Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
Completed · Not applicable
Conditions studied: Non-small Cell Lung Cancer
In brief
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Key facts
- Study ID
- NCT03700437
- Run by
- Indiana University
- People needed
- 12
- Starts
- 2018-11-02
- Expected to finish
- 2022-03-23
- Last updated by the study team
- 2022-05-12
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 years at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Eastern cooperative group (ECOG) performance status of 0 to 2
- Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) and have advanced disease.
- BMI ≥ 19
- Patients should be on maintenance therapy for advanced NSCLC as defined as treatment with single agent immunotherapy, single agent chemotherapy plus immunotherapy or single agent molecularly targeted therapy for a minimum of 2 months prior to study entry
- If a patient is on a treatment that lowers their ANC, their ANC has to be ≥ 1500 on the first day of fasting
You may not qualify if…
- 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
- Linsitinib
- Picropodophyllin
- 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.
Where it is running
- Eskenazi Hospital — Indianapolis, Indiana, United States
- Indiana University Hospital — Indianapolis, Indiana, United States
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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