CompletedNCT00459134Updated Sep 28, 2021Results posted

L-Arginine Supplements in Treating Women Who Are Cancer Survivors

An interventional study of ArginMax and Placebo in Sexual Dysfunction, Sexuality and Reproductive Issues and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Wake Forest University Health Sciences. Completed at 25 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 186
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Read the 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.

Conditions studied

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

In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 186 participants (actual)

Study arms

Experimental
Arm I: ArginMax
ArginMax® 3 pills twice daily
Dietary Supplement: ArginMax
Placebo comparator
Arm II: Placebo
Patients receive oral placebo 3 pills twice daily
Dietary Supplement: Placebo

Interventions

Dietary supplementArginMax
Given orally
Also known as: L-arginine
Dietary supplementPlacebo
Given orally

What researchers measure

Primary outcomes

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.
Time frame: 12 weeks

Secondary outcomes

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.
Time frame: 12 weeks

Results

Posted Jan 19, 2015

Participant flow

Participant flow — Overall Study
Milestone	Arm I: ArginMax	Arm II: Placebo
Started	94	92
Completed	71	67
Not completed	23	25
Withdrew: Physician decision	1	1
Withdrew: Withdrawal by subject	8	7
Withdrew: Lost to follow-up	6	7
Withdrew: Surgery	1	2
Withdrew: Toxicity	4	5
Withdrew: Progression	1	0
Withdrew: Multiple reasons	2	3

Outcome measures

PrimarySexual 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.

Time frame:: 12 weeks
Reported as:: Least squares mean · units on a scale

Sexual Function
units on a scale	Arm I: ArginMax	Arm II: Placebo
Sexual Function	17.81 ± 0.90	17.15 ± 0.91

Statistical analysis

Arm I: ArginMax vs Arm II: Placebo · Mixed Models Analysis · p = 0.576 (This p-value is not adjusted for multiple comparisons.) · Mean difference (final values): 0.66 · 95% CI -1.67 to 3.00Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.

SecondaryQuality 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.

Time frame:: 12 weeks
Reported as:: Least squares mean · units on a scale

Quality of Life
units on a scale	Arm I: ArginMax	Arm II: Placebo
Quality of Life	89.96 ± 1.38	85.47 ± 1.39

Statistical analysis

Arm I: ArginMax vs Arm II: Placebo · Mixed Models Analysis · p = 0.010 (This p-value is not adjusted for multiple comparisons.) · Mean difference (final values): 4.49 · 95% CI 1.09 to 7.89Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm I: ArginMax	—	6/79 (7.6%)	64/79 (81%)
Arm II: Placebo	—	4/77 (5.2%)	60/77 (77.9%)

Most frequent serious events

Most frequent serious events
Event	Arm I: ArginMax	Arm II: Placebo
Hot FlashesGeneral disorders	3/79	3/77
HyperglycemiaMetabolism and nutrition disorders	0/79	1/77
HeadacheNervous system disorders	1/79	0/77
Infection - VulvaInfections and infestations	1/79	0/77
InsomniaPsychiatric disorders	1/79	0/77
Pain - AbdomenGastrointestinal disorders	1/79	0/77

Most frequent other events

Most frequent other events
Event	Arm I: ArginMax	Arm II: Placebo
Hot FlashesGeneral disorders	56/79	43/77
HeadacheGeneral disorders	20/79	25/77
NeuropathyNervous system disorders	19/79	11/77
NauseaGastrointestinal disorders	5/79	8/77

Baseline characteristics

All randomized participants

Age, Categorical
Age, Categorical(Participants)	Arm I: ArginMax	Arm II: Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	86	83	169
>=65 years	8	9	17

Age, Continuous
Age, Continuous(years)	Arm I: ArginMax	Arm II: Placebo	Total
Median	51 (28 to 72)	49 (23 to 71)	50 (23 to 72)

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I: ArginMax	Arm II: Placebo	Total
Female	94	92	186
Male	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I: ArginMax	Arm II: Placebo	Total
Hispanic or Latino	1	5	6
Not Hispanic or Latino	92	84	176
Unknown or Not Reported	1	3	4

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I: ArginMax	Arm II: Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	20	18	38
White	73	73	146
More than one race	1	0	1
Unknown or Not Reported	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Arm I: ArginMax	Arm II: Placebo	Total
United States	94	92	186

Study locations

25 sites

CCOP - Christiana Care Health Services
Newark, Delaware 19713, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida 33140, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia 30912-4000, United States
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois 60612, United States
CCOP - Central Illinois
Decatur, Illinois 62526, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana 46601, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa 52403-1206, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana 70112, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana 71130-3932, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106, United States
CCOP - Beaumont
Royal Oak, Michigan 48073-6769, United States
CCOP - Heartland Research Consortium
Saint Louis, Missouri 63131, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri 65804, United States
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York 13057, United States
CCOP - North Shore University Hospital
Manhasset, New York 11030, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina 27216, United States
Hugh Chatham Memorial Hospital
Elkin, North Carolina 28621, United States
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina 27534, United States
Caldwell Memorial Hospital
Lenoir, North Carolina 28645, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina 27157-1096, United States
CCOP - Columbus
Columbus, Ohio 43215, United States
CCOP - Main Line Health
Wynnewood, Pennsylvania 19096, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota 57104, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00459134
Lead sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Apr 11, 2007
Start date: May 1, 2007
Primary completion: Jun 1, 2010
Completion: Jun 1, 2010
Results posted: Jan 19, 2015
Last update: Sep 28, 2021

Study contacts

Kathryn M. Greven, MD

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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