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Carcinoma, Non-Small-Cell LungNCT01419587

Ketogenic Diet With Chemoradiation for Lung Cancer (KETOLUNG)

A study testing Ketogenic diet in people with Carcinoma, Non-Small-Cell Lung, run by University of Iowa at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by lung cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Ketogenic diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Jul 2011to 11 Jul 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented NSCLC.
  • Candidate for primary chemoradiation as decided by both medical and radiation oncology.
  • Cancer should be staged via AJCC as IIIA or IIIB.
  • Stage IV patients are considered provided they have a single non-CNS metastasis (that is amenable to treatment with radiation therapy).
  • Age ≥ 18 years
  • ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
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  • Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes ≥ 3,000/mm3
  • absolute neutrophil count ≥ 1,500/mm3
  • platelets ≥ 100,000/mm3
  • total bilirubin < 1.5 mg/dl
  • Hgb A1C < or = to 8%
  • AST(SGOT) < or = to 2 X institutional upper limit of normal
  • creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Not pregnant. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Life expectancy of 3 or less months.
  • Prior thoracic radiotherapy.
  • Prior therapy, with the intent to treat, the current diagnosis of lung cancer.
  • Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
  • Systemic corticosteroids for any reason (inhaled corticosteroids are allowed).
  • Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
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  • Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%).
  • Diabetes is not exclusionary provided the patient is not maintained with either oral medications or insulin.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as determined by study team members.
  • Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
  • Female and male patients of all ethnic groups will be eligible for treatment in these protocols.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Non-small Cell Lung Cancer

This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by lung cancer patients.

Read the detailed description

Standard treatment for lung cancer includes chemotherapy concurrent with radiation therapy (chemoradiation).

This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for lung cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing.

Participants will:

  • Utilize a specialized ketogenic diet designed by bionutritional services of the clinical research unit. This diet begins 2 days before chemoradiation and continues through at least 5 weeks of chemoradiation.
  • Have blood drawn for research purposes weekly to determine measurements of oxidative stress
  • Have urine collected sporadically through the study to determine measurements of oxidative stress
  • Keep a diary of concomitant medications, side effects, and blood sugars
  • Have follow-up to monitor for outcomes and overall survival
Being tested
Ketogenic diet
Keywords
Carcinoma, Non-Small-Cell Lung, Non small cell lung cancer, NSCLC, Ketogenic Diet, radiotherapy, paclitaxel, carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic dietDietary supplement

    A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

Study groups in NCT01419587
Study groupRoleWhat they receive
Ketogenic dietExperimentalDiet formulated to maintain elevated ketones during therapy
Receives: Dietary Supplement: Ketogenic diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Adverse Events (Safety)

    Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.

    Measured: Weekly for 8 weeks

Secondary outcomes (4)

  1. Ketone levels

    Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.

    Measured: Daily during treatment for 6 weeks

  2. Blood glucose levels

    Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.

    Measured: Daily during treatment for 6 weeks

  3. Oxidative stress parameters

    Determine oxidative stress parameters in plasma and urine samples during the course of treatment.

    Measured: Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up

  4. Progression Free Survival (months)

    From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy.

    Measured: Every 12 months for 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completion30 Jun 2017
  4. Study completion11 Jul 2017

Why it stopped: Poor accrual and compliance

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01419587
Sponsor's protocol ID
201102773
Other IDs
1R21CA161182
Status last verified
Jan 2018
First submitted
29 Jul 2011
Last updated
8 Jan 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Zahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic Cancer: The University of Iowa Experience of Two Phase 1 Clinical Trials. Radiat Res. 2017 Jun;187(6):743-754. doi: 10.1667/RR14668.1. Epub 2017 Apr 24.

    PubMed 28437190

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic diet in people with Carcinoma, Non-Small-Cell Lung, run by University of Iowa at 1 site 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 17 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: stopped early, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was stopped early (reason given: Poor accrual and compliance). Results are not available in the source record.

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?

Frequency of Adverse Events (Safety) (time frame: Weekly for 8 weeks). 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 NCT01419587, 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 8 Jan 2018.

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