The purpose of this study is to examine if pressurechamber treatment (HBOT) can reduce early
stages of breast cancer related lymphedema, and to explore the mechanisms involved in the
Drug: Medical Oxygen
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Full eligibility criteria for NCT02895724
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Participant in "LYCA - exercise"
Declared cancer free
Completed chemotherapy and radiotherapy (maximum 1 year after completed treatment)
Lymphedema present when measured at "Lyca-exercise" 1 year follow-up: >3% increase in
inter limb volume change from the baseline measurement, AND a score of 2 points or
more on NRS for symptoms (heaviness, tightness, swelling), persisting more than 4
Two or more of the following clinical criteria must be present (i-iii are compared
with the unaffected side): i) decreased visibility of subcutaneous veins on the
ventral lower arm or dorsal hand, ii) loss of normal contours in the region of the
medial side of the elbow/distal end of the upper arm, iii) thicker skin and subcutis
on palpation, iv) pitting edema.
Unability to equalize pressure in the ears in spite of drain treatment by Ear- Nose-
and Throat specialist.
Severe heart failure detected during pre-examination for HBOT
Intractable Claustrophobia non-responsive of standard pre-medication
All locations for NCT02895724
View full eligibility
Tris trial is registered with FDA with number: NCT02895724. The sponsor of the trial is Danish Cancer Society and it is looking for 20 volunteers for the current phase.
Official trial title: Hyperbaric Oxygen Therapy to Reduce Lymphedema After Breast Cancer -an Explorative Clinical Trial
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