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Cognitive Side Effects of Cancer TherapyEarly Phase 1IMPACTNCT02415387

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

A Early Phase 1 study testing typhoid vaccine in people with Cognitive Side Effects of Cancer Therapy and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years, women only
What is being tested?
typhoid vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
172 participants
Where
1 siteUnited States
Study dates
1 Jan 2014to 27 Apr 2021
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
typhoid vaccine, Placebo
Medical subject headings
Depression, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • typhoid vaccineBiological

    Given IM

  • PlaceboOther

    Also called PLCB

    Given IM

Study groups in NCT02415387
Study groupRoleWhat they receive
Arm I (inactive typhoid vaccine, placebo)ExperimentalPatients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
Receives: Biological: typhoid vaccine; Other: Placebo
Arm II (placebo, inactive typhoid vaccine)Placebo comparatorPatients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
Receives: Biological: typhoid vaccine; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC Change in Level of IL-6

    AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.

    Measured: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine

Secondary outcomes (2)

  1. AUC Change in Pain

    Self-reported intensity of pain on 0-9 scale (0 = no pain; 9 = pain as bad as you can imagine). AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.

    Measured: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine

  2. AUC Change in Fatigue

    Self-reported intensity of fatigue on 0-9 scales (0 = no fatigue; 9 = fatigue as bad as you can imagine). AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.

    Measured: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2015 (estimated)
  2. Study start1 Jan 2014
  3. Primary completion27 Apr 2021
  4. Study completion27 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02415387
Sponsor's protocol ID
OSU-13194
Other IDs
NCI-2014-01251
Acronym
IMPACT
Status last verified
Jul 2024
First submitted
9 Apr 2015
Last updated
24 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Madison AA, Renna M, Andridge R, Peng J, Shrout MR, Sheridan J, Lustberg M, Ramaswamy B, Wesolowski R, Williams NO, Noonan AM, Reinbolt RE, Stover DG, Cherian MA, Malarkey WB, Kiecolt-Glaser JK. Conflicts hurt: social stress predicts elevated pain and sadness after mild inflammatory increases. Pain. 2023 Sep 1;164(9):1985-1994. doi: 10.1097/j.pain.0000000000002894. Epub 2023 Mar 22.

    PubMed 36943254

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing typhoid vaccine in people with Cognitive Side Effects of Cancer Therapy and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC Change in Level of IL-6 (time frame: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02415387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.

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