The Effect of Hyperbaric Oxygen Therapy on Breast Cancer Patients With Late Radiation Toxicity

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.

Condition:

Breast Cancer

Treatment:

Hyperbaric oxygen therapy

Start Date:

August 28, 2019

Sponsor:

UMC Utrecht

For More Information:

https://clinicaltrials.gov/show/NCT04193722

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