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New treatment option for Fibrosis Syndrome
Official title Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
ClinicalTrials.gov ID: NCT06912763
What this study is testing
What is Pravastatin (drug)?
Pravastatin (drug) is an investigational medicine, being studied as a potential treatment for fibrosis syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- Eligibility Criteria Eligibility criteria (observational registry or randomization)
- Prior history of head and neck cancer with no active disease.
- Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
- Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
- No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
You likely can't join if
- Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
- History of myopathy/rhabdomyolysis.
- History of acute myocardial infarction or severe coronary disease.
- Pregnant/post-menopausal, or male.
- History of diabetes mellitus.
- Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine...
See the full eligibility criteria
- Eligibility Criteria Eligibility criteria (observational registry or randomization)
- Prior history of head and neck cancer with no active disease.
- Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
- Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
- No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
- No history of myopathy/rhabdomyolysis.
- Creatinine clearance \<30mL/min.
- No history of acute myocardial infarction or severe coronary disease.
- Non-pregnant/post-menopausal, or male.
- No history of diabetes mellitus
- Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
- 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
- Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
- History of myopathy/rhabdomyolysis.
- History of acute myocardial infarction or severe coronary disease.
- Pregnant/post-menopausal, or male.
- History of diabetes mellitus.
- Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
- Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.