Purpose:

Lymphedema is a common debilitating late effect among patients post-head and neck cancer (HNC) treatment. Head and neck lymphedema was associated with symptom burden, functional impairment, and decreased quality of life. The objective of this study was to determine the feasibility and potential efficacy of the use of photobiomodulation (PBM) therapy for head and neck lymphedema, symptom burden, and neck range of motion among HNC survivors.

Methods:

This was a single-arm, pre- and post-design clinical trial. Eligible patients included those with lymphedema after completion of complete decongestive therapy (CDT) and 3 to 18 months after completion of cancer therapy. The intervention included PBM therapy 2 times a week for 6 weeks for a total of 12 treatments. Lymphedema, symptom burden, and neck range of motion were measured at baseline, end-of-intervention, and 4-week post-intervention.

Results:

Of the 12 patients enrolled in the study, 91.7% (n = 11) completed the study intervention and assessment visits, and no adverse events were reported. When comparing the baseline to 4-week post-intervention, we found statistically significant improvements in the severity of external lymphedema, symptom burden, and neck range of motion (all P < .05).

Conclusion:

PBM therapy was feasible and potentially effective for the treatment of head and neck lymphedema. Future randomized controlled trials are warranted to examine the efficacy of PBM therapy for HNC-related lymphedema.

Trial Registration Number and Date of Registration:

ClinicalTrials.gov Identifier: NCT03738332; date of registration: November 13, 2018.

中文翻译：

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头颈癌相关淋巴水肿的光生物调节疗法：试点可行性研究

 目的：

淋巴水肿是头颈癌 (HNC) 治疗后患者常见的一种使人衰弱的晚期效应。头颈部淋巴水肿与症状负担、功能障碍和生活质量下降相关。本研究的目的是确定使用光生物调节 (PBM) 疗法治疗 HNC 幸存者头颈部淋巴水肿、症状负担和颈部活动范围的可行性和潜在疗效。

 方法：

这是一项单臂、设计前和设计后的临床试验。符合条件的患者包括完成完全去充血治疗（CDT）后以及完成癌症治疗后3至18个月后出现淋巴水肿的患者。干预措施包括每周 2 次 PBM 治疗，持续 6 周，总共 12 次治疗。在基线、干预结束和干预后 4 周测量淋巴水肿、症状负担和颈部活动范围。

 结果：

在参加该研究的 12 名患者中，91.7%（n = 11）完成了研究干预和评估访视，并且没有报告不良事件。当将基线与干预后 4 周进行比较时，我们发现外部淋巴水肿的严重程度、症状负担和颈部活动范围有统计学上的显着改善（所有P < .05）。

 结论：

PBM 疗法对于治疗头颈部淋巴水肿是可行的并且可能有效。未来的随机对照试验有必要检验 PBM 疗法对 HNC 相关淋巴水肿的疗效。

试用注册号和注册日期：

ClinicalTrials.gov 标识符：NCT03738332；报名日期：2018年11月13日。