Self‑manual lymph drainage for head and neck lymphedema
Official title: The Effect of Manual Lymph Drainage for Cancer Treatment-related External Lymphedema in the Head and Neck - a Pilot and Feasibility Study of a Randomized Controlled Trial
Run by Lund University · NCT07215169 · Data updated 2026-11-12
This trial will test whether different intensities of self‑applied manual lymph drainage help people with head and neck lymphedema after radiotherapy for oropharyngeal cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Lund, Skåne County) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | October 10, 2025 |
| Trial ID | NCT07215169 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (>18 years) with oropharyngeal cancer treated with curative (chemo)radiotherapy of at least 68 Gy within the past year who have clinically measurable external head and neck lymphedema and can perform self‑MLD and give informed consent.
✕Probably not a fit
Patients who are pregnant, have recent head and neck surgery or Botox in the treatment area, active locoregional infection, prior daily self‑MLD or other concurrent lymphedema treatments (e.g., compression), or uncontrolled psychiatric/substance use problems are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a feasibility randomized controlled trial conducted at Skåne University Hospital in Lund, Sweden, comparing a highly intensive (HIT) versus a lower intensity (LIT) self‑manual lymph drainage program for external head and neck lymphedema. Eligible adults treated with curative (chemo)radiotherapy to the primary site (≥68 Gy) within the past year and with clinically confirmed lymphedema will be randomized. The HIT arm requires frequent self‑MLD sessions (multiple times daily with specified stroke counts) while the LIT arm follows a lower frequency protocol, and outcomes and adherence will be monitored over 12 weeks. The primary aim is to determine feasibility and inform a future larger randomized trial of efficacy.
Why it matters
Potential benefit: If successful, the intervention could reduce facial and neck swelling, improve comfort and function, and provide a low‑cost self‑care option for radiation‑related head and neck lymphedema.
How similar studies have gone: Manual lymph drainage is commonly used in clinical practice and small trials and case series suggest possible symptom benefit in head and neck lymphedema, but high‑quality randomized evidence is limited and this study is a feasibility step toward that evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • a previous diagnosis of oropharyngeal cancer (all histological types are accepted) * curative treatment with (chemo)radiotherapy to at least 68Gy at the primary site completed no more than 1 year before the study inclusion * age \>18 years * ability to give written and informed consent. Exclusion Criteria: * • pregnancy * surgery or Botox injections in the tissue of the head and neck area * Locoregional deep infection i.e., suspected abscess at the scheduled time points for measurements. * prior daily treatment with Self MLD * other treatment of head and neck lymphedema, for example compression * psychiatric disorders * substance abuse problems
Where it's running
-
Lund university
Lund, Skåne County, Sweden Recruiting
Study contacts
- Principal investigator: Eva Ekvall Hansson, Professor — Lund University, Medical Faculty, Dep of Health Sciences
- Study coordinator: Eva Ekvall Hansson, Professor, RPT
- Email: eva.ekvall-hansson@med.lu.se
- Phone: +46462221986
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.