Manual Lymph Drainage for External Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
HIT
Other interventionManual 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.
LIT
Other interventionManual Lymph Drainage 20 completions, first over the neck, then the face, and finally the neck again once a day.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: HITExperimental treatment 1 intervention
Group B: LITOther 1 intervention
Trial outcomes
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
Time frame
Two and twelve weeks after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lund University
Lead sponsor
Lund University Hospital
Collaborator
Source ClinicalTrials.gov