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Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies.
Cancer 2008; 112(7):1600-6C

Abstract

BACKGROUND

The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer.

METHODS

Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM.

RESULTS

Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003).

CONCLUSIONS

The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further.

Authors+Show Affiliations

Department Oncology, Finsen Centre/National University Hospital, Copenhagen, Denmark. jens.benn.soerensen@rh.regionh.dkNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18300265

Citation

Sorensen, Jens Benn, et al. "Double-blind, Placebo-controlled, Randomized Study of Chlorhexidine Prophylaxis for 5-fluorouracil-based Chemotherapy-induced Oral Mucositis With Nonblinded Randomized Comparison to Oral Cooling (cryotherapy) in Gastrointestinal Malignancies." Cancer, vol. 112, no. 7, 2008, pp. 1600-6.
Sorensen JB, Skovsgaard T, Bork E, et al. Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. Cancer. 2008;112(7):1600-6.
Sorensen, J. B., Skovsgaard, T., Bork, E., Damstrup, L., & Ingeberg, S. (2008). Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. Cancer, 112(7), pp. 1600-6. doi:10.1002/cncr.23328.
Sorensen JB, et al. Double-blind, Placebo-controlled, Randomized Study of Chlorhexidine Prophylaxis for 5-fluorouracil-based Chemotherapy-induced Oral Mucositis With Nonblinded Randomized Comparison to Oral Cooling (cryotherapy) in Gastrointestinal Malignancies. Cancer. 2008 Apr 1;112(7):1600-6. PubMed PMID: 18300265.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies. AU - Sorensen,Jens Benn, AU - Skovsgaard,Torben, AU - Bork,Ellen, AU - Damstrup,Lars, AU - Ingeberg,Sten, PY - 2008/2/27/pubmed PY - 2008/5/7/medline PY - 2008/2/27/entrez SP - 1600 EP - 6 JF - Cancer JO - Cancer VL - 112 IS - 7 N2 - BACKGROUND: The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer. METHODS: Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM. RESULTS: Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, P< .01) and C (11%, P< .005). Duration was significantly longer in B than in both A (P= .035) and C (P= .003). CONCLUSIONS: The frequency and duration of OM are significantly improved by prophylactic chlorhexidine and by cryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/18300265/Double_blind_placebo_controlled_randomized_study_of_chlorhexidine_prophylaxis_for_5_fluorouracil_based_chemotherapy_induced_oral_mucositis_with_nonblinded_randomized_comparison_to_oral_cooling__cryotherapy__in_gastrointestinal_malignancies_ L2 - https://doi.org/10.1002/cncr.23328 DB - PRIME DP - Unbound Medicine ER -