Clinical trial · Interventional
L-Arginine Supplements in Treating Women Who Are Cancer Survivors
A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
NCT00459134CI-TRIAL-00054135completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sexual Dysfunction | — | UNRESOLVED | — |
| Sexuality and Reproductive Issues | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ArginMax | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: ArginMax
- description
- ArginMax® 3 pills twice daily
- interventionNames
- Dietary Supplement: ArginMax
- type
- PLACEBO_COMPARATOR
- label
- Arm II: Placebo
- description
- Patients receive oral placebo 3 pills twice daily
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Sexual Function
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: 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 0-2. * Must be able to take oral medication * Must be 18 years old or older * Must be minority (non-white) female. EXCLUSION CRITERIA: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.