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Home › Conditions › Oral Mucositis

Oral Mucositis

6 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Oral Mucositis

17 trials tracked for Oral Mucositis: 3 in phase 3 or 4 and 1 with published results. The most-cited published study has 124 citations.

17Trials tracked
3Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 3 Phase 2 9 Phase 1 1 Other / NA 4
  1. Phase 3 ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients Completed · 124 cited
  2. Phase 3 DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer Completed
  3. Phase 3 GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer Completed
  4. Phase 2 Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers Completed
  5. Phase 2 Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma Completed
  6. Phase 2 Efficacy of SNX-1012 in the Treatment of Oral Mucositis Completed
Show 11 more trials
  1. Phase 2 A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer Completed
  2. Phase 2 Herbal Mouthrinse for Oral Mucositis Study Completed
  3. Phase 2 A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis Completed
  4. Phase 2 Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer Completed
  5. Phase 2 Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis Completed
  6. Phase 2 Cox-2 Inhibition in Radiation-induced Oral Mucositis Completed
  7. Phase 1 Study to Characterize the Effect of Heparin on Palifermin Activity Completed
  8. N/A Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis Completed
  9. N/A Prevention of Oral Mucositis Using Photobiomodulation Therapy Completed
  10. N/A A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis Completed
  11. N/A Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis Completed

Showing the 17 most-cited and recently-updated of 17 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Oral Mucositis: what the trials found

Palifermin has demonstrated significant clinical impact on oral mucositis outcomes. In a Phase 2 trial, Palifermin was associated with a significantly lower cumulative incidence rate of oral mucositis compared to the control group (p<0.001) 11. Additionally, Phase 1 data showed that Palifermin resulted in a lower ratio to baseline of epithelial cell proliferation as measured by Ki67 staining and a lower ratio to baseline of Amylase compared to the control 13.

Other interventions investigated include SGX942 [2, 8] and GC4419 [1, 5], though specific outcome metrics for these agents were not reported as statistically significant or definitive in the provided data. Trial results for sargromistim showed no significant difference in the mean number of days for mucositis to heal (p=0.92) or in overall quality of life scores (p=0.28) 3.

Recent results — preliminary, needs further review

  • Several interventions are currently under investigation but lack established corroboration: - Photobiomodulation Therapy (PBM) showed a statistically significant difference in the severity and duration of oral mucositis compared to matched controls (p=0.03) 14. - Low-level laser therapy showed a statistically significant reduction in both the severity of oral mucositis and levels of inflammatory mediators (p<0.05) 15. - Other experimental interventions include RRx-001 4, Neem Mouthrinse 9, celecoxib 10, SNX-1012 12, Oral Mucosa Deterging and Periodontal Debridement 16, and episil® 17.

For the clinician treating this condition

  • Palifermin is supported by evidence showing a significant reduction in the cumulative incidence of oral mucositis and lower levels of amylase compared to control groups.
  • Photobiomodulation Therapy (PBM) and low-level laser therapy have shown statistically significant improvements in mucositis severity and inflammatory markers in preliminary studies, though these are not yet established as standard of care.
  • Evidence for several other interventions, including sargromistim and various mouth rinses, did not reach statistical significance in the reported trials.

AI synthesis of 11 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Immunonutrition may improve management of radiation-induced oral mucositis in head and neck cancer patients
Allergy & Immunology Sys. Review
Immunonutrition may improve management of radiation-induced oral mucositis in head and neck cancer patients Immunonutrition may help manage mouth sores in head and neck cancer
This narrative review examines the role of immunonutrition for managing oral mucositis in patients with head and neck malignancies undergoin…
Patients with head and neck cancer often suffer from painful mouth sores. New evidence suggests immunonutrition could help manage these symp…
Frontiers Jul 28, 2026
Network meta-analysis of interventions for oral mucositis in breast cancer patients
Oncology Meta-analysis
Network meta-analysis of interventions for oral mucositis in breast cancer patients Zinc and Honey Extract Beat Costly Treatments for Cancer Mouth Sores
This network meta-analysis of 869 patients evaluated interventions for oral mucositis in breast cancer. Zinc most effectively reduced overal…
• Zinc slashes mouth sore risk nearly in half for chemo patients • Breast cancer patients facing painful eating and swallowing struggles ben…
May 9, 2026
Meta-analysis finds photobiomodulation therapy effective for oral mucositis in cancer patients
Oncology Meta-analysis
Meta-analysis finds photobiomodulation therapy effective for oral mucositis in cancer patients Photobiomodulation therapy reduces oral mucositis in cancer patients
This meta-analysis of randomized trials evaluated photobiomodulation therapy for oral mucositis in cancer patients. The pooled data showed a…
A review of 329 patients finds light therapy cuts painful mouth sores during cancer treatment, easing suffering and improving quality of lif…
May 8, 2026
Modified oral cryotherapy protocol associated with reduced pain in HSCT recipients with oral mucositis
Oncology Cohort
Modified oral cryotherapy protocol associated with reduced pain in HSCT recipients with oral mucositis Modified cooling protocol linked to less severe mouth pain after stem cell transplant
A retrospective cohort study of 361 hematopoietic stem cell transplant recipients with oral mucositis found that an optimized nursing protoc…
A modified cooling protocol with special ice slurry and cheek ice packs reduced severe mouth pain by 66% for stem cell transplant patients.
Frontiers Apr 2, 2026
Photobiomodulation reduces severe oral mucositis (RR 0.46) and pain (RR 0.35) in head and neck cancer patients
Oncology Meta-analysis
Photobiomodulation reduces severe oral mucositis (RR 0.46) and pain (RR 0.35) in head and neck cancer patients Can light therapy ease the brutal mouth sores and pain of head and neck cancer treatment? A review of 30 studies suggests it can
A meta-analysis of 30 RCTs (n=1748) found photobiomodulation significantly reduced the risk of severe oral mucositis (RR 0.46, 95% CI: 0.29-…
A review of 30 studies shows light therapy significantly reduces severe mouth sores and pain for head and neck cancer patients while improvi…
Mar 30, 2026
Meta-analysis: Zinc supplements show time-dependent efficacy in preventing oral mucositis after chemoradiotherapy
Oncology Meta-analysis
Meta-analysis: Zinc supplements show time-dependent efficacy in preventing oral mucositis after chemoradiotherapy Can a simple mineral help cancer patients avoid painful mouth sores from treatment? New analysis says yes, with timing being key
A meta-analysis of 16 RCTs (n≈1076) found zinc supplementation significantly delayed OM onset (MD=1.37, 95% CI: 0.78 to 1.95, P<0.001) and r…
Zinc supplements delay painful mouth sores in cancer patients and reduce risk at 2 weeks and 7-9 weeks, with timing and dosage being key to …
Mar 30, 2026

Questions about Oral Mucositis

Is propolis dry extract an optimal treatment for oral mucositis in breast cancer?

Propolis dry extract is the optimal treatment specifically for preventing moderate-to-severe oral mucositis in breast cancer patients, though zinc is better for overall prevention.

Full answer →
Does photobiomodulation reduce the risk of severe oral mucositis in head and neck cancer?

Yes, photobiomodulation significantly reduces the risk of severe oral mucositis in head and neck cancer patients, with a 54% risk reduction shown in a recent meta-analysis.

Full answer →
Which intervention was found most effective for reducing oral mucositis in breast cancer patients?

Zinc supplements were most effective for reducing overall oral mucositis in breast cancer patients, based on a network meta-analysis of 10 RCTs.

Full answer →
Is photobiomodulation therapy effective for reducing oral mucositis in cancer patients?

Yes, photobiomodulation therapy is effective for reducing oral mucositis in cancer patients, with studies showing about a 50% reduction in risk.

Full answer →
Does zinc supplements help prevent oral mucositis after chemoradiotherapy?

Yes, zinc supplements may help prevent oral mucositis after chemoradiotherapy, especially when started early and used topically, but evidence is limited.

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See all 5 questions about Oral Mucositis →