Clinical trial · Interventional
Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy
NCT03574194CI-TRIAL-00065922terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Suspended due to COVID-19 pandemic
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methionine-restricted diet | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Methionine-restricted diet
- description
- 6-10 weeks methionine-restricted diet (MRD) curative intent radiation therapy course of 6 weeks or less.
- interventionNames
- Dietary Supplement: Methionine-restricted diet
Primary outcomes (1)
- 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.
- timeFrame
- One year from the start of methionine-restricted diet (MRD)
- description
- The expected cumulative rate of grade 3-5 toxicity is less than 15%
Secondary outcomes (1)
- measure
- Patient adherence to the MRD will be assessed by measuring plasma methionine levels 2 weeks and 6 weeks after starting the MRD
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.