The Efficacy and Safety of Captopril in Preventing Capecitabine-induced Hand-foot Syndrome: A Randomized Double-blinded Placebo-controlled Clinical Trial

Hand-foot syndrome (HFS) is a prevalent skin reaction to cytotoxic systemic therapy, mainly Capecitabine.
The present study aimed to determine etiologies of HFS in addition to its prevention in colorectal cancer patients with Capecitabine-containing chemotherapy regimen.
In this randomized double-blinded study, we recruited 66 eligible patients. The first 33 patients received 25 mg captopril twice daily, while the other 33 were given two placebo tablets.
All the patients were assessable for safety and efficacy. Captopril demonstrated a favorable safety profile. The participants in the two groups did not have any significant differences in terms of the median age and the level of hemoglobin (P = 0.45, P = 0.06, respectively). However, the CEA tumor marker was significantly higher in those with HFS (P < 0.05). The incidence of HFS in men and women were 8 (18.6%) and 3 (13%) cases, respectively, and the patients’ sex did not affect the incidence of this syndrome (P = 0.73).
Furthermore, according to the stage of colorectal cancer, the difference between the two groups was significant (P < 0.05). Meanwhile, there were no significant differences concerning the grade of colorectal cancer (P = 0.2).
The results herein revealed that administration of captopril in colorectal cancer patients with Capecitabine-containing chemotherapy regimen reduced the symptoms and incidence of HFS.
On the other hand, CEA tumor marker and the stage of colorectal cancer were in correlation with incidence of HFS.