Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer (IMPACT)
Primary Purpose
Cognitive Side Effects of Cancer Therapy, Depression, Recurrent Breast Carcinoma
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
typhoid vaccine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Cognitive Side Effects of Cancer Therapy
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
Sites / Locations
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I (inactive typhoid vaccine, placebo)
Arm II (placebo, inactive typhoid vaccine)
Arm Description
Patients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02415387
First Posted
April 9, 2015
Last Updated
April 20, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02415387
Brief Title
Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
Acronym
IMPACT
Official Title
The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (inactive typhoid vaccine, placebo)
Arm Type
Experimental
Arm Description
Patients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
Arm Title
Arm II (placebo, inactive typhoid vaccine)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
Intervention Type
Biological
Intervention Name(s)
typhoid vaccine
Intervention Description
Given IM
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given IM
Primary Outcome Measure Information:
Title
Change in level of IL-6
Description
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.
Time Frame
At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.
Secondary Outcome Measure Information:
Title
Change in pain
Description
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
Time Frame
At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.
Title
Change in fatigue
Description
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
Time Frame
At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Kiecolt-Glaser, PhD
Organizational Affiliation
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
We'll reach out to this number within 24 hrs