Abstract
Purpose
Lymphedema (LE) is a common complication after breast cancer treatment, which negatively affects the quality of life (QOL). Hyperbaric Oxygen Treatment (HBOT) is an established treatment for radiation-induced tissue injury, but evidence of effect on breast cancer-related LE is inconclusive. We aimed to explore effects of HBOT on early breast cancer-related LE and the implications for QOL.
Methods
We invited women with breast cancer treated with surgery, axillary dissection and radiotherapy, who had participated in a randomized controlled trial and who presented with LE 1 year after surgery. In a prospective observational study design, change in LE was assessed with perometry, dual-energy X-ray absorptiometry (DXA) and lymphoscintigraphy, and QOL by validated self-report scales. Participants were offered 40 sessions of HBOT on every weekday for 8 weeks and were followed for 6 months.
Results
Out of 50 eligible participants, 20 women accepted participation. Nineteen women initiated and completed treatment and follow-up. None of the objective measures of LE severity showed consistent changes during the study period, but participants reported significant improvements in QOL (physical functioning, fatigue, insomnia and breast and arm symptoms), with improvements peaking at 6-month follow-up.
Conclusion
Participants receiving HBOT experienced improved QOL without consistently significant changes in arm mass, volume or lymphatic drainage. These results call for studies into differential effect in patient sub-groups, and a large-scale, randomized placebo-controlled trial with long-term follow-up to assess the effect of HBOT in patients with soft tissue radiation injuries after breast cancer seems warranted.
Trial registration
Danish Health and Medicines Authority, EUDRACT no. 2015–000,604-25 Ethical committee of the Capitol Region, No. R96-A6604-14-S22.
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Data availability
Data may be available by contacting the corresponding author upon reasonable request.
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Acknowledgements
The authors acknowledge the valuable input from senior statistician Elisabeth Wreford Andersen at the Danish Cancer Society Research Center in discussions about methodology in analyses of data.
Funding
The study was funded by Knæk Cancer (2014) through a grant obtained by Susanne Oksbjerg Dalton and by TrygFonden through a grant obtained by Gunn Ammitzbøll. OH’s research position was also funded by the Ellabfonden in Denmark. The funding sources have had no role in the design of the study; collection, analysis, and interpretation of data; and writing the manuscript.
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Contributions
GA: conceptualization, data curation, formal analysis, funding acquisition, methodology, investigation, project administration, validation, writing—original draft and writing—review and editing.
CJ: conceptualization, funding acquisition, methodology, resources, supervision and writing—review and editing.
CL: methodology, resources, supervision and writing—review and editing.
NK: conceptualization, funding acquisition, methodology, resources and writing—review and editing.
BZ: conceptualization, funding acquisition, methodology, investigation, resources and writing—review and editing.
LTJ: conceptualization, methodology, investigation, resources and writing—review and editing.
OH: conceptualization, funding acquisition, methodology and writing—review and editing.
SOD: conceptualization, funding acquisition, methodology, resources, supervision and writing—review and editing.
MF: data curation, investigation, project administration, validation and writing—review and editing.
HR: investigation, project administration, validation, writing—review and editing.
All authors read and approved the final manuscript.
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This study was performed in line with the principles of the Declaration of Helsinki. All participants gave written informed consent before any initiation of study activities. The trial was approved by the Danish Health and Medicines Authority as a trial including medicinal gas (EUDRACT no. 2015–000604-25), and the Ethical committee of the Capitol Region (No. R96-A6604-14-S22).
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The authors declare no competing interests.
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Ammitzbøll, G., Hyldegaard, O., Forchhammer, M. et al. Effects of an early intervention with Hyperbaric Oxygen Treatment on arm lymphedema and quality of life after breast cancer—an explorative clinical trial. Support Care Cancer 31, 313 (2023). https://doi.org/10.1007/s00520-023-07774-8
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DOI: https://doi.org/10.1007/s00520-023-07774-8