-being and appetite, suggesting that Panax ginseng may enhance quality of life for CRF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Dose Asian Ginseng (Panax Ginseng) for Cancer-Related Fatigue: A Preliminary Report. Yennurajalingam, S., Reddy, A., Tannir, NM., et al.[2015]

A systematic review of seven randomized controlled trials found that ginseng significantly reduces cancer-related fatigue (CRF), with a standard mean difference of -0.21, indicating its potential effectiveness in improving patient energy levels.

Ginseng also showed improvements in physical and emotional well-being, suggesting it may enhance overall quality of life for cancer patients, although the effects can vary based on production methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Ginseng on Cancer-Related Fatigue: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Luo, WT., Huang, TW.[2023]

Heat-processing American ginseng significantly enhances its antiproliferative effects on human breast cancer cells, particularly by increasing the content of beneficial ginsenosides like Rg3.

The 2-hour steamed extract not only reduced the number of viable cancer cells but also led to cell cycle arrest in the G1 phase and decreased the expression of cyclins A and D1, indicating a potential mechanism for its cancer-fighting properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemopreventive effects of heat-processed Panax quinquefolius root on human breast cancer cells. Wang, CZ., Aung, HH., Zhang, B., et al.[2021]

In a study of 127 cancer patients experiencing fatigue, both Panax ginseng extract (PG) and placebo led to significant improvements in cancer-related fatigue (CRF) scores, but PG did not show superior efficacy compared to placebo after 28 days of treatment.

Patients taking PG experienced fewer side effects compared to those on placebo, suggesting a potential safety benefit, but overall, there is no strong evidence to recommend PG specifically for treating CRF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer. Yennurajalingam, S., Tannir, NM., Williams, JL., et al.[2019]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Korean red ginseng for cancer-related fatigue in colorectal cancer patients with chemotherapy: A randomised phase III trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

High-Dose Asian Ginseng (Panax Ginseng) for Cancer-Related Fatigue: A Preliminary Report. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Ginseng on Cancer-Related Fatigue: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Chemopreventive effects of heat-processed Panax quinquefolius root on human breast cancer cells. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer. [2019]