Evaluating a Fasting-mimicking Diet in Combination With Immunotherapy in Patients With Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FMD, Regular Diet Plus FMD.
- Who it may be relevant to
- Registry conditions: Stage IV NSCLC, NSCLC, Immunotherapy, Fasting Mimicking Diet. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Impact of Intermittent Fasting in Combination With Checkpoint Inhibitors in Patients With Non-small Cell Lung Cancer
Overview
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Detailed description
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
Interventions
- Dietary supplement FMD
Plant-based diet program - Combination product Regular Diet Plus FMD
Patients will eat a RD with the first 3 cycles, then receive 3 cycles of FMD as they continue cycles 4-6
Primary outcome measures
- Feasibility of fasting mimicking diet intervention [Time frame: Through study completion up to 2 years.]
- Compliance [Time frame: Through study completion up to 2 years.]
Secondary outcome measures (6)
- Immune Mediated Toxicities [Time frame: Through study completion up to 2 years.]
- Overall response rate (ORR) [Time frame: Through study completion up to 2 years.]
- Disease control rate (DCR) [Time frame: Through study completion up to 2 years.]
- Progression Free Survival (PFS) [Time frame: Through study completion up to 2 years.]
- Functional Assessment of Cancer Therapy-Lung-(FACT-L) [Time frame: Through study completion up to 2 years.]
- European Organization for the Research and Treatment of Cancer Quality of Life -(EORTC QLQ-C30) [Time frame: Through study completion up to 2 years.]
Eligibility criteria
Inclusion criteria
- 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
- Newly diagnosed histologically or cytologically confirmed stage IV Non-Small Cell Lung Cancer (NSCLC). Patients with locally advanced NSCLC that are not candidates for definitive therapy but are candidates for trial are allowed per investigator discretion.
- BMI 19 kg/m2
- Patients should be enrolled prior to starting standard of care immunotherapy for the treatment of stage IV NSCLC. Patients should be on PD (L)1 inhibitor alone (i.e., with PD-L1 expression 50%) in the metastatic setting. The investigators will allow single agent pembrolizumab only as the checkpoint inhibitor.
- Patients requiring palliative radiation or definitive radiation to an oligometastatic disease prior to the initiation of single agent checkpoint inhibitors are allowed once radiation has been completed and patients have recovered from toxicities.
Exclusion criteria
- Self-reported weight loss of > 10% in the 6 weeks prior to study entry
- History of symptomatic hypoglycemia or uncontrolled diabetes
- Prior therapies with inhibitors of insulin growth factor I(IGF-1) such as Linsitinib or Picropodophyllin
- Concurrent use of somatostatin
- Concurrent use of immunosuppressive medications including sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, dexamethasone, or cyclosporine
- Significant food allergies which would make the subject unable to consume the food provided.
- History or current evidence of any uncontrolled 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 4 centers
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- Jesse Brown VA Medical Center, Chicago, IL — Chicago
- Richard L. Roudebush VA Medical Center, Indianapolis, IN — Indianapolis
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis
Identifiers
NCT: NCT06671613 · ONCB-014-24S · 14094145/CX002843