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Mucositis Prevention for Patients Receiving High Dose Chemotherapy and Stem Cell Transplantation: Preventive Strategies - There is Always More to do
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences. (Prof Gunnar Birgegård)
2012 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

The aim of this thesis was to investigate oral cryotherapy (OC) as prophy-laxis against oral mucositis (OM) in patients given high-dose chemotherapy for stem cell transplantation (SCT). A new mouth rinse device was tested for possible additive effect to OC.

For study I-III, 78 patients were randomised to OC or standard oral care (SOC). Papers I and II showed that OC patients had significantly less severe mucositis, pain, opioid use, lower C-reactive protein and less parenteral nutrition treatment (TPN).

There was no difference in relapse rate, and 5-year survival was unexpectedly significantly better in the OC group (Paper III). In paper IV, the local effect of OC on the mucosa of the mouth was investigated by the use of an infrared thermograph. Change in surface temperature in eight areas of the mouth cavity was measured after cooling of the mouth in healthy volunteers. A substantial lowering of the temperature (-12.9 °C, mean) was seen which could explain the efficacy of OC. To exclude that acute cooling in itself is traumatic, the proinflammatory cytokine IL-6 was measured in saliva and showed no increase after cooling. Paper V reported a study in 40 allogeneic SCT patients. 20 were given SOC including OC and 20 in addition received Caphosol®, a calcium phosphate mouth rinse, during chemotherapy and until day 21. Severity of mucositis, use of opioids and TPN, effects on nutrition and CRP levels were measured. No significant difference was found between the groups in any of these variables, but a non-significant trend for an advantage for the combination could be seen. IL-6 saliva levels were measured. There was a substantial increase (more than 10-fold), in mean IL-6 levels from baseline to beginning of mucositis and a weak correlation between increased IL-6 levels and severity of OM, suggesting that IL-6 in saliva may be a useful marker of the inflammatory mucosal process.

This thesis demonstrates that OC is effective as prophylaxis against chemotherapy-induced OM. As a consequence of this work, OC has been introduced as the standard of care in all SCT patients in our institution.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2012. , p. 57
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 798
Keyword [en]
oral mucositis, stem cell transplantion, oral cryotherapy, cooling, cytokine IL-6
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:uu:diva-179508ISBN: 978-91-554-8438-5 (print)OAI: oai:DiVA.org:uu-179508DiVA: diva2:545031
Public defence
2012-09-28, Robergsalen, ing 40, 4 tr, Akademiska. sjukhuset, Uppsala, 13:15 (English)
Opponent
Supervisors
Available from: 2012-09-07 Created: 2012-08-17 Last updated: 2013-01-22
List of papers
1. Oral cryotherapy reduces mucositis and opioid use after myeloablative therapy-a randomized controlled trial
Open this publication in new window or tab >>Oral cryotherapy reduces mucositis and opioid use after myeloablative therapy-a randomized controlled trial
2007 (English)In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 15, no 10, p. 1155-1161Article in journal (Refereed) Published
Abstract [en]

Introduction: Mucositis is a major complication in myeloablative therapy, which often necessitates advanced pharmacological pain treatment, including i.v. opioids. Attempts to prevent oral mucositis have included oral cryotherapy, which has been shown to reduce mucositis, but there is a lack of knowledge concerning the effect of oral cryotherapy on opioid use by reducing the mucositis for patients treated with myeloablative therapy before bone marrow transplantation (BMT). Aim: The aim of the present study was to evaluate if oral cryotherapy could delay or alleviate the development of mucositis and thereby reduce the number of days with i.v. opioids among patients who receive myeloablative therapy before BMT. Materials and methods: Eighty patients 18 years and older, scheduled for BMT, were included consecutively and randomised to oral cryotherapy or standard oral care. A stratified randomisation was used with regard to type of transplantation. Intensity of pain, severity of mucositis and use of opioids were recorded using pain visual analogue scale (VAS) scores, mucositis index scores and medical and nursing charts. Results: This study showed that patients receiving oral cryotherapy had less pronounced mucositis and significantly fewer days with i.v. opioids than the control group. In the autologous setting, cryotherapy patients also needed significantly lower total dose of opioids. Conclusion: Oral cryotherapy is an effective and well-tolerated therapy to alleviate mucositis and consequently reduce the number of days with i.v. opioids among patients treated with myeloablative therapy before BMT.

Keyword
Oral cryotherapy, Bone marrow transplantation, Mucositis, Oral pain, Opioid use
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-11834 (URN)10.1007/s00520-007-0245-8 (DOI)000249632900004 ()17393189 (PubMedID)
Available from: 2007-10-26 Created: 2007-10-26 Last updated: 2017-12-11Bibliographically approved
2. Oral cryotherapy reduces mucositis and improves nutrition: a randomised controlled trial
Open this publication in new window or tab >>Oral cryotherapy reduces mucositis and improves nutrition: a randomised controlled trial
2010 (English)In: Journal of Clinical Nursing, ISSN 0962-1067, E-ISSN 1365-2702, Vol. 19, no 15-16, p. 2146-2151Article in journal (Refereed) Published
Abstract [en]

Aim and objective. To investigate if oral cryotherapy during myeloablative therapy may influence frequency and severity of mucositis, nutritional status and infection rate after bone marrow transplantation. Background. Patients treated with intensive myeloablative treatment before bone marrow transplantation are all at risk to develop mucositis. Oral mucositis causes severe pain and oral dysfunction, which can contribute to local and systemic infections and bleeding; it may even interrupt cancer therapy. Oral mucositis also decreases the oral food intake, which increases the risk for malnutrition and infection. Reduced food intake, loss of fat and muscles, alterations in energy and substrate metabolism leads to malnutrition. Design. A randomised controlled trial with a random assignment to experimental or control group. Method. A stratified randomisation was used with regard to the type of transplantation. Mucositis was measured on WHO mucositis scale. Number of days of total parenteral nutrition, infection rate, weight, albumin levels and days at hospital was compared. Results. There were significantly fewer patients in the experimental group with mucositis grade 3-4 than in the control group and significantly lower number of days in the hospital (allogeneic patients). Less total parenteral nutrition was needed in the experimental group in both settings, and the S-albumin level was significantly better preserved. No significant difference could be found with regard to infection rate. Conclusion. Oral cryotherapy reduced mucositis, number of hospital days, the need for total parenteral nutrition and resulted in a better nutritional status. Relevance to clinical practice. Nurses caring for patients treated with myeloablative therapy should place high priority to prevent oral mucositis and hereby reduce its side effects.

Keyword
bone marrow transplantation, infection rate, mucositis, nutritional status, oral cryotherapy, total parenteral nutrition
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-135665 (URN)10.1111/j.1365-2702.2010.03255.x (DOI)000279937600009 ()
Available from: 2010-12-08 Created: 2010-12-07 Last updated: 2017-12-11Bibliographically approved
3. Five year follow-up of survival and relapse in patients who received cryotherapy during high dose chemotherapy for stem cell transplantation shows no safety concerns
Open this publication in new window or tab >>Five year follow-up of survival and relapse in patients who received cryotherapy during high dose chemotherapy for stem cell transplantation shows no safety concerns
2012 (English)In: European Journal of Cancer Care, ISSN 0961-5423, E-ISSN 1365-2354, Vol. 21, no 6, p. 822-828Article in journal (Refereed) Published
Abstract [en]

We have previously published a randomised controlled study of the efficacy of cryotherapy in preventing acute oral mucositis after high-dose chemotherapy for stem cell transplantation. The present study is a 5-year follow-up safety study of survival in these patients. In the previously published study oral cryotherapy (cooling of the oral cavity) during high-dose chemotherapy significantly reduced mucositis grade and opiate use in the treated group. All patients were followed up for at least 5 years with regard to relapse and death rates. Baseline data, transplant complications and mucositis data were compared. Significantly more patients (25/39) who received oral cryotherapy were alive after 5 years compared to 15/39 in the control group (P= 0.025). Relapse rates were similar. The only baseline difference was a lower proportion of patients in complete remission at transplantation in the control group (6 vs. 13, P= 0.047). This 5-year follow-up study gave no support for safety concerns with cryotherapy.

National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-179505 (URN)10.1111/ecc.12009 (DOI)000314038700016 ()22967016 (PubMedID)
Available from: 2012-08-17 Created: 2012-08-17 Last updated: 2017-12-07Bibliographically approved
4. The effect of cryotherapy on oral mucosa: a study in healthy volunteers
Open this publication in new window or tab >>The effect of cryotherapy on oral mucosa: a study in healthy volunteers
2012 (English)In: Medical Oncology, ISSN 1357-0560, E-ISSN 1559-131X, Vol. 29, no 5, p. 3587-3591Article in journal (Refereed) Published
Abstract [en]

Oral cryotherapy causes local vasoconstriction, which reduces blood flow and reduces the cytotoxic damage to the oral mucosa, has been shown to reduce oral mucositis after intense cytostatic treatment. The main object of this study was to investigate the effect of oral cryotherapy on the temperature in the oral mucosa, the level of proinflammatory cytokine interleukin-6 (IL-6) in saliva and the effect on blood pressure in healthy volunteers, before and after 1 h of cooling the oral cavity with crushed ice. Twelve healthy volunteers [mean age 32.4 (SD 13.2) (20-56) years] were treated with oral cryotherapy in the form of crushed ice. Temperature measurements were performed in the oral mucosa using infrared thermograph following a flowchart protocol. Blood pressure (BP) was measured with a sphygmomanometer. Saliva was analysed for inflammatory cytokine IL-6, using an enzyme-linked immunosorbent assay (ELISA). All participants fulfilled the cooling session. The temperature in the oral cavity decreased significantly (mean 12.9 degrees C, p < .002). The systolic BP was marginally but significantly higher after cooling (similar to 5 mmHg, p = .019). We could not detect any differences in cytokine IL-6 levels before and after oral cooling. We conclude that cryotherapy during 1 h lowers the mucosal temperature as much as similar to 12.9 degrees C, which explains the significant protective effect against mucosal damage by cytostatic drugs. The cooling caused no increase in IL-6 levels. Systemic blood pressure was marginally increased.

Keyword
oral cooling, thermographic measurement, interleukin (IL)-6, oral cavity temperature, blood pressure
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-179504 (URN)10.1007/s12032-012-0230-z (DOI)000311513800085 ()22476810 (PubMedID)
Available from: 2012-08-17 Created: 2012-08-17 Last updated: 2017-12-07Bibliographically approved
5. Caphosol® mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation: A pilot study
Open this publication in new window or tab >>Caphosol® mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation: A pilot study
2015 (English)In: European Journal of Oncology Nursing, ISSN 1462-3889, E-ISSN 1532-2122, Vol. 19, p. 50-53Article in journal (Refereed) Published
Abstract [en]

PURPOSE: To investigate if adding Caphosol(®), a mouthwash solution, to oral cryotherapy (OC) further protects against oral mucositis (OM), a toxic painful complication to high dose chemotherapy.

METHOD: The study was a randomised, controlled, study design. Patients ≥16 years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol(®) (n = 20) or control group receiving OC only (n = 20). OC was given from start to end of HDCT. Caphosol(®), from day 0 to day 21.

RESULT: There were no significant differences regarding age or gender between the groups. Mucositis was assessed with the World Health Organisation (WHO) grading scale. Pain was assessed with a 10 cm visual analogue scale (VAS) from 0 = no pain to 10 = worst imaginable pain. Start and duration of therapy with pain relieving drugs, serum C-reactive protein values, and number of days of hospitalisation were collected from the medical records. Data on OM, oral pain, use of i.v. opioids and total parenteral nutrition were collected during 22 days. There was no significant difference between the groups on OM, oral pain, use of i.v. opioids or TPN between the groups.

CONCLUSION: The study showed no additional effect of combining Caphosol(®) with OC.

National Category
Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-179503 (URN)10.1016/j.ejon.2014.07.011 (DOI)000350074400009 ()25224595 (PubMedID)
Available from: 2012-08-17 Created: 2012-08-17 Last updated: 2017-12-07Bibliographically approved

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