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

Trial Summary

What is the purpose of this trial?

Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings. The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.

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.

What data supports the effectiveness of the treatment Acupuncture for Lung Cancer?

Research suggests that vitamin D supplementation may improve survival in early-stage lung cancer patients with low vitamin D levels, and high vitamin D intake is linked to lower lung cancer risk and better outcomes. Additionally, proper nutrition, including an anti-inflammatory diet, can enhance treatment responses and improve quality of life for lung cancer patients. ^{1 2 3 4 5}

Is green tea extract (EGCG) safe for human use?

Green tea extract, particularly EGCG, is generally considered safe for human use, but long-term safety data is limited. Some studies suggest it can be used safely in cancer prevention, but more research is needed to fully understand its long-term effects. ^{6 7 8 9 10}

How does acupuncture differ from other treatments for lung cancer?

Acupuncture for lung cancer is unique because it is a non-drug therapy that involves inserting thin needles into specific points on the body to potentially help manage symptoms and improve quality of life, unlike conventional treatments that typically involve chemotherapy or radiation. ^{11 12 13 14 15}

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Diet and lung cancer. A review of the epidemiologic evidence in humans. [2019]

2. Greece pubmed.ncbi.nlm.nih.gov

The Role of Nutritional Support in Malnourished Patients With Lung Cancer. [2022]

3. United States 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. [2019]

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

Meta-analysis of the correlation between vitamin D and lung cancer risk and outcomes. [2019]

5. England 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Modulation of signal transduction by tea catechins and related phytochemicals. [2018]

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

Putative cancer chemopreventive agents of dietary origin-how safe are they? [2021]

8. United States 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. [2013]

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

Progress in cancer chemoprevention: development of diet-derived chemopreventive agents. [2018]

10. England pubmed.ncbi.nlm.nih.gov

The synergistic apoptotic interaction of panaxadiol and epigallocatechin gallate in human colorectal cancer cells. [2021]

11. United States 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. [2012]

12. China pubmed.ncbi.nlm.nih.gov

[Regularity of prescriptions for intermediate and advanced lung cancer based on latent structure combined with association rules]. [2022]

13. China 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]. [2016]

14. United States 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. [2022]

15. China 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]. [2016]