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

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.

Timeline

Start

2019-08-28

Primary completion

2023-05-08

Completion

2023-05-08

Outcome

Missed primary endpoint

paper offering HBOT to women with late local toxic effects was not effective for reducing pain PMID 38329746 ↗

paper 32 of 52 women (62%) in the control arm (odds ratio [OR], 0.63; 95% CI, 0.32-1.23; P = .18). PMID 38329746 ↗

Publications

• Mink van der Molen DR, Batenburg MCT, Maarse W, van den Bongard DHJG, Doeksen A, de Lange MY, van der Pol CC, Evers DJ, Lansdorp CA, van der Laan J, van de Ven PM, van der Leij F, Verkooijen HM. Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):464-474. doi: 10.1001/jamaoncol.2023.6776.
• Batenburg MCT, van den Bongard HJGD, Kleynen CE, Maarse W, Witkamp A, Ernst M, Doeksen A, van Dalen T, Sier M, Schoenmaeckers EJP, Baas IO, Verkooijen HM. Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design. Trials. 2020 Nov 27;21(1):980. doi: 10.1186/s13063-020-04869-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oxygen	Other / unclassified	100 %	Inhaled

Indications