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

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

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

Patients receive oral placebo twice daily (total of 6 capsules per day).
Placebo: Given orally

Arm I - Placebo

Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).
Placebo: Given orally
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules

Arm II - Low Dose

Oral L-arginine twice daily = 6 capsules per day.
Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules
Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily

Arm III - High Dose

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

International Index of Erectile Function (IIEF)

Retention is the percentage of participants who complete the 8 week visit.

Retention

Adherence is the percentage of prescribed pills taken by the participants

Adherence

Quality of life is quantified by the Functional Assessment of Cancer Therapy - Prostate (FACT_P) questionnaire. The FACT questionnaire is comprised of four subscales - social, emotional, functional, and physical. Each subscale is obtained by summing over 6-7 items, each of which is coded on a 0 to 4 scale. Negatively worded questions are reverse scored and higher scores for each subscale indicate better HRQOL. The social, functional, and physical subscales range from 0 to 28 while the emotional subscale ranges from 0 to 24. The overall score (FACT-G) is the sum over the four subscales and ranges from 0 to 108. Patients also completed 12 questions related to prostate cancer, and the prostate subscale score is the sum of those responses (with some items reverse scored). Scores range from 0 to 48, and as with the other FACT subscales higher scores indicate better HRQOL. FACT-P is the sum of FACT-G and the prostate subscale. This questionnaire was added half-way through the study.

Assessment of Quality of Life

Overall Study

Dr. Doug Case

Male Erectile Disorder

Prostate Cancer

Radiation Toxicity

Placebo

Given orally 3 capsules ArginMax and 3 Placebo capsules

Oral L-Arginine

Patients will take 6 capsules of ArginMax twice daily

W F Baptist Health

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

turnera/zhubný nádor

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

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