Tongue-out Radiation Therapy for Head and Neck Cancer

Overseen By Brieanna Marino, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yvonne Mowery

Disqualifiers: Glottic cancer, Posterior pharyngeal wall, Widely metastatic, Surgical resection, Induction chemo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new radiation therapy for head and neck cancer that involves extending the tongue during treatment. The goal is to determine if this method can reduce common side effects such as mouth soreness, difficulty swallowing, and taste changes, while also accelerating recovery. Individuals with certain types of head and neck cancer who can comfortably extend their tongue for at least one minute may be suitable candidates for this study.

As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance future cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for head and neck cancer patients?

Studies have shown that the "tongue-out" radiation therapy (TORT) technique can reduce the amount of radiation reaching the tongue and nearby areas. This reduction means these sensitive parts receive less exposure, potentially lessening side effects like soreness or trouble swallowing.

Research also suggests that the "tongue-out" position might help avoid common issues associated with regular radiation therapy, such as oral health problems. While radiation therapy carries risks, including the possibility of developing other cancers later, TORT's ability to lower the dose to certain areas might help reduce some of these risks.

Overall, TORT appears to be a promising method, aiming to make radiation therapy safer and more comfortable for individuals with head and neck cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tongue-out Radiation Therapy (TORT) because it offers a fresh approach to treating head and neck cancers by emphasizing a unique positioning technique. Unlike standard treatments that typically don't alter physical positioning, TORT involves patients sticking out their tongues during radiation sessions. This "tongue-out" position helps to reduce the radiation dose to critical areas like the oral tongue and pharyngeal constrictor muscles. By potentially minimizing damage to healthy tissues, TORT aims to improve treatment outcomes and reduce side effects.

What evidence suggests that the "tongue-out" radiation therapy technique is effective for head and neck cancer?

Research has shown that the "tongue-out" radiation therapy (TORT) technique, which participants in this trial will receive, might help reduce side effects in head and neck cancer treatment. By sticking the tongue out during radiation, the technique lowers the amount of radiation reaching the tongue and certain muscles. This could lead to less mouth pain, easier swallowing, and better taste over time. One study found that TORT reduced the radiation dose to the tongue compared to traditional methods. These findings suggest that TORT might improve patients' quality of life by lessening unpleasant treatment effects. ^{1 5 6 7 8}

Who Is on the Research Team?

Yvonne Mowery, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with head and neck cancers, specifically in the oropharynx, larynx, or hypopharynx. Participants should be able to stick their tongue out during radiation therapy sessions to potentially reduce side effects.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

Must be willing to comply with all study procedures

I am not pregnant or breastfeeding and use birth control.

Exclusion Criteria

I have early-stage voice box cancer and will receive radiation therapy only to my larynx.

I will receive chemotherapy or immunotherapy before my scheduled radiotherapy.

My cancer originates from the back wall of my throat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive tongue-out radiation therapy (TORT) to reduce radiation dose to the oral tongue and PCM

6 weeks

Weekly visits for radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of dysphagia and quality of life

58 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Tongue-out Radiation Therapy (TORT)

Trial Overview The study tests a new technique called Tongue-out Radiation Therapy (TORT) where patients protrude their tongues during treatment. The goal is to see if this reduces the severity of common side effects like mouth sores, swallowing difficulties, and taste changes compared to traditional methods.

How Is the Trial Designed?

Group I: Tongue-out radiation therapy (TORT) Experimental Treatment 1 Intervention

A treatment positioning technique for patients with head and neck tumors at particular subsites (e.g., oropharynx, larynx, hypopharynx). Protruding the tongue, i.e. "tongue-out" position, during pre-treatment simulation and subsequent treatment induces anatomical changes that facilitate decreased radiation dose to the oral tongue and PCM. All patients will be treated with IMRT. All IMRT techniques, including static field IMRT, helical IMRT (Tomotherapy), and VMAT are allowed.

Who Is Running the Clinical Trial?

Yvonne Mowery

Lead Sponsor

Radiological Society of North America

Collaborator

Trials

27

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07227792

Tongue-out Radiation Therapy (TORT) for the Mitigation of ... The long-term goal is to determine whether TORT results in reduced severity and faster recovery from acute treatment-related toxicities ( ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850024001620

Pharyngeal Constrictor-Sparing Salvage Stereotactic Body ... Dosimetric comparison of oral tongue dose with tongue-out radiation therapy compared to non-tongue-out radiation therapy for head & neck cancer: Clinical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6205818/

Radiation therapy's efficacy on tongue cancer: a population ... This study was performed to assess whether the survival of patients who receive both surgery and radiation therapy is better than those treated by surgery ...

4. amportal.astro.org amportal.astro.org/sessions/pqa-04-21638

Gynecological Cancer, Head and Neck Cancer ... Outcomes in Patients with Head and Neck Cancer Treated with Radiation Therapy ... Tongue-Out Radiotherapy for Head and Neck Cancer. Speaker: Whoon Jong Kil ...

5. mdpi.com mdpi.com/2072-6694/13/19/4912

An Updated Review on Head and Neck Cancer Treatment ... Direct exposure of the oral cavity to radiation damages taste buds, causing hypogeusia or dysgeusia in patients, affecting their quality of life. [7]. There are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5727249/

Common oral complications of head and neck cancer ... Patients undergoing radiation therapy for the head and neck are susceptible to a significant and often abrupt deterioration in their oral health.

7. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/analysis-clarifies-risk-of-second-malignancies-with-radiation-therapy-for-hpv-positive-head-and-neck-cancers

Second Malignancy Risk with RT for HPV+ Head & Neck ... Analysis Clarifies Risk of Second Malignancies with Radiation Therapy for HPV-Positive Head and Neck Cancers. Risk is not trivial; finding may ...

8. practicalradonc.org practicalradonc.org/article/S1879-8500(24)00139-5/fulltext

Radiation Therapy for HPV-Positive Oropharyngeal ... Cervical nodal level V can safely be omitted in the treatment of locally advanced oropharyngeal squamous cell carcinoma with definitive IMRT.