Head and Neck NeoplasmsNCT01975766
Ketogenic Diet Phase 1 for Head & Neck Cancer
A study testing Ketogenic diet and External beam radiation therapy in people with Head and Neck Neoplasms, run by Bryan Allen at 1 site in United States.
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 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Ketogenic diet and External beam radiation therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 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 squamous cell carcinoma of the oropharynx, larynx or hypopharynx. HPV status will not be assessed for eligibility; while HPV status may affect response to therapy, efficacy is not an outcome measure for this phase I study.
- Candidate for primary chemoradiation as decided by an interdisciplinary team including otolaryngology, medical oncology, and radiation oncology.
- Cancer should be staged via AJCC as stage II, III or IVa.
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
- Patients must have normal organ and marrow function as defined below:
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- leukocytes ≥ 3,000/mm3
- absolute neutrophil count ≥ 1,500/mm3
- platelets ≥ 100,000/mm3
- total bilirubin < 1.5 mg/dl
- Hgb A1C < 8%
- AST(SGOT) < 2 X institutional upper limit of normal
- creatinine < 1.5 X institutional upper limit of normal OR calculated 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 neck and/or upper thoracic radiotherapy that would cause an overlap of treatment fields.
- Prior therapy to the head and neck, with the intent to treat, the current diagnosis of head \& neck cancer.
- Known / established G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Chronic system corticosteroids for any reason (inhaled corticosteroids are allowed). Pre-medication for chemotherapy is acceptable.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
About this study
Official title: A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck 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 patients.
Read the detailed description
Standard treatment for head \& neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for head \& neck 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
- Conditions
- Head and Neck Neoplasms
- Being tested
- Ketogenic diet, External beam radiation therapy
- Keywords
- Carcinoma, squamous cell of head and neck, Head and neck cancer, ketogenic diet, radiotherapy, cisplatin
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
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.
External beam radiation therapyDevice
Also called radiation therapy, intensity modulated radiation therapy, IMRT
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic diet | Experimental | Ketogenic diet designed to sustain ketone levels through treatment. Receives: Dietary Supplement: Ketogenic diet; Device: External beam radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (safety)
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
Measured: weekly for 5 weeks
Secondary outcomes (4)
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 5 weeks
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 5 weeks
Oxidative stress parameters
Determine oxidative stress parameters in plasma and urine samples during the course of treatment.
Measured: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up
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.
- First posted5 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completion11 Jul 2017
Why it stopped: Poor accrual
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 Head and Neck NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan Allen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Nutricia North America, Holden Comprehensive Cancer Center
- Responsible party
- Sponsor-investigator, Bryan Allen, University of Iowa
- Investigators
- Bryan G. Allen, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975766
- Sponsor's protocol ID
- 201309759
- Other IDs
- 3P30CA086862
- Status last verified
- Jun 2018
- First submitted
- 29 Oct 2013
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on clinicaltrials.gov
Publications
Allen BG, Bhatia SK, Buatti JM, Brandt KE, Lindholm KE, Button AM, Szweda LI, Smith BJ, Spitz DR, Fath MA. Ketogenic diets enhance oxidative stress and radio-chemo-therapy responses in lung cancer xenografts. Clin Cancer Res. 2013 Jul 15;19(14):3905-13. doi: 10.1158/1078-0432.CCR-12-0287. Epub 2013 Jun 6.
PubMed 23743570
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01975766
- Acronym / sponsor ID
- 201309759
- Conditions
- Head and Neck Neoplasms
- Keywords
- Carcinoma, squamous cell of head and neck, Head and neck cancer, ketogenic diet, radiotherapy, cisplatin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bryan AllenUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Nutricia North America, Holden Comprehensive Cancer Center
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 5 Nov 2013 (estimated)
- 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.
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 patients.
Detailed description
Standard treatment for head \& neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for head \& neck 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic diet | Experimental | Dietary Supplement: Ketogenic diet, Device: External beam radiation therapyKetogenic diet designed to sustain ketone levels through treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically documented squamous cell carcinoma of the oropharynx, larynx or hypopharynx. HPV status will not be assessed for eligibility; while HPV status may affect response to therapy, efficacy is not an outcome measure for this phase I study.
- Candidate for primary chemoradiation as decided by an interdisciplinary team including otolaryngology, medical oncology, and radiation oncology.
- Cancer should be staged via AJCC as stage II, III or IVa.
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
Key exclusion criteria (10 listed)
- Life expectancy of 3 or less months.
- Prior neck and/or upper thoracic radiotherapy that would cause an overlap of treatment fields.
- Prior therapy to the head and neck, with the intent to treat, the current diagnosis of head \& neck cancer.
- Known / established G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Chronic system corticosteroids for any reason (inhaled corticosteroids are allowed). Pre-medication for chemotherapy is acceptable.
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 |
|---|---|---|
| Ketogenic dietA ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America. | Dietary supplement | Ketogenic diet |
| External beam radiation therapyAlso: radiation therapy, intensity modulated radiation therapy, IMRT | Device | Ketogenic diet |
Primary outcome
Frequency of adverse events (safety)
Time frame: weekly for 5 weeks
Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
4 secondary outcomes
Ketone levels
Time frame: Daily during treatment for 5 weeks
Blood glucose levels
Time frame: daily during treatment for 5 weeks
Oxidative stress parameters
Time frame: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up
Progression Free Survival (months)
Time frame: Every 12 months for 60 months
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Results publication: PubMed 23743570Allen BG, Bhatia SK, Buatti JM, Brandt KE, Lindholm KE, Button AM, Szweda LI, Smith BJ, Spitz DR, Fath MA. Ketogenic diets enhance oxidative stress and radio-chemo-therapy responses in lung cancer xenografts. Clin Cancer Res. 2013 Jul 15;19(14):3905-13. doi: 10.1158/1078-0432.CCR-12-0287. Epub 2013 Jun 6.
- Individual participant dataSharing planned: Yes. Data will be shared on clinicaltrials.gov
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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.
Bryan G. Allen, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet and External beam radiation therapy in people with Head and Neck Neoplasms, run by Bryan Allen 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 15 inclusion and 10 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 26 Jun 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). 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 5 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 NCT01975766, 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 26 Jun 2018.