The effect of Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicitY

Phase 3

Completed

• Conditions: 10006232; Breast cancer; 10006291; 10006295; malignant breast tumor

• Registration Number: NL-OMON55553
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-02-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 240

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.

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 exclusions 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patient reported breast/chest wall pain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician<br /><br>reported pain and radiation toxicity (according to CTCAE criteria version<br /><br>4.03), tissue oxygenation previous to HBOT and after HBOT and side-effects of<br /><br>HBOT.</p><br>