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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03563352
Other study ID # 0S-17-4
Secondary ID NCI-2018-009480S
Status Withdrawn
Phase
First received
Last updated
Start date August 30, 2018
Est. completion date September 24, 2020

Study information

Verified date December 2020
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This trial studies nutritional preferences and product accessibility in oral nutritional supplements in participants with breast, colorectal, upper gastrointestinal, or prostate cancer. Learning what participants like and dislike about their current or past used nutritional supplements may help doctor know how to improve them.


Description:

PRIMARY OBJECTIVES: I. Identify how patients with cancer are obtaining nutrition to support medical management. SECONDARY OBJECTIVES: I. Examine associations of gastrointestinal side effects with specific diagnoses and respective medical therapies. II. Understand how patients access information regarding nutritional supplements. III. Evaluate patient satisfaction with currently available oral nutritional supplements (ONS). IV. Identify patient preferences in formulating a novel nutritional supplement. OUTLINE: Participants attend an interview over 15 minutes and complete surveys.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 24, 2020
Est. primary completion date September 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to comprehend English (both reading and writing) - Subjects in the inpatient and outpatient setting with the diagnosis of breast cancer, colorectal cancer, upper gastrointestinal cancer (including gastric, pancreatic, and cholangiocarcinoma), or prostate cancer - Receiving chemotherapy, biologic, or hormonal therapy in the University of Southern California (USC) Norris Comprehensive Cancer Center Day Hospital - Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: - Patients with a mental disability that makes them unable to understand and respond to the questions - Patients with reported non-oncologic associated deficits in taste and smell

Study Design


Intervention

Other:
Interview
Attend an interview
Survey Administration
Ancillary studies

Locations

Country Name City State
United States USC / Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The way patients with cancer choose and obtain nutritional supplements to support medical management Data from the oral nutritional supplement survey that examines quality, quantity, access and affordability of oral nutrional supplements will be summarized. Up to 1 year
Secondary Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies Data from the survey will be used for testing the association of gastrointestinal side effects with specific diagnosis and medical therapies. Up to 1 year
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