PMID- 34537889
OWN - NLM
STAT- MEDLINE
DCOM- 20220106
LR  - 20220531
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Print)
IS  - 0941-4355 (Linking)
VI  - 30
IP  - 2
DP  - 2022 Feb
TI  - New photobiomodulation device for prevention and cure of radiotherapy-induced 
      oral mucositis and dermatitis: results of the prospective Safe PBM study.
PG  - 1569-1577
LID - 10.1007/s00520-021-06574-2 [doi]
AB  - PURPOSE: The study aims to assess the feasibility, safety, and tolerability of 
      CareMin650, a new photobiomodulation device, in patients treated by radiotherapy 
      (RT) and to collect preliminary data on efficacy for prevention and treatment of 
      oral mucositis (OM) and radiation dermatitis (RD). METHODS: Safe PBM is a French, 
      multicentric, prospective, non-comparative study which include patients with head 
      and neck cancer (H&NC, cohort A) or breast cancer (BC, cohort B) treated in 
      prophylactic (cohorts A1 and B1) or curative setting (cohort A2 and B2). 
      Prophylactic treatment was administered from D1 to end of RT, at a dose of 
      3 J/cm(2). Curative treatment started when a grade 1 to grade 3 lesion had 
      occurred and was pursued until end of RT. Primary endpoint was incidence of 
      device-related adverse events (AEs). OM and RD lesions were graded according to 
      CTCAE V3. RESULTS: Overall, 72 patients were included (22, 9, 23, and 18 in 
      cohorts A1, A2, B1, and B2, respectively). No device-related AE was reported 
      after 1312 CareMin650 sessions. In cohorts A1 and B1, median time to first OM or 
      RD lesion was 20 days. One BC patient developed G3 RD after completion of RT and 
      discontinuation of CareMin650. Four H&NC patients developed G3 OM. In cohorts A2 
      and B2, lesions improved or stabilized in 71% of patients. Rates of satisfaction 
      were high among patients and users. CONCLUSION: CareMin650 is feasible, safe, and 
      well tolerated for preventive or curative treatment of OM and RD in cancer 
      patients treated with RT. Preliminary efficacy results are promising.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Bensadoun, Rene-Jean
AU  - Bensadoun RJ
AD  - Centre de Haute Energie, 10 Bd Pasteur, 06 000, Nice, France. 
      renejean.bensadoun@che-nice.com.
FAU - Bollet, Marc A
AU  - Bollet MA
AD  - Institut de Radiotherapie Et de Radiochirurgie Hartmann, 4 rue Kleber, 92300, 
      Levallois-Perret, France.
AD  - Maison de L'apres-Cancer Institut Rafael, 3 Boulevard Binau, 92300, 
      Levallois-Perret, France.
FAU - Liem, Xavier
AU  - Liem X
AD  - Departement de Radiotherapie Et Curietherapie, Centre Oscar Lambret, Lille, 
      France.
FAU - Cao, Kim
AU  - Cao K
AD  - Departement de Radiotherapie, Institut Curie, Paris, France.
FAU - Magne, Nicolas
AU  - Magne N
AD  - Departement de Radiotherapie, Institut de Cancerologie Lucien Neuwirth, 108 bis, 
      avenue Albert Raimond, 42270, Saint-Priest en Jarez, France.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210919
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
SB  - IM
MH  - *Head and Neck Neoplasms/radiotherapy
MH  - Humans
MH  - *Low-Level Light Therapy
MH  - Prospective Studies
MH  - *Radiodermatitis/etiology/prevention & control
MH  - *Stomatitis/etiology/prevention & control
PMC - PMC8449745
OTO - NOTNLM
OT  - Breast cancer
OT  - Head and neck cancer
OT  - Oral mucositis
OT  - Photobiomodulation
OT  - Radiation dermatitis
COIS- The authors declare no competing interests.
EDAT- 2021/09/20 06:00
MHDA- 2022/01/07 06:00
PMCR- 2021/09/19
CRDT- 2021/09/19 20:53
PHST- 2021/06/14 00:00 [received]
PHST- 2021/09/13 00:00 [accepted]
PHST- 2021/09/20 06:00 [pubmed]
PHST- 2022/01/07 06:00 [medline]
PHST- 2021/09/19 20:53 [entrez]
PHST- 2021/09/19 00:00 [pmc-release]
AID - 10.1007/s00520-021-06574-2 [pii]
AID - 6574 [pii]
AID - 10.1007/s00520-021-06574-2 [doi]
PST - ppublish
SO  - Support Care Cancer. 2022 Feb;30(2):1569-1577. doi: 10.1007/s00520-021-06574-2. 
      Epub 2021 Sep 19.