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

NCT01105130 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00012793U10CA081851REBACCCWFU 98110
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Male Erectile Disorder; Prostate Cancer; Radiation Toxicity

Keywords

radiation toxicity; male erectile disorder; prostate cancer

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF)

  The International Index of Erectile Function (IIEF) questionnaire consists of 15 questions, each of which is scored on a 0 to 5 or 1 to 5 scale. It is comprised of five domains, each scored as the sum of 2 to 5 questions. Erectile function is the sum of six questions with a range from 1 to 30. Higher scores indicate better functioning.

  8 weeks

Secondary Outcomes (3)

• Retention

  8 weeks

• Adherence

  8 weeks

• Assessment of Quality of Life

  8 weeks

Study Arms (3)

Arm I - Placebo

PLACEBO COMPARATOR

Patients receive oral placebo twice daily (total of 6 capsules per day).

Other: Placebo

Arm II - low dose

EXPERIMENTAL

Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).

Other: Placebo; Drug: Oral L-Arginine

Arm III - high dose

EXPERIMENTAL

Oral L-arginine twice daily = 6 capsules per day.

Drug: Oral L-Arginine

Interventions

Placebo OTHER

Given orally

Arm I - Placebo; Arm II - low dose

Oral L-Arginine DRUG

Given orally 3 capsules ArginMax and 3 Placebo capsules

Also known as: ArginMax, Placebo

Arm II - low dose; Arm III - high dose

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

W F Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms; Radiation Injuries

Interventions

Arginine; ArginMax

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest NCORP Research Base

dcase@wakehealth.edu

(336) 716-1048

Study Officials

• James J. Urbanic, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 16, 2010
• Study Start: October 1, 2010
• Primary Completion: February 4, 2014
• Study Completion: February 4, 2014
• Last Updated: September 28, 2021
• Results First Posted: July 21, 2015

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)