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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin. |
|
| Control Group | No Intervention | Women instructed to maintain current intake and take a provided multivitamin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-Based Diet | Behavioral | Women will be provided with 3 meals daily, delivered to their home, for 8 weeks, along with a multivitamin, and will attend weekly office visits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Percentage of women who are randomized in the study out of the all women approached. | 1 year |
| Retention | Percentage of women who start the intervention who go on to complete 8-week testing | 8 weeks |
| Compliance | The percentage of daily calorie intake from "on-plan" food will be calculated for each participant. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| FACT-B | 8 weeks | |
| EORTC QLQ-C30 | 8 weeks | |
| FACT-COG |
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Inclusion Criteria:
Exclusion Criteria:
Only women will be enrolled due to low numbers of male breast cancer patients and inability to create subgroup analyses.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas M Campbell, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39702320 | Derived | Scales TQ, Smith B, Blanchard LM, Wixom N, Tuttle ET, Altman BJ, Peppone LJ, Munger J, Campbell TM, Campbell EK, Harris IS. A whole food, plant-based diet reduces amino acid levels in patients with metastatic breast cancer. Cancer Metab. 2024 Dec 19;12(1):38. doi: 10.1186/s40170-024-00368-w. | |
| 39417128 | Derived |
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Data will be made available for collaboration or other purposes with appropriate data use agreements in place.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| 8 weeks |
| Brief Fatigue Inventory (BFI) | 8 weeks |
| Symptom Inventory | 8 weeks |
| Serum breast cancer biomarkers | CA 15-3, CEA, CA 27.29 | 8 weeks |
| Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT) | 8 weeks |
| Changes in nutrient intakes based on 3 day food diaries | Assess baseline diet compared to intervention diet | 8 weeks |
| Weight | 8 weeks |
| Blood Pressure | 8 weeks |
| Inflammatory Markers | CBC, CRP | 8 weeks |
| Hormonal Levels | Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3 | 8 weeks |
| Metabolic Markers | Lipids, CMP | 8 weeks |
| Tumor Metabolic Activity | PET/CT scan SUV Uptake | 8 weeks |
| Circulating Tumor Cells | 8 weeks |
| cell-free DNA | 8 weeks |
| Scales TQ, Smith B, Blanchard LM, Wixom N, Tuttle ET, Altman BJ, Peppone LJ, Munger J, Campbell TM, Campbell EK, Harris IS. A whole food, plant-based diet reduces amino acid levels in patients with metastatic breast cancer. medRxiv [Preprint]. 2024 Oct 22:2024.10.09.24315165. doi: 10.1101/2024.10.09.24315165. |
| 38553649 | Derived | Campbell EK, Campbell TM, Culakova E, Blanchard L, Wixom N, Guido JJ, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A whole food, plant-based randomized controlled trial in metastatic breast cancer: feasibility, nutrient, and patient-reported outcomes. Breast Cancer Res Treat. 2024 Jul;206(2):273-283. doi: 10.1007/s10549-024-07284-z. Epub 2024 Mar 30. |
| 38446316 | Derived | Campbell TM, Campbell EK, Culakova E, Blanchard LM, Wixom N, Guido JJ, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A whole-food, plant-based randomized controlled trial in metastatic breast cancer: weight, cardiometabolic, and hormonal outcomes. Breast Cancer Res Treat. 2024 Jun;205(2):257-266. doi: 10.1007/s10549-024-07266-1. Epub 2024 Mar 6. |
| 38045318 | Derived | Campbell EK, Campbell TM, Culakova E, Blanchard LM, Wixom N, Guido J, Fetten J, Huston A, Shayne M, Janelsins M, Mustian K, Moore RG, Peppone LJ. A Whole Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Feasibility, Nutrient, and Patient-Reported Outcomes. Res Sq [Preprint]. 2023 Nov 21:rs.3.rs-3606685. doi: 10.21203/rs.3.rs-3606685/v1. |
| 37986940 | Derived | Campbell TM, Campbell EK, Culakova E, Blanchard L, Wixom N, Guido J, Fetten J, Huston A, Shayne M, Janelsins MC, Mustian KM, Moore RG, Peppone LJ. A Whole-Food, Plant-Based Randomized Controlled Trial in Metastatic Breast Cancer: Weight, Cardiometabolic, and Hormonal Outcome. Res Sq [Preprint]. 2023 Nov 8:rs.3.rs-3425125. doi: 10.21203/rs.3.rs-3425125/v1. |
| D017437 |
| Skin and Connective Tissue Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |