Clinical trial NCT00459134: L-Arginine Supplements in Treating Women Who Are Cancer Survivors
Official title: A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: sexual dysfunction
sexuality and reproductive issues
unspecified adult solid tumor, protocol specific
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-04-11
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sexual Function
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Augusta
country: United States
facility: MBCCOP - Medical College of Georgia Cancer Center
state: Georgia
city: Chicago
country: United States
facility: MBCCOP - JHS Hospital of Cook County
state: Illinois
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Cedar Rapids
country: United States
facility: Cedar Rapids Oncology Associates
state: Iowa
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: Shreveport
country: United States
facility: Feist-Weiller Cancer Center at Louisiana State University Health Sciences
state: Louisiana
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Royal Oak
country: United States
facility: CCOP - Beaumont
state: Michigan
city: Saint Louis
country: United States
facility: CCOP - Heartland Research Consortium
state: Missouri
city: Saint Louis
country: United States
facility: CCOP - St. Louis-Cape Girardeau
state: Missouri
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, PC - Northeast Center
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Burlington
country: United States
facility: Alamance Cancer Center at Alamance Regional Medical Center
state: North Carolina
city: Elkin
country: United States
facility: Hugh Chatham Memorial Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: Southeastern Medical Oncology Center - Goldsboro
state: North Carolina
city: Lenoir
country: United States
facility: Caldwell Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Wynnewood
country: United States
facility: CCOP - Main Line Health
state: Pennsylvania
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn M. Greven, MD
role: PRINCIPAL_INVESTIGATOR
References: