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

NCT02895724 | Unknown Phase 2 DMC

• 1 other identifier: H-16019587
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Secondary Lymphedema

Keywords

Hyperbaric oxygen therapy; secondary lymphedema

Outcome Measures

Primary Outcomes (1)

• Arm volume

  measured by perometry and DXA scans

  8 months

Secondary Outcomes (4)

• lymph clearance

  8 months

• Functional impairment

  8 months

• psychological well-being

  8 months

• blood biomarkers

  8 months

Study Arms (2)

HBOT receivers

EXPERIMENTAL

Participants in a post breast cancer surgery randomized controlled trial detected with lymphedema 1 year postoperatively are invited to 40 consequtive treatments of hyperbaric oxygen therapy to reduce lymphedema. The experimental drug is 100% medical oxygen given in a pressure chamber of 2,4 bar,every treatment lasting approximately 100 minutes.

Drug: Medical Oxygen

blodsample comparison

NO INTERVENTION

Matched Lymphedema free participants from LYCA Exercise recruited to donate blood samples for comparison on important blod biomarkers and collagen levels.

Interventions

Medical Oxygen DRUG

Hyperbaric oxygen therapy

HBOT receivers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Cancer Society: lead
• Rigshospitalet, Denmark: collaborator
• Herlev Hospital: collaborator

Study Officials

• Ole Hyldegaard, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02