What is the clinical evidence from this study?

Study design: RCT. Population: Malignant disease (n=25). Intervention: Antioxidant regimen (vitamins E, C and N-acetylcysteine) vs. Placebo. Primary outcome: Fall of > 10% in left ventricular ejection fraction.

January 1, 1996Open Access

Cardioprotection in Patients Undergoing Chemo- and/or Radiotherapy for Neoplastic Disease. A Pilot Study.

PWP WagdiGastroZentrum Hirslanden Zürich MFM FluriUniversity of Bern BABeat C. AeschbacherUniversity of Bern

Key Result

An antioxidant regimen of vitamins E, C, and N-acetylcysteine prevented a >10% fall in left ventricular ejection fraction compared to placebo (0% vs 46%) in patients receiving chemo- or radiotherapy.

Study Design

Type

RCT (n=25)

Blinding

Double-blind

Randomization

Randomized

Structured PICO

Does an antioxidant regimen (vitamins E, C, and N-acetylcysteine) prevent left ventricular ejection fraction decline in patients undergoing chemo- and/or radiotherapy for neoplastic disease?

Population

25 patients undergoing curative chemotherapy (n=13) and/or radiotherapy (n=12) for neoplastic disease. Exclusions: high cardiac output states, known or suspected coronary or valvular heart disease, reduced left ventricular function or preexisting regional wall motion abnormalities, obstruction to venous return, and patients on cardioactive drugs.

Intervention

Antioxidant regimen: Vitamin E 600 mg oral daily beginning first day of therapy, plus Vitamin C 1 gm and N-acetylcysteine 200 mg only on days in which therapy was applied.

Comparator

Matching placebo.

Outcome

Change in left ventricular ejection fraction (LVEF) determined by radionuclide ventriculography before and within 3 weeks of termination of therapy.surrogate

A combination of vitamins E, C, and N-acetylcysteine may provide short-term cardioprotection against left ventricular ejection fraction decline in patients receiving cardiotoxic chemo- or radiotherapy.

Main Result

Absolute Event Rate: 0% vs 46%

Limitations

Small number of patients precludes a definitive statement

Abstract

OBJECTIVES: To assess the cardioprotective efficiency of an antioxidant regimen (vitamins E, C and N-acetylcysteine) in patients receiving high dose chemo- and/or radiotherapy for malignant disease. METHODS: Prospective, placebo controlled, randomized and double blinded pilot study involving 13 patients receiving chemotherapy and 12 patients receiving radiotherapy. RESULTS: In patients receiving antioxidants, left ventricular ejection fraction did not change (63 +/- 4% to 63 +/- 4%). In the placebo group, ejection fraction changed from 67 +/- 6% to 61 +/- 4% (p = 0.03). No patient in the antioxidant group and 6/13 (46%) patients in the placebo group showed a fall of > 10% in the left ventricular ejection fraction. In the chemotherapy group, the left ventricular ejection fraction changed from 62% (+/- 2) to 63% (+/- 2) in the patients treated with antioxidants (ns) and from 63% (+/- 5) to 61% (+/- 5) in patients treated with placebo (ns). No patient showed a significant fall in ejection fraction in the antioxidant group, whereas 2/7 (29%) in the placebo group showed a reduction > or = 10%. In the radiotherapy group, left ventricular ejection fraction did not change ¿64% (+/- 6) to 64% (+/- 5)¿ in patients treated with antioxidants (ns) and changed from 70% (+/- 8) to 60% (+/- 4) in patients treated with placebo (p = 0.008). No patient in the antioxidant group, but 4/6 (66%) patients in the placebo group showed a fall of > or = 10% in ejection fraction. CONCLUSION: The small number of patients in the study precludes a definitive statement. The preliminary results however suggest efficient cardioprotection by this nontoxic and inexpensive antioxidant combination, so larger studies are warranted for confirmation.

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