CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 172 enrolled
Drug / intervention
typhoid vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02415387
NCT02415387Early Ph 1Completed

The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment

Ohio State University Comprehensive Cancer Center·interventional·Posted Apr 14, 2015·Updated Jul 24, 2024

In Brief

A Early Phase 1 clinical trial evaluating typhoid vaccine and Placebo for Cognitive Side Effects of Cancer Therapy and 7 related conditions. Completed, enrolled 172 participants across 1 site.

Detailed Summary

This randomized clinical trial uses an inactive typhoid vaccine to briefly stimulate an immune response in patients with stage I-IIIA breast cancer who received primary cancer treatment and studies whether patients' fitness levels affect how their bodies handle a challenge to their immune system. A vaccine is a substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms such as bacteria or viruses. Immune responses may cause excess inflammation in the body and behavioral changes, such as depression, fatigue, pain, and problems with thinking and reasoning. Studying immune responses in patients with breast cancer who have undergone primary cancer treatment may help doctors learn whether physical fitness can protect the body from effects of immune system stress and whether it may be able to reduce health problems in patients with breast cancer.

Study Details

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 14, 2015
Enrollment StartJan 1, 2014
Primary CompletionApr 27, 2021
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 11.2 years ago

Interventions

typhoid vaccinebiological

Given IM

Placeboother

Given IM