Completed Studies

Soy

The goal of this study was to find out if anti-estrogen compounds extracted from soy beans could have a cancer prevention effect in healthy women at high risk for breast cancer.  The study found that in postmenopausal women, no significant good or bad effects were seen on the breast. But in pre-menopausal women, there was a possibility that these soy compounds could increase the growth rate of breast cells, which is undesirable.  The outcome of the study was therefore to caution women- particularly younger women- against the use of soy extracts, although the consumption of whole soy foods (like edemame or tofu) has no known harmful effects.

 

Aspirin and Spectral Biomarkers

Aspirin use has been shown in many studies to have protective effects against colon cancer.  In this study, we tested a new way of looking at colon cells, to see if the beneficial effects of aspirin could be assessed after a short time of aspirin use,  by shining a light on the colon cells.  The study was successful in this regard; after three months of treatment, participants in the aspirin group showed normalization of these markers, but participants who received placebo did not.  Therefore, this new and accurate way of evaluating colon cells is being tested further in our ongoing studies and will be an important aid to studies of colon cancer prevention.

 

Selenium

Selenium is a food component that has shown promise for cancer prevention, but clinical trials have shown mixed results.  In this study, we looked at a particular form of selenium given to healthy men, in three doses, to better understand the absorption of this compound when given by mouth, and the effects of different doses.

 

In a second selenium study, we conducted additional investigations to see what is the best form of selenium to use in cancer prevention studies. Healthy male volunteers took two different forms of selenium, to study relative absorption and excretion.  These two studies will guide the design of future prevention trials using selenium in people who are selenium-deficient.

 
 

Photodynamic Therapy for Prevention of Mouth Cancer

Over the past three decades, photodynamic therapy (PDT) has developed as a light-based tool which aids in the destruction of abnormalities that occur on the surface of organs, such as the skin, the lining of the mouth, the lung, and the gut. It involves the use of a drug that makes cancer and pre-cancer cells sensitive to laser light; when laser light is then applied to the abnormal areas, these are destroyed. In the mouth, people at risk for cancer may develop whitish patches called leukoplakia which can then progress to cancer.  This trial tested the safety and effectiveness of a newer form of PDT, and found that this was safe and had some effectiveness.  These findings help to form the basis for additional, larger trials in the future.

Colon Cancer Prevention with a Colon-Cleansing Laxative

Polyethylene glycol (PEG) is a laxative that is used to cleanse the colon in preparation for colonoscopy.  Findings from the laboratories at Northwestern and other universities suggested that PEG may also prevent colon cancer. We conducted the first human trial to evaluate early signals of colon protection, using two different doses of PEG versus a placebo.  We found that the use of PEG in this setting is safe, and changes suggestive of colonic protection were seen.  Larger trials are now needed to establish PEG as a strategy for colon cancer prevention.

 

Tamoxifen as a Pill vs. a Gel for Safer Breast Cancer Prevention

Tamoxifen is a well proven medication for breast cancer prevention and the treatment of duct carcinoma in situ (DCIS, or Stage zero ductal cancer). However, many women decline tamoxifen pills for fear of side effects. In this study we tested a new way of delivering an active form of tamoxifen (4-hydroxytamoxifen or 4-OHT) as a gel applied to the breast skin in women who needed surgery for DCIS. We found that the 4-OHT gel was as effective as tamoxifen pills in decreasing the growth rate of DCIS cells, suggesting that 4-OHT gel may be substituted for oral tamoxifen in future studies. Particularly important was the fact that very little 4-OHT appeared in the circulation of women in the gel group, raising expectations that 4-OHT gel would cause few side effects and would be more acceptable to women. Additional studies of this approach are now ongoing.

 

Colon Cancer Prevention in People with Inflammatory Bowel Disease

Myo-inositol is a compound that has shown promise as an anti-inflammatory agent. People with inflammatory bowel disease and abnormal colonic cells are at increased risk for colon cancer.  We found that the use of myo-inositol decreased the molecular changes that are associated with colon cancer risk, and further development of myo-inositol in this setting may therefore be useful.

 
 

NCPC Publications

Alber KM, Murff H, Ness R, Seidner D, Zhu X, Shrubsole M, Tull MB, Benante KA, Segura AJ, Kalinichenko K, Hou L, Jovanovic B, Della'Zanna G, Richmond E, Khan SA, Dai Q. Evaluating intermittent dosing of aspirin for colorectal cancer prevention. DOI: 10.1200/JCO.2018.36.15_suppl.TPS1594 Journal of Clinical Oncology 36, no. 15_suppl - published online before print.

Benante KA, Xu Y, Tull MB, Segura AJ, Alber KM, Kalinichenko K, Hou L, Jovanovic B, Perloff M, Heckman-Stoddard BM, Dimond EP, Khan SA. A phase IIB pre-surgical trial of oral tamoxifen (TAM) versus transdermal 4-hydroxytamoxifen (4-OHT) in women with DCIS of the breast. DOI: 10.1200/JCO.2018.36.15_suppl.TPS1595 Journal of Clinical Oncology 36, no. 15_suppl - published online before print.

Jovanovic DB, Subramanian H, Helenowski IB, Roy HK, Backman V (2015) Clinical Trial Laboratory Data Nested With in Subject: Components of Variance, Sample Size and Cost. Biom Biostat Int J 2(2): 00029. DOI: 10.15406/bbij.2015.02.00029

Mavese JM, Farmer RL, Bergan RC. Inhibition of cancer cell invasion and metastasis by genistein. Cancer Metastasis Rev. 2010 Sep;29(3):465-82.

Xu L, Wang SS, Healey MA, Faupel-Badger JM, Wilken JA, Battaglia T, Szabo E, Mao JT, Bergan RC. The ninth annual American association for cancer research international conference on frontiers in cancer prevention research. Cancer Prev Res (Phila). 2011 Apr;4(4):616-21.

Marshall JR, Ip C, Romano K, Fetterly G, Fakih M, Jovanovic BD, Perloff M, Cromwell J, Davis W, French-Christy R, Dew A, Coomes M, Bergan RC. Methyl selenocysteine: single-dose pharmacokinetics in men. Cancer Prev Res. 2011 Nov;4(11):1938-44.

Khan SA, Chatterton RT, Michel N, Bryk M, Lee O, Ivancic D, Heinz R, Zalles CM, Helenowski IB, Jovanovic BD, Franke AA, Bosland MC, Wang J, Hansen NM, Bethke KP, Dew A, Coomes M, Bergan RC. Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.  Cancer Prev Res. 2012 Feb;5(2):309-19.​

Lee O, Helenowski IB, Chatterton RT Jr, Jovanovic BD, Khan SA. Prediction of menopausal status from estrogen-related gene expression in benign breast tissue. Breast Cancer Res Treat. 2012 Feb;131(3):1067-76.

Dew A, Khan SA, Babinski C, Michel N, Heffernan M, Stephan S, Jordan N, Jovanovic BD, Carney P, Bergan RC. Recruitment strategy cost and impact on minority accrual to a breast cancer prevention trial. Clin Trials. 2013 Apr;10(2):292-9.

Lee O, Khan SA. A Fitting Prescription for All: Whole Soyfoods as Part of a Varied Plant-Based Diet. Oncology (Williston Park). 2013 May;27(5):450, 452, 454.

Wong SJ, Campbell B, Massey B, Lynch DP, Cohen EE, Blair E, Selle R, Shklovskaya J, Jovanovic BD, Skripkauskas S, Dew A, Kulesza P, Parimi V, Bergan RC, Szabo E. A phase I trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia. Oral Oncology. 2013 Sep;49(9):970-6.

Lee O, Lazzeroni M, Khan SA. Innovative Approaches to Tamoxifen Administration for Breast Cancer Prevention. In: Tamoxifen Concepts and Cancer New Paradigms, Chap 5. (Ed. de Mello). Nova Biomedical, New York, NY 2013.

Lee O, Page K, Ivanvic D, Helenowski I, Parini V, Sullivan ME, Margenthaler JA, Chatterton RT Jr, Jovanovic BD, Dunn BK, Heckmann-Stoddard BM, Foster K, Muzzio M, Shklovskaya J, Skripkauskas S, Kulesza P, Green D, Hansen NM, Bethke KP, Jeruss JS, Bergan RC, Khan SA. A randomized phase II presurgical trial of transdermal 4-hydroxytamoxifen gel versus oral tamoxifen in women with ductal carcinoma in situ of the breast. Clin Cancer Res. 2014 Jul 15;20(14):3672-82.

Lee O, Khan SA. Novel routes for administering chemoprevention: Local transdermal therapy to the breasts. Semin Onc. 2016 Feb; 43(1):107-15. PMID: 26970129.

Roy HK, Turzhitsky V, Wali R, Rodosevich AJ, Jovanovic BD, Della’Zanna G, Umar A, Rubin DT, Goldberg MJ, Bianchi L, De La Cruz M, Bogojevic A, Helenowski IB, Rodriguez LM, Chatterton R, Skripkauskas S, Page K, Weber CR, Huang X, Richmond E, Bergan RC, Backman V. Spectral markers for chemoprevention of colonic neoplasia: a placebo-controlled double-blinded trial with aspirin. Gut. 2017 Feb;66(2)2:85-92.

Marshall JR, Burk RF, Ondracek RP, Hill KE, Perloff M, Davis W, Pili R, George S, Bergan RC. Selenomethionine and methyl selenocysteine: multiple-dose pharmacokinetics in selenium-replete men. Oncotarget. 2017 Apr 18;18(16):26312-22.

Bradford EM, Thompson CA, Goretsky T, Yang GY, Rodriguez LM, Li L, Barrett TA. Myo-inositol reduces β-catenin activation in colitis. World J Gastroentrol. 2017 Jul 28;23(28):5115-26.

Wali RK, Bianchi L, Kupfer S, De La Crz M, Jovanovic BD, Weber C, Goldberg MJ, Rodriguez LM, Bergan R, Rubin D, Tull MB, Richmond E, Parker B, Khan SA, Roy HK. Prevention of colonic neoplasia with polyethylene glycol: a short term placebo-controlled double-blinded trial. PLoS One. 2018 Apr 4;13(4).

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Content on NUcancerprevention.org is a courtesy from the Northwestern Cancer Prevention Consortium at Northwestern University. While we strive to maintain the most current and up to date information possible, NCPC does not guarantee accuracy, completeness, or relevance of the information supplied. The thoughts, views, and information found here do not necessarily reflect the views of Northwestern University or Northwestern Medicine. 

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