Track topics on Twitter Track topics that are important to you
PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works with or without enzyme inhibitors in treating erectile function and quality of life of prostate cancer survivors previously treated with radiation therapy.
- To determine the "best dose" (defined as the dose that shows the greatest improvement in the erectile function domain of the International Index of Erectile Function [IIEF] after 8 weeks of therapy) of an L-arginine/Korean ginseng/gingko biloba/damiana-based supplement (L-arginine) to be used in a subsequent phase III trial in prostate cancer survivors previously treated with radiotherapy.
- Evaluate the toxicity of treatment with L-arginine with or without phosphodiesterase-5 inhibitors.
- Estimate trial accrual, retention, adherence, and variability.
- Assess changes in quality of life (QOL) and sexual function as defined by changes in the QOL of these patients using the Expanded Prostate Cancer Index Composite, changes in the other domains of the IIEF (i.e., orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction), changes in the Sexual Encounter Profile, and changes in the percentage of "yes" (positive) responses to either of the two global efficacy questions.
OUTLINE: Patients are stratified according to age (< 65 years vs ≥ 65 years) and current use of phosphodiesterase-5 (PDE-5) inhibitors (yes vs no). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo twice daily (total of 6 capsules per day).
- Arm II: Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
- Arm III: Patients receive oral L-arginine twice daily (total of 6 capsules per day).
In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Patients may also receive oral sildenafil, tadalafil, or vardenafil (PDE-5 inhibitors).
Patients complete the International Index of Erectile Function and the Expanded Prostate Cancer Index Composite-26 at baseline and at weeks 4 and 8. Patients also complete the Sexual Encounter Profile Questionnaire and the Global Efficacy Questionnaire at weeks 4 and 8.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
L-arginine/Korean ginseng/ Gingko biloba/damiana-based supplement, placebo
Not yet recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:14:33-0400
RATIONALE: L-arginine supplements may improve the quality of life and sexual function in women who are cancer survivors. PURPOSE: This randomized clinical trial is studying an L-arginine ...
The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth (Xerostomia).
Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rat...
Ginseng has been used for many years in a wide array of anecdotal medicinal properties. Animal and limited clinical research points to the vascular effects of Korean Red Ginseng (KRG). The...
The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract a...
Korean ginseng has been widely evaluated to treat human diseases; however, most studies on Korean ginseng have focused on its root. In this study, polysaccharides [acidic-polysaccharide-linked glycope...
Korean Red Ginseng (steamed and dried white ginseng, Meyer) is well known for enhancing vital energy and immune capacity and for inhibiting cancer cell growth. Some clinical studies also demonstrated...
The potential therapeutic values of Korean Red Ginseng extract (KRGE) in autoimmune disorders of nervous system have not been fully investigated.
Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safet...
Recent studies have shown that Korean Red Ginseng (KRG) successfully protects against dopaminergic neuronal death in the nigrostriatal pathway of a Parkinson's disease (PD) mouse model induced by 1-me...
Medical practice or discipline that is based on the knowledge, cultures, and beliefs of the people of KOREA.
An enzyme that activates arginine with its specific transfer RNA. EC 18.104.22.168.
A family of ENZYMES that, in the presence of calcium ion, converts ARGININE to CITRULLINE in proteins.
An enzyme that catalyzes the phosphorylation of the guanidine nitrogen of arginine in the presence of ATP and a divalent cation with formation of phosphorylarginine and ADP. EC 22.214.171.124.
Enzymes that catalyze the methylation of arginine residues of proteins to yield N-mono- and N,N-dimethylarginine. This enzyme is found in many organs, primarily brain and spleen.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...