Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Depression |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 3/15/2019 |
| Start Date: | January 2014 |
| End Date: | September 2022 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | Jamesline@osumc.edu |
| Phone: | 800-293-5066 |
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.
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.
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, and a fitness
test on a stationary bike. 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.
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, and a fitness
test on a stationary bike. 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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Janice Kiecolt-Glaser, PhD
Phone: 614-293-3499
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