L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT01105130
First received: April 14, 2010
Last updated: December 16, 2013
Last verified: December 2013

April 14, 2010
December 16, 2013
October 2010
November 2013   (final data collection date for primary outcome measure)
Determine the best dose of ArginMax [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The best dose will be defined as the one that results in the greatest improvement in erectile function.
Erectile function score as assessed at baseline and at 4 and 8 weeks [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01105130 on ClinicalTrials.gov Archive Site
  • Assessment of Toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Accrual for use in design of a subsequent Phase III clinical trial [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Retention for use in the design of a subsequent Phase III trial [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adherence for use in the design of a subsequent Phase III clinical trial [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life and sexual function for use in the design of a subsequent Phase III clinical trial [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Toxicity as assessed by the CTEP Active Version of the CTCAE [ Designated as safety issue: Yes ]
  • Accrual [ Designated as safety issue: No ]
  • Retention [ Designated as safety issue: No ]
  • Adherence [ Designated as safety issue: No ]
  • Quality of life and sexual function [ Designated as safety issue: No ]
Not Provided
Not Provided
 
L-Arginine Supplementation With or Without Enzyme Inhibitors Treating Erectile Function of Prostate Cancer Survivors
A Randomized Phase II Dose Finding Study of ArginMax for Its Effect on Erectile Function and Quality of Life in Survivors of Prostate Cancer Previously Treated With Radiotherapy

RATIONALE: L-arginine supplements may improve the quality of life and erectile function in men who are prostate cancer survivors.

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.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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, FACT-P, and the Global Efficacy Questionnaire at weeks 4 and 8.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Male Erectile Disorder
  • Prostate Cancer
  • Radiation Toxicity
  • Drug: Placebo
    Given orally
    Other Name: Placebo
  • Dietary Supplement: Oral L-arginine
    Given orally 3 capsules ArginMax and 3 Placebo capsules
    Other Names:
    • ArginMax
    • Placebo
  • Dietary Supplement: L-Arginine
    Patients will take 6 capsules of ArginMax twice daily
    Other Name: ArginMax
  • Placebo Comparator: Arm I
    Patients receive oral placebo twice daily (total of 6 capsules per day).
    Intervention: Dietary Supplement: Oral L-arginine
  • Experimental: Arm II
    Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Oral L-arginine
  • Experimental: Arm III
    Oral L-arginine twice daily = 6 capsules per day.
    Intervention: Dietary Supplement: L-Arginine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2013
November 2013   (final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Male prostate cancer survivor previously treated with radiotherapy and who identifies himself as concerned with sexual quality of life, including erectile dysfunction. (seed implants are eligible)
  • Had successful sexual activity prior to the commencement of radiotherapy.
  • Erectile dysfunction, defined as inability to achieve or maintain an erection sufficient for satisfactory sexual performance
  • Interested in sexual activity and agrees to make at least one sexual intercourse attempt with a partner every week during the study.
  • The usage of PDE-5 inhibitors will be voluntary and will serve as a stratification factor. Patients taking PDE-5 inhibitors must agree to assume the responsibility for the cost of PDE-5 inhibitor treatment during the protocol period (8 week period) as this is not covered in the cost of the trial.
  • Patients currently taking PDE-5 inhibitors sildenafil (Viagra®, Pfizer Pharmaceuticals), tadalafil(Cialis®, Lilly ICOS, LLC), and vardenafil (Levitra®, Bayer Healthcare / Schering Plough Corp.)must agree to take the medication only as prescribed by their treating physician.
  • Patients taking PDE-5 inhibitors as part of this study must be on a stable dose of drug for at least one month prior to study entry.
  • Must be able to take oral medications.
  • > 6 months following completion of all cancer therapy
  • No evidence of prostate cancer
  • Prior malignancies allowed if no evidence of recurrent disease.
  • If previously taken LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents, serum testosterone must have returned to the laboratory normal range
  • No planned surgery while on protocol or for 4 weeks following completion of protocol
  • Prior cystoscopy is permitted.
  • Age > 18
  • ECOG performance status 0/1.
  • Patients must agree not to start taking an herbal product for erectile dysfunction during the eight weeks of study intervention.

EXCLUSION CRITERIA:

  • No other concurrent erectile dysfunction therapies permitted (i.e. vacuum pump,cavernosal injections, and other drug therapies). Past use of these and other therapies permitted if the patient can meet the inclusion criteria above.
  • No testosterone supplementation permitted.
  • Use of LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti- androgen (e.g., Casodex,Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months.
  • Prior prostate or lower genitourinary surgery (bladder, penis, urethra, testicles)including transurethral resection of prostate (TURP). (Prior vasectomy is allowed)
  • Serious cardiovascular disease (unstable angina, supraventricular arrhythmia, myocardial infarction, symptomatic congestive heart failure, cardiac arrhythmia, coronary artery bypass surgery within 6 months prior to registration).
  • Hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg)
  • Stroke or spinal cord injury within 6 months before registration.
  • Patients on Persantine, heparin, Lovenox, warfarin, ginkgo biloba, Plavix, Disalcid, other blood-thinning medication or with a history of bleeding disorders will be excluded.(Aspirin < 325mg allowed)
  • Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.
  • Current or prior use of any organic nitrate within the last 6 months (e.g., use of nitroglycerin)
  • May not receive other investigational agents or devices during 30 days prior to start of study drug.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax (l-arginine, ginseng, or ginkgo biloba)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105130
CCCWFU 98110, U10CA081851
Yes
Wake Forest Cancer Center CCOP Research Base
Wake Forest Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Study Chair: James J. Urbanic, MD Comprehensive Cancer Center of Wake Forest University
Wake Forest Cancer Center CCOP Research Base
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP