Ginseng for Cancer-Related Fatigue

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Ginseng, Stimulants, MAOIs, others

Disqualifiers: Major depression, Schizophrenia, Uncontrolled hypertension, others

Compensation: Varies

Number of Visits: 102

165 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot take ginseng, methylphenidate, modafinil, or certain other medications like phenobarbital and MAOIs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Panax Ginseng for cancer-related fatigue?

Research suggests that ginseng, including Panax ginseng and its variants like American ginseng, may help improve cancer-related fatigue, as seen in various studies and trials. ^{1 2 3 4 5}

Is ginseng safe for humans?

Research shows that ginseng, including Panax ginseng and American ginseng, is generally safe for humans and does not increase adverse events (unwanted side effects) compared to controls in clinical trials. ^{1 2 3 5 6}

How does the treatment Panax Ginseng differ from other treatments for cancer-related fatigue?

Panax Ginseng is unique because it is a natural herbal remedy often used to boost energy, and it is being studied for its potential to improve cancer-related fatigue, which has limited treatment options. Unlike other treatments, it is taken orally in a standardized extract form, but studies have shown it may not be significantly more effective than a placebo. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Sriram Yennurajalingam, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with cancer who feel very tired every day, have a certain level of physical ability (Zubrod ≤ 2), and rate their fatigue at least 4 out of 10. They must not be severely anemic, use chronic steroids, or have uncontrolled diabetes. Pregnant women can't join; others must agree to use birth control.

Inclusion Criteria

I am not taking long-term steroids.

Memorial delirium assessment scale </= 13

Hemoglobin level of >/=8 g/dL within 2 weeks of enrollment

Exclusion Criteria

I am currently taking prescribed medications.

I am not on any full-dose blood thinning medication.

I have had hepatitis A, B, or C in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants take ginseng by mouth, in capsule form, every day for 29 days, 2 times a day (morning and afternoon), 2 capsules each day.

4 weeks

Visits on Day 15, Day 29

Treatment Part 2

Participants in Part 2 are randomly assigned to take either a placebo or ginseng for 29 days, 2 times a day (morning and afternoon), 2 capsules each day.

4 weeks

Visits on Day 15, Day 29

Extension

Participants may continue to take ginseng from Days 29-57 if tolerated well, following the same dosing schedule.

4 weeks

Visits on Day 36, Day 57

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires and blood tests.

4 weeks

Visits on Day 36, Day 57

Treatment Details

Interventions

• Panax Ginseng

Trial Overview Researchers are testing if ginseng can reduce cancer-related fatigue and improve mood symptoms like depression and anxiety. Participants will either receive ginseng or a placebo while also completing questionnaires about their symptoms.

Participant Groups

Group I: Panax Ginseng Experimental Treatment 2 Interventions

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.

Group II: Ginseng (Part 2) Experimental Treatment 2 Interventions

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.

Group III: Placebo (Part 2) Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Indena S.p.A

Industry Sponsor

Trials

10

Recruited

570+

Findings from Research

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 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]

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 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 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]

References

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

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

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

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

5. 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]

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

Ginseng and Ginseng Herbal Formulas for Symptomatic Management of Fatigue: A Systematic Review and Meta-Analysis. [2023]

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]