Hyperbaric Oxygen Therapy to Reduce Lymphedema After Breast Cancer -an Explorative Clinical Trial

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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 disease progress.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Cancer Society
• Collaborators: Herlev Hospital; Rigshospitalet, Denmark

Criteria

Inclusion Criteria:

• 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 weeks

• 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.

Exclusion Criteria

• Pregnancy

• Undrained pneumothorax

• 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