Open AccessCan acetylcysteine ameliorate cisplatin‐induced toxicities and oxidative stress without decreasing antitumor efficacy? A randomized, double‐blind, placebo‐controlled trial involving patients with head and neck cancer
Author(s) -
Visacri Marília B.,
Quintanilha Júlia C. F.,
Sousa Vanessa M.,
Amaral Laís S.,
Ambrósio Rosiane,
Calonga Luciane,
Curi Silvia F. B. B.,
Leme Mayra F.,
Chone Carlos T.,
Altemani João M. C.,
Mazzola Priscila G.,
Malaguti Carina,
Vercesi Aníbal E.,
Lima Carmen S. P.,
Moriel Patricia
Publication year - 2019
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.2072
Subject(s) - cisplatin , medicine , placebo , oxidative stress , acetylcysteine , chemotherapy , head and neck cancer , toxicity , concomitant , pharmacology , radiation therapy , cancer , gastroenterology , antioxidant , pathology , chemistry , biochemistry , alternative medicine
The protective antioxidant activity of acetylcysteine (NAC) against toxicity due to cisplatin has been reported in experimental models; however, its efficacy in patients has not been elucidated. The aim of this study was to investigate the possible protective effect of NAC on cisplatin‐induced toxicity and the effect of NAC on clinical response and oxidative stress in patients treated for head and neck cancer. This was a randomized, double‐blind, placebo‐controlled trial conducted in patients receiving high‐dose cisplatin chemotherapy concomitant to radiotherapy. Patients were randomly assigned to groups and received: (a) 600 mg NAC syrup, orally once daily at night for 7 consecutive days or (b) placebo, administered similarly to NAC. Nephro‐, oto‐, hepato‐, myelo‐, and gastrointestinal toxicities, clinical responses, and plasma and cellular markers of oxidative stress were evaluated. Fifty‐seven patients were included (n = 28, NAC arm; and n = 29, placebo arm). A high prevalence of most types of toxicities was observed after cisplatin chemotherapy; however, the parameters were similar between the two groups. There was a predominance of partial response to treatment. In the cellular and plasmatic oxidative stress analyses, minor differences were observed. Overall, there was no statistically significant difference between the groups for all outcomes. These findings show that low‐dose oral NAC does not protect patients with head and neck cancer from cisplatin‐induced toxicities and oxidative stress. The antitumor efficacy of cisplatin was apparently not impaired by NAC.