Sexual DysfunctionNCT00459134
L-Arginine Supplements in Treating Women Who Are Cancer Survivors
A study testing ArginMax in people with Sexual Dysfunction and Sexuality and Reproductive Issues, run by Wake Forest University Health Sciences at 25 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- ArginMax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 May 2007to 1 Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403-1206
MBCCOP - JHS Hospital of Cook County
Chicago, Illinois, 60612
CCOP - Columbus
Columbus, Ohio, 43215
CCOP - Central Illinois
Decatur, Illinois, 62526
Hematology Oncology Associates of Central New York, PC - Northeast Center
East Syracuse, New York, 13057
Hugh Chatham Memorial Hospital
Elkin, North Carolina, 28621
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, 27534
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645
CCOP - North Shore University Hospital
Manhasset, New York, 11030
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
CCOP - Beaumont
Royal Oak, Michigan, 48073-6769
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804
CCOP - Heartland Research Consortium
St Louis, Missouri, 63131
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096
About this study
Official title: A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
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
- Sexual Dysfunction, Sexuality and Reproductive Issues, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- ArginMax, Placebo
- Keywords
- sexual dysfunction, sexuality and reproductive issues, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Sexual Dysfunction, Physiological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginMaxDietary supplement
Also called L-arginine
Given orally
PlaceboDietary supplement
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I: ArginMax | Experimental | ArginMax® 3 pills twice daily Receives: Dietary Supplement: ArginMax |
| Arm II: Placebo | Placebo comparator | Patients receive oral placebo 3 pills twice daily Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study start1 May 2007
- Primary completion1 Jun 2010
- Study completion1 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Greven, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459134
- Sponsor's protocol ID
- IRB00001487
- Other IDs
- U10CA081851, REBACCCWFU 97106
- Status last verified
- Sep 2021
- First submitted
- 9 Apr 2007
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
- ClinicalTrials.gov ID
- NCT00459134
- Acronym / sponsor ID
- IRB00001487
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 May 2007 (actual)
- Primary completion
- 1 Jun 2010 (actual)
- Study completion
- 1 Jun 2010 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: ArginMax | Experimental | Dietary Supplement: ArginMaxArginMax® 3 pills twice daily |
| Arm II: Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients receive oral placebo 3 pills twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginMaxAlso: L-arginineGiven orally | Dietary supplement | Arm I: ArginMax |
| PlaceboGiven orally | Dietary supplement | Arm II: Placebo |
Primary outcome
Sexual Function
Time frame: 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.
1 secondary outcome
Quality of Life
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn M. Greven, MD principal investigator
Wake Forest University Health Sciences
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArginMax in people with Sexual Dysfunction and Sexuality and Reproductive Issues, run by Wake Forest University Health Sciences at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.