Manual Lymph Drainage for External Lymphedema

NCT07215169 | Recruiting

• 1 other identifier: 2023-04456-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of a randomized controlled trial. The future randomized controlled trial will compare two groups following different intensities of manual lymphatic drainage for external head- and neck lymphedema among persons treated with radiotherapy for head- and neck cancer.

Conditions

Lymphedema of Face; Neoplasms; Radiotherapy Side Effect; Lymphedema Due to Radiation

Keywords

Head and neck lymphedema management

Outcome Measures

Primary Outcomes (1)

• Recruitment rate, retention rate, adverse events, and ability to collect outcomes

  of recruitment rate, calculated as the percentage of individuals who agreed to be in the study among those who were qualified; retention rate, calculated as the percentage of individuals who completed the intervention; the ability to collect data, calculated as the percentage of completed collected data at baseline and follow-up; and adverse events, which is the num-ber of harmful or negative events that may have influenced the study procedure

  Two and twelve weeks after inclusion

Study Arms (2)

HIT

EXPERIMENTAL

High-intensity treatment with manual lymphedema drainage.

Other: HIT

LIT

OTHER

Low-intensity treatment with manual lymphedema drainage, which is the standard treatment.

Other: LIT

Interventions

HIT OTHER

Manual Lymph Drainage 20 completions, first over the neck, then the face, and finally the neck again. This is repeated every second hour during the daytime.

HIT

LIT OTHER

Manual Lymph Drainage 20 completions, first over the neck, then the face, and finally the neck again once a day.

LIT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a previous diagnosis of oropharyngeal cancer (all histological types are accepted)
• age \>18 years
• ability to give written and informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lund University: lead
• Lund University Hospital: collaborator

Study Sites (1)

Lund university

Lund, Skåne County, 22100, Sweden

RECRUITING

MeSH Terms

Conditions

Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Eva Ekvall Hansson, Professor

  Lund University, Medical Faculty, Dep of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Ekvall Hansson, Professor, RPT

CONTACT

+46462221986; eva.ekvall-hansson@med.lu.se

Agneta Hagren, Registered Nurse

CONTACT

+4646175964; agneta.hagren@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The person who will do the randomization, the outcome assessor, and the care provider will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot and feasibility study of a randomized controlled trial

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

SE (1)