The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: The Netherlands Cancer Institute

Criteria

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;

• Completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.

Exclusion Criteria:

• Poor responder to questionnaires (i.e. return of ≤ 2 UMBRELLA questionnaires);

• Previous HBOT;

• Contra-indications for HBOT (e.g. (severe) chronic obstructive pulmonary disease (COPD) or 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).