Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494111
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Systemic Therapy of Open-label Prophylactic Pravastatin or PentoxifyllineTocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae STOP4-LATE-FIBROSE
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Systemic Therapy of Open-label Prophylactic Pravastatin or PentoxifyllineTocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae STOP4-LATE-FIBROSE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedemafibrosis
Detailed Description:
Primary Objectives Determine the relative utility of pentoxifyllinetocopherol or pravastatin to reduce clinician-rated radiation lymphedemafibrosis
Secondary Objectives Determine the relative effect size observed of pentoxifyllinetocopherol or pravastatin to reduce objective imaging-derived measures of radiation lymphedemafibrosis-related sequalae
Determine the relative effect size observed of pentoxifyllinetocopherol or pravastatin to reduce patient-reported measures of toxicity associated with lymphedemafibrosis-related sequalae
Secondary Objectives Determine the relative effect size observed of pentoxifyllinetocopherol or pravastatin to reduce objective imaging-derived measures of radiation lymphedemafibrosis-related sequalae
Determine the relative effect size observed of pentoxifyllinetocopherol or pravastatin to reduce patient-reported measures of toxicity associated with lymphedemafibrosis-related sequalae
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-05763 | OTHER | None | None |