Table 1.
Select studies in the treatment of radiation fibrosis in the head and neck.
| Study | Intervention | Study design and population | Results |
|---|---|---|---|
| Delanian et al. 73 | A combination of PTX (800 mg/d) and Vit E (1000 IU/d) was administered orally for at least 6 months | Phase 2 trial | 53% mean regression of fibrosis surface areas |
| Forty-three patients presenting with 50 distinct zones of chronic radiotherapy damage | Mean linear dimensions diminished from 6.5–4.5 cm | ||
| Mean subjective objective medical management and analytic (SOMA) scores improved significantly, from 13.2 to 6.9 | |||
| Chua et al. 17 | 8-week course of pentoxifylline at a dose of 400 mg two to three times daily | Pilot study | The mean dental gap before treatment was 12.5 mm compared with 16.5 mm at the end of treatment (P = .023) |
| Sixteen patients diagnosed with severe trismus (dental gap ⩽25 mm) after finishing radiotherapy for nasopharyngeal carcinoma | |||
| Hartl et al. 21 | Botox (Allergan) or 250 units of Dysport (Ipsen) * injected transcutaneously into the masseters | Prospective, nonrandomized | No improvement in trismus at 1 month |
| Nineteen patients in complete remission with radiation-induced pain and trismus with or without masticator spasms | Improvement in the function (P = .004), pain (P = .002), and cramps (P = .004) | ||
| No side effects occurred. | |||
| Landeen et al. 13 | Sodermix cream (280 IU/g superoxide dismutase) once daily on fibrotic area or placebo | Prospective, blinded study d | 46.4% Improvement in study arm vs 43.3% in placebo (Not statistically significant) |
| Randomized, prospective, blinded. | |||
| ⩾18 years, H&N radiation therapy-induced fibrosis | |||
| Zatarain et al. 67 | Stretching exercises with or without Dynasplint device during treatment and 3 months post-treatment | Phase 3, randomized 40 patients undergoing radiotherapy treatment for head and neck cancer | No benefit from using Dynasplint device regarding jaw opening (only 25% compliance in intervention arm) |
| Bourgier et al. 16 | Pravastatin 40 mg/d for 12 months | Phase 2 trial | 35.7% had ⩾30% decrease in thickness |
| Sixty NSCC cases in remission | 50% had decrease in severity | ||
| Grade ⩾2 cutaneous and subcutaneous neck radiation-induced fibrosis |
*
Dysport ipsen: abobotulinumtoxinA injection Dynasplint® Dynasplint systems company, Maryland, USA.