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.
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
- Conditions the study is for
- Cognitive Side Effects of Cancer Therapy, Depression, Recurrent Breast Carcinoma
- 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
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:
- 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.
- Conditions
- Cognitive Side Effects of Cancer Therapy, Depression, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Arm I (inactive typhoid vaccine, placebo) | Experimental | Patients 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 comparator | Patients 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.
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)
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
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.
- First posted14 Apr 2015 (estimated)
- Study start1 Jan 2014
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive Side Effects of Cancer TherapyStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Kiecolt-Glaser, Ohio State University Comprehensive Cancer Center
- Investigators
- Janice Kiecolt-Glaser, PhD, Principal investigator, Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IMPACT Study: Inflammatory Responses, Mood and Physical Fitness After Cancer Treatment
- ClinicalTrials.gov ID
- NCT02415387
- Acronym / sponsor ID
- IMPACT / OSU-13194
- Conditions
- Cognitive Side Effects of Cancer Therapy, Depression, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (inactive typhoid vaccine, placebo) | Experimental | Biological: typhoid vaccine, Other: PlaceboPatients receive inactive typhoid vaccine IM at visit 1 followed by placebo IM 30 days later at visit 2. |
| Arm II (placebo, inactive typhoid vaccine) | Placebo comparator | Biological: typhoid vaccine, Other: PlaceboPatients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| typhoid vaccineGiven IM | Biological | Arm I (inactive typhoid vaccine, placebo), Arm II (placebo, inactive typhoid vaccine) |
| PlaceboAlso: PLCBGiven IM | Other | Arm I (inactive typhoid vaccine, placebo), Arm II (placebo, inactive typhoid vaccine) |
Primary outcome
AUC Change in Level of IL-6
Time frame: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine
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.
2 secondary outcomes
AUC Change in Pain
Time frame: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
AUC Change in Fatigue
Time frame: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36943254Madison 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Kiecolt-Glaser, PhD principal investigator
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 7 Nov 2026.