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| ID | Type | Description | Link |
|---|---|---|---|
| 14094145/CX002843 | Other Grant/Funding Number | VA Clinical Science Research & Development |
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| Name | Class |
|---|---|
| Indiana University | OTHER |
| US Department of Veterans Affairs Cooperative Studies Program | NETWORK |
| L-Nutra Inc | INDUSTRY |
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The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Cancer cells use an increased supply of glucose to make energy and do not have protection against fasting that normal cells do. Because of this, researchers would like to study how fasting may help immunotherapy target cancer cells. Initial studies suggest that fasting may decrease the side effects of immunotherapy and increase the chances of your cancer responding to the immunotherapy. Patient populations will have non-small cell lung cancer in which pembrolizumab have been recommended to treat the cancer as part of standard care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Diet | Active Comparator | Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6. |
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| FMD | Experimental | Plant based diet program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMD | Dietary Supplement | Plant-based diet program |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of fasting mimicking diet intervention | Feasibility will be defined as the proportion of the patients who can finish the 3 cycles FMD without serious adverse events. The investigators define FMD as being a feasible intervention in NSCLC receiving checkpoint inhibitors if 70% of patients on study complete 3 cycles of FMD. | Through study completion up to 2 years. |
| Compliance | Compliance will be measured by analysis of daily food diaries at the end of each FMD cycle. | Through study completion up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Mediated Toxicities | Toxicities as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. | Through study completion up to 2 years. |
| Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shadia Jalal, MD | Contact | (317) 274-5500 | Shadia.Jalal@va.gov | |
| Aleksandra Radovanovich, RN | Contact | (317) 988-3338 | aleksandra.radovanovich@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Shadia Jalal, MD | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System, Long Beach, CA | Recruiting | Long Beach | California | 90822 | United States |
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Multi-center, open label, phase 2, randomized (partial crossover design) study evaluating the feasibility of FMD in stage IV NSCLC patients receiving single agent checkpoint inhibitors. Participants will be randomized 1:1 in blocks of 3. There is no blinding or stratification. Patients with high PDL1 NSCLC will be randomized to two arms: (Arm 1) 3 cycles of RD+PD1 inhibitors followed by 3 cycles of FMD+PD1 inhibitors or (Arm 2) 3 cycles of FMD+PD1 inhibitors.
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| Regular Diet Plus FMD | Combination Product | Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6 |
|
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ORR defined as complete response (CR) + partial response (PR) per RECIST 1.1 criteria.
| Through study completion up to 2 years. |
| Disease control rate (DCR) | Defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) per RECIST 1.1 . | Through study completion up to 2 years. |
| Progression Free Survival (PFS) | Defined as time from day 1 of starting on study to disease progression by RECIST 1.1 or death from any cause. | Through study completion up to 2 years. |
| Functional Assessment of Cancer Therapy-Lung-(FACT-L) | A 36-item, questionnaire measured on a 5-point Likert scale with response options ranging from "not at all" to "very much." Total scores are summed in the range of 0 to 136. Higher scores indicate better QOL. | Through study completion up to 2 years. |
| European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30) | A 30-item questionnaire measured on a 4-point response option ranging from ("not at all," to "very much"), except the global QoL scale which, has a 7-point response from ("very poor" to "excellent"). Scores range from 0-100, a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. | Through study completion up to 2 years. |
| Jesse Brown VA Medical Center, Chicago, IL | Recruiting | Chicago | Illinois | 60612 | United States |
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| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Recruiting | Indianapolis | Indiana | 46202-2884 | United States |
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| St. Louis VA Medical Center John Cochran Division, St. Louis, MO | Recruiting | St Louis | Missouri | 63106-1621 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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