Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Translational Genomics Research Institute | OTHER |
Not provided
Not provided
Not provided
This study will evaluate the effects of the ketogenic diet in patients with metastatic pancreatic cancer while receiving chemotherapy.
A randomized, phase II trial designed to evaluate the progression free survival in patients with metastatic pancreatic cancer on triplet therapy (nab-paclitaxel + gemcitabine + cisplatin) while on ketogenic diet or non-ketogenic diet. This study also aims to compare the changes in serum metabolites and quality of life between the two arms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketogenic (KD) + Triplet | Experimental | Ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days. |
|
| Non-ketogenic + Triplet | No Intervention | Non-ketogenic diet plus nab-paclitaxel 125 mg/m2, cisplatin 25 mg/m2, and gemcitabine 1000 mg/m2 all administered intravenously (IV) on Days 1 and 8 every 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Other | Ketogenic diet (KD) will consist of macros: dietary carbohydrates restricted to < 30 g/day; daily protein intake will be targeted to 1.5 g/kg/day (targeted to ideal body weight). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival per RECIST 1.1 | Progression-free survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the number of responses by RECIST 1.1 | To compare the number of complete responses/partial responses as defined by CT scan using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN). | 36 months |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steve Norton, MBA PhD | Translational Drug Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | United States | ||
| USC/Norris Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35425930 | Derived | Yang L, TeSlaa T, Ng S, Nofal M, Wang L, Lan T, Zeng X, Cowan A, McBride M, Lu W, Davidson S, Liang G, Oh TG, Downes M, Evans R, Von Hoff D, Guo JY, Han H, Rabinowitz JD. Ketogenic diet and chemotherapy combine to disrupt pancreatic cancer metabolism and growth. Med. 2022 Feb 11;3(2):119-136. doi: 10.1016/j.medj.2021.12.008. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Ketogenic diet with standard of care chemotherapy versus non-ketogenic diet with standard of care chemotherapy
Not provided
Not provided
Not provided
Not provided
| To compare the disease control rate using the Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1). |
(Partial Response + Complete Response + Stable Disease for at least 9 weeks) |
| 36 months |
| Cancer Biomarkers | Change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) | 36 months |
| Cancer Biomarkers returning to normal | Rates of normalization of CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) | 36 months |
| Change in BMI | To compare the average weight (kg), using BMI calculation (BMI = weight (kg) / height (m2)) | 36 months |
| Compare insulin levels | To compare average insulin levels | 36 months |
| To compare the average HbgA1c level | To compare the average HbgA1c levels | 36 months |
| To compare changes in serum metabolites | To compare changes in serum metabolites | 36 months |
| To compare quality of life between arms via the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLC-C30 (EORTC QLQ-C30) assessment. | Higher scores in the quality of life on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire QLC-C30 (EORTC QLQ-C30) assessment may show a better outcome. | 36 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| Nuvance Health-Danbury Hospital | Danbury | Connecticut | 06810 | United States |
| Nuvance Health | Norwalk | Connecticut | 06856 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | United States |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |