CancerNCT03574194
Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy
A study testing Methionine-restricted diet in people with Cancer and Lung Cancer, run by West Virginia University at 1 site in United States.
Trial summary
A diet consisting of a reduced quantity of the essential amino acid methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- Methionine-restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2018to 31 Dec 2021
- 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
- Men and women over age 18
- Any non-skin cancer malignancy to be treated with standard of care, curative-intent, radiation therapy with an RT course of 6 weeks or less, without concurrently administered cytotoxic chemotherapy. Patients with oligometastatic disease being treated with local consolidative radiation therapy are also eligible. Pathologic confirmation of malignancy is not required if the treating physician(s) agree that this lesion is highly likely to be malignant and the patient elects to forego biopsy.
- The RT plan must achieve standard normal tissue dose-volume constraints.
- Zubrod Performance status 0-2
- Adequate organ and marrow function (leukocytes ≥ 2,000/μL, platelets ≥ 50,000/μL, hemoglobin > 8.0 g/dL, total bilirubin ≤ 3 X ULN, AST(SGOT)/ALT(SPGT) ≤ 3 X ULN, albumin > 2.0 g/dL, calcium < 10.5 mg/dL, creatinine ≤ 3 X ULN)
- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential
- Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Prior radiation therapy that would result in overlap of radiation fields.
- Unintentional weight loss of >10% of normal body weight over a period of 6 months or less.
- Use of an appetite stimulant in the past 6 months for unintentional weight loss.
- Allergy to soy (an ingredient in both methionine-free medical food supplements).
- Administration of cytotoxic chemotherapy within 4 weeks prior to initiation of the study treatment.
- Use of ongoing biologic/targeted/immune/hormonal therapy will be permitted.
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- There should be no intention for the patient to receive other local therapy (radiotherapy and/or surgery) or cytotoxic chemotherapy within 4 weeks after completion of the study treatment
- Active systemic, pulmonary, or pericardial infection.
- Psychiatric illness/social situations that would limit compliance with study requirements. * - Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Cancer Institute - Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506
About this study
A diet consisting of a reduced quantity of the essential amino acid methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice. However, to date, dietary restriction of methionine has not been tested in combination with radiation therapy in humans as a strategy to improve patient outcomes.
Read the detailed description
Radiation therapy (RT) is often given concurrently with systemic chemotherapy in order to sensitize the cancer cells to radiation and increase local and regional disease control. However, chemotherapy is often associated with significant toxicity and many patients cannot tolerate it. As such, exploring alternative approaches to radiosensitization that may be more tolerable for patients is important. One innovative strategy that has potential to enhance both the safety and efficacy of SBRT is a methionine-restricted diet (MRD) as an adjunct to radiation therapy. While normal cells can tolerate some degree of methionine deficiency, the vast majority of cancer cells are methionine auxotrophs that require dietary intake of methionine. In the absence of methionine, cancer cells undergo cell cycle arrest and cell death. Preclinical data suggests that consuming a reduced quantity of methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice; Phase 1 clinical trials have also demonstrated the safety of the diet with and without concurrent chemotherapy; however, dietary restriction of methionine has not been tested in combination with radiation therapy in humans. This protocol will test our hypothesis that a MRD will be a safe addition to radiation therapy for a variety of human malignancies.
- Conditions
- Cancer, Lung Cancer, Prostate Cancer, Breast Cancer
- Being tested
- Methionine-restricted diet
- Medical subject headings
- Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methionine-restricted dietDietary supplement
The methionine-restricted diet diet (MRD) will begin 2 weeks prior to radiation therapy to deplete methionine stores in the body, continue during radiation, and extend for approximately 2 weeks after the last radiation fraction for a total of 6-10 weeks (depending on duration of radiation course).
| Study group | Role | What they receive |
|---|---|---|
| Methionine-restricted diet | Experimental | 6-10 weeks methionine-restricted diet (MRD) curative intent radiation therapy course of 6 weeks or less. Receives: Dietary Supplement: Methionine-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of combined MRD plus RT will be assessed by measuring the rate of 1-year grade 3 or higher adverse events definitely, probably, or possibly related to MRD and RT, using CTCAE version 5.0.
The expected cumulative rate of grade 3-5 toxicity is less than 15%
Measured: One year from the start of methionine-restricted diet (MRD)
Secondary outcomes (1)
Patient adherence to the MRD will be assessed by measuring plasma methionine levels 2 weeks and 6 weeks after starting the MRD
Plasma methionine levels less than 13 uM will be considered compliant
Measured: Measurements will be done 2 weeks and 6 weeks after starting the MRD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start12 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Suspended due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 6-10 weeks methionine-restricted diet (MRD) with standard of care curative-intent radiation therapy (6 week course or less), without concurrent chemotherapy
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Responsible party
- Sponsor
- Investigators
- Joshua Weir, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574194
- Sponsor's protocol ID
- WVU010518
- Status last verified
- Apr 2023
- First submitted
- 15 Jun 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy
- ClinicalTrials.gov ID
- NCT03574194
- Acronym / sponsor ID
- WVU010518
- Conditions
- Cancer, Lung Cancer, Prostate Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended due to COVID-19 pandemic
- Enrolment
- 8 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- West Virginia Clinical and Translational Science Institute
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Jun 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.
A diet consisting of a reduced quantity of the essential amino acid methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice. However, to date, dietary restriction of methionine has not been tested in combination with radiation therapy in humans as a strategy to improve patient outcomes.
Detailed description
Radiation therapy (RT) is often given concurrently with systemic chemotherapy in order to sensitize the cancer cells to radiation and increase local and regional disease control. However, chemotherapy is often associated with significant toxicity and many patients cannot tolerate it. As such, exploring alternative approaches to radiosensitization that may be more tolerable for patients is important. One innovative strategy that has potential to enhance both the safety and efficacy of SBRT is a methionine-restricted diet (MRD) as an adjunct to radiation therapy. While normal cells can tolerate some degree of methionine deficiency, the vast majority of cancer cells are methionine auxotrophs that require dietary intake of methionine. In the absence of methionine, cancer cells undergo cell cycle arrest and cell death. Preclinical data suggests that consuming a reduced quantity of methionine sensitizes cancer cells to radiation therapy and reduces metastasis formation and disease progression in mice; Phase 1 clinical trials have also demonstrated the safety of the diet with and without concurrent chemotherapy; however, dietary restriction of methionine has not been tested in combination with radiation therapy in humans. This protocol will test our hypothesis that a MRD will be a safe addition to radiation therapy for a variety of human malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 6-10 weeks methionine-restricted diet (MRD) with standard of care curative-intent radiation therapy (6 week course or less), without concurrent chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Methionine-restricted diet | Experimental | Dietary Supplement: Methionine-restricted diet6-10 weeks methionine-restricted diet (MRD) curative intent radiation therapy course of 6 weeks or less. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women over age 18
- Any non-skin cancer malignancy to be treated with standard of care, curative-intent, radiation therapy with an RT course of 6 weeks or less, without concurrently administered cytotoxic chemotherapy. Patients with oligometastatic disease being treated with local consolidative radiation therapy are also eligible. Pathologic confirmation of malignancy is not required if the treating physician(s) agree that this lesion is highly likely to be malignant and the patient elects to forego biopsy.
- The RT plan must achieve standard normal tissue dose-volume constraints.
- Zubrod Performance status 0-2
- Adequate organ and marrow function (leukocytes ≥ 2,000/μL, platelets ≥ 50,000/μL, hemoglobin > 8.0 g/dL, total bilirubin ≤ 3 X ULN, AST(SGOT)/ALT(SPGT) ≤ 3 X ULN, albumin > 2.0 g/dL, calcium < 10.5 mg/dL, creatinine ≤ 3 X ULN)
Key exclusion criteria (9 listed)
- Prior radiation therapy that would result in overlap of radiation fields.
- Unintentional weight loss of >10% of normal body weight over a period of 6 months or less.
- Use of an appetite stimulant in the past 6 months for unintentional weight loss.
- Allergy to soy (an ingredient in both methionine-free medical food supplements).
- Administration of cytotoxic chemotherapy within 4 weeks prior to initiation of the study treatment.
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 |
|---|---|---|
| Methionine-restricted dietThe methionine-restricted diet diet (MRD) will begin 2 weeks prior to radiation therapy to deplete methionine stores in the body, continue during radiation, and extend for approximately 2 weeks after the last radiation fraction for a total of 6-10 weeks (depending on duration of radiation course). | Dietary supplement | Methionine-restricted diet |
Primary outcome
Safety of combined MRD plus RT will be assessed by measuring the rate of 1-year grade 3 or higher adverse events definitely, probably, or possibly related to MRD and RT, using CTCAE version 5.0.
Time frame: One year from the start of methionine-restricted diet (MRD)
The expected cumulative rate of grade 3-5 toxicity is less than 15%
1 secondary outcome
Patient adherence to the MRD will be assessed by measuring plasma methionine levels 2 weeks and 6 weeks after starting the MRD
Time frame: Measurements will be done 2 weeks and 6 weeks after starting the MRD
Results and safety
The study was stopped early (reason given: Suspended due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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.
Joshua Weir, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methionine-restricted diet in people with Cancer and Lung Cancer, run by West Virginia University 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 8 inclusion and 9 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 25 Apr 2023. 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: Suspended due to COVID-19 pandemic). 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?
Safety of combined MRD plus RT will be assessed by measuring the rate of 1-year grade 3 or higher adverse events definitely, probably, or possibly related to MRD and RT, using CTCAE version 5.0. (time frame: One year from the start of methionine-restricted diet (MRD)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.