Treatment for dry mouth caused by radiation therapy
Official title: A Phase I/IIa, Dose Escalation Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults With Radiation-Induced Xerostomia and Hyposalivation
Run by RiboX Therapeutics Ltd. · NCT06714253 · Data updated 2026-11-12
This study is testing a new treatment for dry mouth caused by radiation therapy to see if it can help adults who haven't found relief from other options.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | RiboX Therapeutics Ltd. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Status | Recruiting |
| Started | March 5, 2025 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT06714253 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have a history of head and neck cancer and are experiencing persistent xerostomia or hyposalivation after radiation treatment.
✕Probably not a fit
Patients with active infections, uncontrolled diabetes, or other malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study evaluates the safety, tolerability, and efficacy of RXRG001, a circular RNA treatment, administered in the ducts of the parotid glands for adult patients suffering from radiation-induced xerostomia and hyposalivation. The study consists of two parts: the first part is an open-label, single-arm design with ascending doses, while the second part is a randomized, double-blind, placebo-controlled design with bilateral administrations. The aim is to determine the effectiveness of RXRG001 in alleviating symptoms of dry mouth in patients who have not found relief from previous treatments.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from dry mouth due to radiation therapy.
How similar studies have gone: While this approach is novel, similar studies targeting xerostomia have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria\* 1. At least 18 years of age 2. Free from recurrence of your cancer and never have had another form of cancer for at least 2 years 3. Suffering from xerostomia and/or hyposalivation and have xerostomia symptoms which were not resolved after treatment for at least 3 months 4. Both parotid glands on imaging examination Exclusion Criteria\* 1. Any active infection 2. Heart failure, reduced kidney function or uncontrolled diabetes (Hemoglobin A1c \>=8%) 3. History of autoimmune diseases known to potentially affect the salivary glands 4. Any malignancy, other than head and neck cancer within the past 3 years except for certain skin and cervical cancers 5. Active smoker or use tobacco products or have a history of substance or alcohol abuse * Other criteria apply
Where it's running
-
Stanford Medicine
Palo Alto, California, United States Recruiting -
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States Recruiting -
John Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States Recruiting -
NYU Langone Medical Center
New York, New York, United States Recruiting -
Penn Medicine - Otorhinolaryngology - Head and Neck Surgery Perelman
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: RiboX Therapeutics Ltd.
- Email: RiboX-SPRINX1-RX-RIX-CS101-Study-Mailbox@ribox-tx.com
- Phone: 617-999-8257
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sialendoscopy versus photobiomodulation to prevent radiation‑related dry mouth
This trial compares a minimally invasive duct‑clearing procedure (sialendoscopy) with a light‑based laser therapy (photobiomodulation) to try to prevent dry mouth in adults receiving radiation for head and neck cancer.
-
Spermidine to prevent radiation-induced dry mouth in head and neck cancer
This trial will try if taking spermidine capsules twice daily during radiotherapy prevents dry mouth in adults with head and neck cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.