Ignite Creation Date:
2024-05-06 @ 12:24 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03753334
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2018-11-14
Brief Title:
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Étude Pilote randomisée de Phase IIB contrôlée Par placébo évaluant lEffet thérapeutique dUne supplémentation en Omega-3 Principalement EPA Chez Des Patients en récidive Biochimique ou en Progression du Cancer de la Prostate
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
RCT-EPAII-BCR
Brief Summary:
Prostate cancer biochemical recurrence BCR occurs in 20-50 of patients following radical prostatectomy or radiotherapy Due to significant risk of side effects and uncertainty about the benefits physicians and patients are seeking alternatives to delay androgen deprivation therapy ADT for non-metastatic BCR Long-chain omega-3 fatty acids LCn3 mainly found in seafood and fatty fish have beneficial effects against prostate cancer in pre-clinical experimental studies and randomized clinical trials of intermediate prostate cancer outcomes The current observational evidence also supports testing LCn3 in prostate cancer patients LCn3 have beneficial effects on inflammation cardiovascular psychological and other outcomes contrasting sharply with ADT-associated side effects
Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement 5g of omega-3-rich fish oil daily including 4g of monoglycerides eicosapentaenoic acid MAG-EPA in 40 men experiencing BCR or prostate cancer progression after a curative treatment
This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial
Investigators propose to conduct a pilot randomized placebo-controlled trial to determine the effects over one year of an innovative LCn3 supplement 5g of omega-3-rich fish oil daily including 4g of monoglycerides eicosapentaenoic acid MAG-EPA in 40 men experiencing BCR or prostate cancer progression after a curative treatment
This project proposes a simple intervention by dietary supplementation that could eventually help to prevent or delay ADT-related side effects and thus could contribute to diminish the heavy individual and societal burden of prostate cancer The clinical data generated by this pilot trial will serve as basis for a larger-scale phase II clinical trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None