Thompson Cancer Survival Center has boasted a strong mission to participate in research and clinical trials since its inception. Thompson frequently participates as an approved site in national trials. Such participation ensures our patients and providers are offered access to the latest in novel therapeutics or treatments. The Thompson team also initiates trials or studies and plays the leading role in answering important questions about cancer care.
Thompson leads the way:
January 19, 2022, the Covenant Health International Review Board approved such a study for active enrollment and its findings could dramatically impact recommendations to improve patients’ quality of life. Providers must achieve a balance between effectively treating and eradicating a patient’s cancer while managing the side effects and symptoms caused by not only cancer but also the aggressive treatments.
Patients who are being treated for head, neck, and some chest cancers can experience symptoms that cause great discomfort and can be difficult to manage.
These symptoms can create secondary complications that impact patients’ ability to maintain their nutrition needs. This negative domino effect can continue, even leading to the pausing or discontinuation of treatment. Finding ways to prevent and offset these consequences can be literally life-changing for patients.
Thompson Cancer Survival Center’s Clinical Nutrition team, Chelsea Johnson and Amanda Mondini, Clinical Dietitians, along with Radiation Oncologist, Dr. Daniel Scaperoth, have launched a study to define the helpfulness of using oral aloe vera juice in oncology care. Chelsea Johnson shares the following information about the clinical trial.
How did this start?
In 2021, Dr. Daniel Scaperoth, one of Thompson’s well-respected radiation oncologists with over 30 years of experience in the medical field, approached fellow clinical dietitian, Amanda Mondini, and me about developing a nutrition-focused research study. Of course, we jumped at the opportunity to tackle a topic that could benefit our patients in their fight against cancer.
Why do we need this study?
After a review of literature from the past ten years, our team consistently came to the same conclusion: we need more high-quality, human studies on oral aloe vera in the oncology setting. Our team witnesses some patients voluntarily use 100% oral aloe vera to alleviate symptoms, but not every patient is willing to try without clear study-based evidence. Quantitative data will strengthen recommendations beyond first-hand accounts to provide exceptional evidence-based practice.
Once a need was identified, our team began working closely with the radiation oncology department, clinical trials department, integrity-compliance office, patient-family services department, statisticians, and the Covenant Health International Review Board (CH IRB) to assure this project is completed with honesty, fairness, compassion, and excellence.
What is the problem?
Potential side effects of concurrent chemotherapy and radiation therapy in neck and chest cancers include:
- Mucositis (inflammation and swelling of tissue in the mouth and digestive tract)
- Esophagitis (inflammation and irritation of the tissue in the esophagus)
- Dysphagia (difficulty swallowing)
- Mouth sores
These side effects are not only harmful to a patient’s nutrition status but can cause breaks in cancer treatment. Poor nutrition status and treatment breaks have been shown to influence how well cancer treatment works. If we can find a feasible way to delay symptom onset or better manage symptoms, we hopefully can improve a patient’s nutrition status, quality of life, and treatment efficacy.
Dr. Scaperoth said it best when describing our “why” behind the study. He says, “Treatment of cancer in the neck and chest can be very difficult for our patients. I’m hoping this study will show whether we can improve their quality of life with the addition of aloe vera juice to our standard regimen.”
Why aloe vera?
Aloe vera offers a natural, cost-effective, low-risk possibility for alleviating symptoms. The aloe vera plant has been used to treat topical burns. There is evidence suggesting it can be used for similar side effects with cancer treatment when taken by mouth. Studies have even shown promising evidence supporting aloe vera for gut inflammation. Our team hopes similar outcomes apply to the upper GI tract in treatment-induced inflammation.
What is aloe vera?
Aloe vera, also known as Aloe barbadensis, is a succulent plant used in traditional medicine. The gel from the leaves can be used topically for burns or moisture. (*Some people have used oral aloe vera as a laxative, but this is not recommended. In fact, the Food and Drug Administration (FDA) has officially ruled that aloe vera juice is not safe as a stimulant laxative.)
In this study, the aloe vera juice used by patients has been fractionally distilled to remove compounds that can cause nausea, abdominal cramping, and diarrhea.
Removing barriers to access:
Thanks to the generosity of the Thompson Cancer Survival Center Foundation, enrolled patients in the aloe vera group will receive 100% aloe vera liquid supplements at no cost during treatment. We are proud and appreciative of the Foundation’s support as our team works to contribute to TCSC offering leading-edge cancer care in East Tennessee.
What about study design?
This study aims to determine whether to add oral aloe vera liquid supplement to standard care for head, neck, and chest wall cancer symptom management during chemotherapy and radiation therapy.
We hope to recruit a total of 100 patients, divided into 2 equal-size cohorts. Sub-investigators and study coordinators will be blinded to randomization. Blinding means the providers will not know if a patient is receiving aloe or not with their care. Blinding removes bias and improves the reliability of results. Patients will be randomized (like a flip of a coin) into 1 of 2 arms, either receiving aloe vera juice with the standard of care treatments or standard of care treatments alone.
Cohort 1 will include patients diagnosed with lip, oral cavity, hard palate, tongue, tonsil, pharyngeal, laryngeal, and neck cancers. Cohort 2 will include patients diagnosed with esophageal, mediastinal, and chest wall cancers. Targeting two cohorts expands our research to both mucositis and esophagitis. Patients will be evaluated weekly by blinded providers. Patients will be assessed from day one to the final day of treatment. However, they are welcome to voluntarily use aloe vera beyond their treatment.
In order to ensure consistent dosimetry and accurately document treatment volumes, a medical physicist or dosimetrist will monitor all plans and make measurements and adjustments as needed. This eliminates differences that could confuse the results of the study.
- A friendly reminder: Please, always tell your healthcare providers about any dietary supplements you’re taking. (These include herbs, vitamins, minerals, and natural or home remedies). Reporting this helps us keep you safe by monitoring for potential drug-nutrient interactions and side effects.
- As of January 19, 2022, the CH IRB approved this study for active enrollment.
- If you or someone you know would like to learn more about this study, please contact your registered dietitians at (865) 331-1757.
- To learn how you can donate to the Thompson Cancer Survival Center Foundation and be part of making studies like this one possible, visit: https://www.covenanthealth.com/philanthropy/ways-to-give/
- To learn about other clinical research going on at Thompson Cancer Survival Center, visit https://www.thompsoncancer.com/services/clinical-trials/
At the time of publishing this blog, the first official patient has been randomized and enrolled in the trial. We will provide updates on enrollment and findings.