The Beam: Proton therapy clinical trials; prevention and treatment of ocular melanoma; beating the winter blues

Clinical trials are critical to advancing treatment for cancer patients; learn about risk factors for ocular melanoma; tips on keeping winter mood swings at bay

Why are clinical trials in radiation oncology important?

If you or a loved one is going through treatment for cancer, you may have wondered about clinical trials. How do they benefit patients?  How does someone enroll, and who is eligible to enroll in one?  

"Clinical trials are the gold standard for us to understand how best to screen, treat and/or follow patients with cancer,” said Yolanda Tseng, MD, MPhil, who leads the clinical trials program for the Radiation Oncology Division at Fred Hutch Cancer Center and the University of Washington. “We want to be able to continually improve outcomes and/or reduce negative effects to the patient.”

Tseng studies proton therapy and other forms of radiation therapy for patients with blood cancers like leukemia and lymphoma and tumors of the brain and central nervous system.

“By determining ahead of time who is eligible for a trial, defining the strategy or treatment that will be uniformly given, and monitoring patients at set time points, clinical trials attempt to minimize bias so that we can evaluate if new strategies or treatments are safe and/or effective,” she said.

Preclinical trials: Studies done on animals before human trials can begin. The researchers are looking for signs of safety and efficacy. After having studied the risks as much as possible, and if there is promise for the new treatment in animals, the trial can begin a clinical (human) phase.

Phase I: Clinical trials that assess if the new treatment is safe in humans or how much of the treatment a patient can tolerate before toxicities (side effects) occur.

Phase II: Clinical trials that focus on gathering more data on whether the new treatment may be effective in humans.

Phase III: Clinical trials are the gold standard in research because they compare the new treatment with the current standard of care by randomly assigning an eligible participant to one of the two treatment options. Randomization reduces bias, which otherwise can influence the results of a trial. In randomized trials, patients can’t choose which treatment to receive. 

Fred Hutch has one of the most active clinical trial programs in the world and is part of the only National Cancer Institute-designated Comprehensive Cancer Center in Washington state.

"Clinical trials are critical to advancing treatment for cancer patients because they allow us to rigorously test new promising therapies,” said Smith Apisarnthanarax, MD, who is currently enrolling patients with certain liver cancers in a clinical trial at Fred Hutch. “By doing so, we can expand treatment options for our patients that are not only leading-edge but grounded in solid scientific evidence."

According to Tseng, if a treatment is being studied in a clinical trial, by definition there is equipoise (or uncertainty) about its safety or effectiveness. Because of this, she counsels her patients on the risks associated with that trial. Despite inherent risks, many patients participate so they can contribute to science and provide a legacy to future patients with their condition.

“It is a selfless contribution — one that forms the foundation on how we advance the care of our patients,” she said.

Is it easy to participate?

There are many active clinical trials at Fred Hutch and UW Medicine and if our physicians and clinical research team think a patient is an appropriate candidate, they will address it during consultation. It’s always completely up to the patient and their family whether to participate, and there are no negative consequences to the quality of care they will receive either way.

Some trials open at the proton therapy facility involve other treatment modalities, such as chemotherapy.

Because these may happen before radiation, patients are counseled by the medical oncologists on trial participation. Sometimes, this can happen at another institution offering the trial, such as Seattle Children’s Hospital.

“Regardless, when a trial is exploring treatment related to radiation therapy, we recommend the family have a consultation with a radiation oncologist early,” said childhood cancers expert Ralph Ermoian, MD, who treats many children with proton therapy. “We want the family to be able to make a decision about whether enrolling on the study is right for them, knowing all the parts and nuances.”

Once the patient enrolls, there will be paperwork to fill out. Due to strict regulatory oversight, treatment can be delayed up to a few weeks to confirm eligibility.

While a trial will try to align visits to what is typically done if a patient is not on a trial, participation in a clinical trial may still require extra time and/or visits because of additional procedures and information that needs to be collected. For example, for trials studying radiation to the brain, patients may need to take pre- and post-treatment tests to assess their cognitive function.

Finally, there are financial considerations to consider. Some health insurance providers will pay some or all of the costs associated with participating in a clinical trial. Most often, the study itself covers the cost of the intervention while the insurance provider pays for routine care. However, some trials do not cover expenses, meaning the patient may have to pay. Always ask your care team and your insurance provider in advance to determine which costs are likely to be covered.

“Clinical trials are vital to improving our treatments for patients, especially those who have conditions where current treatments don't have the best outcomes,” said Lia Halasz, MD, who treats brain and central nervous system cancers at the proton therapy facility. “Clinical trials have allowed us to have the great innovation in oncology that we've had at Fred Hutch over the past decades.”

There are open clinical trials investigating the effectiveness of proton therapy in the treatment of leptomeningeal metastases from breast or lung cancer, liver cancer, prostate cancer and childhood cancers. Check out Fred Hutch’s clinical trials pages for open trials and for answers to many frequently asked questions.

How to prevent and treat ocular melanoma  

Ocular melanoma is a rare form of cancer affecting the eye, most commonly involving the middle layer of the eye, called the uvea.

This type of tumor can be aggressive and spread, especially if untreated. That’s why it’s a good idea to have a yearly check-up with an optometrist, even if you don’t wear glasses. An optometrist can monitor the health of your eyes, as there may not be obvious signs or symptoms of ocular melanoma.

However, there are a few telltale symptoms. See an optometrist or ophthalmologist immediately if you notice any of the following:

  • a new, dark spot in your vision
  • a change in the way your pupil looks
  • a blind spot or blurry vision
  • flashing lights or floaters

As with many cancers, there isn’t a known cause for ocular melanoma, but there are factors that increase the risk of developing it. Be especially mindful if you have:

  • light eye color, fair skin color, or propensity to sunburn
  • moles/freckles in the eye (iris nevi)
  • inherited skin conditions, such as ocular or oculodermal melanocytosis (discoloration on the eyeball)
  • high exposure to UV rays from the sun or tanning beds

Luckily, there are ways to lower your risk of ocular melanoma, such as the following:

  • Always wear sunglasses with broad-spectrum UV protection when you’re outside, especially when it’s sunny.
  • Wear a broad-brimmed hat to protect your eyes from the sun.
  • Get into the habit of thinking about eye protection whenever you’re outside in the sun.

If you are diagnosed with ocular melanoma, there are many treatment options, but proton therapy using pencil beam scanning (PBS) is the gold standard of treatment for large tumors or tumors near the optic nerve.  And Fred Hutch has experts in treating ocular melanoma as well as equipment specifically designed for treating the eye.

aA comparison scan for ocular cancer showing much less radiation dose for proton therapy to non-target areas.
The illustration is an example of an ocular treatment plan which shows the difference between proton therapy using pencil beam scanning on the left, and standard X-ray radiation on the right. The image demonstrates the sparing of healthy tissue to radiation dose with protons. Fred Hutch News Service

“PBS [pencil beam scanning] is the most advanced form of proton therapy, allowing us to manipulate proton dose distributions even more accurately,” said Jatinder Saini, PhD, MBA, clinical professor and lead medical physicist. “One of the key advantages of using PBS for ocular treatments is the remarkable reduction in treatment time.”

Saini, who managed the process for testing and implementing PBS for ocular melanoma at Fred Hutch, said that uniform scanning treatment delivery may require seven to 10 minutes per patient, but PBS treatments can be completed in 30 to 60 seconds.

“This efficiency is crucial for enhancing patient comfort, as it minimizes the need for the patient to gaze at a specific point for long periods,” he said.

PBS has a sharp dose fall-off and spot-by-spot radiation delivery, which enables physicians to minimize radiation exposure to healthy critical organs around the eye like the brain and pituitary gland. Ocular tumors tend to be tiny and require extremely narrow proton beams for effective treatment, Saini said.

Due to the precision needed for treatment, it’s important to be seen by radiation oncologists who specialize in treating ocular cancers and tumors. They work closely with patients’ ophthalmologists, as well as the planning dosimetrists and physicists, to determine the location and extent of the tumor.

If you have symptoms of ocular melanoma, see an ophthalmologist. If you have been diagnosed, ask your doctor about proton therapy as a treatment option and check out our pages on protons for ocular cancers: Proton Therapy for Ocular Melanoma | Fred Hutch Cancer Center.

Winter blues got you down? Some tips to help you get through

By Elizabeth Darlington, MSW, LICSW

Whether you are from the Seattle area or are just in town for proton therapy, you can’t miss that it’s getting dark outside very early in the day. Seattle is one of the northernmost cities in the contiguous United States, which means that winters are darker, and days are shorter than most of the country.

Add to that, there’s a lot of rain in Seattle this time of year.

Many people in the Pacific Northwest enjoy winter because it’s a great time to cozy up indoors and settle in with a good book or a warm cup of tea. But for others, the winter gray and wet can be challenging in terms of mental health.

Here are some tips for patients and caregivers who are hoping to feel more energized this winter season:

Lighten up: To lift your mood, try to get natural light as soon after you wake up as possible, as well as throughout the day. Of course, this is challenging when it’s dark in the morning, but an inexpensive indoor sun lamp can be very helpful in fighting Seasonal Affective Disorder, or SAD. Then, head outside later in the day, even if it’s just for a short while. Your body — and mood — will thank you for the extra Vitamin D.

Get moving: Movement can also improve your mood. People often wait until they feel like moving, but on a wet and chilly day, that might mean waiting all day! In fact, people need to just move first to feel better. Try turning on music and doing some gentle stretching or dancing indoors. Chair yoga is also an effective and safe way to get some movement.

Breathe deep: Breathing exercises are a great way to both feel more grounded and to boost energy, especially a breathing exercise called the “physiological sigh.” Take a deep breath in, followed by a shorter “sip-like” breath, and then exhale slowly.  Alternatively, you can make your second inhale even deeper than the first, whichever one feels good to you. This can be particularly restorative and also help with anxiety.

Take time for you: Find time to practice self-care, whatever that means to you. Self-care can involve doing things you love, but it can be as simple as checking in with yourself and your own body — what is it telling you? What emotions are coming up? What thoughts? What can you do to be kinder to yourself? This habit can take a lot of practice and patience. Sometimes, your body needs to rest, sometimes to vent, sometimes to cry. In this way, you are caring for yourself in the moment.  

Set a timer! Much as this idea may seem silly, timers can be a great way to incorporate new habits. You can set a timer to remind yourself to drink water, to do some deep breathing, to get up from your spot and move a little bit, or to check in with yourself.

Don’t forget to ask for help: Sometimes, cancer forces us to act in ways that we aren’t used to. If you’ve always been an independent person, it can be hard to do, but alleviating your burden can be especially important during the dark, wet, chilly part of the year. Seek support in as many ways as possible, from friends and family if available, or by calling on our social workers.

Fred Hutch’s social workers are here to help provide emotional support to patients and caregivers, and to connect with community resources for mental health as well as practical concerns. Do not hesitate to ask our patient navigator team to put you in contact with the social work department or call  206.606.1076.

Remember, all feelings are valid. Having a cancer diagnosis or being a caregiver for someone with cancer is hard and can be especially so this time of year. You may have heard the phrase “feel your feelings.” This just means that anything you are feeling is okay, even if that’s grief, annoyance or anger.

Naming that feeling and allowing yourself to lean into it helps you to move through it.  Eventually, the strong emotions will shift, and often people feel some relief. Be gentle, non-judgmental and compassionate with yourself.

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Are you interested in reprinting or republishing this story? Be our guest! We want to help connect people with the information they need. We just ask that you link back to the original article, preserve the author’s byline and refrain from making edits that alter the original context. Questions? Email us at communications@fredhutch.org

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