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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55553

Enrollment

240

Registered

2019-08-28

Start date

2019-12-04

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer malignant breast tumor

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion 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; - Finished surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.

Exclusion criteria

Exclusion criteria: - Poor responder (i.e. return of 2 days); - Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).

Design outcomes

Primary

Measure	Time frame
Patient reported breast/chest wall pain.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)