Non-small Cell Lung CancerNCT03700437
Fasting-mimicking Diet With Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)
A study testing Fasting-Mimicking Diet in people with Non-small Cell Lung Cancer, run by Indiana University at 3 sites in United States.
Trial summary
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Fasting-Mimicking Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Nov 2018to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eskenazi Hospital
Indianapolis, Indiana, 46202
Indiana University Hospital
Indianapolis, Indiana, 46202
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer
The purpose of this study is to learn the effects of fasting on cancer cells while you get maintenance treatment.
Read the 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 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
- To assess a patient's willingness to fast for second cycle
Correlative Objectives
- To assess DNA damage via measurement of γ-Η2ΑΧ foci in PBMCs at baseline and following one cycle of FMD (day 21 or day 28)
- To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients post FMD as compared to baseline (prior to fasting)
- To measure the changes in immune markers prior to and after administering the FMD
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Fasting-Mimicking Diet
- Keywords
- fasting, diet, chemo-immunotherapy, lung cancer, circulating tumor cells
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Fasting, Lung Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting-Mimicking DietOther
Chemo-immunotherapy + FMD (fast-mimicking diet)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fasting-Mimicking Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the patients who can finish the FMD without serious adverse events
To assess feasibility, compliance will be measured by a daily log
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start2 Nov 2018
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadia Jalal, Indiana University
- Investigators
- Shadia Jalal, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700437
- Sponsor's protocol ID
- IUSCC-0662
- Status last verified
- May 2022
- First submitted
- 25 Sep 2018
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42060951
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study to Evaluate Fasting-mimicking Diet in Patients Receiving Chemo-immunotherapy for Treatment of Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03700437
- Acronym / sponsor ID
- IUSCC-0662
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- fasting, diet, chemo-immunotherapy, lung cancer, circulating tumor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- To assess a patient's willingness to fast for second cycle
Correlative Objectives
- To assess DNA damage via measurement of γ-Η2ΑΧ foci in PBMCs at baseline and following one cycle of FMD (day 21 or day 28)
- To assess spheroid formation from circulating tumor cells (CTCs) isolated from patients post FMD as compared to baseline (prior to fasting)
- To measure the changes in immune markers prior to and after administering the FMD
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting-Mimicking Diet (FMD) | Experimental | Other: Fasting-Mimicking DietParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting-Mimicking DietChemo-immunotherapy + FMD (fast-mimicking diet) | Other | Fasting-Mimicking Diet (FMD) |
Primary outcome
Proportion of the patients who can finish the FMD without serious adverse events
Time frame: 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)
To assess feasibility, compliance will be measured by a daily log
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 42060951Ghaddar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadia Jalal, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting-Mimicking Diet in people with Non-small Cell Lung Cancer, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the patients who can finish the FMD without serious adverse events (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.