Improving Quality of Life

Safety, Effectiveness and Cost of Complementary Therapies

At the OICC, we are committed to studying the safety, effectiveness and cost of complementary treatments used by people living with cancer. We have several ongoing clinical studies and systematic reviews in this area.




The Canadian/US Integrative Oncology Study (CUSIOS). Advanced integrative oncology treatment for patients with advanced stage cancer

Funded by an anonymous Canadian foundation

Working in partnership with Bastyr University, the OICC and CCNM research have initiated a North American study to explore the impact of advanced integrative care delivered by NDs for patients with advanced cancer. Seven clinics across NA are recruiting patients to participate in this prospective observational study to describe quality of life and survival outcomes for patients with advanced stage breast, colorectal, ovarian, and pancreatic cancers. This study will run over six years with the goal of enrolling over 400 patients with late stage cancer. Outcomes associated with quality of life and survival will be assessed.

STUDY STATUS: The OICC is now actively recruiting patients to participate in this observational study.

INVESTIGATORS: Dugald Seely, ND, MSc, FABNO (Co-Principal Investigator & Site Investigator); Leanna J. Standish (Co-Principal Investigator & Site Investigator); Neil McKinney, ND (Site Investigator); Gurdev Parmar, ND, FABNO (Site Investigator); Eric Marsden, ND (Site Investigator); Dan Rubin, ND, FABNO (Site Investigator); Erin Sweet, ND, FABNO (Site Investigator)


The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial: (The Thoracic POISE Trial)

Funded by an anonymous Canadian foundation

Working in collaboration with the Ottawa Hospital Research Institute (OHRI), OICC and CCNM research have launched an 11 year study to explore the impact of integrative cancer care for patients with lung and gastroesophageal cancers. This study uses a pragmatic randomized design to enroll patients into either a combination of conventional and complementary medicine care (integrative care group) or conventional care alone (control group). Outcomes associated with thoracic surgery, quality of life, survival and cost effectiveness will be evaluated within three centres across Canada including Ottawa, Hamilton and Kelowna with an aim of randomizing over 340 participants.

STUDY STATUS: This clinical trial is currently in development and not actively recruiting.

INVESTIGATORS: Dugald Seely, ND, MSc, FABNO (Co-Principal Investigator); Andrew Seely, MD (Co-Principal Investigator)


Adjuvant Melatonin in the Prevention of Recurrence and Mortality Following Lung Cancer Resection: A Randomized Placebo Controlled Clinical Trial

Funded by the Lotte and Hecht Memorial Foundation


Adjuvant Melatonin in the Prevention of Recurrence and Mortality Following Lung Cancer Resection: A Phase II substudy of Randomized Placebo Controlled Clinical Trial

Funded by the Gateway for Cancer Research Foundation


Natural Health Products and Breast Cancer: A Series of Systematic Reviews

Funded by the Canadian Institutes of Health Research (CIHR)

Please note: Works described in this abstract have been presented as a combination of oral and poster research presentations at over four conferences including the International Society for Complementary and Alternative Medicine Research, the Society for Integrative Oncology, the American Association of Naturopathic Medicine, and the Interdisciplinary Network of Complementary and Alternative Medicine.

Background: Breast cancer patients and women at risk of breast cancer frequently resort to natural health products (NHPs) to reduce their disease risk and to manage hot flashes. To date there are no evidence-based guidelines for which NHPs are safe and efficacious, or harmful and ineffective in the context of breast cancer.

Objective: To systematically review and summarize the literature around commonly used  NHPs for the treatment and prevention of breast cancer, and to assess for potential interactions with conventional cancer therapies, particularly hormonal therapies.

Methods: We systematically searched four electronic databases for human level evidence pertaining to five natural health products with evidence for use in breast cancer: Black cohosh, Soy, Red clover, Flax, and Vitamin D.

Results: Of 8751 records screened, 194 were included for full review and analysis: 33 randomized controlled trials, 22 uncontrolled trials, 49 cohort studies, 21 nested case control studies, and 58 case control studies. Overall, there was no consistent evidence suggesting an increased risk of breast cancer or breast cancer recurrence associated with use of the reviewed NHPs; conversely, there was some evidence suggesting that use of these agents may be associated with decreased breast cancer risk. Some benefit on hot flashes was found when compared to baseline but not placebo. Specifically, of four observational studies of black cohosh, two found no association with risk of breast cancer, while two reported significantly decreased risk of primary breast cancer and recurrence. With respect to soy, there was no evidence of harmful effects on serum estrogen levels, endometrial thickness, mammographic density or changes, nipple aspirate volume, uterine or vaginal tissue, based on the inclusion of 33 RCTs and 9 uncontrolled trials. There were no observational studies indicating increased risk of breast cancer from soy, including four studies of soy among tamoxifen users. One RCT of flaxseed in women with breast cancer, demonstrated a significant decrease in c-erbB2 (HER2) expression, a significant increase in apoptotic index, and a significant decrease in the Ki-67 index, a marker of proliferation. With respect to vitamin D, none of the 3 RCTs and 7 reports of uncontrolled trials reported serious adverse effects associated with high dose vitamin D (HDD) supplementation in women with breast cancer, at doses ranging from 8000 and 10,000 IU/d for up to 4months, and 50,000 IU/wk for up to 12weeks. Three studies suggested that HDD may reduce musculoskeletal pain and/ or disability secondary to bone metastasis or aromatase inhibitor therapy (letrozole, anastrozole).

Conclusion: There is preliminary data suggesting that black cohosh, soy, and red clover may be associated with reduced risk of primary breast cancer and/ or recurrence. Evidence on the use of black cohosh, soy, red clover, and flax for the treatment of hot flashes in women with breast cancer is equivocal.

STUDY STATUS: Complete with a number of peer-reviewed publications and some still in process.

INVESTIGATORS: Dugald Seely, ND, MSc, FABNO (Principal Investigator); Heidi Fritz MA, ND; Gillian Flower ND; Deborah Kennedy MBA, ND; Rochelle Fernandes MSc, ND(c); Jessie McGowan PhD; Becky Skidmore PhD; Kieran Cooley ND, MSc(c); Stephen Sagar MD, FRCPC; Raimond Wong MD, FRCPC; Dean Fergusson PhD.


Natural Health Products and Lung Cancer: A Series of Systematic Reviews

Funded by the Canadian Institutes of Health Research (CIHR)

Please note: Works described in this abstract have been presented as a combination of oral and poster research presentations at a number of conferences including the International Society for Complementary and Alternative Medicine Research, the Society for Integrative Oncology, the American Association of Naturopathic Medicine, the Canadian Association of Naturopathic Doctors, the Canadian Cancer Research Conference, and the Interdisciplinary Network of Complementary and Alternative Medicine.

Background: Lung cancer is the leading cause of cancer mortality worldwide. Although smoking cessation is the most important chemopreventive strategy, there has been no summary of current evidence around other complementary strategies used for the treatment and prevention of this disease.

Objective: To systematically review and summarize the literature around commonly used  NHPs for the treatment and prevention of lung cancer, and to assess for potential interactions with conventional cancer therapies.

Methods: We searched seven electronic databases for all levels of evidence pertaining to the safety and efficacy of seven NHPs with evidence for use in lung cancer: Vitamin A, Selenium, Vitamin D, Fish-derived omega-3 fatty acids, Polysaccharide K (PSK), Vitamin C, and Green Tea.

Results: Of 18,229 articles screened, 594 studies were included for full review. Findings highlight a number of clinically relevant results. Selenium may lower risk of lung cancer in those with lower selenium levels (<106 ng/mL) and may reduce certain side effects of chemotherapy and radiation. Vitamin D supplementation to achieve optimal levels may be beneficial as higher 25(OH)D levels (≥21.6 ng/mL or 54 nmol/L) have been associated with better survival among advanced patients. Fish-derived omega-3 oils, specifically eicosapentanoic acid (EPA), may slow cancer-associated cachexia. PSK may improve hematological parameters, cancer associated symptoms, and survival. Evidence on the use of green tea and vitamin C as an intervention for lung cancer is too limited to make any real claim as yet. Vitamin A may increase the risk of lung cancer when given to smokers and should not be used in the treatment or prevention of lung cancer.

Conclusion: Vitamin D, EPA, and PSK should be seriously considered for use in lung cancer patients and deserve futher research. Selenium may be beneficial among certain cases. VitaminA is contraindicated in smokers.

STUDY STATUS: Complete with a number of peer-reviewed publications and some still in process.

INVESTIGATORS: Dugald Seely, ND, MSc, FABNO (Principal Investigator); Heidi Fritz MA, ND; Deborah Kennedy MBA, ND; Rochelle Fernandes MSc, ND(c); Sarah Vadeboncoeur ND; Kieran Cooley ND, MSc(c); Andrew Seely MD, FRCPC; Stephen Sagar MD, FRCPC; Raimond Wong MD, FRCPC; Dean Fergusson PhD.

Voices of Support

 

“I applaud the OICC’s commitment to being a leader in integrative oncology research. From interactions with mutual patients, I realize that the clinical care provided by the OICC has real value to the people under our care, and that this care can and should be expanded to others. With the research that we’ve done together already and the approach you take in science and clinical care, I believe the OICC will achieve great prominence as a valuable resource for patients.”

Andrew J.E. Seely, MD, PhD, FRCSC
Associate Scientist, Ottawa Health Research Institute
Associate Professor of Surgery, University of Ottawa
Research Director, Division of Thoracic Surgery and Critical Care Medicine of The Ottawa Hospital


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