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Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting

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Abstract

Objectives

This study aimed to assess the cost-effectiveness of photobiomodulation therapy (PBMT) in association with a Preventive Oral Care Program (POCP) compared with POCP alone in the treatment of radiotherapy (RT)-induced oral mucositis (OM).

Methods

The cost-effectiveness was evaluated from the health provider perspective and conducted alongside a randomized, double-blind clinical trial. Participants were randomly assigned to either PBMT (n = 25) or control (n = 23) group. The PBMT group participants received PBMT associated with POCP. In the control group, patients were submitted to POCP alone. Costs were identified, quantified, and valued through observation and consultation of the hospital’s financial sector database and estimated in Brazilian real and converted to international dollars using the purchasing power parity exchange rate. The incremental cost-effectiveness ratio (ICER) was estimated by considering the prevention of severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores, measured by the OHIP-14 and patient-reported OM symptoms scale (PROMS).

Results

The incremental cost of PBMT was $857.35, and the cost per session was $25.69. The ICER was $ 2867.39 to avoid one case of severe OM and $ 2756.75 to prevent one interruption in RT due to OM. ICER to reduce 1 point in OHIP-14 and PROMS scores were $170.79 and $31.75, respectively.

Conclusion

PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions. PBMT is a promising therapy, especially to avoid interruptions in oncological treatment.

Trial registration

ReBEC-RBR-5h4y4n

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Funding

We thank the Foundation for Research Support in the State of Goiás—FAPEG/Ministry of Health of Brazil/ Brazilian National Council for Scientific and Technological Development—CNPq (PPSUS–201710267001233), and the Brazilian National Council for Scientific and Technological Development—CNPq (307906-7) for funding this study. This funding source did not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Author information

Authors and Affiliations

  1. Laboratory of Oral Pathology, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil

    Allisson Filipe Lopes Martins & Sebastião Silvério de Sousa-Neto

  2. Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil

    Túlio Eduardo Nogueira, Cláudio Rodrigues Leles & Elismauro Francisco Mendonça

  3. Araujo Jorge Cancer Hospital, R. 239, 206 - Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil

    Marília Oliveira Morais & Angélica Ferreira Oton-Leite

  4. Laboratory of Pharmacology and Cellular Toxicology, Pharmacy Faculty, Federal University of Goias, 5ª Avenida Esquina com Rua 240, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-170, Brazil

    Marize Campos Valadares

  5. Department of Radiotherapy, Araujo Jorge Cancer Hospital, R. 239, 206–Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil

    Nilceana Maya Aires Freitas

Authors
  1. Allisson Filipe Lopes Martins
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  2. Túlio Eduardo Nogueira
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  3. Marília Oliveira Morais
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  4. Sebastião Silvério de Sousa-Neto
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  5. Angélica Ferreira Oton-Leite
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  6. Marize Campos Valadares
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  8. Cláudio Rodrigues Leles
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  9. Elismauro Francisco Mendonça
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Allisson Filipe Lopes Martins, Marília Oliveira Morais, Sebastião Silvério Sousa-Neto, Angélica Ferreira Oton-Leite, and Tulio Eduardo Nogueira. The methods of the study were designed by Allisson Filipe Lopes Martins, Marize Campos Valadares, Nilcena Maya Aires Freitas, Cláudio Rodrigues Leles, and Elismauro Francisco de Mendonça. The first draft of the manuscript was written by Allisson Filipe Lopes Martins and Tulio Eduardo Nogueira. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Elismauro Francisco Mendonça.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval

This research was approved by the Ethics Research Committee of Universidade Federal de Goiás (Protocol 2.053.687/2017) and the Araujo Jorge Cancer Hospital (Protocol 2.131.323/2017).

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All participants signed an informed consent to participate of this study.

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Lopes Martins, A.F., Nogueira, T.E., Morais, M.O. et al. Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting. Support Care Cancer 29, 1245–1256 (2021). https://doi.org/10.1007/s00520-020-05607-6

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