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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 chemotherapy target cancer cells instead of normal cells. Initial studies suggest that fasting may decrease the side effects of chemotherapy and increase the chances of your cancer responding to the chemotherapy. Patient populations will have non-small cell lung cancer in which chemo-immunotherapy with carboplatin/pemetrexed and pembrolizumab have been recommended to treat the cancer as part of standard care.
Primary Objective 1. To determine the feasibility and compliance of administering a fasting-mimicking diet (FMD) in patients with advanced NSCLC receiving maintenance therapy
Secondary Objectives
1. To assess a patient's willingness to fast for second cycle
Correlative Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting-Mimicking Diet (FMD) | Experimental | Participants randomized to the intervention arm (FMD) will be provided with Chemolieve®, a plant-based FMD that provides ~300 calories/fasting day and includes all the food to be consumed during the dietary intervention including supplements Subjects will start the diet 3 days prior to chemo-immunotherapy and continue on the first day of chemo-immunotherapy for the first 4 cycles of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting-Mimicking Diet | Other | Chemo-immunotherapy + FMD (fast-mimicking diet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the patients who can finish the FMD without serious adverse events | To assess feasibility, compliance will be measured by a daily log | Between screening/baseline (28 to 4 days before Cycle 1 Day 1) and Cycle 1 Day 21 or 28 (Cylces last 21 or 28 days, based on treatment) |
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Inclusion Criteria:
Exclusion Criteria:
Self-reported weight loss of > 10% in the 6 weeks prior to study entry
History of diabetes mellitus or patients with a known recent elevated A1c > 6
History of symptomatic hypoglycemia
Prior therapies with inhibitors of IGF-1 such as
Concurrent use of somatostatin
Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
Significant food allergies (screening checklist in Appendix 3) which would make the subject unable to consume the food provided
History or current evidence of any medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator.
Pregnant or lactating females are not eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Shadia Jalal, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42060951 | Derived | Ghaddar F, Ahmed S, Kirsch B, Jennewein L, Uhrich MM, Althouse SK, Longo V, Jalal S. Brief Report: A Pilot Study Evaluating the Feasibility, Safety, and Compliance With a Fasting-Mimicking Diet in Patients With Metastatic Non-Small Cell Lung Cancer. Clin Lung Cancer. 2026 May;27(4):24-28. doi: 10.1016/j.cllc.2026.03.017. Epub 2026 Apr 1. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D005215 | Fasting |
| D008175 | Lung Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indiana University Melvin & Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |