drugset / Trial / NCT04193722
The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial
RandomizedParallel-groupOpen-labelTreatment
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
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 |