Acupuncture for Lung Cancer

(POISE Trial)

Recruiting at 1 trial location

Overseen By Mark Legacy, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Small cell, Carcinoid, GIST, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for patients undergoing surgery for lung, gastric, or esophageal cancer by using a mix of standard and complementary treatments. It will test whether adding therapies like acupuncture, special nutrition, and exercise recommendations can reduce surgery-related issues and help patients live longer, healthier lives. Participants will be split into two groups: one will receive only standard medical care, while the other will also receive complementary care guided by a naturopathic doctor. Suitable candidates for this trial are those eligible for complete surgery to remove lung, gastric, or esophageal cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study administered Coriolus Versicolor to patients without causing harmful effects. It has been used safely in Japan, with few reported side effects. Research shows that green tea extract is safe for adults at a daily dose of 338 mg. Probiotic Pro12 has been shown to be safe for lung cancer patients and may even help reduce some cancer symptoms. Theracurmin, a form of curcumin, was tested and found safe even at high doses in cancer patients, with no increase in side effects. Vitamin D3 is generally safe and is linked to benefits for bone health and possibly lung cancer prevention.

These treatments are part of an integrative care approach, combining standard cancer treatment with complementary methods. Evidence suggests these treatments are well-tolerated and safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this integrative approach for lung cancer because it combines standard medical treatments with complementary therapies. Unlike typical treatments that primarily focus on surgery and chemotherapy, this approach includes natural supplements like Coriolus Versicolor and Theracurmin 2X, which may enhance the body's immune response and reduce inflammation. Additionally, it incorporates lifestyle modifications such as nutrition and physical activity recommendations, which can improve overall well-being and potentially enhance treatment outcomes. This innovative combination aims to provide a more holistic care experience, potentially offering better quality of life and improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for lung cancer?

This trial will compare an Integrative Care approach with Standard Care for lung cancer patients. Participants in the Integrative Care arm will receive complementary treatments alongside standard surgical and oncologic care. Research has shown that Coriolus Versicolor, a medicinal mushroom included in the Integrative Care arm, may strengthen the immune system, reduce tumor-related symptoms, and possibly extend the lives of lung cancer patients. Studies on green tea extract, another component of the Integrative Care arm, suggest it can lower lung cancer risk and has cancer-fighting effects by causing cancer cells to die and stopping their growth. Probiotic Pro12, also part of the Integrative Care arm, might improve the effectiveness of some cancer treatments, potentially helping patients with certain types of lung cancer live longer. Theracurmin 2X, a form of curcumin included in the Integrative Care arm, may assist in treating lung cancer by targeting cancer cell pathways, reducing stress, and helping regulate cells. Taking Vitamin D3, another treatment in the Integrative Care arm, has been linked to lower death rates from lung cancer, indicating it might help reduce mortality from this disease. Together, these treatments in the Integrative Care arm offer a comprehensive approach that addresses different aspects of lung cancer and supports patient well-being. ^{4 5 6 7 8}

Who Is on the Research Team?

Dugald Seely, ND, MSc

Principal Investigator

The Canadian College of Naturopathic Medicine

Andrew Seely, MD, PhD, FRCSC

Principal Investigator

Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults ready to undergo complete removal of lung, gastric, or esophageal cancer. It's not for those who've had minor lung surgery, seen a naturopathic doctor recently, are pregnant/breastfeeding, used experimental drugs lately, have certain tumor types or recent active cancer treatment.

Inclusion Criteria

My lung, stomach, or esophagus cancer can be completely removed by surgery.

Exclusion Criteria

I have had a part of my lung removed due to cancer.

Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study

Pregnant or breastfeeding women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Care

Participants receive integrative care guided by a naturopathic doctor and standard surgical and oncologic care

2-3 days pre-op

1 visit (in-person)

Surgery and Immediate Post-operative Care

Participants undergo curative-intent surgery and receive immediate post-operative care

1 day

Inpatient stay

Post-operative Follow-up

Participants are monitored for adverse events and recovery, including integrative care interventions

3-4 weeks

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for cancer recurrence, survival, and quality of life

12 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Coriolus Versicolor
• Green Tea Extract
• Nutrition Recommendations
• Physical Activity Recommendations
• Probiotic Pro12
• Provitalix Pure Whey Protein
• Psychological Recommendations
• Theracurmin 2X
• Trident SAP 66:33 Lemon
• Vitamin D3 Drops

Trial Overview The trial tests an integrative approach combining nutrition and physical activity guidance with psychological support and supplements like Green Tea Extract and Vitamin D3. The goal is to improve quality of life after thoracic surgery by reducing complications and the risk of cancer returning.

How Is the Trial Designed?

Group I: Integrative Care (Treatment) Experimental Treatment 10 Interventions

Participants in the Integrative arm will receive standard surgical and oncologic care at The Ottawa Hospital plus complementary care guided by a naturopathic doctor at The Centre for Health Innovation

Group II: Standard Care (Control) Active Control 1 Intervention

Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

The Canadian College of Naturopathic Medicine

Collaborator

Trials

23

Recruited

2,600+

Lotte & John Hecht Memorial Foundation

Collaborator

Trials

18

Recruited

4,600+

The Centre for Health Innovation

Collaborator

Trials

2

Recruited

130+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Published Research Related to This Trial

The review highlights that while dietary compounds like indole-3-carbinol, curcumin, quercetin, epigallocatechin gallate, and capsaicin are considered potential cancer chemopreventive agents, their long-term safety for healthy individuals remains uncertain due to limited toxicological data.

Some of these compounds, particularly capsaicin and quercetin, have been identified as suspected carcinogens, and their ability to interact with other drugs raises concerns about their use without further safety investigations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putative cancer chemopreventive agents of dietary origin-how safe are they? Verschoyle, RD., Steward, WP., Gescher, AJ.[2021]

An anti-inflammatory diet that includes antioxidants, dietary fiber, and adequate protein can enhance treatment responses and improve the quality of life for lung cancer patients.

Proper nutritional therapy is crucial at all stages of lung cancer, as it can help prevent disease progression, support tissue regeneration after surgery, and improve overall nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Nutritional Support in Malnourished Patients With Lung Cancer. Kasprzyk, A., Bilmin, K., Chmielewska-Ignatowicz, T., et al.[2022]

Higher levels of vitamin D and calcium intake are associated with a reduced risk of lung cancer, with a significant odds ratio of 0.72 indicating a strong inverse relationship based on a meta-analysis of 22 studies.

Increased serum levels of vitamin D (25(OH)D) not only lower lung cancer risk but also correlate with improved survival rates, as shown by an odds ratio of 0.39 for reduced mortality, suggesting that maintaining adequate vitamin D levels could be beneficial for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the correlation between vitamin D and lung cancer risk and outcomes. Liu, J., Dong, Y., Lu, C., et al.[2019]

This pilot study involving 180 patients with non-small cell lung cancer (NSCLC) aims to evaluate the effectiveness of early oral nutritional supplements (ONS) enriched with immunonutrients alongside nutritional counseling during immunotherapy, focusing on various health outcomes like progression-free survival and treatment tolerance.

The study suggests that immunonutrition could enhance supportive care for NSCLC patients undergoing immunotherapy, although current evidence on its efficacy remains inconclusive, highlighting the need for further large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling. Caccialanza, R., Cereda, E., Agustoni, F., et al.[2022]

A study of 91 lung cancer patients treated at an integrative cancer center in Korea found that those receiving integrative cancer treatment (ICT) had a 50% lower mortality rate compared to those receiving only traditional Korean medicine (TKM).

Patients with advanced-stage lung cancer had significantly higher mortality rates, but the integration of TKM with conventional treatments showed potential survival benefits, indicating that ICT may enhance outcomes for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative cancer treatment may have a survival benefit in patients with lung cancer: A retrospective cohort study from an integrative cancer center in Korea. Bae, K., Kim, E., Kong, JS., et al.[2022]

The study found that the tea polyphenol (-)-epicatechin significantly enhances the incorporation of EGCG into human lung cancer cells, leading to increased apoptosis and growth inhibition of these cells.

Combining EGCG with other cancer-preventive agents like sulindac and tamoxifen further boosts its effectiveness, suggesting that whole green tea may be a better option for cancer prevention than EGCG alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic effects of (--)-epigallocatechin gallate with (--)-epicatechin, sulindac, or tamoxifen on cancer-preventive activity in the human lung cancer cell line PC-9. Suganuma, M., Okabe, S., Kai, Y., et al.[2013]

Food-derived products are being explored as safe and effective chemopreventive agents for various cancers, with over 40 candidates currently under clinical evaluation, including compounds like curcumin and green tea polyphenols.

The National Cancer Institute emphasizes the importance of isolating active compounds from these food-derived agents to better understand their mechanisms and enhance their potential for cancer prevention, especially in higher-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in cancer chemoprevention: development of diet-derived chemopreventive agents. Kelloff, GJ., Crowell, JA., Steele, VE., et al.[2018]

The combination of Panaxadiol (PD) and Epigallocatechin gallate (EGCG) significantly enhances the anticancer effects on human colorectal cancer cells, with increased cell death observed when both compounds are used together compared to PD alone.

The study indicates that apoptosis plays a crucial role in the enhanced effectiveness of the PD and EGCG combination, as evidenced by increased apoptotic cell percentages and docking analysis showing their binding to different sites on the annexin V protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The synergistic apoptotic interaction of panaxadiol and epigallocatechin gallate in human colorectal cancer cells. Du, GJ., Wang, CZ., Qi, LW., et al.[2021]

Beta carotene shows strong potential as a protective agent against lung cancer, but other components in green and yellow vegetables may also contribute to lower cancer rates observed in studies.

Cessation of cigarette smoking is likely to have a much greater impact on reducing lung cancer risk than any dietary changes, highlighting the importance of smoking prevention and cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and lung cancer. A review of the epidemiologic evidence in humans. Colditz, GA., Stampfer, MJ., Willett, WC.[2019]

In a study of 155 patients with non-small cell lung cancer (NSCLC), vitamin D supplementation did not show a significant overall benefit in relapse-free survival (RFS) or overall survival (OS) compared to placebo.

However, in patients with early-stage adenocarcinoma and low vitamin D levels, those receiving vitamin D had significantly better 5-year RFS (86% vs. 50%) and OS (91% vs. 48%), suggesting that vitamin D may be particularly beneficial for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D Supplementation and Survival of Patients with Non-small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. Akiba, T., Morikawa, T., Odaka, M., et al.[2019]

A comprehensive analysis of 713 studies on Chinese medicine for treating intermediate and advanced lung cancer identified 327 different medicines, with a focus on those that tonify Qi and nourish Yin, indicating a tailored approach based on specific syndromes.

Commonly used prescriptions included Shashen Maidong Decoction and Liujunzi Decoction, which are designed to address symptoms like cough and dyspnea, highlighting the importance of symptom management alongside cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Regularity of prescriptions for intermediate and advanced lung cancer based on latent structure combined with association rules]. Zhang, D., Feng, ZZ., Wang, L., et al.[2022]

A study of 800 treatment recipes for lung cancer from 8 Chinese oncologists revealed that coix seed, poria, and pinelliae tuber are the most commonly used herbs, indicating a consensus on key herbal treatments.

The primary treatment method accepted by experts is the Pi invigorating and phlegm removing method, with notable regional differences: South China oncologists focus more on heat toxin and blood stasis, while North China oncologists emphasize supplementing qi and yin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Consensuses on lung cancer treatment by Chinese medicine experts from Beijing and Guangzhou and medication features in the North and South China]. Wang, SM., Lin, LZ., Nie, H.[2016]

Epidemiological and experimental studies suggest that green tea and its active component EGCG can inhibit tumor development and growth by targeting specific receptor tyrosine kinases (RTKs) and related signaling pathways.

EGCG and other polyphenolic compounds like resveratrol and curcumin not only inhibit cell proliferation and induce apoptosis but also affect key transcription factors, indicating their potential as effective agents in cancer prevention and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of signal transduction by tea catechins and related phytochemicals. Shimizu, M., Weinstein, IB.[2018]

In a study of 70 non-small-cell lung cancer patients, wheat-size moxibustion therapy significantly reduced the neutrophil-to-lymphocyte ratio (NLR), indicating improved immune function after 6 weeks of treatment.

Patients receiving moxibustion therapy also reported significant improvements in quality of life measures, including physical, emotional, and cognitive functioning, compared to the control group, which showed no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact on neutrophil-to-lymphocyte ratio and quality of life in the patients of non-small-cell lung cancer treated with grain-size moxibustion: a randomized controlled trial]. Zhang, M., Guan, L.[2016]

In a 10-year study of 239 non-small-cell lung cancer patients, long-term use of Pan-Asian medicine plus vitamins (PAM+V) significantly reduced mortality rates, with an 83% reduction in stage IIIB and a 72% reduction in stage IV deaths compared to short-term use during chemotherapy.

When combined with conventional therapy, PAM+V improved survival rates for stage IIIA, IIIB, and IV patients, suggesting that this complementary treatment could enhance outcomes and warrant further prospective trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer survival with herbal medicine and vitamins in a whole-systems approach: ten-year follow-up data analyzed with marginal structural models and propensity score methods. McCulloch, M., Broffman, M., van der Laan, M., et al.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7277906/

Trametes versicolor (Synn. Coriolus ... For example, a 9% absolute reduction in 5-year mortality was recorded with one additional patient alive for every 11 patients treated. They also reported a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25784670/

Polysaccharide K and Coriolus versicolor extracts for lung ... Conclusions: PSK may improve immune function, reduce tumor-associated symptoms, and extend survival in lung cancer patients. Larger, more rigorous randomized ...

3. cancer.gov cancer.gov/about-cancer/treatment/cam/hp/mushrooms-pdq

Medicinal Mushrooms (PDQ®)–Health Professional Version One review included preclinical studies conducted in lung cancer models using either PSK or other T. versicolor preparations. [16] Data from ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214799324000699

Turkey tail mushroom (Trametes versicolor): an edible ... Over the past decade, studies have consistently reported the anticancer properties of T. versicolor polysaccharide against cancer cell lines such as MCF-7 and ...

5. cureus.com cureus.com/articles/148546-therapeutic-effects-of-medicinal-mushrooms-on-gastric-breast-and-colorectal-cancer-a-scoping-review

Therapeutic Effects of Medicinal Mushrooms on Gastric, ... Findings from these studies indicated Turkey Tail played a role in prolonging overall survival in gastric cancer patients, with few exceptions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4788765/

A safety assessment of Coriolus versicolor biomass as a ... No adverse or lethal effects were observed as a consequence of the daily administration of CV biomass. In addition, compared with the control ...

7. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/coriolus-versicolor

Coriolus versicolor Until safety data become available, pregnant or breastfeeding women should avoid taking Coriolus. Adverse Reactions. Rare: Dark colored ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-648/turkey-tail-mushroom

TURKEY TAIL MUSHROOM - Uses, Side Effects, and More The PSP and PSK in turkey tail mushroom might help slow cancer growth and boost the immune system. People use turkey tail mushroom to improve response to cancer ...