Methionine-Restricted Diet to Potentiate The Effects of Radiation Therapy

NCT03574194 | Terminated DMC

• 1 other identifier: WVU010518
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Lung Cancer; Prostate Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (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.

  The expected cumulative rate of grade 3-5 toxicity is less than 15%

  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

  Measurements will be done 2 weeks and 6 weeks after starting the MRD

Study Arms (1)

Methionine-restricted diet

EXPERIMENTAL

6-10 weeks methionine-restricted diet (MRD) curative intent radiation therapy course of 6 weeks or less.

Dietary Supplement: Methionine-restricted diet

Interventions

Methionine-restricted diet DIETARY_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).

Methionine-restricted diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

WVU Cancer Institute - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joshua Weir, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6-10 weeks methionine-restricted diet (MRD) with standard of care curative-intent radiation therapy (6 week course or less), without concurrent chemotherapy

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 29, 2018
• Study Start: June 12, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)