Posts Tagged ‘cancer clinical trials’

Winship Trial Reduces Mortality Rate for APL Patients

Winship's APL team (left to right): Martha Arellano, Kaitlin Sitchenko, Anand P. Jillella, Vamsi Kota, Ann Shen, Emily Bennett.

Winship’s APL team (left to right): Martha Arellano, Kaitlin Sitchenko, Anand P. Jillella, Vamsi Kota, Ann Shen, Emily Bennett.

Winship oncologist Anand Jillella, MD is spearheading a clinical trial for patients with Acute Promyelocytic Leukemia (APL) that could change the mortality rate for this disease on a major scale.

Often called the heart attack of leukemias, APL is a highly aggressive disease that is curable if treated early. A third of patients, however, do not survive the first month of treatment. By observing and analyzing the problem, Jillella and his team of physicians, nurses, and research staff came up with a collaborative approach that decreases mortality from 30 percent to about five percent. This new trial is open to patients all across the country.

Jillella has found that some physicians who treat patients with APL may not be familiar with the potential complications that can develop during treatment. He took a very detailed treatment algorithm and boiled it down to a three-step process that can be easily shared. “As soon as we get a call from a community physician, we send the simplified algorithm via smart phone,” says Jillella. “We come up with a treatment plan based on what the patient is experiencing and follow up with them regularly to get them through that difficult first month.”

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Massage Therapy Used to Combat Breast Cancer-Related Fatigue

cancer and massage therapyFatigue is the most common side effect of cancer treatment according to the National Cancer Institute. Many breast cancer survivors describe their fatigue as more intense than the feelings of being tired that we all experience from time to time. Reported characteristics include feeling tired, weak, worn-out, heavy, slow, or lack of energy and difficulty getting-up-and-going.

Currently, researchers from Winship Cancer Institute of Emory University are investigating the benefits of massage therapy on breast cancer survivors with extreme fatigue.

“We decided to look at massage therapy for cancer fatigue because cancer-related fatigue is one of the most prevalent and debilitating symptoms experienced by people with cancer,” explains Mark Rapaport, MD, principle investigator for this study. “Many studies investigating massage for patients with cancer have been focused on depression, anxiety or pain.”

“We already know that frequent massage can enhance the immune system and reduce anxiety, and it has been reported that massage therapy can stimulate energy, and reduce symptoms such as nausea and pain,” says Mylin Torres, MD, associate professor in Emory’s Department of Radiation Oncology, serves as a co-investigator on the study. “We believe that there are many positive effects to be gained by therapeutic massage and we hope to prove that, among other biological advantages, massage may diminish the incapacitation that cancer-related fatigue can cause for our patients.”

Participants in the six-week study are post-surgery breast cancer patients, between the ages of 18 and 65, who have been treated with standard chemotherapy, chemoprevention and/or radiation, and are suffering with breast cancer-related fatigue. They are broken into three groups.

  • Group one receives a typical Swedish-type massage
  • Group two does not receive a massage
  • Group three receives a light touch massage.

Throughout the clinical trial, participants’ vital signs are taken and blood drawn to check for immune markers. The study staff also regularly checks in with each participant to record any changes in their life or their health. So far, the findings are promising.

View this Fox21 news clip to learn more about recent findings from the cancer fatigue trial!

 

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Takeaways from the Pancreatic Cancer Live Chat at Winship

Pancreatic Cancer Chat

Thanks to everyone who joined us Tuesday, May 12th for the live online pancreatic cancer program chat at Winship Cancer Institute of Emory University hosted by Drs. El-Rayes & Kooby.

Drs. El-Rayes & Kooby answered several of your questions about pancreatic cancer risk factors, symptoms and therapy. There are a variety of treatment options for pancreatic cancer; for some patients, a combination of treatment methods may be used. Check out the conversation by viewing the chat transcript! Here are just a few highlights from the chat:

Question: Who is at the most risk for pancreatic cancer?

David Kooby, MDDr. Kooby: Pancreatic cancer can affect anyone. People with a family history of pancreatic cancer in first degree relatives have an increased risk. Smokers are at risk, as tobacco appears to be a causative factor. Other groups who have an elevated risk of getting pancreatic cancer are those with new onset or long-standing diabetes mellitus and those with one of several uncommon genetic syndromes: BRAC2, HPSS, FMS, Peutz Jegher. Other associations include age over 60, chronic pancreatitis, and obesity. Many of the symptoms for pancreatic cancer are vague, which makes this a difficult disease to diagnose.

Question: When surgery is not an option, are there any treatments beyond chemo and radiation?

Bassel El-Rayes, MDDr. El-Rayes: A number of novel therapies are currently on clinical trials and those include drugs that stimulate the immune system or drugs that target specific molecular abnormalities in cancer (targeted therapies). In addition, in certain situations there are options to use therapies that ablate (physically destroy the tumor). These include nano knife.

 

Question: Are qualifying patients given the option to participate in these trials Dr. El-Rayes?

Bassel El-Rayes, MDDr. El-Rayes: When we evaluate patients in the clinic, we always discuss with them the different options of therapy, including, standard therapy vs. clinical trials. For patients to participate in clinical trials, they have to meet predefined criteria. If patients are interested in clinical trials, we will screen them to determine whether or not the meet these criteria.

 

Question: My sister and brother have both been diagnosed with pancreatic cancer within months of each other. There are three remaining siblings. Can you address how we can be tested?

Bassel El-Rayes, MDDr. El-Rayes: The first step would be to see a genetic counselor to look for a possible genetic link. There, they can test for specific genes that might indicate a higher risk in the family.
David Kooby, MDDr. Kooby: If the genetic testing doesn’t yield any abnormality, the second step would be to consult with a pancreatic cancer specialist. These specialists are either gastroenterologists or medical oncologists. Currently, there are no set guidelines on how frequently family members of current patients should be tested. Your specialist can outline a plan that works best for you and your family. Researchers at institutions like Winship are actively working on better methods for screening for pancreatic cancer.

If you missed this chat, be sure to check out the full list of questions and answers on the web transcript. For more information go to the Pancreatic Cancer at Winship Cancer Institute website or 404-778-7777 to learn more from a registered nurse.

If you have additional questions for Drs. El-Rayes & Kooby, feel free to leave a comment in our comments area below.

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Cancer Clinical Study Leads to Video Tool for Prostate Cancer Patients

At Emory, research plays a key role in the mission to serve our patients and their families. Medical advances and improvements to patient care have been made possible by research and volunteer participation in clinical trials. More than 1,000 clinical trials are offered at Emory, making a difference in people’s lives, today.

Recently, a clinical study initiated by Winship Cancer Institute of Emory University, found that providing prostate cancer patients with a video-based education tool significantly improved their understanding of key terms necessary to making decisions about their treatment.

The breakthrough study was led by three Winship at Emory investigators; Viraj Master, MD, PhD, FACS; Ashesh Jani, MD; and Michael Goodman, MD, MPH; and is the feature cover story of this month’s Cancer, the peer-reviewed journal of the American Cancer Society.

In 2013, Master, Jani and Goodman released an Emory study that showed that prostate cancer patients (treated at Grady Hospital in Atlanta) experienced a severe lack of understanding of prostate key terms. The original study showed only 15 percent of the patients understood the meaning of “incontinence”; less than a third understood “urinary function” and “bowel habits”; and fewer than 50 percent understood the word “impotence.”

In response to their findings, the three principle investigators jumped to find a solution to the problem. The latest study explored using a video-based tool to educate prostate cancer patients on key terminology. The physicians predicted that with a better understanding of terms linked to disease, patients would be able to participate in shared and informed decision-making throughout the prostate cancer treatment process.

About the Prostate Cancer Video Trial:

  • 56 male patients were recruited from two low-income safety net clinics and received a key term comprehension test before and after viewing the educational video.
  • The video software (viewed by participants on iPads) featured narrated animations depicting 26 terms that doctors and medical staff frequently use in talking with prostate cancer patients.
  • Learn more by watching this video:

clinical trials for prostate cancer

Results of the Prostate Cancer Video Trial:

Participants who viewed the educational video demonstrated statistically significant improvements in comprehension of prostate terminology. For instance, before viewing the application, 14 percent of the men understood “incontinence”; afterward, 50 percent of them demonstrated understanding of the term.

“This shows that video tools can help patients understand these critical prostate health terms in a meaningful way. The ultimate goal is to give patients a vocabulary toolkit to further enable them to make shared and informed decisions about their treatment options,” says Viraj Master. “Our next goal is to improve the tool further, and study this tool at different centers.”

Learn more about clinical trials at Emory >>

Find a clinical trial at Emory >>

 

Additional Information about the Prostate Cancer Trial:

The research for this study was made possible by a Winship Cancer Institute multi-investigator pilot grant and the contributions of faculty and students from Winship, the Rollins School of Public Health and the Emory School of Medicine.

This study was led by three Winship at Emory investigators: Viraj Master, MD, PhD, FACS, Winship urologist and director of clinical research in the Department of Urology at Emory University; Ashesh Jani, MD, professor of radiation oncology in the Emory School of Medicine; and Michael Goodman, MD, MPH, associate professor of epidemiology with the Rollins School of Public Health.

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Clinical Trials Responsible for Advances in Medical Treatment

Tamara Mobley, 38 and married with 8 and 12 year old sons, has been battling multiple myeloma for five years now under the care of Dr. Sagar Lonial at the Winship Cancer Institute of Emory University. She went on a clinical trial at Winship in order to get the most advanced drug for treating this blood cancer. Because of that trial, the drug is now FDA-approved and is helping Tamara maintain her active life.

Clinical trials are responsible for most advances in medical treatment, but they can’t take place without volunteer participants like Tamara. Unfortunately, there are still many misconceptions about clinical trials that keep people from participating.

For instance, some believe joining a clinical trial is a last resort in the treatment process, which was not the case for Tamara and many other Winship patients. For Tamara, enrolling in a clinical trial was a good option once her standard cancer drugs stopped working.

In the video below, Fox 5 Atlanta talked to Tamara and Dr. Lonial about the decision to participate in a clinical trial.

Atlanta News, Weather, Traffic, and Sports | FOX 5

It is important to speak with your physician about participating in a clinical trial. For more information about a specific trial, please contact the lead research coordinator.

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5 Actions to Consider When Diagnosed with Cancer

5 Things to ConsiderA common symptom of a new cancer diagnosis is pure and utter bewilderment. The American healthcare system can be a confusing maze involving dozens of options and decisions. Helping someone understand what comes next is an important part of my job as an oncologist and is necessary to assure a patient’s overall wellbeing.

Here are five actions to consider taking after receiving a cancer diagnosis.

  1. Get a second opinion. Before starting any cancer treatment, get at least one additional physician or team of physicians to review your case and give an opinion on both the diagnosis and possible treatment options. In fact, you may be required to get a second opinion by your insurance company. Don’t worry about offending your doctor. Getting a second opinion is a very common practice.
  2. Look for a clinical trial. Tens of thousands of people benefit each year from volunteering to participate in a clinical trial. Clinical trials can provide you with access to treatments not otherwise available, including new drugs and therapies for many types of cancer. Winship Cancer Institute is proud to offer patients access to hundreds of cancer clinical trials.

Phase I Trials – Where All Anticancer Drugs Begin

Donald Harvey, MD

R. Donald Harvey, PharmD, FCCP BCOP, director of the Winship Cancer Institute of Emory University’s Phase I Clinical Trials section

Each of the agents we use to treat cancer had a beginning, a first step, in understanding how safe and effective they might be.  As drugs are developed, we ask questions in different ways at each step, or phase, of testing. The National Cancer Institute reminds us that clinical trials are available for all patients at all points in their cancer journey, not just for patients with advanced cancer that is not responding to treatment.

When a drug is first given to patients, it enters testing in a phase I trial, where we ask questions such as:

  • What is the right dose?
  • How should it be given (e.g., by mouth, by vein, under the skin)?
  • What is the right schedule of treatment?
  • What side effects are there and how severe are they?
  • How often do we see side effects?
  • Where did the drug go in the patient? How well was it absorbed? How was it metabolized and/or eliminated? (Pharmacokinetics)
  • What did the drug do to the patient, both in blood and at the site of the cancer? (Pharmacodynamics)

Patients courageous enough to enter phase I trials are asked to do many time-consuming but important things during the trial. Frequently, patients are asked to spend 10-12 hours in our clinical trials unit and/or come in daily up to 14 times during the first treatment period, or cycle. During these visits, blood is drawn, tumor or bone marrow biopsies may be performed and safety tests are conducted, all in an effort to get a complete picture of drug effect, disposition and side effects.

Participation in phase I clinical trials:

To participate in a phase I trial, patients typically have cancer that has not been effectively treated with other therapies, and most trials require patients to be otherwise relatively healthy. Phase I trials usually enroll 10-40 patients, but may be larger or smaller depending on the questions being asked. Two types of phase I trials exist: those where the drug is being given for the first time, or first-in-human trials; and those where there is prior experience and the drug is given in combination with another drug or drugs (also called phase IB trials). In each, the investigational agent is given to small groups of patients, and doses are increased in each group. Both types are critical to the next step of development to define the dose, frequency, and understand what cancer types are most likely to benefit.

Phase I trials help to determine the future of drugs in cancer treatment. Right now, the large number of new agents in early testing indicates great potential in the transformation of therapy. People in good health may choose to participate in clinical trials simply to help researchers find better treatments. Participation in clinical trials is completely voluntary, but you should also speak with your physician before deciding to enroll.

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About Dr. Harvey

R. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.