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

Last updated: March 28, 2025
Sponsor: UMC Utrecht
Overall Status: Completed

Phase

3

Condition

Cancer

Breast Cancer

Treatment

Hyperbaric oxygen therapy

Clinical Study ID

NCT04193722
NL69081.041.19
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiationtoxicity questionnaire;

  • Participation >12 months in the UMBRELLA cohort;

  • Previous treatment with radiotherapy for breast cancer;

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

Exclusion

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, severeheart 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 toscheduled holidays > 2 days);

  • Not meeting criteria for HBOT (e.g. due to complaints similar to late radiationtoxicity, not caused by radiotherapy).

Study Design

Total Participants: 189
Treatment Group(s): 1
Primary Treatment: Hyperbaric oxygen therapy
Phase: 3
Study Start date:
August 28, 2019
Estimated Completion Date:
May 08, 2023

Study Description

Objective: The aim of this study is to assess whether HBOT reduces pain, and improves physical functioning and QoL in breast cancer patients with late radiation toxicity.

Study design: Randomized controlled trial, nested within the prospective UMBRELLA breast cancer cohort according to the TWiC's design. UMBRELLA is a prospective cohort study including all breast cancer patients visiting the University Medical Center (UMC) Utrecht department of Radiotherapy. In total 120 patients will be randomized in a ratio of 2:1.

Study population: Breast cancer patients participating in the UMBRELLA cohort who have given informed consent to be invited for future research (e.g. cmRCT's), and who have reported symptoms of late radiation toxicity.

Intervention: Eligible patients will be referred to the HBO center for a standard HBO treatment. HBOT consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber.

Main study parameters/endpoints: The primary endpoint of this study is patient reported breast/chest wall pain. Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician reported pain and radiation toxicity (according to CTCAE criteria version 4.03, tissue oxygenation previous to HBOT and after HBOT and side-effects of HBOT.

Connect with a study center

  • University Medical Center Utrecht

    Utrecht, 3508GA
    Netherlands

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.