Clinical trial NCT02415387: Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
Official title: The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cognitive Side Effects of Cancer Therapy
Depression
Recurrent Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 172
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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 in breast cancer survivors.

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 inactive typhoid vaccine intramuscularly (IM) at visit 1 followed by placebo IM 30 days later at visit 2.

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

There is an initial screening visit where patients in both arms complete an audio-recorded interview that includes questions about changes in mood and emotion throughout their lives, body measurements, a finger stick to assess for anemia and diabetes markers. During visit 1 and 2, patients in both arms will have blood drawn periodically and complete sets of questionnaires that assess feelings, health behaviors, and personality. Patients also complete cognitive tasks and a temperature sensitivity task at 3-4.5 hours post-injection.

Eligibility criteria: Inclusion Criteria:

* Women who have been diagnosed with stage I-IIIA breast cancer will be recruited 1-10 years after the completion of all primary cancer treatment except for longer-term hormonal therapies (tamoxifen, aromatase inhibitors)
* All women will be postmenopausal

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
* Alcohol or drug abuse
* Smoking
* Medication exclusions will include steroids as well as statins and other medications with anti-inflammatory actions
* Women who have received a typhoid vaccine within the last three years

Primary outcomes:
measure: AUC Change in Level of IL-6
timeFrame: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine
Secondary outcomes:
measure: AUC Change in Pain
timeFrame: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
measure: AUC Change in Fatigue
timeFrame: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
name: Janice Kiecolt-Glaser, PhD
role: PRINCIPAL_INVESTIGATOR
References: