Radiation Oncology/HN-supportive care
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Cevimeline (Exovac) - 30 mg TID. Can increase to 45 mg.
- 2 randomized studies comparing with placebo: PRT 003 and PRT 004.
- FDA approved for Sjogren's (but not XRT)
- PRT 003 and 004
- Randomized. 570 patients (284 in PRT 003, 286 in PRT 004). Cevimeline 30mg TID or placebo. Possible dose-escalation to 45 mg TID at 6 weeks
- 2007 PMID 17379432 -- "Cevimeline for the treatment of postirradiation xerostomia in patients with head and neck cancer." (Chambers MS, Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1102-9.)
- Outcome: PRT 003: improvement in dry mouth civemeline 47% vs. placebo 33% (SS); no difference in PRT 004. Both studies significantly greater stimulated salivary flow
- Conclusion: well tolerated, improves unstimulated salivary flow
Caphosol (artificial saliva) Website (Rx only)
- 1 box = 30 doses. use 4 to 10 doses / day.
- Supersatured solution of calcium and phosphate.
- Indicated for xerostomia and mucositis
- RTOG 97-09
- Netherlands - PMID 16804929 — "Radiotherapy alone, versus radiotherapy with amifostine 3 times weekly, versus radiotherapy with amifostine 5 times weekly: a prospective randomized study in squamous cell head and neck cancer." Jellema AP et al. Cancer. 2006 Jun 27; [Epub ahead of print]
- Randomized. RT alone vs amifostine 5 days/wk vs amifostine 3 days/wk, both at 200 mg/m2. All received bilateral neck RT. Assessed acute and late xerostomia and QOL at 6 weeks and every 6 months until 2 yrs.
- Difference in grade 2 or greater xerostomia at 6 months but not later. 28% of pts discontinued amifostine.
- Biotene products (Website) (OTC)
- Mouthwash, gum, gel, liquid (spray bottle). Also toothpaste.
- Numoisyn (Website) (Rx)
- Lozenges (100 per bottle) - use PRN, up to 16/day
- Liquid (30 cc or 300 cc bottle) - use 2 cc (1/2 tsp) PRN, rinse in mouth
- South Korea
- Randomized. 12 patients with H&N cancer and radiation-induced xerostomia. Arm 1) real acupuncture vs. Arm 2) sham acupuncture BIW x 6 weeks. Measured whole stimulated and unstimulated salivary flow rate, and questionnaire at 3 and 6 weeks after acupuncture
- 2008 PMID 18532895 -- "Manual Acupuncture Improved Quality of Life in Cancer Patients with Radiation-Induced Xerostomia." (Cho JH, J Altern Complement Med. 2008 Jun 4. [Epub ahead of print])
- Outcome: Whole salivary flow rate: no difference. Unstimulated flow rate: acupuncture significantly better. Subjective: acupuncture significantly less xerostomia
- Conclusion: Significantly improved amelioration of subjective xerostomia
- Genoa (Italy) -- placebo vs. prophylactic fluconazole
- Randomized. 270 patients with H&N tumors, excluding glottic T1-2. Conventional RT fractionation. Arm 1) fluconazole 100 mg QD vs. Arm 2) placebo. Starting 6th treatment until end of treatment. ~50% patients had baseline yeast cultured. If patients developed candidiasis, they could stop protocol and be treated with antimycotics at MD discretion
- 2008 PMID 18419630 -- "Effects of fluconazole in the prophylaxis of oropharyngeal candidiasis in patients undergoing radiotherapy for head and neck tumour: results from a double-blind placebo-controlled trial." (Corvo R, Eur J Cancer Care (Engl). 2008 May;17(3):270-7.)
- Outcome: candidiasis-free survival improved at 6 weeks fluconazole 81% vs. placebo 64% (SS) and 8 weeks 76% vs. 57% (SS); time-to-outbreak fluconazole 56 days vs. placebo 47 days; mean duration of RT fluconazole 39.9 days vs. placebo 43.5 days (SS)
- All adverse events: fluconazole 70% vs. placebo 67% (NS) - most related to RT not fluconazole
- Conclusion: Prophylaxis with fluconazole significantly reduces rate and improves time to development of oral candidiasis
Loramyc mucoadhesive buccal tablet (MBT)
- Nice (France) -- placebo vs. prophylactic miconazole
- Randomized. 282 patients, H&N cancer. Arm 1) single-dose 50mg MBT miconazole vs. Arm 2) 500 mg oral gel (MOG) miconazole in 4 doses
- 2007 PMID 18044772 -- "Comparison of the efficacy and safety of miconazole 50-mg mucoadhesive buccal tablets with miconazole 500-mg gel in the treatment of oropharyngeal candidiasis: a prospective, randomized, single-blind, multicenter, comparative, phase III trial in patients treated with radiotherapy for head and neck cancer." (Bensadoun RJ, Cancer. 2007 Nov 28 [Epub ahead of print])
- Outcome: Clinical success MBT 56% vs. MOG 49% (NS), superiority for MBT if multiple oral lesions
- Conclusion: MBT Loramyc well tolerated and not inferior; can be recommended as first-line treatment
Please see Skin care
- Therabite - plastic device used to stretch the jaw
- Stack of tongue blades
- Sahlgrenska University Hospital (Sweden) -- prophylactic PEG tube versus as-needed enteral support
- Randomized multicenter trial. 134 patients with stage III/IV H&N cancer treated with curative intent therapy including radiotherapy (58% oropharynx, 69% chemoradiotherapy). Arm 1) PEG inserted prior to treatment start. Arm 2) Treatment per standard clinical practice. Rigorous 2-year follow-up with EORTC health-related quality of life (HRQOL) questionnaires, dietitian visits.
- 2012 PMID 21374756 -- "Impact of prophylactic percutaneous endoscopic gastrostomy on malnutrition and quality of life in patients with head and neck cancer: a randomized study" (Silander E, Head Neck. 2012 Jan;34(1):1-9.)
- Outcome: 73% of control group eventually required enteral feeding support. HRQOL better in prophylactic PEG arm, biggest difference at 6 months: global health status 64 vs. 52, p=0.02. Less weight loss in prophylactic PEG arm, but p=NS: 8.8 vs 9.6 kg at 6 months. Overall survival similar, logrank p=0.41.
- Conclusion: Malnutrition is common after treatment for advanced H&N cancer. Prophylactic PEG may improve quality of life and reduce weight loss.
- Peter MacCallum Cancer Centre (Australia) -- NGT vs PEG tube
- Randomized. Closed early due to poor accrual. 33/150 patients, H&N cancer planned for curative RT, 'anticipated to require enteral feeding' (whole oral cavity RT, AHFX, CRT, >10% weight loss). Arm 1) percutaneous endoscopic gastrostomy (PEG) tube vs. Arm 2) nasogastric (NGT) tube. Criteria for insertion: intake <50% of calculated daily nutritional requirement and/or >5kg weight loss from start of treatment
- 2008 PMID 19032398 -- "Randomized study of percutaneous endoscopic gastrostomy versus nasogastric tubes for enteral feeding in head and neck cancer patients treated with (chemo)radiation." (Corry J, J Med Imaging Radiat Oncol. 2008 Oct;52(5):503-10.)
- Outcome: No difference in absolute weight, upper arm circumference at 6 weeks post treatment. No difference in weight loss at 6 months. Median duration of use PEG 4.6 months vs. NGT 2.2 months (SS)
- Toxicity: No difference in G3 dysphagia. PEG site infections 27%, NGT dislodgement 61%. No difference in chest infection. QoL overall no difference, but more pain with PEG (SS), more inconvenience with NGT (SS), more altered body image with NGT (SS) during first week. No difference at removal.
- Cost: NGT $76 vs. PEG $736
- Patient selection: Off study, when patients allowed to choose, NGT = 73 patients and PEG = 32 patients
- Conclusion: No evidence to support routine use of PEG tubes over NGT