The effect of hyperbaric oxygen therapy on breast cancer patients with late radiation toxicity

Phase 1

• Conditions: ate radiation toxicity; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002635-28-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-14
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire
-Participation >12 months in the UMBRELLA cohort;
-Previous treatment with radiotherapy for breast cancer;
-Finished surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Poor responder (i.e. return of =2 UMBRELLA questionnaires);
-Previous HBOT;
-Contra-indications for HBOT (e.g. (severe) COPD/asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure);
-Current metastatic disease or recurrent breast cancer.
Additional exclusion criteria based on screening visit
-Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays > 2 days);
-Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified