theanine and Stomatitis

Capecitabine-based adjuvant chemotherapy for colorectal cancer patients often causes adverse events (AEs), such as diarrhea, stomatitis, anorexia, and hand-foot syndrome (HFS). Cystine and theanine were reported to attenuate some chemotherapy-associated AEs, and hence are also expected to attenuate capecitabine-induced AEs. Therefore, we aimed to investigate the safety and efficacy of cystine/theanine treatment in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery.. A total of 100 colorectal cancer patients treated with capecitabine as an adjuvant chemotherapy after surgery were randomly allocated into the cystine/theanine group (n = 52) or the placebo group (n = 48). The primary endpoint was incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology Group (JCOG) version. The secondary endpoints included incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale.. There were no significant differences in capecitabine-induced AEs between the two groups. However, the incidence rate of diarrhea of grade 1 or higher tended to be lower in the cystine/theanine group than the placebo group (18.4% vs. 28.9%, p = 0.169) as well as the incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale) (67.4% vs. 77.8%, p = 0.185, 67.3% vs. 80.0%, p = 0.124, respectively).. This trial demonstrated that cystine/theanine treatment of colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery is safe and has the tendency to reduce the incidence rate of diarrhea or HFS.. UMIN000024784.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anorexia; Antineoplastic Combined Chemotherapy Protocols; Capecitabine; Chemotherapy, Adjuvant; Colorectal Neoplasms; Cystine; Diarrhea; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Female; Glutamates; Hand-Foot Syndrome; Humans; Male; Middle Aged; Stomatitis

Cystine and theanine are amino acids that contribute to the production of glutathione, which is the most potent antioxidant in the body, and it has been reported that these amino acids prevent immunosuppression, has anti- inflammatory effect, and reduce invasiveness.. To evaluate the effect of oral administration of amino acids cystine and theanine on stomatitis during chemotherapy.. For 17 patients with Grade 1(CTCAE v4.0)or worse stomatitis during chemotherapy for gastrointestinal cancer or breast cancer, cystine 700 mg and theanine 280 mg/ day were orally administered for 28 days, and the degree of stomatitis was evaluated objectively and subjectively.. As an objective evaluation, changes in Grade showed improvement in 11 cases(64.7%), 5 cases unchanged(29.4%), and 1 case was worse(5.9%). Subjective assessment, pain was in remission(30.8%)or disappeared(61.5%)in 4 of 13 cases. Food intake increased in 5 patients(29.4%). 15 of 17 patients(88.2%)felt it was effective.. Oral administration of amino acids cystine and theanine during chemotherapy can reduce the symptoms of stomatitis.

Topics: Administration, Oral; Amino Acids; Cystine; Glutamates; Humans; Stomatitis