Zinc may prevent Barrett’s esophagus-related esophageal cancer, human study shows

By Donna Loyle, communications specialist, LIMR

The micronutrient zinc administered orally as zinc gluconate (an over-the-counter lozenge) may help to prevent cancer of the esophagus in patients diagnosed with the pre-malignant condition called Barrett’s esophagus (BE), according to the results of a first-ever pilot study in humans conducted, in part, by investigators at the Lankenau Institute for Medical Research (LIMR) and physicians at the Lankenau Medical Center.

Patients with BE, the esophageal condition caused by long-term gastrointestinal reflux disease, have a significantly higher risk of developing cancer of the esophagus than the general population. Moreover, esophageal cancer has one of the lowest five-year survival rates of any cancer: less than 20 percent.

“Finding a way to effectively treat BE and stop its progression to cancer has been paramount among those in the gastroenterology community,” noted Gary Newman, MD, a gastroenterologist at Lankenau Medical Center and one of the new study’s authors.

Preclinical studies in rodents done at Thomas Jefferson University School of Medicine and elsewhere suggested that zinc deficiency was associated with higher rates of chemically induced esophageal cancer (squamous cell carcinoma). Could the same be true regarding esophageal adenocarcinoma in humans diagnosed with BE?

“We wanted to determine if the chemopreventive action reported for zinc’s inhibition of esophageal cancer in rodents extends to the Barrett’s-driven esophageal adenocarcinoma in humans,” noted James Mullin, PhD, LIMR professor and one of the study’s authors. “Our pilot study in humans offers promising data that this may be true.”

The researchers conducted a small pilot study involving over 100 BE patients from 2012 to 2019. Study participants were randomized into two study arms. One group took two zinc gluconate lozenges each morning and evening for 14 days. Dosage was 13.2 mg of zinc per lozenge for a daily intake of 52.8 mg. The other group took a sodium gluconate placebo.

After 14 days, biopsies of study participants’ esophageal tissue were taken for RNA and protein analyses. The researchers found an intriguing pattern in the nature of the molecular changes observed. Among the notable findings they discovered an uptick in genes that have been shown in previous studies to suppress tumors, and a down regulation in genes known to promote tumor growth.

“Overall, this study suggests that daily zinc prophylaxis could be a significant proactive step that a Barrett’s esophagus patient could take to reduce the lifetime risk of esophageal adenocarcinoma,” wrote the study’s authors, which included those at LIMR; the divisions of Gastroenterology and Pathology at Lankenau Medical Center; the Wistar Institute; Thomas Jefferson University; and Saint Joseph’s University.

The authors concluded that these promising results from a small sampling of BE patients suggests the imperative of conducting a larger prospective clinical trial that would study the therapeutic value of zinc in more patients, specifically targeting the issue of whether zinc prophylaxis reduces the risk of Barrett’s patients acquiring esophageal adenocarcinoma.

The manuscript “Zinc gluconate induces potentially cancer chemopreventive activity in Barrett’s esophagus: a phase 1 pilot study” was published in the journal Digestive Diseases and Sciences. The full manuscript is available at https://bit.ly/3dUFDi7.

The current manuscript follows an earlier publication (https://bit.ly/3bSqP2P) from LIMR and Lankenau’s Gastroenterology group describing drug delivery of zinc to Barrett’s tissue.

The current study was supported by funding from the Sharpe-Strumia Research Foundation and internal funding from LIMR. The pilot study provided research training to — and benefited from the assistance of ­— more than a dozen gastroenterology fellows at Lankenau Medical Center during its seven years of patient recruitment.

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MLHPP Managing Committee 2020 Election is open

Main Line Health Physician Partners (MLHPP), Main Line Health’s Clinically Integrated Network, is currently running its 2020 election for independent members of its Managing Committee.  There are 2 Primary Care and 3 Specialist positions available.  All independent network members should have received an e-mail with voting instructions last week, along with a subsequent e-mail that contained a link to a Survey Monkey election ballot.  All independent members who have not received these e-mails should check their Spam folders and ensure that they have not opted out of receiving Survey Monkey e-mails in the past.

If you have questions, please contact Melissa Rafferty, System Director Primary Care Service Line and MLHPP, via e-mail RaffertyMe@mlhs.org or by phone 484-580-4002.   The election will end as of Close of Business (COB) Wednesday, May 27, 2020.  25% of the MLHPP independent physician network must vote for the election to be valid.  To date, 15% of the network has voted.  Your vote is important!

Thank you for your time and attention to this important matter.  The physicians on this committee will be representing you.  PLEASE VOTE!

From Lawrence Livornese MD

Chair, MLHPP Network Development Committee

Chair, MLH Department of Medicine

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Mental Health Awareness Month

Colleagues-

I want to take the opportunity to highlight a very special awareness for May: May is Mental Health Awareness Month. During this month, we take time to raise awareness about mental health by promoting ways to stay connected so that no one ever feels alone or without the support and help they need. 1 in 5 individuals will experience mental health challenges in their lifetime, which equates to over 47 million people.

The ripple effect of mental health challenges affects the person, their families, the community and ultimately the world. The events of the past few months have underscored the need for people to have access to services that promote mental health and wellbeing. If you or a loved one are experiencing any mental health issues, please reach out and get the help you need. I am proud to highlight some of the wonderful resources MLH has to offer:

  • FIRSTCALL’s confidential 24 hour helpline – 800-382-2377 is available to you and your household members for in the moment support and referrals to counseling and a variety of other services.
  • Our Behavioral Health Services and support groups
  • Mirmont Treatment Center
  • Women’s Emotional Wellness Centers
  • CIRT Teams are available for confidential peer-to-peer support to help employees cope following a distressing workplace event
  • Headspace – an app which is currently free to all healthcare providers for 2020. This is a guided meditation, mindfulness and sleep aid
  • Mindful Moments – Led by Regina Carr Tierney is offered twice a week for 30 minutes
  • FREE health coaching: 610-225-6277
  • Several other wellness resources can be found on Wellspring

These past few months have proven to be very challenging times for all of us and we all have different ways of coping. We hope you will utilize these different levels of support and resources if you believe they might be helpful. Let’s keep an eye out for each other. If you see something concerning in a colleague’s demeanor and outlook, say something to connect them with help. Now more than ever before, we need each other.

With deep appreciation,

Jack

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2019-2020 MLH Medical Staff Meetings

Attendance at 50% (1) Hospital Staff meeting per Calendar Year is required for Active Staff members by the MLH Medical Staff Bylaws.

You may attend any ONE of the following meetings, at the hospital of your choice, whether that hospital is/is not your primary facility.

THERE ARE NO EXCUSED ABSENCES.

Spring 2020 Meetings

Tuesday, June 2, 2020 5:00PM Lankenau Medical Center – Center Pew

Auditorium- GoToMeeting with more information to come

Questions? Contact the Medical Staff Affairs Office at 484-337-8031

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Clinical Trial of the Week: Treatment study for patients with certain types of gynecologic cancer

By Donna Loyle, communications specialist, LIMR

May is Women’s Health Month, which makes this an ideal time to highlight the FIRST study. Researchers are studying a treatment regimen in patients who have been newly diagnosed with certain types of stage 3 or 4 ovarian, fallopian tube, or peritoneal cancer. Treatments being studied include the experimental intravenous drug TSR-024, an immunotherapy medication, and Zejula™ (niraparib), an FDA-approved anti-cancer oral drug.

This randomized, double-blind, phase III study is open to patients for whom platinum-based neoadjuvant chemotherapy is planned. It is also open to patients with inoperable ovarian cancer and macroscopic residual disease after primary debulking surgery (PDS) and recovery from PDS.

Patients must not have mucinous, germ cell, transitional cell, or undifferentiated tumor, or low-grade or grade 1 epithelial ovarian cancer.

All trial participants receive current standard of care, including chemotherapy. Patients are then randomized into three groups:

  • Arm 1: Receives placebos for both medications
  • Arm 2: Receives TSR-042 placebo and niraparib
  • Arm 3: Receives both TSR-042 and niraparib

 

Participants may receive these treatments for up to three years. Special note: This trial is open only to patients of the principal investigators David O. Holtz, MD, and Xiaomang Stickles, MD. For more, email cancertrials@mlhs.org or visit www.mainlinehealth.org/research/clinical-trials/first

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Celebrating clinical research professionals

By Donna Loyle, communications specialist, LIMR

This Wed., May 20, is International Clinical Trials Day, which makes this a great time to recognize the clinical research professionals at the Lankenau Institute for Medical Research (LIMR), Main Line Health and around the globe for their important contributions to public health and medicine. Today, more than ever, we’re counting on the diligence, compassion and dedication of these professionals to help find new treatments and vaccines to eradicate COVID-19.

While we can’t celebrate Clinical Trials Day in person this year, we did want to take this opportunity to thank Main Line Health’s clinical research professionals for all that they do. Currently the team is administering about 100 clinical studies (recruiting for about 60 of those). Most trials are studying cancer and cardiovascular disease, but the team is running studies for other disorders as well.

For example, LIMR’s Clinical Research Center (CRC) is available to support Main Line Health clinicians who want to administer convalescent human plasma to their COVID-19 patients. We are registered in a nationwide Expanded Access program being run through the Mayo Clinic to obtain donated plasma. The CRC can guide clinicians through the process of registering for the program, and then assist them with the follow-up and reporting requirements. Prepared step-by-step guidance is available for your teams for distribution. For more, contact Samantha Ferrante, CRC associate director, at 732.604.9218 or ferrantesa@mlhs.org, or Paul Gilman, MD, CRC director, at 484.476.4837 or gilmanp@mlhs.org.

For more about the clinical trials that are recruiting patients at Main Line Health, visit mainlinehealth.org/clinical-trials.

Pictured are the MLH Clinical Trials Professionals (note: photo was taken before social-distancing guidelines were put in place).

For more on International Clinical Trials Day, visit: www.clinicaltrialsday.org.

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2019-2020 MLH Medical Staff Meetings

Attendance at 50% (1) Hospital Staff meeting per Calendar Year is required for Active Staff members by the MLH Medical Staff Bylaws.

You may attend any ONE of the following meetings, at the hospital of your choice, whether that hospital is/is not your primary facility.

THERE ARE NO EXCUSED ABSENCES.

Spring 2020 Meetings

Thursday, May 14, 2020 5:30PM Bryn Mawr Hospital – Pennypacker Auditorium- GoToMeeting with more information to come
Tuesday, June 2, 2020 5:00PM Lankenau Medical Center – Center Pew

Auditorium

 

Questions? Contact the Medical Staff Affairs Office at 484-337-8031

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Clinical Trial of the Week: For patients with advanced non-squamous NSCLC

By Donna Loyle, communications specialist, LIMR

Main Line Health is recruiting patients for a new phase III clinical trial studying the safety and efficacy of administering a combined use of FDA-approved medications to treat patients who have been diagnosed with stage 4 non-squamous, non-small cell lung cancer (NSCLC).

All study participants are administered intravenously the immunotherapy drugs Keytruda® (pembrolizumab) and Alimta® (pemetrexed), as well as the anti-cancer medication Paraplatin® (carboplatin). Patients are randomized into three groups; the dosages and timing of drug administration vary by group. Patients are followed for up to two years.

Eligible patients must have PD-L1 expression Tumor Proportion Score (TPS) >= 1% in tumor cells, and no prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Other inclusion and exclusion criteria apply.

Study #EA5163 is approved for all MLH acute care hospitals. The principal investigator is Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit www.mainlinehealth.org/research/clinical-trials/ea5163

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Memorandum-COVID-19 Antibody Assay

By Pradeep K Bhagat, MD

Effective Wednesday May 6, Main Line Health Laboratories will begin performing an FDA-approved assay for COVID-19 IgG antibodies. This test will be performed at Lankenau Medical Center core laboratory with a routine turnaround time of less than 24 hours. According to the manufacturer, Abbot Diagnostics, the positive predictive value 14 days post-symptom onset is 100% and negative predictive value is 99.63%. However, there may be false positive results depending on several factors, including cross-reactivity, the prevalence of the disease in population and other unknown possible causes.

Antibody testing for COVID-19 is a relatively recent development. There is limited literature and little experience with results of this assay. The SARS-CoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection. This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 infection indicating recent or past infection, however it is unknown if the presence of antibodies confers protective immunity1. The Infectious Disease Society of America states that current antibody testing is best suited for public health purposes and should not be used to determine immunity to SARS-CoV-22.

The Abbott SARS-CoV2-IgG assay is an automated chemiluminescent microparticle immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum or plasma.

Patients may have their serum collected at MLHL outpatient laboratories or in physician offices.  Please consult the MLH Laboratory web page at www.Mainlinehealth.org/labs for outpatient lab locations and hours.  Specimens from physician offices may be picked up by courier by calling the MLH Laboratories Client Service Center at 484-580-4200.  The specimen requirement is one centrifuged gold top serum separator tube.

To order:

  • In Epic, search LAB6738.
  • For script or paper lab requisitions order “COVID-19 IgG antibodies by immunoassay.” A checkbox option may be added to customized paper requisitions by emailing Jack Galamb at galambj@mlhs.org or calling 484-580-4206.
  • Contact your EHR vendor to have the test added to your pick list.

If you have are any questions, please contact Dr. Pradeep Bhagat, Medical Director, Main Line Health Laboratories, BhagatP@mlhs.org, 484-476-3521; Dr. Lawrence Livornese, System chair, Department of Medicine, LivorneseL@mlhs.org; or Dr. Mark Ingerman, System chief, Division of Infectious Diseases and Infection Prevention, IngermanM@mlhs.org.

Ref:

  1. Architect SARS-CoV-2 IgG package insert April 2020
  2. https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody-testing-primer.pdf
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“Physician Resources”: Physician Wellness Committee

By Walter Klein, MD Chair and Susan Gregory, MD Vice Chair

We would like to make sure everyone is aware of the resources available to you including the employee assistance program First Call. This program is available to everyone on the medical staff not just MLH employees.

First Call offers not only counseling services to physicians, it also provides additional resources to you and members of your household such as childcare and parenting (see attachments).   More importantly, Sharon O’Brien who runs the Employee assistance program informed us that instead of calling the 1-800 number listed in the attachments, physicians can directly call Mary Jo Wells, the program’s clinical manager at 484.337.4288 or email her at wellsmj@mlhs.org for priority referral.   If you know someone who may need help please encourage them to reach out to First Call.  We need to take care of ourselves and each other during these challenging times.

Physician Self-Care Resources

FirstCall Resources

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