Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer Who Received Chemotherapy

Protocol: OSU-13194

Full Title

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

Purpose

This randomized clinical trial uses a typhoid vaccine to cause an immune response in patients with stage I-IIIA breast cancer who received chemotherapy and studies whether patients' fitness levels affect how well 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 chemotherapy 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 who have undergone chemotherapy.

Study Objective

PRIMARY OBJECTIVES:

I. To evaluate the relationships between cardiorespiratory fitness and inflammatory and behavioral responses (negative mood, fatigue, pain, and cognitive problems) to typhoid vaccine.

II. To determine the effects of age and depressive symptoms on inflammatory and behavioral responses to typhoid vaccine and placebo.

III. To assess the ability of cardiorespiratory fitness to moderate age- and depression-related responses to typhoid vaccine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive typhoid vaccine intramuscularly (IM) at visit 1 followed by placebo IM 14-30 days later at visit 2.

ARM II: Patients receive placebo IM at visit 1 followed by typhoid vaccine IM 14-30 days later at visit 2.

During each visit, patients in both arms complete an audio-recorded questionnaire that includes questions about mood, feelings, health behaviors, health, and personality. Patients also complete cognitive tasks at 3-4.5 hours post-injection and receive a cold tolerance test following the post-injection assessment.

Are you eligible?

Inclusion Criteria:

Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-8 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors); recruit women who have received one of the two most common stage I-IIIA chemotherapy regimens, either docetaxel/cyclophosphamide or doxorubicin/cyclophosphamide followed by paclitaxel to provide uniformity of prior treatment

All women will be postmenopausal, defined as having follicle-stimulating hormone (FSH) and estradiol within the institutional postmenopausal range at the time of study entry and no menstrual cycle in the last 12 months

Exclusion Criteria:

A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)

Anemia (defined as having a hemoglobin level less than 11.7 g/dL for white women, following the Ohio State University (OSU) hospital’s criteria, and 11.5 for African American women, based on data from Beutler and Waalen)

Alcohol or drug abuse

Smoking

Individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week

Women with blood pressures above 180/100 or below 80/50

Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions

Antidepressant users who have been medicated for at least three months will not be excluded

Women who have received typhoid vaccine within three years or any other vaccine within three months will be excluded