Does L-arginine/Korean ginseng/gingko biloba/damiana-based supplement improve the sexual function and quality of life of female cancer survivors: A randomized trial.

9016 Background: There is a lack of research to support interventions that may be effective in improving quality of life and sexual function disorders in female cancer survivors. L-arginine/Korean ginseng/gingko biloba/damiana-based supplement (ArginMax) contains L-arginine, which enhances systemic nitric oxide synthesis, resulting in vasodilation that may improve sexual function. Methods: This was a 12 week, randomized, placebo controlled trial. Eligible patients were females at least 6 months from active treatment and without current evidence of cancer. All patients took 3 capsules two times daily (6 total/day) and kept pill diaries. The primary outcome measure was the Female Sexual Function Inventory (FSFI) while the secondary outcome measure was the FACT-G quality of life instrument. Assessments including toxicities were made at baseline, 4, 8, and 12 weeks. Results: 186 patients were accrued to this trial between 5/10/07 and 3/24/10. Ages ranged from 23 to 79 with a median of 50 years. 76% of the participants were White, 21% were Black, and 3% were Hispanic. Patients were survivors of breast (78%), gynecological (12%) or other (10%) primaries. There was a high rate of sexual dysfunction at baseline: 58% <1 intercourse per month, 67% moderate to extreme dissatisfaction, and 64% moderate to extreme disinterest. Overall sexual function, as measured by the FSFI, improved by 3 points in the control group and 3.7 points in the ArginMax arm over the 12 week study period, a difference that was not statistically significant (p = .610). FACT-G total quality of life scores, however, were significantly better at 12 weeks among participants receiving ArginMax compared to those receiving placebo (LS means of 87.5 vs 82.9, p = .009). The physical (24.6 vs 22.9, p = .001) and functional (21.6 vs 19.8, p = .007) subscale scores were most impacted. Toxicities were similar on both arms, although more hot flashes were reported on the ArginMax versus placebo arm (73% vs 59%, p = .065). Conclusions: This trial documented a high rate of sexual dysfunction in female cancer survivors. While ArginMax had no significant impact on sexual function, quality of life was significantly better at 12 weeks for the participants receiving ArginMax. Supported by NCI/DCP CCOP Research Base Grant 5 U10 CA081851-11.