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Walladbegi, J., Svanberg, A. & Gellerstedt, M. (2019). Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation. BMJ Open, 18(8), Article ID e021993.
Open this publication in new window or tab >>Protocol for a randomised controlled trial to study cryoprevention of chemotherapy-induced oral mucositis after autologous stem cell transplantation
2019 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 18, no 8, article id e021993Article in journal (Refereed) Published
Abstract [en]

Introduction A majority of patients who receive myeloablative therapy prior to hematopoetic stem cell transplantation develop oral mucositis (OM). This adverse cytotoxic effect manifests as oral mucosal erythema and ulcerations and frequently necessitates high doses of morphine for pain alleviation. OM may also interfere with food intake and result in parenteral nutrition, weight loss and impaired quality of life. To date, there have been a few studies of evidence-based interventions for prevention of OM. Cooling the oral mucosa using ice chips in conjunction with chemotherapy is known to reduce the severity of OM although clinical application is still limited due to several disadvantages. The primary endpoint of this study is therefore to evaluate the efficacy of an innovative intraoral cooling device (Cooral) compared with ice cooling in reducing the degree of OM, in patients with myeloma or lymphoma.

Method and analysis A total of 180 patients from four different university hospitals in Sweden will be randomised to ice or Cooral in a proportion of 1:1. The degree of OM will be assessed at eight intraoral locations, in accordance with the Oral Mucositis Assessment Scale and WHO scale. Patients will be registered beginning at admission and will continue until discharge or until day +28. The primary variable is analysed in a multiple linear regression model. The significance level used is 5%.

Ethics and dissemination The study protocol, questionnaire, diaries and letter of invitation to participants have been reviewed by the local ethical board in Göteborg. The trial results will be published in a peer-reviewed journal and disseminated to participants.

Trial registration number NCT03203733; Pre-results.

Protocol version Version 4, 2017-06-05

National Category
Health Sciences
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-30320 (URN)10.1136/bmjopen-2018-021993 (DOI)
Available from: 2019-06-19 Created: 2019-06-19 Last updated: 2019-06-24Bibliographically approved
Svanberg, A. (2019). To be safe at home or at hospital after autologous stemcell transplantation – why readmission to hospital. Journal of Nursing & Care, 8(2), Article ID 482.
Open this publication in new window or tab >>To be safe at home or at hospital after autologous stemcell transplantation – why readmission to hospital
2019 (English)In: Journal of Nursing & Care, ISSN 2167-1168, Vol. 8, no 2, article id 482Article in journal (Refereed) Published
Abstract [en]

Abstract Background: Chemotherapy in connecting with autologous stem cell transplantation (SCT) is an established treatment for patients diagnosed with myeloma and lymphoma. Chemotherapy has side effects nausea/vomiting, infection, diarrhoea, fatigue and oral mucositis. SCT often requires hospitalization for weeks. Today it is common to treat patients in an outpatient care in combination with visits at the clinic/ward. Despite experience about outpatient care in connection with SCT, it is still a small proportion of patients who are treated on an outpatient basis. Reasons to readmit unplanned from homecare to hospital are mainly incidence of infection. Purpose: To investigate in what extend patients undergoing autologous SCT, received an outpatient care or care at a University hospital in Sweden during transplant period and if the treatment at outpatient care was interrupted to study the reason for readmitting to hospital care, also to compare intra venous (iv) treatment with antibiotics or total parenteral nutrition and length of hospital stay. Methods: The study was a quantitative, retrospective, descriptive design. A review from medical and nursing records of 88 adult patients who underwent autologous SCT in 2013-2014 and treated at a University Hospital in Sweden. Results: Thirty-nine patients were cared for outside hospital at home/home-like environment and 28 of them were readmitted to hospital. Forty-nine was cared for at hospital ward. The results showed that the main reason of readmission to hospital was related to nausea/vomiting, oral mucositis, stomach problem or other reason. No patients treated outside the hospital in the home/home-like environment the entire post-transplant period (n=11) needed total parenteral nutrition in contrast to patients readmitted to hospital (n=28) where 7 patients needed total parenteral nutrition. Among patients cared for at hospital ward during the entire post- transplant period (n=49), 17 patients needed total parenteral nutrition. Conclusion: Staying at home during the transplant period leads to less total parenteral nutrition, iv antibiotics and fewer days in the hospital.

National Category
Health Sciences
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-30319 (URN)10.4172/2167-1168.1000482 (DOI)
Available from: 2019-06-19 Created: 2019-06-19 Last updated: 2019-06-20Bibliographically approved
Hjorth, M., Sjöberg, D., Svanberg, A., Kaminsky, E., Langenskiöld, S. & Rorsman, F. (2018). Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial. BMJ Open, 8(10), Article ID e023064.
Open this publication in new window or tab >>Nurse-led clinic for patients with liver cirrhosis-effects on health-related quality of life: study protocol of a pragmatic multicentre randomised controlled trial
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2018 (English)In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 8, no 10, article id e023064Article in journal (Refereed) Published
Abstract [en]

INTRODUCTION: Liver cirrhosis affects health-related quality of life (HRQoL) even in its early stages. Morbidity is especially high when the disease decompensates and self-care actions become essential. Nurse involvement in secondary prevention in other chronic diseases has contributed to better symptom control, less need of inpatient care and improved HRQoL. In order to evaluate the impact of nurse involvement in the follow-up of patients with liver cirrhosis, we decided to compare structured nurse-led clinics, inspired by Dorothea Orem's nursing theory and motivational strategies, with a group of patients receiving standard care. The primary outcome is HRQoL and the secondary outcomes are quality of care, visits to outpatient clinics or hospitals, disease progress and health literacy.

METHODS AND ANALYSIS: This is a pragmatic, multicentre randomised controlled study conducted at six Swedish hepatology departments. Eligible patients are adults with diagnosed cirrhosis of the liver (n=500). Participants are randomised into either an intervention with nurse-led follow-up group or into a standard of care group. Recruitment started in November 2016 and is expected to proceed until 2020. Primary outcomes are physical and mental HRQoL measured by RAND-36 at enrolment, after 1 and 2 years.

ETHICS AND DISSEMINATION: The study is ethically approved by the Regional Ethical Review Board in Uppsala. The results shall be disseminated in international conferences and peer-reviewed articles.

TRIAL REGISTRATION NUMBER: NCT02957253; Pre-results.

Keywords
economics, health-related quality Of life, liver cirrhosis, nurse-led clinic, nursing, qualituy of care
National Category
Health Sciences
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-28815 (URN)10.1136/bmjopen-2018-023064 (DOI)000454739500129 ()30337316 (PubMedID)2-s2.0-85055070906 (Scopus ID)
Available from: 2018-10-23 Created: 2018-10-23 Last updated: 2019-01-18Bibliographically approved
Svanberg, A. & Birgegård, G. (2015). Addition of aprepitant (EMEND®) to standard antiemetic care during seven days post chemotherapy before stem cell transplantation provides significant reduction of vomiting. Oncology, 89(1)
Open this publication in new window or tab >>Addition of aprepitant (EMEND®) to standard antiemetic care during seven days post chemotherapy before stem cell transplantation provides significant reduction of vomiting
2015 (English)In: Oncology, ISSN 0030-2414, Vol. 89, no 1Article in journal (Refereed) Published
Abstract [en]

Chemotherapy-induced nausea/vomiting (CINV) is a major problem for patients treated with high-dose chemotherapy (HDCT) conditioning before stem cell transplantation (SCT), both during chemotherapy and afterwards (delayed nausea/vomiting). The standard of care (5-HT3 antagonist and dexamethasone) appears to be ineffective against delayed nausea and vomiting. The objective of this study was to compare standard antiemetic treatment with standard treatment plus prolonged treatment with aprepitant (Emend®) until 7 days after the end of chemotherapy in patients treated with HDCT before autologous SCT. Ninety-six patients were randomized to the experiment (EXP) group receiving Emend in addition to standard antiemetics or to the control (CTR) group receiving placebo. Emend or placebo treatment started 1 h before the first HDCT dose for SCT and ended 7 days after HDCT. Thirty-eight patients in the EXP group experienced complete response (no vomiting) compared to 16 patients in the CTR group. There was a significant difference between the EXP (0.63 ± 2.71) and the CTR (3.72 ± 4.91) group during 10 days after the end of HDCT (p = 0.001) with regard to the number of vomiting episodes. No difference with regard to days of nausea or in the use of antiemetic rescue was noted between the groups. We conclude that standard antiemetic treatment can be improved by addition of aprepitant continued for 7 days after the end of chemotherapy.

Place, publisher, year, edition, pages
S. Karger, 2015
Keywords
Chemotherapy-induced nausea/vomiting Chemotherapy Stem cell transplantation Antiemetic Aprepitant
National Category
Nursing
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-20602 (URN)10.1159/000371523 (DOI)
Available from: 2016-01-04 Created: 2016-01-04 Last updated: 2016-01-04Bibliographically approved
Walladbegi, J., Svanberg, A. & Jontell, M. (2015). Efficacy of a novel intraoral cooling device. In: : . Paper presented at MASCC/ISOO International Symposium on Supportive Care in Cancer 2015, Copenhagen, 25-27 June 2015.
Open this publication in new window or tab >>Efficacy of a novel intraoral cooling device
2015 (English)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

Background: Oral mucositis (OM) is a common debiliating adverse effect following high dose chemotherapy prior to bone marrow transplantation. OM often interferes with food intake and lead to malnutrition, weight loss and impaired quality of life. These adverse effects may require intravenous morphine for pain alleviation, Although uncomfortable to the patient, oral cryotherapy with ice chips has been shown to reduce the grade and extent of OM. Purpose: The purpose of the present study is to evaluate whether an intraoral cooling device has the same effectiveness as ice chips when it comes to cooling the oral mucosa. Method: Five healthy volunteers (mean age 36.2 years) chewed ice under surveillance for 30 minutes. Before the start of and immediately after the termination of the ice chewing, the intraoral mucosal temperature was measured using a modified thermometer. The same protocol was used to asses the cooling efficacy obtained by the newly developed intraoral device. Results: No statistical significant differences in cooling of teh oral mucosa (p=0.12) were obtained. The mean surface temperature following cooling was 25.7 degrees Celcius with ice chips and 24.7 degrees Celcius with the cooling device. Conclucion: The cooling device is as effective as ice chips in terms of cooling the oral mucosa. The next step in this research is to use the cooling devise to establish the highest surface temperature of the oral mucosa, during infusion of chemotherapy, that will still result in prevention of oral mucositis.

National Category
Nursing
Research subject
Health and Welfare
Identifiers
urn:nbn:se:du-20604 (URN)
Conference
MASCC/ISOO International Symposium on Supportive Care in Cancer 2015, Copenhagen, 25-27 June 2015
Available from: 2016-01-04 Created: 2016-01-04 Last updated: 2016-01-04Bibliographically approved
Kamsvag-Magnusson, T., Thorsell-Cederberg, J., Svanberg, A., von Essen, L., Arvidson, J., Mellgren, K., . . . Ljungman, G. (2013). Parents’ and children’s perceptions of distressrelated to oral mucositis during hematopoietic stem cell transplantation. Acta Paediatrica, 103(6), 630-636
Open this publication in new window or tab >>Parents’ and children’s perceptions of distressrelated to oral mucositis during hematopoietic stem cell transplantation
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2013 (English)In: Acta Paediatrica, ISSN 0803-5253, Vol. 103, no 6, p. 630-636Article in journal (Refereed) Published
Abstract [en]

Aim

Oral mucositis is a common and debilitating side effect of haematopoietic stem cell transplantation. Our study investigated parents' and children's experiences of oral mucositis treatment and whether the parents' perceptions accurately reflected the children's views.

Methods

We analysed 71 questionnaires completed by the parents of children who had undergone haematopoietic stem cell transplantation, together with 38 questionnaires completed by children who were 7 years of age or over.

Results

The parent proxy and child self-reports showed good to excellent agreement. For example, 86% of the parents and 83% of the children reported oral pain and 44% of the parents and 47% of the children reported difficulty swallowing often or very often. The majority of the parents (61%) were satisfied with the pain treatment that had been given to their child. However, the treatment provided for oral mucositis was not altogether consistent.

Conclusion

Oral mucositis affected the majority of the children undergoing haematopoietic stem cell transplantation, causing considerable pain and discomfort. The parent proxy reports proved to be reliable and are an important supplement to child self-reports on symptoms related to oral mucositis. But there is a clear need to establish more evidence-based care for children suffering from oral mucositis.

Place, publisher, year, edition, pages
John Wiley & Sons, 2013
Keywords
Haematopoietic stem cell transplantation; Oral mucositis; Pain; Parent proxy; Questionnaire
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:du-15526 (URN)10.1111/apa.12627 (DOI)000335754700020 ()24612395 (PubMedID)
Available from: 2014-09-12 Created: 2014-09-12 Last updated: 2016-01-04Bibliographically approved
Svanberg, A., Öhrn, K. & Birgegård, G. (2012). Caphosol, a calciumphosphate mouthwash, gives no additional protectiion against mucositis inpatients with cryotherapy undergoing stem cell transplantation. In: : . Paper presented at MASCC/ISOO International Symposium.
Open this publication in new window or tab >>Caphosol, a calciumphosphate mouthwash, gives no additional protectiion against mucositis inpatients with cryotherapy undergoing stem cell transplantation
2012 (English)Conference paper, Poster (with or without abstract) (Refereed)
National Category
Medical and Health Sciences
Research subject
Hälsa och välfärd, Oral cryoterapi för patienter som behandlas med cytostatika
Identifiers
urn:nbn:se:du-10565 (URN)
Conference
MASCC/ISOO International Symposium
Available from: 2012-08-21 Created: 2012-08-21 Last updated: 2016-01-04Bibliographically approved
Svanberg, A., Öhrn, K. & Birgegård, G. (2012). 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. European Journal of Cancer Care, 21(6), 822-828
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.

Keywords
prevention; haematopoietic stem cell transplantation; chemotherapy; survival
National Category
Clinical Medicine
Research subject
Hälsa och välfärd
Identifiers
urn:nbn:se:du-15520 (URN)10.1111/ecc.12009 (DOI)000314038700016 ()22967016 (PubMedID)
Available from: 2014-09-12 Created: 2014-09-12 Last updated: 2017-12-05Bibliographically approved
Svanberg, A., Öhrn, K., Brostrom, H. & Birgegard, G. (2012). The effect of cryotherapy on oral mucosa: a study in healthy volunteers. Medical Oncology, 29(5), 3587-3591
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.

National Category
Dentistry
Research subject
Hälsa och välfärd
Identifiers
urn:nbn:se:du-11635 (URN)10.1007/s12032-012-0230-z (DOI)000311513800085 ()
Available from: 2013-01-09 Created: 2013-01-09 Last updated: 2017-12-06Bibliographically approved
Svanberg, A., Öhrn, K. & Birgegård, G. (2010). Oral cryotherapy reduces mucositis and improves nutrition: a randomised controlled trial. Journal of Clinical Nursing, 19(15-16), 2146-2151
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.

Place, publisher, year, edition, pages
Blackwell Publishing, 2010
Keywords
bone marrow transplantation; infection rate; mucositis; nutritional status; oral cryotherapy; total parenteral nutrition
National Category
Health Sciences Clinical Medicine
Research subject
Hälsa och välfärd
Identifiers
urn:nbn:se:du-15519 (URN)10.1111/j.1365-2702.2010.03255.x (DOI)000279937600009 ()20659194 (PubMedID)
Available from: 2014-09-12 Created: 2014-09-12 Last updated: 2017-12-05Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0003-2960-4994

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