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 trial tests whether Wisconsin ginseng can reduce fatigue in cancer patients. Fatigue is a challenging symptom for those with cancer, impacting daily life and treatment. The study compares the effects of ginseng to a placebo (a harmless pill with no active ingredients) to determine its effectiveness. Individuals who frequently feel tired due to cancer, but have somewhat managed their pain and sleep issues, might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

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 there any evidence suggesting that Wisconsin ginseng is likely to be safe for humans?

Research has shown that Wisconsin ginseng (Panax quinquefolius) may help manage cancer-related fatigue. Studies have tested a daily dose of 2000mg of this ginseng for eight weeks. Results suggest it can reduce fatigue without causing noticeable side effects. These studies reported no serious health issues, indicating the treatment was generally well-tolerated by patients. This makes Wisconsin ginseng a potentially safe option for managing cancer-related fatigue. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Wisconsin Ginseng for cancer-related fatigue because it offers a natural alternative to standard options like stimulants or antidepressants. Unlike these conventional treatments, Wisconsin Ginseng is derived from a plant known for its potential to boost energy and reduce fatigue. This herbal remedy is thought to work by enhancing the body's resilience to stress and improving physical performance, which could provide a gentler approach with fewer side effects. Additionally, it is taken orally twice a day, making it easy to incorporate into daily routines.

What evidence suggests that Wisconsin Ginseng might be an effective treatment for cancer-related fatigue?

Research has shown that Wisconsin ginseng, also known as Panax quinquefolius, can help reduce cancer-related tiredness. One study found that patients taking 1000mg or 2000mg daily felt less tired than those taking smaller amounts or a placebo. Another study discovered that after 4 weeks, patients using ginseng experienced a greater reduction in fatigue compared to those on a placebo. Importantly, these improvements occurred without any noticeable side effects. In this trial, one group of participants will receive Western ginseng, while another group will receive a placebo. Overall, Wisconsin ginseng has shown promise in helping cancer patients feel less tired. ^{1 2 3 6 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]

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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23853057/

Wisconsin Ginseng (Panax quinquefolius) to improve cancer ... A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks.

2. onclive.com onclive.com/view/ginseng-improves-cancer-related-fatigue-in-phase-iii-trial

Ginseng Improves Cancer-Related Fatigue in Phase III Trial At 4 weeks, patients in the ginseng cohort showed a change from baseline on the MFSI-SF of 14.4 versus 8.2 in the placebo group, and a statistically significant ...

3. trialx.com trialx.com/clinical-trials/listings/297251/wisconsin-ginseng-for-decreasing-cancer-related-fatigue/

Wisconsin Ginseng for Decreasing Cancer Related Fatigue This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from ...

4. ascopost.com ascopost.com/issues/september-1-2013/american-ginseng-improves-cancer-related-fatigue/

American Ginseng Improves Cancer-Related Fatigue Fatigue was significantly reduced in ginseng recipients at 8 weeks, and no discernible toxicities were associated with ginseng treatment.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3888141/

Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer ... The two highest doses of ginseng (1000 and 2000mg/day) outperformed the 750mg/day dose and placebo in every one of the eight predetermined study endpoints (33).

6. cancer.gov cancer.gov/clinicaltrials/NCI-2024-03375

Wisconsin Ginseng for Decreasing Cancer Related Fatigue This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03730298

American Ginseng for the Prevention of Moderate-severe ... The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women ...