Tactile Medical presented two-month data from the largest randomized controlled trial on head and neck cancer-related lymphedema at the ASCO 2025 Annual Meeting. The study compared the effectiveness of their Flexitouch Plus pneumatic compression device against usual care, involving 236 participants across multiple sites. Early results indicate that both usual care and the Flexitouch Plus device are effective, with the device offering faster access to therapy and significant swelling reduction.
This research is vital because it addresses the significant unmet need for accessible and effective lymphedema treatment among head and neck cancer survivors. Current standard treatments often face access barriers, leading to delays in care. The study demonstrates that at-home pneumatic compression therapy provides a viable alternative, potentially increasing the number of patients who receive timely and effective treatment. This is particularly important given that a high percentage of head and neck cancer survivors develop lymphedema.
The two-month data revealed that while both treatment arms showed symptom improvement, participants using the Flexitouch Plus device received treatment significantly faster (17.9 days vs. 29.8 days for usual care) and had a higher rate of treatment initiation (94.9% vs. 71%). Furthermore, the device group experienced more significant swelling reduction as measured by digital photography and specific grading scores. While both groups reported symptom improvement, the Flexitouch Plus group showed statistically significant improvements in three out of six quality-of-life subscales.
This positive two-month data suggests that Flexitouch Plus can play a significant role in improving the management of head and neck cancer-related lymphedema. The anticipated six-month data could further strengthen the evidence supporting the device’s efficacy, potentially leading to broader insurance coverage, inclusion in clinical guidelines, and increased awareness among both patients and healthcare providers. This could ultimately improve access to much-needed lymphedema care for this patient population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
