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

This study is currently recruiting participants.
Verified September 2017 by Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02415387
First Posted: April 14, 2015
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center
  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.

Condition Intervention
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 Biological: typhoid vaccine Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in level of IL-6 [ Time Frame: At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours. ]
    Blood will be drawn for IL-6 in serum samples measured using an electrochemilluminescence 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 [ Time Frame: At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours. ]
    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 [ Time Frame: At baseline prior to vaccine or placebo administration, and then every 90 minutes post-inoculation for 7.5 hours. ]
    Self-reported intensity of fatigue on 0-9 scales (0 = no fatigue; 9 = fatigue as bas 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


Estimated Enrollment: 180
Actual Study Start Date: January 2014
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (typhoid vaccine, placebo)
Patients receive typhoid vaccine IM at visit 1 followed by placebo IM 14-30 days later at visit 2.
Biological: typhoid vaccine
Given IM
Other: Placebo
Given IM
Other Name: PLCB
Placebo Comparator: Arm II (placebo, typhoid vaccine)
Patients receive placebo IM at visit 1 followed by typhoid vaccine IM 14-30 days later at visit 2.
Biological: typhoid vaccine
Given IM
Other: Placebo
Given IM
Other Name: PLCB

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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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
  • Women who have ever received typhoid vaccine or have received any other vaccine within three months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415387


Contacts
Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 Jamesline@osumc.edu
Contact: Janice Kiecolt-Glaser, PhD 614-293-3499 Janice.Kiecolt-Glaser@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice Kiecolt-Glaser, PhD    614-293-3499    Janice.Kiecolt-Glaser@osumc.edu   
Principal Investigator: Janice Kiecolt-Glaser, PhD         
Sponsors and Collaborators
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
  More Information

Additional Information:
Responsible Party: Janice Kiecolt-Glaser, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02415387     History of Changes
Other Study ID Numbers: OSU-13194
NCI-2014-01251 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 9, 2015
First Posted: April 14, 2015
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs