.: ORİJİNAL ARAŞTIRMA
The Effect of Oral Cryotherapy and Gargling with Cold Water in the Prevention and Symptom Management of Oral Mucositis the Patients with Breast Cancer Undergoing Chemotherapy: An Assessor-Blinded, Parallel-Group, Three-Arm, Randomized Controlled Study
Kemoterapi Tedavisi Gören Meme Kanserli Hastalarda Oral Mukozitin Önlenmesinde ve Semptom Yönetiminde Oral Kriyoterapi ve Soğuk Suyla Gargara Yapmanın Etkisi: Değerlendirici-Kör, Paralel Gruplu, Üç-Kollu, Randomize Kontrollü Çalışma
Turkiye Klinikleri J Nurs Sci. 2025;17(1):249-58
doi: 10.5336/nurses.2024-105009
Makale Dili: EN
Tam Metin
ABSTRACT
Objective: To determine the effects of oral cryotherapy (OC) and gargling with cold water (GCW) in the prevention and symptom management of oral mucositis (OM) in patients with breast cancer undergoing chemotherapy. Material and Methods: This parallel-grouped, three-arm, randomized, and assessor-blinded trial used the OC and GCW. 105 eligible patients with breast cancer were assigned to 3 groups. OC (n=35) and GCW (n=35) for intervention groups were performed in three stages: I) instructions on by the investigator at the hospital; II) the implementation accompanied by the investigator at the hospital; III) the individual application of at home by patients. The patients in the control group (n=35) received standard care. Additionally, ''Patient Information Form '', ''Edmonton Symptom Assessment Scale'', ''World Health Organization Mucositis Scale (OTS)'', and ''Visual Analog Scale (VAS)'' were conducted. Results: OTS and VAS scales, the OC group was significantly more effective than the GCW and control groups throughout the beginning 21-day period. During the 1st 16 days of evaluating the OTS and VAS conditions, the GCW groups showed significantly more effectiveness than the control group. Conclusion: OC alone was effective and safe for treating OM. The results of this study showed the clinical applicability of OC in the management of OM. OC and GCW significantly reduced the pain and toxicity scale in the first 16 days. There was no significant difference between the GCW and control groups between the 16-21 days.
Keywords: Adjuvant chemotherapy; breast cancer; nursing; oral cryotherapy; oral mucositis
Objective: To determine the effects of oral cryotherapy (OC) and gargling with cold water (GCW) in the prevention and symptom management of oral mucositis (OM) in patients with breast cancer undergoing chemotherapy. Material and Methods: This parallel-grouped, three-arm, randomized, and assessor-blinded trial used the OC and GCW. 105 eligible patients with breast cancer were assigned to 3 groups. OC (n=35) and GCW (n=35) for intervention groups were performed in three stages: I) instructions on by the investigator at the hospital; II) the implementation accompanied by the investigator at the hospital; III) the individual application of at home by patients. The patients in the control group (n=35) received standard care. Additionally, ''Patient Information Form '', ''Edmonton Symptom Assessment Scale'', ''World Health Organization Mucositis Scale (OTS)'', and ''Visual Analog Scale (VAS)'' were conducted. Results: OTS and VAS scales, the OC group was significantly more effective than the GCW and control groups throughout the beginning 21-day period. During the 1st 16 days of evaluating the OTS and VAS conditions, the GCW groups showed significantly more effectiveness than the control group. Conclusion: OC alone was effective and safe for treating OM. The results of this study showed the clinical applicability of OC in the management of OM. OC and GCW significantly reduced the pain and toxicity scale in the first 16 days. There was no significant difference between the GCW and control groups between the 16-21 days.
Keywords: Adjuvant chemotherapy; breast cancer; nursing; oral cryotherapy; oral mucositis
ÖZET
Amaç: Kemoterapi gören meme kanserli hastalarda oral mukozitin (OM) önlenmesi ve semptom yönetiminde oral kriyoterapi (OK) ve soğuk suyla gargara (SSG) yapmanın etkisini belirlemek. Gereç ve Yöntemler: Bu paralel gruplu, üç-kollu, randomize ve değerlendiricinin kör olduğu araştırmada müdahale gruplarına OK ve SSG uygulandı. Meme kanseri olan 105 uygun hasta 3 gruba ayrıldı. Müdahale grupları için OK (n=35) ve SSG (n=35) 3 aşamada gerçekleştirildi: I) Hastanedeki araştırmacı tarafından verilen talimatlar; II) hastanede araştırmacı eşliğinde uygulama; III) Hastaların evde bireysel uygulaması. Kontrol grubundaki hastalar (n=35) standart bakım aldı. Ayrıca hastalara ''Hasta Bilgi Formu'', ''Edmonton Semptom Değerlendirme Ölçeği'', ''Dünya Sağlık Örgütü (DSÖ) Mukozit Ölçeği [World Health Organization Mucositis Scale (OTS)]'' ve ''Görsel Analog Skala (VAS)'' uygulandı. Bulgular: OTS ve VAS ölçeklerinde, OK grubu, başlangıç 21 günlük süre boyunca SSG yapan grup ve kontrol gruplarına göre anlamlı düzeyde daha etkiliydi. OTS ve VAS ölçeklerinin değerlendirilmesinin ilk 16 günü boyunca SSG grupları, kontrol grubuna göre önemli ölçüde daha fazla etkinlik gösterdi. Sonuç: OM tedavisinde tek başına OK etkili ve güvenlidir. Bu çalışmanın sonuçları, OM tedavisinde OK'nin klinik olarak uygulanabilirliğini gösterdi. OK ve SSG yapan bireylerde, ilk 16 günde ağrı ve toksisite ölçeğini önemli ölçüde azalttı. SSG ve kontrol grupları arasında 16-21 gün arasında anlamlı bir fark yoktur.
Anahtar Kelimeler: Adjuvan kemoterapi; meme kanseri; hemşirelik; oral kriyoterapi; oral mukozit
Amaç: Kemoterapi gören meme kanserli hastalarda oral mukozitin (OM) önlenmesi ve semptom yönetiminde oral kriyoterapi (OK) ve soğuk suyla gargara (SSG) yapmanın etkisini belirlemek. Gereç ve Yöntemler: Bu paralel gruplu, üç-kollu, randomize ve değerlendiricinin kör olduğu araştırmada müdahale gruplarına OK ve SSG uygulandı. Meme kanseri olan 105 uygun hasta 3 gruba ayrıldı. Müdahale grupları için OK (n=35) ve SSG (n=35) 3 aşamada gerçekleştirildi: I) Hastanedeki araştırmacı tarafından verilen talimatlar; II) hastanede araştırmacı eşliğinde uygulama; III) Hastaların evde bireysel uygulaması. Kontrol grubundaki hastalar (n=35) standart bakım aldı. Ayrıca hastalara ''Hasta Bilgi Formu'', ''Edmonton Semptom Değerlendirme Ölçeği'', ''Dünya Sağlık Örgütü (DSÖ) Mukozit Ölçeği [World Health Organization Mucositis Scale (OTS)]'' ve ''Görsel Analog Skala (VAS)'' uygulandı. Bulgular: OTS ve VAS ölçeklerinde, OK grubu, başlangıç 21 günlük süre boyunca SSG yapan grup ve kontrol gruplarına göre anlamlı düzeyde daha etkiliydi. OTS ve VAS ölçeklerinin değerlendirilmesinin ilk 16 günü boyunca SSG grupları, kontrol grubuna göre önemli ölçüde daha fazla etkinlik gösterdi. Sonuç: OM tedavisinde tek başına OK etkili ve güvenlidir. Bu çalışmanın sonuçları, OM tedavisinde OK'nin klinik olarak uygulanabilirliğini gösterdi. OK ve SSG yapan bireylerde, ilk 16 günde ağrı ve toksisite ölçeğini önemli ölçüde azalttı. SSG ve kontrol grupları arasında 16-21 gün arasında anlamlı bir fark yoktur.
Anahtar Kelimeler: Adjuvan kemoterapi; meme kanseri; hemşirelik; oral kriyoterapi; oral mukozit
REFERANSLAR:
- GLOBACAN 2022. Access to: 25.11.24 [Link]
- Seyhan Ak E, Çavdar İ. Meme kanserinde sistemik tedaviler (kemoterapi, hormonoterapi, hedefe yönelik tedavi) ve hemşirelik bakımı. Uzun Ö, editör. Meme Kanseri ve Hemşirelik Bakımı. 1. Baskı. Ankara: Türkiye Klinikleri; 2019. p.20-7.
- Marchesi F, Tendas A, Giannarelli D, Viggiani C, Gumenyuk S, Renzi D, et al. Cryotherapy reduces oral mucositis and febrile episodes in myeloma patients treated with high-dose melphalan and autologous stem cell transplant: a prospective, randomized study. Bone Marrow Transplant. 2017;52(1):154-6. [Crossref] [PubMed]
- Idayu Mat Nawi R, Lei Chui P, Wan Ishak WZ, Hsien Chan CM. Oral cryotherapy: prevention of oral mucositis and pain among patients with colorectal cancer undergoing chemotherapy. Clin J Oncol Nurs. 2018;22(5):555-60. [Crossref] [PubMed]
- Askarifar M, Lakdizaji S, Ramzi M, Rahmani A, Jabbarzadeh F. The effects of oral cryotherapy on chemotherapy-induced oral mucositis in patients undergoing autologous transplantation of blood stem cells: a clinical trial. Iran Red Crescent Med J. 2016;18(4):e24775. [Crossref] [PubMed] [PMC]
- Wodzinski A. Potential benefits of oral cryotherapy for chemotherapy-induced mucositis. Clin J Oncol Nurs. 2016;20(5):462-5. [Crossref] [PubMed]
- Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, et al; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2014;120(10):1453-61. Erratum in: Cancer. 2015;121(8):1339. [Crossref] [PubMed] [PMC]
- Cascinu S, Fedeli A, Fedeli SL, Catalano G. Oral cooling (cryotherapy), an effective treatment for the prevention of 5-fluorouracil-induced stomatitis. Eur J Cancer B Oral Oncol. 1994;30B(4):234-6. [Crossref] [PubMed]
- Dumontet C, Sonnet A, Bastion Y, Salles G, Espinouse D, Coiffier B. Prevention of high dose L-PAM-induced mucositis by cryotherapy. Bone Marrow Transplant. 1994;14(3):492-4. [PubMed]
- Karagözoğlu S, Filiz Ulusoy M. Chemotherapy: the effect of oral cryotherapy on the development of mucositis. J Clin Nurs. 2005;14(6):754-65. [Crossref] [PubMed]
- World Health Organization (WHO). Handbook for Reporting Results for Cancer Treatment. WHO Offset publication. 1979;48. [Link]
- Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17(1):45-56. [Crossref] [PubMed]
- Kurt S, Unsar S. Assessment of symptom control in patients with cancer in Northwestern Turkey. Eur J Oncol Nurs. 2011;15(2):137-44. [Crossref] [PubMed]
- Wang L, Gu Z, Zhai R, Zhao S, Luo L, Li D, et al. Efficacy of oral cryotherapy on oral mucositis prevention in patients with hematological malignancies undergoing hematopoietic stem cell transplantation: a meta-analysis of randomized controlled trials. PLoS One. 2015;10(5):e0128763. [Crossref] [PubMed] [PMC]
- Chen J, Seabrook J, Fulford A, Rajakumar I. Icing oral mucositis: oral cryotherapy in multiple myeloma patients undergoing autologous hematopoietic stem cell transplant. J Oncol Pharm Pract. 2017;23(2):116-20. [Crossref] [PubMed]
- Katranci N, Ovayolu N, Ovayolu O, Sevinc A. Evaluation of the effect of cryotherapy in preventing oral mucositis associated with chemotherapy-a randomized controlled trial. Eur J Oncol Nurs. 2012;16(4):339-44. [Crossref] [PubMed]
- Alvariño-Martín C, Sarrión-Pérez MG. Prevention and treatment of oral mucositis in patients receiving chemotherapy. J Clin Exp Dent. 2014;6(1):e74-80. [Crossref] [PubMed] [PMC]
- Riley P, Glenny AM, Worthington HV, Littlewood A, Clarkson JE, McCabe MG. Interventions for preventing oral mucositis in patients with cancer receiving treatment: Oral cryotherapy. Cochrane Database of Systematic Reviews. 2015;12:CD011552. [Crossref] [PubMed] [PMC]
- Spivakovsky S. Oral cryotherapy reduced oral mucositis in patients having cancer treatments. Evid Based Dent. 2016;17(3):80. [Crossref] [PubMed]
- Cheng KK, Leung SF, Liang RH, Tai JW, Yeung RM, Thompson DR. Severe oral mucositis associated with cancer therapy: impact on oral functional status and quality of life. Support Care Cancer. 2010;18(11):1477-85. [Crossref] [PubMed]
- Nurdaş A. Experimental Treatments of Oral Mucositis due to Cancer Therapies: Comparative Literature Review. SSRJ| Social Sciences Research Journal. 2025;14(1):22-37.
- Carulli G, Rocco M, Panichi A, Chios CF, Ciurli E, Mannucci C, et al. Treatment of oral mucositis in hematologic patients undergoing autologous or allogeneic transplantation of peripheral blood stem cells: a prospective, randomized study with a mouthwash containing camelia sinensis leaf extract. Hematol Rep. 2013;5(1):21-5. [Crossref] [PubMed] [PMC]
- Batlle M, Morgades M, Vives S, Ferrà C, Oriol A, Sancho JM, et al. Usefulness and safety of oral cryotherapy in the prevention of oral mucositis after conditioning regimens with high-dose melphalan for autologous stem cell transplantation for lymphoma and myeloma. Eur J Haematol. 2014;93(6):487-91. [Crossref] [PubMed]
- Gori E, Arpinati M, Bonifazi F, Errico A, Mega A, Alberani F, et al. Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group. Bone Marrow Transplant. 2007;39(6):347-52. [Crossref] [PubMed]
- Eilers J, Harris D, Henry K, Johnson LA. Evidence-based interventions for cancer treatment-related mucositis: putting evidence into practice. Clin J Oncol Nurs. 2014;18 Suppl:80-96. [Crossref] [PubMed]
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