CompletedPhase 1/2

Supplementation of L-arginine in Patients With Non-resectable Brain Metastases

70 participantsStarted 2004-05

Plain-language summary

This study evaluates the nutritional supplement arginine as supportive measure for patients with unresectable metastatic brain tumors that receive radiation therapy with palliative intent

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients with pathology-confirmed diagnostic of solid cancer and measurable brain metastases by CT scan and/or MRI Inclusion Criteria: * Unresectable criteria by neurosurgeon * Recursive partitioning analysis (RPA) -Radiation Therapy Oncology Group (RTOG) class II (Karnofsky's performance score ≥ 70 and extracranial metastases and/or non-controlled primary tumor) * Measurable brain lesion/s by contrast-enhanced CT or MRI * Absolute granulocyte count more or equal than 2000/mm3 * Hemoglobin more or equal than 9 g/L (patients with lower levels were transfused before the randomization) * Normal renal laboratory (serum creatinine \<1.5 mg/dL and 24-h creatinine clearance \>60 mL/min) * Normal hepatic function (aspartate aminotransferase and alanine aminotransferase \<2.5 times the upper limit of normal) * Stable body weight and composition for at least one month prior enrollment Exclusion Criteria: * Prior treatment for brain metastases and/or brain tumor. * Primary brain tumor * Hematologic malignancies * Solid tumors of germinal origin * Contraindication for external radiation therapy. * Allergy to L-arginine.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline of the scoring form NCI CTCAE v3 for detecting and quantifying potential adverse events

Timeframe: Baseline and thereafter every 7 days starting from day 1 of L-arginine or placebo administration and through study completion, an average of 1 year

Change from baseline of quality of life questionnaire

Timeframe: Baseline and thereafter every 7 days starting from day 1 of L-arginine or placebo administration and through study completion, an average of 1 year

Change from baseline in signs and symptoms of neurological disease

Timeframe: Baseline and at 4 weeks counted from the last day of treatment

Trial details

NCT IDNCT02844387

SponsorInstituto de Oncología Ángel H. Roffo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-11

View on ClinicalTrials.gov More Unresectable Multiple Brain Metastases trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline of the scoring form NCI CTCAE v3 for detecting and quantifying potential adverse events

Timeframe: Baseline and thereafter every 7 days starting from day 1 of L-arginine or placebo administration and through study completion, an average of 1 year

Change from baseline of quality of life questionnaire

Timeframe: Baseline and thereafter every 7 days starting from day 1 of L-arginine or placebo administration and through study completion, an average of 1 year

Change from baseline in signs and symptoms of neurological disease

Timeframe: Baseline and at 4 weeks counted from the last day of treatment