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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if panax ginseng, a herbal supplement, can reduce fatigue and improve symptoms like depression and anxiety in cancer patients. Researchers will also assess the safety of ginseng use. Participants will take either ginseng or a placebo (a harmless pill with no active ingredients) for a short period to observe any differences in symptoms. Suitable candidates have cancer, experience daily fatigue for at least two weeks, and rate it at least 4 out of 10 in severity. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

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.

Is there any evidence suggesting that Panax Ginseng is likely to be safe for humans?

Research has shown that Panax ginseng is generally safe for people. In past studies, participants taking ginseng did not report any serious side effects. One study found that using Panax ginseng did not cause any severe health problems. Another study showed that even at higher doses, ginseng was well-tolerated. Additionally, participants took American ginseng, which is similar, at 2000 mg per day for eight weeks without any noticeable harmful effects. This suggests that Panax ginseng is likely safe, especially since no major side effects have been reported. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for cancer-related fatigue, which often involve medications like modafinil or corticosteroids, Panax ginseng offers a natural alternative. Researchers are excited about this treatment because Panax ginseng is derived from a plant known for its potential to boost energy and reduce fatigue. It works differently by potentially enhancing physical and mental performance through its adaptogenic properties. Additionally, its simple oral administration makes it an accessible option for those seeking complementary therapies alongside conventional cancer treatments.

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

Studies have shown that Panax ginseng can help reduce fatigue in cancer patients. In one study, 87% of patients felt less tired after just 15 days. Another study found that taking ginseng significantly reduced fatigue levels. These findings suggest that ginseng might effectively help cancer patients manage tiredness. Participants in this trial will receive either Panax ginseng or a placebo to further evaluate its effectiveness. Although the exact mechanism remains unclear, researchers believe that ginseng's active ingredients, called ginsenosides, help boost energy. Overall, early results appear promising for those dealing with cancer-related fatigue. ^{1 3 6 7 8}

Who Is on the Research Team?

Sriram Yennurajalingam, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32691627/

Ginseng and Cancer-Related Fatigue: A Systematic ...

American ginseng, containing more than 5% ginsenosides, consumed at the dosage of 2000 mg/day for up to eight weeks significantly reduced fatigue.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35184068/

Effects of Ginseng on Cancer-Related Fatigue

The pooled results showed that ginseng consumption led to significant reductions in CRF levels (standard mean difference [SMD], -0.21; 95% ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1226845325001216

The study on the efficacy of improving cancer-related ...

Prospective trial results indicate that Ginseng Guben Oral Liquid significantly improves fatigue scores, including the multidimensional fatigue ...

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ascopubs.org

ascopubs.org/doi/10.1200/jco.2013.31.15_suppl.9642

High-dose Asian ginseng (Panax ginseng) for cancer ...

21/24 (87%) patients had an improved FACIT-F fatigue score by day 15. Global Symptom Evaluation score of PG for fatigue was better in 15/24 patients (63%) with ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03407716

Ginseng in Decreasing Cancer-Related Fatigue After ...

This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2210803321000208

Treatment of cancer-related fatigue with ginseng

This study suggests that ginseng can improve fatigue in cancer patient. However more well-designed randomized trials are needed.

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tcr.amegroups.org

tcr.amegroups.org/article/view/74187/html

a network meta-analysis of randomized controlled trials - Li

Efficacy and safety of methylphenidate and ginseng in cancer-related fatigue: a network meta-analysis of randomized controlled trials.

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Wisconsin Ginseng ( Panax quinquefolius ) to Improve Cancer ...

Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with ...