Clinical trial · Interventional
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
NCT06912763CI-TRIAL-00119316recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibrosis | — | UNRESOLVED | — |
| Fibrosis Syndrome | — | UNRESOLVED | — |
| Head &Amp; Neck Cancer | — | UNRESOLVED | — |
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ketoprofen | Drug | — | UNRESOLVED |
| Pentoxifylline | Drug | — | UNRESOLVED |
| Pirfenidoneone | Drug | — | UNRESOLVED |
| Pravastatin (drug) | Drug | — | UNRESOLVED |
| Standard of Care (SOC) | Other | — | UNRESOLVED |
| tocopherol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Treatment with Pravastatin QD
- description
- 40 mg/day for 12 months
- interventionNames
- Drug: Pravastatin (drug)
- type
- EXPERIMENTAL
- label
- Treatment with Pentoxifylline TID + Tocopherol
- description
- 400 mg/1000 IU vitamin E for 12 months
- interventionNames
- Drug: Pentoxifylline
- Drug: tocopherol
- type
- EXPERIMENTAL
- label
- Treatment with Ketoprofen TID
- description
- 75 mg for 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Eligibility Criteria Eligibility criteria (observational registry or randomization) 1. Prior history of head and neck cancer with no active disease. 2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s) 3. Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy. 4. No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers. 5. No history of myopathy/rhabdomyolysis. 6. Creatinine clearance \<30mL/min. 7. No history of acute myocardial infarction or severe coronary disease. 8. Non-pregnant/post-menopausal, or male. 9. No history of diabetes mellitus 10. Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine 11. No contraindications for magnetic resonance imaging a Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional Exclusion Criteria 1. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism. 2. History of myopathy/rhabdomyolysis. 3. History of acute myocardial infarction or severe coronary disease. 4. Pregnant/post-menopausal, or male. 5. History of diabetes mellitus. 6. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine. 7. Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional 8. Participants who are receiving any other investigational agents. 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study 10. Participants with psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available
No reference posted for this study.