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. 2015 Feb 12;3:e765. doi: 10.7717/peerj.765

Table 2. Trial and patient characteristics (see Appendix D, Table 1 for more details).

Study N Duration Country Mean age(range; years) Sex(% female) Baseline characteristics Intervention Comparator
Lambrecht et al., 2013 58 Belgium 56 (30–78) 72 Malignant neoplasms of the head and neck (all stages) and before undergoing chemotherapy and radiotherapy (first cycle); intervention at treatment start and before the onset of oral mucositis (OM). Caphosol® (Calcium phosphate) one minute rinse 15 ml, four to ten times daily plus standard care (Magic mouth wash, analgesics, antimycotics, antibiotics, parenteral tube) for 14 weeks (unspecified administration). Standard care (Magic mouth wash, analgesics, fluconazole, antibiotics, parenteral tube) for 14 weeks (unspecific administration).
Raphael et al., 2014 34 Netherlands 11 (4–18) 44 Haematological malignancies and before undergoing Hematopoietic stem cell transplantation (HSCT) and chemotherapy (first cycle) at the onset of OM. Caphosol® (Calcium phosphate; unspecified usage) plus standard care (unspecified) self-administered for the duration of OM. NaCl 0.9% mouth rinse (unspecified usage) plus standard care (unspecified) self-administered for the duration of OM.
Sangthawan, Phungrassami & Sinkitjarurnchai, 2013 139 3 months Thailand 18 above Histologically documented diagnosis of head and neck cancer (all stages); Kanofsky performance status at least 70 and before undergoing radiation therapy (1st cycle) before the onset of OM. Zinc sulfate oral syrup (5 mg per 1cc) 10cc three times daily for five to seven weeks self-administered. Placebo (unspecified components) three times daily for five to seven weeks self-administered.
Jahangard-Rafsanjani et al., 2013 77 21 days Iran 32 (18–55) 43 Acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL) undergoing allogenic HSCT (cycle unspecified); Karnofsky performance status <70%; Intervention at HSCT start and before the onset of OM. Selenium tablet (200 mcg) twice daily during transplantation and 14 days after (staff administered) plus standard care (20 drops of nystatin every three hours, chewable sucralfate tablet 500 mg every eight hours and mouth washes containing chlorhexidine 0.02% plus 10cc diluted povidone iodine every three hours). Placebo tablet (unspecified) twice daily during transplantation and 14 days after (staff administered) plus standard care.
Markiewicz et al., 2012 40 Poland 37 (19–57) 40 AML or ALL or chronic myelogenous leukemia undergoing HSCT; intervention on the first day of conditioning before the onset of OM. Calcium phosphate solution (equal volume, unspecified amount) four times daily self-administered until absolute neutrophil count ≥0.2 g/l. Topical mouth care extract of salvia leaves twice daily, povidone-iodine mouth solution once daily, fluconazole mouth solution, glycerine (50 mg), vitamin A (10 g) and vitamin E (10 g) with or without benzocoaine (2.5 g) twice daily self-administered until absolute neutrophil count ≥ 0.2 g/l.
Mansouri et al., 2012 60 3 weeks Iran 15 above 33 Hematologic malignancies undergoing high-dose chemotherapy conditioning regimen for allogenic HSCT (AML, ALL, CML, MDS) (cycle unspecified) intervention one day before conditioning and before the onset of OM. Zinc sulfate capsule 220 mg (50 mg zinc elemental) twice daily 12-h intervals for three weeks administered by hospital staff. Placebo capsules (unspecified components) twice daily in 1-hour intervals for three weeks administered by hospital staff.
Arbabi-kalati et al., 2012 50 20 weeks Iran 49 (18–79) 48 Patients undergoing chemotherapy with same OM probability and Karnofsky performance ≥60 (1st cycle) intervention at treatment start and before the onset of OM. Zinc sulfate capsule 220 mg three times daily self-administered until the end of chemotherapy. Placebo capsule (similar shape, taste, color to intervention) three times daily self-administered until the end of chemotherapy.
Mehdipour et al., 2011 45 8 weeks Iran 15 above Hematological malignancies and acute myeloid leukemia undergoing chemotherapy (cycle unspecified); intervention start unspecified; before the onset of OM. Zinc sulfate mouthwash (0.2% dilution) rinse twice daily for 14 days administered by an investigator.
Buntzelet al., 2010 39 7 years Greece 63 (38.7–83) 20 Head and neck (squamous cell carcinoma) cancer undergoing chemoradiotherapy (cycle unspecified) intervention at two days before starting radiotherapy. Sodium selenite oral fluid 500 µg one hour before radiotherapy; 300 µg during weekends and official holidays for unspecified length; unspecified administration. No intervention.
Lin et al., 2010 97 12 months Taiwan 52 (36–65) 20 Head and neck (nasopharangeal carcinoma) cancer or oral cancer (all stages) undergoing radiotherapy (recurrent or not); intervention start unspecified. Oral zinc capsules (25 mg Pro-Z) three times daily for two months; unspecified administration. Soybean oil capsules three times daily for two months; unspecified administration.
Watanabe et al., 2010 31 10 months Japan 65 (35–78) 23 HNC (stage II–IV) undergoing radiotherapy or radiochemotherapy (cycle unspecified) intervention at treatment start. Polaprezinc (Promac granules® 15%) 0.5 g dissolved in 20 ml of 5% sodium alginate solution four times daily (three minute oral rinse then swallow) until end of radiotherapy; Azulene (Azunol® Gargle liquid 4%) in 100 ml water four times daily (three minute oral rinse no swallow) until end of radiotherapy; unspecified administration.
Madan et al., 2008 80 6 weeks India 54 (18 above) 17 Head and neck malignancies (stage II–IV) undergoing radiotherapy (first cycle) intervention at treatment start before the onset of OM. 1% Povidone-iodine 10 ml mouthwash, twice daily for six weeks self-administered. Plain water 10 ml mouthwash, twice daily for six weeks self-administered.
Lin et al., 2006 100 12 months Taiwan 51 (39–62) 14 Head and neck cancer (stage I–IV) undergoing chemoradiotherapy (cycle unspecified) from first to last day of radiotherapy; OM status unspecified. Zinc capsules (25 mg Pro-Z) three times daily for two months; unspecified administration. Soybean oil capsules three times daily for two months; unspecified administration.
Vokurka et al., 2005 148 30 months Czech Republic 54 (20–70) 39 Patients undergoing high dose chemotherapy and autologous peripheral stem cell transplantation (unspecified cycle); intervention start unspecified. Povidone-iodine solution diluted 1:100 (Betadine 1 ml and 100 ml water for injection) mouth wash four times two minute gargle daily administered by study nurse for unspecified completion length. Saline (NaCl 9% water solution) mouth wash four times, two minute gargle daily administered by study nurse for unspecified completion length.
Ertekin et al., 2004 27 13 weeks Turkey 56 (18–71) 22 Head and neck cancer undergoing radiotherapy; (unspecified cycle); Karnofsky’s performance status ≥70; intervention at treatment start. Zinc sulfate (50 mg Zinc; Zinco 220 capsule) three times daily at eight hour intervals during radiotherapy and six weeks after treatment; unspecified administration. Empty placebo capsules taken three times daily at eight hour intervals during radiotherapy and six weeks after treatment; unspecified administration.
Papas et al., 2003 95 United States 43 (18–70) 6 HSCT (AML or ALL or chronic myelogenous leukemia, Hodgkin’s disease, non-Hodgkin’s lymphoma, multiple myelomas, myelodysplastic syndrome, breast cancer, ovarian cancer, other) (cycle unspecified); intervention start one week prior to treatment at screening. Caphosol® (Calcium phosphate) rinse four times daily, ten times daily when OM developed until engraftment and the resolution of OM; prior to HSCT four topical fluoride treatments of 1%F as neutral 2% NaF gel at screening; administered by trained unit nurses. Aqueous sodium fluoride 0.01% 30 ml rinse four times daily, ten times daily when OM developed until engraftment and the resolution of OM; prior to HSCT four topical treatments with placebo gel administered by trained unit nurses.