L-Arginine Supplements in Treating Women Who Are Cancer Survivors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459134
• Other study ID #: IRB00001487
• Secondary ID: U10CA081851REBAC
• Status: Completed
• Phase: N/A
• Start date: May 1, 2007
• Est. completion date: June 1, 2010

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

OUTLINE: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2 or 3), type of malignancy (pelvic vs nonpelvic), and ovarian functional status (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive an oral L-arginine-based nutritional supplement (ArginMax®) twice daily.

• Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Sexual function, quality of life, and toxicity are assessed at baseline and every 4 weeks for 12 weeks.

PROJECTED ACCRUAL: A total of 186 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 1, 2010
• Est. primary completion date: June 1, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sexual Dysfunction
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Dietary Supplement:
• ArginMax
Given orally
• Placebo
Given orally

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina
United States	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa
United States	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	Hematology Oncology Associates of Central New York, PC - Northeast Center	East Syracuse	New York
United States	Hugh Chatham Memorial Hospital	Elkin	North Carolina
United States	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina
United States	Caldwell Memorial Hospital	Lenoir	North Carolina
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	CCOP - Heartland Research Consortium	Saint Louis	Missouri
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Function	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.	12 weeks
Secondary	Quality of Life	Patients filled out the FACT-G quality of life questionnaire at baseline and at 4, 8, and 12 weeks following randomization. The FACT-G questionnaire is comprised of 7 questions related to physical well-being, 7 questions related to social well-being, 6 questions related to emotional well-being, and 7 questions related to functional well-being. Subscale scores range from 0 to 24 (Emotional) or 0 to 28 (Functional, Social, and Physical). A total FACT-G score is computed as the sum of the individual subscales; the overall score ranges from 0 to 108. Higher scores indicate better quality of life. The primary comparison was at 12 weeks.	12 weeks