van der Molen 2011.
| Methods |
Allocation: randomised clinical trial Design: parallel‐group |
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| Participants |
Number: 55 Age (mean): 56 years (37 to 78); control: 57 years (32 to 75) Gender: sex ratio: TheraBite jaw motion rehabilitation group: 23 (96%) males, 1 (4%) female; standard group: jaw ROM exercises group: 16 (64%) males, 9 (36%) females Setting: Netherlands Cancer Institute Eligibility criteria: ‐ Squamous cell carcinoma ‐ Oral cavity, oropharynx, hypopharynx, larynx and nasopharynx tumours ‐ Stage III‐IV head and neck cancers ‐ Primary treatment with concomitant chemoradiotherapy (CCRT) with curative intent ‐ Written informed consent Exclusion criteria: ‐ Unable to comprehend the function and use of the rehabilitation exercises and device (e.g. Alzheimer's disease, Korsakov's disease) ‐ Physically unfit to use a rehabilitation device (e.g. neurological deficit) Baseline characteristics: Primary site of tumour: Nasopharynx: 3 (13%) intervention group, (16%) control group Oral cavity/oropharynx: 12 (50%) intervention group, 12 (47%) control group Larynx/hypopharynx: 9 (37%) intervention group, 9 (37%) control group Tumour stage: Stage III‐IV tumours Stage III: intervention group: 7 (29%) control group: 9 (36%) Stage IV: intervention group: 17 (71%), control group: 16 (64%) |
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| Interventions |
Allocation of participants: 55 head and neck cancer patients treated with concomitant chemoradiotherapy (CRT) Intervention A: standard care (control group) ‐ Jaw ROM exercise: 3 times daily; 3 repetitions each ‐ Strengthening exercises: 3 times daily; 5 repetitions each (effortful swallow, Masako manoeuvre, super‐supra‐glottic swallow) (n = 28) Intervention B: ‐ Therabite jaw motion rehabilitation system, 3 times daily, 3 repetitions (slow mouth opening, swallowing with tongue elevated to palate and 50% maximum mouth opening) (n = 27) Interventions began 2 weeks before CRT and continued throughout treatment Use of additional interventions: none |
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| Outcomes |
NB: Specific outcomes of interest to this review are bolded and marked with an asterisk Patients were assessed 2 weeks before the onset of CCRT and approximately 10 weeks after completing same
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| Funding sources | Part of study was supported by an unrestricted research grant from Atos Medical, Horby, Sweden | |
| Declarations of interest | Not reported | |
| Notes | Single‐centre study All patients received 100 mg/m2cisplatin as a 40‐minute IV infusion on days 1, 22 and 43. Intensity‐modulated radiotherapy (IMRT) of 70 Gy in 35 fractions was administered over 7 weeks starting concurrently with chemotherapy. Cross‐over between treatment groups: not reported Sample size calculation: no details Language: English Participants lost to follow‐up: TAU group (n = 3); intervention group (n = 3) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised centrally by computer using blocks of 6 and stratified by tumour site |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not reported |
| Blinding of outcome assessment (detection bias) Primary outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up reported and explained but poor compliance with treatment reported; only 7 patients (17%) practised daily throughout CRT |
| Selective reporting (reporting bias) | Low risk | Protocol is available and reported outcomes matched those planned |
| Other bias | High risk | Patients in control group practised significantly more days than patients in treatment group (P = 0.05; mean 59 and 41 days respectively) Compliance was assessed by use of "familiarity with exercise" score but familiarity does not necessarily equate to compliance |
AJCC: American Joint Committee on Cancer BMI: body mass index CCRT: concomitant chemoradiotherapy CRT: chemoradiotherapy EORTC: European Organisation for Research and Treatment of Cancer FOIS: Functional Oral Intake Scale HNC: head and neck cancer HNCI: Head and Neck Cancer Inventory IOPI: Iowa Oral Performance Instrument IV: intravenous LENT/SOMA scales: Late Effects Normal Tissue (LENT)/Subjective, Objective, Management, Analytic (SOMA) scales M‐DADI: MD Anderson Dysphagia Inventory MRI: magnetic resonance imaging N/A: not applicable NFIS‐HN‐F: Normalcy of Food Intake Scale for Head and Neck ‐ Dietetic Part NFIS‐HN‐L: Normalcy of Food Intake Scale for Head and Neck‐ Logopedic Part NPC: nasopharyngeal carcinoma OPSE: Oropharyngeal Swallowing Efficiency PEG: percutaneous endoscopic gastroscopy PSS‐H&N: Performance Status Scale for Head and Neck ROM: range of motion RT: radiotherapy SCC: squamous cell carcinoma SPSS: Statistical Package for the Social Sciences TAU: treatment as usual TNM: tumour, node, metastasis VAS: visual analogue scale VFSS: videofluoroscopic swallowing study