Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Interested in helping us improve? Please take 2 minutes to answer our questions at https://www.surveymonkey.com/r/SJZ3XVC

The Project Data Sphere Cancer Research Platform will be unavailable for brief periods from 5 PM Eastern Time on Friday, 1/17 until 1 AM on Monday, 1/20.

< Back to Results

Alert icon

This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
  2. After adding all desired datasets to your request, you must complete a request form accessible via the 'My Data Requests' link in your account profile. After submitting your data request form, your request will be delivered to NCI for approval.
  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

Multiple Myeloma, Thyroid, Ovarian, Lung (Small Cell), Lymphoma (Hodgkins), Breast, Lymphoma (Non-Hodgkins), Colorectal, Lung (Non-Small Cell), Uterine Cervix, and Leukemia

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

Unique Dataset IDnci-data-78ClinicalTrial.gov IDNCT00459134
DownloadableNo
SponsorWake Forest University Health SciencesData ProviderNational Cancer InstituteTotal Study Enrolled Patients186RandomizationYesPubMed (PMID)26287032.0
Study PhaseN/ABlinding MethodOtherType(s) of dataN/AIntervention TypePlacebo, DrugDataset TypeOther

NCI Description

This 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.

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

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.

Outcome Measures

Primary: Sexual Function [ Time Frame: 12 weeks ] Secondary: Quality of Life [ Time Frame: 12 weeks ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00459134-D1-Data-Dictionary.pdf

DATA: NCT00459134-D1-Dataset.csv

OTHER: README.pdf