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Type(s) of Cancer
Breast, Lung (Small Cell), Lymphoma (Hodgkins), Leukemia, Ovarian, Colorectal, Multiple Myeloma, Lymphoma (Non-Hodgkins), Lung (Non-Small Cell), Uterine Cervix, Thyroid
Study Phase
Not Applicable
Study Completion Date
June 2010
NCT00459134Uploaded 01-12-2019
Access via NCI by Request
PDS UID - nci-data-391
A Randomized Study to Determine Whether ArginMax Improves the Sexual Function and Quality of Life in Female Cancer Survivors
Provider Information
Provider Data DescriptionThis dataset contains all the data used in the publication cited above (PMID=26287032). Baseline demographic and clinical variables are provided for time = 0 (baseline visit). The primary outcome measures for the study are assessed at each time (0=baseline, 4=4 weeks, 8=8 weeks, and 12=12 weeks). Summary measures that are calculated across the participant?s time on study (e.g., worst toxicities and compliance) are recorded on the time = 99 rows. Note that these are measures determined over the entire study period, not a specific time. Notes: Missing data are denoted by a blank or a ?.? for each variable.
SponsorWake Forest University Health Sciences
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset186
# of Patients Control92
# of Patients Experimental92
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsSexual Dysfunction
Sexuality and Reproductive Issues
Unspecified Adult Solid Tumor, Protocol Specific
Intervention TypeDietary Supplement: ArginMax
Dietary Supplement: Placebo
Drug(s)N/A
Total Enrolled186
RandomizationRandomized
Blinding MethodTriple
Arms InterventionArm I: ArginMax - Experimental
Arm II: Placebo - Placebo Comparator
Secondary IDU10CA081851
PubMed (PMID)NA
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT00459134-D1
Data DictionaryNCT00459134-D1-Data-Dictionary.pdf
DATANCT00459134-D1-Dataset.csv
OTHERREADME.pdf
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