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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01251 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| typhoid vaccine | Biological | Given IM |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Kiecolt-Glaser, PhD | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36943254 | Derived | 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. |
| Label | URL |
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| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Placebo/Vaccine) | Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2. typhoid vaccine: Given IM Placebo: Given IM |
| FG001 | Arm II (Vaccine/Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2014 |
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| Placebo | Other | Given IM |
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| 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. | baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine |
Patients receive inactive typhoid vacccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
typhoid vaccine: Given IM
Placebo: Given IM
| COMPLETED |
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| NOT COMPLETED |
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Our 172 participants fell short of our 180 recruitment goal because COVID-19 issues.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Patients served as her own control between two visits. typhoid vaccine: Given IM Placebo: Given IM |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| Trunk Fat | Mean | Standard Deviation | kg |
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| Vo2peak | Peak oxygen consumption COVID-19 hospital protocols did not permit VO2 assessments on 14 women. | Mean | Standard Deviation | mL/kg/min |
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| Years since treatment | Mean | Standard Deviation | Years |
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| Chemotherapy treatment | Count of Participants | Participants |
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| Radiation treatment | Count of Participants | Participants |
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| Cancer Stage | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| CES-D score | CES-D: Center for Epidemiological Studies-Depression. Scores range from 0 to 60, with higher scores indicating greater depressive symptoms. | Mean | Standard Deviation | units on a scale |
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| Energy (SF-36 RAND) | From SF-36 RAND Health Survey, scores range from 0 to 100, with higher scores indicating more energy or less fatigued. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Each patient had two visits and served as her own control. | Posted | Least Squares Mean | Standard Error | ug*hour/ml | Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine |
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| Secondary | 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. | Each patient had two visits and served as her own control. | Posted | Least Squares Mean | Standard Error | units on a scale*hour | baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine |
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| Secondary | 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. | Each patient had two visits and served as her own control. | Posted | Least Squares Mean | Standard Error | units on a scale*hour | baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine |
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Through study completion, an average of 6 months
Any adverse events (AE) occurring during any part of the protocol will be reported immediately to the PI. A written report of all adverse events will be completed within 48 hours and submitted to the OSU IRB. Annually, IRB reports will include the occurrence of (un-) anticipated adverse events, and the timely progress of the trial, e.g. listing of all serious adverse events that occurred with clinical summaries, enrollment, withdraws, completions, etc.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo arm includes patients who got placebo injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into. | 0 | 170 | 0 | 170 | 2 | 170 |
| EG001 | Inactive Typhoid Vaccine | Inactive typhoid vaccine arm includes patients who got inactive typhoid vaccine injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into. | 0 | 165 | 0 | 165 | 4 | 165 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling ill | General disorders | Non-systematic Assessment | Headache, fatigue, nausea, dizzy, vomit, muscle pain |
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Our study focused on the initial, rapid inflammatory response, and we did not assess antibody responses to the vaccine, one limitation.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Peng | Center for Biostatistics, The Ohio State University | 614-293-5869 | juan.peng@osumc.edu |
| Jun 3, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014436 | Typhoid-Paratyphoid Vaccines |
| ID | Term |
|---|---|
| D022562 | Salmonella Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 25 kg/m^2 to 29.9 kg/m^2 Overweight |
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| >29.9 kg/m^2 Obese |
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| Stage III |
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