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Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574194
Recruitment Status : Suspended (Suspended due to COVID-19 pandemic)
First Posted : June 29, 2018
Last Update Posted : April 12, 2021
Sponsor:
Collaborator:
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cancer Lung Cancer Prostate Cancer Breast Cancer Dietary Supplement: Methionine-restricted diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methionine-restricted diet
6-10 weeks methionine-restricted diet (MRD) curative intent radiation therapy course of 6 weeks or less.
Dietary Supplement: Methionine-restricted diet
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).




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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 ]
    Plasma methionine levels less than 13 uM will be considered compliant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574194


Locations
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United States, West Virginia
WVU Cancer Institute - Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
West Virginia Clinical and Translational Science Institute
Investigators
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Principal Investigator: Joshua Weir, MD West Virginia University
  Study Documents (Full-Text)

Documents provided by West Virginia University:
Informed Consent Form  [PDF] October 28, 2018

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Responsible Party: West Virginia University
ClinicalTrials.gov Identifier: NCT03574194    
Other Study ID Numbers: WVU010518
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases