Acupuncture for Lung Cancer
(POISE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByDugald Seely, ND, MSc
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Ottawa Hospital Research Institute
Disqualifiers: Small cell, Carcinoid, GIST, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345Is 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.
678910How 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.
1112131415Eligibility 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.
My cancer is not small cell, carcinoid, or GIST.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrative Care (Treatment)Experimental Treatment10 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 Control1 Intervention
Participants in the control arm will receive standard surgical and oncologic care at The Ottawa Hospital
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Michael Garron HospitalToronto, Canada
The Ottawa HospitalOttawa, Canada
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
The Canadian College of Naturopathic MedicineCollaborator
Lotte & John Hecht Memorial FoundationCollaborator
The Centre for Health InnovationCollaborator
University of OttawaCollaborator
References
Diet and lung cancer. A review of the epidemiologic evidence in humans. [2019]We reviewed the human epidemiologic studies of the possible protective effect against lung cancer of various dietary constituents, including preformed vitamin A, carotene, vitamin E, selenium, and vitamin C. Beta carotene has strong potential as a protective agent, though constituents of green and yellow vegetables other than carotene may account for the reduced cancer incidence observed in many studies. Selenium also deserves attention as a potential chemopreventive nutrient, though data are limited. Data on vitamin E are sparse and inconclusive, and there is little evidence that vitamin C provides protection against human lung cancer. It is likely that cessation of cigarette smoking would have a far greater influence on reducing lung cancer incidence than any known dietary modification.
The Role of Nutritional Support in Malnourished Patients With Lung Cancer. [2022]This review aimed to aggregate and describe the available data about clinical nutrition in lung cancer and the role of the dietitian in multidisciplinary patient care. Scientific literature was searched in order to summarize key aspects related to clinical nutrition in lung cancer. This information can be used to arrange a proper nutritional therapy that can enhance patient treatment responses, prevent side-effects, shorten recovery time, improve prognosis and increase quality of life. An anti-inflammatory diet rich in antioxidants, immunomodulatory compounds, dietary fibre and an appropriate intake of protein can reduce the risk of initiation and progression of lung cancer, support the regeneration of tissues (also after surgery) and improve the nutritional status during the disease and after remission. A correct intake of nutrients is significant prior to disease occurrence and at every stage of treatment and recovery.
Vitamin D Supplementation and Survival of Patients with Non-small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. [2019]Purpose: Higher serum 25-hydroxyvitamin D (25(OH)D) levels are reportedly associated with better survival in early-stage non-small cell lung cancer (NSCLC). Therefore, whether vitamin D supplementation can improve the prognosis of patients with NSCLC was examined (UMIN000001869).Patients and Methods: A randomized, double-blind trial comparing vitamin D supplements (1,200 IU/day) with placebo for 1 year after operation was conducted. The primary and secondary outcomes were relapse-free survival (RFS) and overall survival (OS), respectively. Prespecified subgroup analyses were performed with stratification by stage (early vs. advanced), pathology (adenocarcinoma vs. others), and 25(OH)D levels (low, <20 ng/mL vs. high, ≥20 ng/mL). Polymorphisms of vitamin D receptor (VDR) and vitamin D-binding protein (DBP) and survival were also examined.Results: Patients with NSCLC (n = 155) were randomly assigned to receive vitamin D (n = 77) or placebo (n = 78) and followed for a median of 3.3 years. Relapse and death occurred in 40 (28%) and 24 (17%) patients, respectively. In the total study population, no significant difference in either RFS or OS was seen with vitamin D compared with the placebo group. However, by restricting the analysis to the subgroup with early-stage adenocarcinoma with low 25(OH)D, the vitamin D group showed significantly better 5-year RFS (86% vs. 50%, P = 0.04) and OS (91% vs. 48%, P = 0.02) than the placebo group. Among the examined polymorphisms, DBP1 (rs7041) TT and CDX2 (rs11568820) AA/AG genotypes were markers of better prognosis, even with multivariate adjustment.Conclusions: In patients with NSCLC, vitamin D supplementation may improve survival of patients with early-stage lung adenocarcinoma with lower 25(OH)D levels. Clin Cancer Res; 24(17); 4089-97. ©2018 AACR.
Meta-analysis of the correlation between vitamin D and lung cancer risk and outcomes. [2019]In this meta-analysis, we analyzed the association between vitamin D levels and lung carcinoma risk and outcomes. Two authors independently searched the Web of Science, Pubmed, EBSCO and Ovid MEDLINE resources with the key words "vitamin D, lung cancer, solar and latitude" and enrolled 22 studies that satisfied the inclusion criteria. The summary odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using the random (or fixed)-effects model. Potential confounders were carefully adjusted. High vitamin D (or calcium) intake and serum 25(OH)D levels each correlated inversely with lung cancer risk [OR = 0.72 (95% CI: 0.61-0.85, p < 0.001) and OR = 0.89 (95% CI: 0.83-0.97, p < 0.05)]. High circulating 25(OH)D levels also reduced lung cancer mortality with the pooled OR reached 0.39 (95% CI: 0.28-0.54, p < 0.001)]. A positive trend was presented in the relationship between serum 25(OH) D and survival (OR = 1.01, 95% CI: 0.87-1.18, p = 0.87). Subgroup analysis revealed that nonsmokers had higher vitamin D levels, which correlated negatively with lung cancer risk (OR = 0.76, 95% CI: 0.65-0.88, p < 0.01). Moreover, lower sun exposure and high latitude associated with lower vitamin D levels. This meta-analysis shows that high vitamin D (or calcium) intake and serum 25(OH)D levels correlate with lower lung cancer risk and better prognosis. UVB and latitude may play a vital role in lung cancer occurrence and progression, although a direct evidence hasn't been obtained.
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]Nutritional support, including nutritional counseling and oral nutritional supplements (ONS), has been recommended as a first-line strategy in patients with non-small cell lung cancer (NSCLC). Evidence on the efficacy of immunonutrition during immunotherapy in these patients is positive, but still limited some secondary endpoints, such as treatment toxicity and tolerance. We hypothesize that early systematic provision of ONS with a high-protein-high calorie mixture containing immunonutrients (Impact®) in addition to nutritional counseling, compared to nutritional counseling alone, is beneficial to patients with NSCLC receiving immunotherapy with or without chemotherapy. We designed the present study to evaluate the efficacy of early systematic provision of ONS enriched with immunonutrients compared to nutritional counseling alone, in patients with NSCLC undergoing immunotherapy. Study endpoints were: treatment response (primary endpoint: progression-free survival), treatment tolerance and toxicity, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile.
Modulation of signal transduction by tea catechins and related phytochemicals. [2018]Epidemiologic studies in human populations and experimental studies in rodents provide evidence that green tea and its constituents can inhibit both the development and growth of tumors at a variety of tissue sites. In addition, EGCG, a major biologically active component of green tea, inhibits growth and induces apoptosis in a variety of cancer cell lines. The purpose of this paper is to review evidence that these effects are mediated, at least in part, through inhibition of the activity of specific receptor tyrosine kinases (RTKs) and related downstream pathways of signal transduction. We also review evidence indicating that the antitumor effects of the related polyphenolic phytochemicals resveratrol, genistein, curcumin, and capsaicin are exerted via similar mechanisms. Some of these agents (EGCG, genistein, and curcumin) appear to directly target specific RTKs, and all of these compounds cause inhibition of the activity of the transcription factors AP-1 and NF-kappaB, thus inhibiting cell proliferation and enhancing apoptosis. Critical areas of future investigation include: (1) identification of the direct molecular target(s) of EGCG and related polyphenolic compounds in cells; (2) the in vivo metabolism and bioavailability of these compounds; (3) the ancillary effects of these compounds on tumor-stromal interactions; (4) the development of synergistic combinations with other antitumor agents to enhance efficacy in cancer prevention and therapy, and also minimize potential toxicities.
Putative cancer chemopreventive agents of dietary origin-how safe are they? [2021]As cancer chemopreventive agents are intended for use by healthy individuals as prophylactics to prevent or retard the development of cancer, they must be amenable to ingestion over prolonged periods without toxicity. Therefore, putative chemopreventive agents need to undergo stringent testing to ensure their safety with regard to chronic exposure in humans. The diet is thought to be a source of chemopreventive agents, and dietary compounds are generally considered to be of low hazard, albeit this notion has not often been put to the test. Here the safety information available for 5 dietary putative chemopreventive compounds, indole-3-carbinol (I3C), curcumin, quercetin, epigallocatechin gallate (EGCG), and capsaicin is reviewed. For these agents, normal dietary intake, doses used in clinical trials, efficacious doses in rodents, and where available, toxic doses are compared. For curcumin, quercetin and capsaicin, toxicological data is only available from studies in rodents. Information on long-term effects in animals beyond 28 or 90 days is lacking for EGCG. Capsaicin and quercetin are suspected carcinogens. I3C and quercetin can modulate the absorption of other drugs given concomitantly. Without further investigation of their toxicology, it is difficult to recommend any of these agents for long-term use in the healthy population.
Synergistic effects of (--)-epigallocatechin gallate with (--)-epicatechin, sulindac, or tamoxifen on cancer-preventive activity in the human lung cancer cell line PC-9. [2013]The study on incorporation of [3H](-)-epigallocatechin gallate (EGCG) into human lung cancer cell line PC-9 indicated that the [3H]EGCG incorporation was significantly enhanced by (-)-epicatechin, an inert tea polyphenol without a galloyl moiety. (-)-Epicatechin enhanced apoptosis, growth inhibition of PC-9 cells, and inhibition of tumor necrosis factor-alpha release from BALB/c-3T3 cells by EGCG and other tea polyphenols with a galloyl moiety in a dose-dependent manner. Moreover, the effects of EGCG on induction of apoptosis were also synergistically enhanced by other cancer-preventive agents, such as sulindac and tamoxifen. This paper reports significant evidence that whole green tea is a more reasonable mixture of tea polyphenols for cancer prevention in humans than EGCG alone and that it is even more effective when it is used in combination with other cancer preventives.
Progress in cancer chemoprevention: development of diet-derived chemopreventive agents. [2018]Because of their safety and the fact that they are not perceived as "medicine," food-derived products are highly interesting for development as chemopreventive agents that may find widespread, long-term use in populations at normal risk. Numerous diet-derived agents are included among the >40 promising agents and agent combinations that are being evaluated clinically as chemopreventive agents for major cancer targets including breast, prostate, colon and lung. Examples include green and black tea polyphenols, soy isoflavones, Bowman-Birk soy protease inhibitor, curcumin, phenethyl isothiocyanate, sulforaphane, lycopene, indole-3-carbinol, perillyl alcohol, vitamin D, vitamin E, selenium and calcium. Many food-derived agents are extracts, containing multiple compounds or classes of compounds. For developing such agents, the National Cancer Institute (NCI) has advocated codevelopment of a single or a few putative active compounds that are contained in the food-derived agent. The active compounds provide mechanistic and pharmacologic data that may be used to characterize the chemopreventive potential of the extract, and these compounds may find use as chemopreventives in higher risk subjects (patients with precancers or previous cancers). Other critical aspects to developing the food-derived products are careful analysis and definition of the extract to ensure reproducibility (e.g., growth conditions, chromatographic characteristics or composition), and basic science studies to confirm epidemiologic findings associating the food product with cancer prevention.
The synergistic apoptotic interaction of panaxadiol and epigallocatechin gallate in human colorectal cancer cells. [2021]Panaxadiol (PD) is a purified sapogenin of ginseng saponins, which exhibits anticancer activity. Epigallocatechin gallate (EGCG), a major catechin in green tea, is a strong botanical antioxidant. In this study, we investigated the possible synergistic anticancer effects of PD and EGCG on human colorectal cancer cells and explored the potential role of apoptosis in the synergistic activities. Effects of selected compounds on HCT-116 and SW-480 human colorectal cancer cells were evaluated by a modified trichrome stain cell proliferation analysis. Cell cycle distribution and apoptotic effects were analyzed by flow cytometry after staining with PI/RNase or annexin V/PI. Cell growth was suppressed after treatment with PD (10 and 20 µm) for 48 h. When PD (10 and 20 µm) was combined with EGCG (10, 20, and 30 µm), significantly enhanced antiproliferative effects were observed in both cell lines. Combining 20 µm of PD with 20 and 30 µm of EGCG significantly decreased S-phase fractions of cells. In the apoptotic assay, the combination of PD and EGCG significantly increased the percentage of apoptotic cells compared with PD alone (p
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]Complementary and alternative medicines are used by up to 48% of lung cancer patients but have seen little formal assessment of survival efficacy. In this 10-year retrospective survival study, the authors investigated Pan-Asian medicine + vitamins (PAM+V) therapy in a consecutive case series of all non-small-cell lung cancer patients (n = 239) presenting at a San Francisco Bay Area Chinese medicine center (Pine Street Clinic). They compared short-term treatment lasting the duration of chemotherapy/radiotherapy with long-term therapy continuing beyond conventional therapy. They also compared PAM+V plus conventional therapy with conventional therapy alone, using concurrent controls from the Kaiser Permanente Northern California and California Cancer Registries. They adjusted for confounding with Kaplan-Meier, Cox regression, and newer methods - propensity score and marginal structural models (MSMs), which when analyzing data from observational studies or clinical practice records can provide results comparable with randomized trials. Long-term use of PAM+V beyond completion of chemotherapy reduced stage IIIB deaths by 83% and stage IV by 72% compared with short-term use only for the duration of chemotherapy. Long-term PAM+V combined with conventional therapy reduced stage IIIA deaths by 46%, stage IIIB by 62%, and stage IV by 69% compared with conventional therapy alone. Survival rates for stage IV patients treated with PAM+V were 82% at 1 year, 68% at 2 years, and 14% at 5 years. PAM+V combined with conventional therapy improved survival in stages IIIA, IIIB, and IV, compared with conventional therapy alone. Prospective trials using PAM+V with conventional therapy for lung cancer patients are justified.
[Regularity of prescriptions for intermediate and advanced lung cancer based on latent structure combined with association rules]. [2022]The present study explored the regularity of prescriptions for the treatment of intermediate and advanced lung cancer to provide references for clinical medication. CNKI, Wanfang, VIP, and CBM were searched for the research papers on the treatment of lung cancer by Chinese medicine published from database inception to May 31, 2021. The relevant information of qualified papers was extracted to establish a database. The Chinese medicines with frequency >3% underwent analysis of the latent structure and association rules by Lantern 5.0 and SPSS Molder 14.1, respectively, and the prescription regularity in the treatment of intermediate and advanced lung cancer was analyzed based on the frequency description. A total of 713 papers were included, involving 327 Chinese medicines with a cumulative frequency of 12 794 and 106 prescriptions with a cumulative frequency of 824. The commonly used Chinese medicines were dominated by deficiency-tonifying, heat-clearing, phlegm-resolving, and cough/dyspnea-relieving drugs, such as Astragali Radix, Atractylodis Macrocephalae Rhizoma, Glycyrrhizae Radix et Rhizoma, Ophiopogonis Radix, Poria, and Hedyotis Diffusa, which are cold, warm, and plain in nature and sweet, bitter, and pungent in flavor, and mainly act on lung, spleen, and stomach meridians. Commonly used prescriptions included Shashen Maidong Decoction, Liujunzi Decoction, and Baihe Gujin Decoction. The latent structure analysis revealed 32 latent variables and 65 hidden classes. Six comprehensive clustering models and 11 core prescriptions were obtained by professional knowledge inference. The common syndromes of intermediate and advanced lung cancer were inferred to be Qi and Yin deficiency in the lung, Qi deficiency in the lung and spleen, Yin deficiency in the liver and kidney, combined phlegm and stasis, phlegm-heat obstructing lung, and Qi stagnation and blood stasis. Forty-four strong associations were screened out by association rules analysis, including four pairwise strong associations(Polygonati Odorati Rhizoma→Ophiopogonis Radix, Polygonati Odorati Rhizoma→Glehniae Radix, Amomi Fructus→Atractylodis Macrocephalae Rhizoma, and Polygonati Rhizoma→Astragali Radix) and 40 triplet strong associations(such as Trichosanthis Radix+Glehniae Radix→Ophiopogonis Radix, Polygonati Odorati Rhizoma+Glehniae Radix→Ophiopogonis Radix, Trichosanthis Radix+Ophiopogonis Radix→Glehniae Radix, and Scutellariae Barbatae Herba+Codonopsis Radix→Hedyotis Diffusa). In the treatment of intermediate and advanced lung cancer, Qi-replenishing and Yin-nourishing drugs are mainly employed, assisted with cancer-resisting, toxin-removing, spleen-invigorating, phlegm/stasis-resolving, and blood-activating drugs based on syndrome differentiation. The roots were treated following the principles of tonifying lungs and replenishing the spleen, and symptoms following the principles of removing the toxin, dispelling stasis, and resolving phlegm.
[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]To explore the impact on neutrophil-to-lymphocyte ratio (NLR) and the quality of life (QOL) in the patients of non-small-cell lung cancer (NSCLC) treated with wheat-size moxibustion therapy.
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]Integrative oncology is being increasingly adopted in mainstream cancer care to strengthen anticancer effects and to control cancer-related symptoms.The objective of this study is to identify the characteristics of patients with lung cancer treated at an integrative cancer center in Korea and to determine the effects of integrative cancer treatment (ICT) on survival outcome in traditional Korean medicine (TKM).We reviewed medical records for lung cancer patients who visited a single integrative clinical setting, East-West Cancer Center, between January 2014 and December 2015. We classified the patients into groups according to their ICT and whether or not they underwent anticancer traditional Korean Medicine treatment with a multiherbal formula containing Panax notoginseng Radix, Cordyceps militaris, P ginseng C.A.Mey., and Boswellia carterii BIRDWOOD (HangAmDan-B), with a herbal formula containing Rhus verniciflua Stoke, or with cultivated wild ginseng pharmacopuncture. A descriptive analysis of the characteristics and a survival analysis using the Kaplan-Meier curves with log rank test and a Cox proportional hazard model were performed.A total of 91 patients were included, and the majority had advanced-stage cancer. Of those patients, 45.1% were in the mono-TKM group and 39.6% were integrative group. Patients with advanced stage had significantly higher mortality than patients with early stage (crude hazard ratio [HR]: 4.41, 95% confidence interval [CI]: 1.56-12.5; adjusted HR: 6.31, 95% CI: 1.24-32.1). In the unadjusted model, for patients in the integrative group, the mortality rate was reduced by 50% compared to mono-TKM group with statistical significance. After adjusting confounders, the mortality rate of integrative group was reduced by 6% compared to mono-TKM group, suggesting positive effect on survival probability of integrative group.The results suggest that integration of TKM and conventional cancer treatment may have survival benefits in patients with lung cancer. Even though this study has limitations including heterogeneity between treatment groups, the study results suggest that ICT has positive effect on survival probability. To clarify the impacts of ICT for lung cancer and other cancers on survival outcome, further prospective study with a rigorous study design is required in multiclinical setting.
[Consensuses on lung cancer treatment by Chinese medicine experts from Beijing and Guangzhou and medication features in the North and South China]. [2016]To study the consensuses on lung cancer treatment by Chinese medicine experts from North China and South China, and to analyze their medication features from viewpoints such as the medication frequency, combination laws, medication classification by collecting 800 recipes on the treatment of lung cancer patients prescribed by 8 Chinese oncologists from Guanganmen Hospital of China Academy of Chinese Medical Sciences, the Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, and Guangdong Provincial Hospital of Traditional Chinese Medicine. Results showed that coix seed, poria, pinelliae tuber were the three herbs most commonly used in treatment of lung cancer by all experts. They generally accepted Pi invigorating and phlegm removing method as the basic treatment method for treating lung cancer. Secondly, they usually used white peony root, heterophylla falsestarwort root, and ophiopogonis tuber, etc. (with higher medication frequency) to nourish yin and moisten Fei. Thirdly, consistency was also shown in clearing heat, detoxication, and anticancer. Smilacis glabra, Rhizoma Smilacis Glabrae, Herba Hedyotis diffusae, Herba Scutellariae Barbatae were herbs used by all experts. However, there were differences between oncologists in North China and South China. Oncologists in South China paid more attention to heat toxin and blood stasis, while those in North China paid more attention to supplementing both qi and yin.