A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 25
- 主要终点
- Sexual Function
研究概览
简要总结
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 supplement to see how well it works compared with a placebo in treating women who are cancer survivors.
详细描述
OBJECTIVES:
Primary
- Determine whether an L-arginine-based nutritional supplement (ArginMax®) improves the quality of life and sexual function in female cancer survivors.
Secondary
- Compare quality of life of patients treated with ArginMax® vs placebo.
- Compare toxicity of these regimens in these patients.
- Describe the sexual function symptom clusters (if any) in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any female cancer survivor who identifies herself as concerned with her sexual quality of life and answering yes to all three of the screening questions.
- •Must express interest in sexual activity
- •At least 6 months following completion of all cancer therapy. Hormonal therapy and treatment with Herceptin are allowed.
- •No evidence of active cancer based on physical exam and/or radiographic images obtained within 3 months of study.
- •Absence of any mental, medical or physical disorder know to affect sexual function.
- •No participation in another study with an investigational study drug or device during the 30 days prior to start of study drug.
- •Lab values must meet the following criteria at study entry: WBC ≥ 2000, Hgb ≥ 10gm/dl, creatinine ≤ 1.5 x ULN, plt ≥ 100,000, T Bili ≤ 1.5
- •ECOG performance status must be 0-
- •Must be able to take oral medication
- •Must be 18 years old or older
- •Must be minority (non-white) female.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax.
- •Currently taking any blood thinner such as aspirin (one 81mg aspirin, or one baby aspirin per day allowed), Persantine, Heparin, Lovenox, or Coumadin (low dose Coumadin for catheter patency is allowed).
- •Patients currently taking Ginkgo Biloba are not allowed on this study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or ability for sexual function.
- •Pregnant women are excluded from this study because ArginMax may be an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ArginMax, breastfeeding should be discontinued if the mother is treated with ArginMax.
- •Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ArginMax. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
- •Any planned surgery during study participation.
研究组 & 干预措施
Arm I: ArginMax
ArginMax® 3 pills twice daily
干预措施: ArginMax (Dietary Supplement)
Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Sexual Function
时间窗: 12 weeks
Patients filled out the Female Sexual Function Index (FSFI) at baseline and at 4, 8, and 12 weeks following randomization. The FSFI is comprised of 2 questions related to desire, 4 questions related to arousal, 4 questions related to lubrication, 3 questions related to orgasm, 3 questions related to satisfaction, and 3 questions related to pain. Subscale scores range from 1.2 to 6 (desire) or 0 to 6 (arousal, lubrication, orgasm, and pain) or 0.8 to 6 (satisfaction). A total FSFI score is computed as the sum of the individual subscales; the overall score ranges from 2 to 36. Higher scores indicate better sexual function. The primary outcome comparison is at 12 weeks.
次要结局
- Quality of Life(12 weeks)