Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer (IMPACT)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Depression; Recurrent Breast Carcinoma; Stage IIIA Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Cognitive Side Effects of Cancer Therapy
• Intervention / Treatment: Other: Placebo; Biological: typhoid vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm I (inactive typhoid vaccine, placebo); Patients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.	Other: Placebo; Given IM; Other Names: PLCB; Biological: typhoid vaccine; Given IM
PLACEBO_COMPARATOR: Arm II (placebo, inactive typhoid vaccine); Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.	Other: Placebo; Given IM; Other Names: PLCB; Biological: typhoid vaccine; Given IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of IL-6	Blood will be drawn for IL-6 in serum samples measured using an electrochemiluminescence method with Meso Scale Discovery kits at the fasting baseline and then every 90 minutes post-inoculation for 7.5 hours.	At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Self-reported intensity of pain on 0-9 scale (0 = no pain; 9 = pain as bad as you can imagine) at baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for the next 7.5 hours	At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.
Change in fatigue	Self-reported intensity of fatigue on 0-9 scales (0 = no fatigue; 9 = fatigue as bad as you can imagine) at baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for the next 7.5 hours	At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Janice Kiecolt-Glaser, PhD, Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (ESTIMATE): April 14, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OSU-13194; NCI-2014-01251 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No