HealthONE - September 08, 2021

Cancer clinical trials provide vital information while giving new hope to patients

While cancer remains a leading cause of death worldwide, it is also one of the oldest diseases known to humankind. Archeologists have found evidence of cancer in remains hundreds of millions of years old. Yet, the most significant improvements in cancer treatment have been made just in the last two decades. Improvements that have been made thanks, in part, to research performed through clinical trials.

“We are making significant improvements in the treatment of more difficult cancers such as pancreatic cancer,” explains Sujatha Nallapareddy, MD, a medical oncologist and hematologist with the Sarah Cannon Cancer Institute at Swedish Medical Center. “Just 10 years ago, we only had two to three drug options for treating pancreatic cancer. Today, we have nearly 10.”

Clinical trials are research studies performed to learn about the safety and efficacy of a particular treatment. “Research begins with laboratory testing and progresses to testing on patients,” Dr. Nallapareddy explains. “Each step along the way is taken carefully and intentionally to ensure the safety of those involved while also advancing our understanding of the treatment.”

Why are clinical trials important?

Many seek out cancer clinical trials as a last resort. When other treatment options have been exhausted, patients sometimes find new hope in a clinical trial. At the same time, clinical trials are very important to the field of cancer treatment. These types of tests not only prove if a new treatment is safe and effective, but they also provide invaluable information to providers to improve how they prevent, diagnose and treat cancer.

“Those participating in the trial benefit because they get the latest advancements in cancer treatment and their results may be more beneficial than what is currently available,” Dr. Nallapareddy suggests. “In addition, all components of the research will benefit future generations. The only way we have gotten to where we are is through the research of those who have come before us.”

What are the phases of clinical trials?

Each clinical trial phase is performed to answer a specific question. “Throughout the phases, we want to learn if it is safe, if it is effective, what side effects it has and if it is better than the current treatment,” Dr. Nallapareddy details.

Before a treatment is approved to use in human clinical trials, an investigational new drug (IND) application must be submitted. At this point, researchers pledge that each participant will give informed consent and that the research will submit to oversight by the Institutional Review Board (IRB). Some trials then begin with Phase 0, which involves only a few small doses in a few people.  At this level, there is not much benefit to the patients, but the process helps the trial advance.

A Phase 1 clinical trial is typically performed on a small group (less than 100) and is meant to judge the safety and side effects of the drug. This phase has the most risk for the patient and usually will be entered only when all other treatment options have been exhausted.

Phase 2 is focused on whether the treatment works. Over the course of several years with several hundred people, the researchers look at the effectiveness and side effects of the treatment.

Phase 3 aims to learn whether the treatment is better than what is currently available. Researchers study the treatment’s safety and effectiveness as compared to treatments that already are available. Participants number into the thousands and are brought in from different populations. In this phase, patients are given different dosages and treatments; these studies are sometimes double-blind studies in which the doctor and the patient both do not know what treatment is being given.

Phase 4 answers the question: what else do we need to know? Using large, diverse populations over a longer period of time, researchers learn what side effects might come up later in the treatment course and what other information may still need to be gathered. This is the least risky phase of clinical trials.

What questions should I ask my doctor about clinical trials?

If you are considering a clinical trial, begin by gaining as much knowledge as possible. “I encourage anyone considering a clinical trial to sit down with their providers and go over all of your options,” Dr. Nallapareddy emphasizes. “Ask why or why not this could be the right treatment for you to try and what other treatments should be considered. Be sure you have a firm understanding of the trial and its potential risks and benefits.” Dr. Nallapareddy explains that medical oncologists have access to many clinical trials and can help find the right fit for their patients. “For example, I have access to around 15 clinical trials for pancreatic cancer across several different resources,” Dr. Nallapareddy says. “Depending on the specifics of your condition, your lifestyle and health goals, we can find a trial or other treatment that is just right for you.”

Dr. Nallapareddy suggests asking:

  1. What is the purpose of this trial?
  2. Why do researchers think it’s better than current options?
  3. How long will I be in the trial?
  4. How will the doctors know if it is working?
  5. How will I be told the trials results?
  6. Who will oversee my care?
  7. What happens if I want to leave the trial?
  8. What are my other treatment choices?
  9. What will happen to my cancer if I don’t take part in this trial?
  10. Is there someone I can talk to who has taken part in the trial?

“Those who participate in clinical trials are heroes in advancing cancer treatment,” Dr. Nallapareddy states. “While all trials come with risk, they also have a good chance of being beneficial to the patient and will always benefit the field of study.”

Sujatha Nallapareddy, MD is a board-certified medical oncologist and hematologist at Rocky Mountain Cancer Centers and is part of the Sarah Cannon Cancer Institute at Swedish Medical Center. She specializes in gastrointestinal cancers, skin cancers, breast cancers, and non-cancerous blood disorders. Dr. Nallapareddy takes a collaborative approach in patient care, taking the time to listen and getting to know her patients and their families as well as educating them on different treatment options, because she believes better outcomes are achieved when patients understand and embrace their care. Dr. Nallapareddy participates in many tumor boards, where she collaborates with other cancer specialists including surgeons, radiologists, pathologists, and radiation oncologists. This allows her to provide a comprehensive, multi-disciplinary approach to cancer treatment recommendations such as chemotherapy, targeted therapies, and immunotherapies. Dr. Nallapareddy has served as a principal investigator for many clinical research trials and emphasizes the importance of participating in clinical research trials when appropriate to ensure her patients are receiving the most up-to-date, cutting-edge treatment for their disease. She does presentations for the community about the risks, treatments, and prevention for colorectal cancers and works closely with Colon Cancer Alliance to increase awareness around cancer prevention.