Dexamethasone is a corticosteroid. Steroid-containing oral pastes or rinses have been used to treat aphthous ulcers (Divers & O'Shaughnessy, 2015; Nicolatou-Galitis et al., 2013; Pilotte et al., 2011; Rugo et al., 2017), also known as canker sores (Mayo Clinic, 2018), and are being studied in the treatment of cancer treatment-related mucositis.
Rambod, M., Pasyar, N., & Ramzi, M. (2018). The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. European Journal of Oncology Nursing, 33, 14–21.
The purpose of the study was to evaluate the effect of zinc sulfate on the incidence and severity of mucositis in patients with leukemia undergoing chemotherapy.
This is a randomized, placebo-controlled, triple-blinded study conducted on patients with leukemia undergoing chemotherapy. The subjects were randomized into an experimental arm where they received zinc sulfate (50 mg) three times daily for 14 days from the first day of chemotherapy; the control group received placebo capsules three times per day. Mucositis was measured by the Oral Mucositis Index and World Health Organization mucositis scale on the 4th, 7th, and 14th day after chemotherapy.
SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: Nemaze Hospitals affiliated to SUMS, Shiraz, Iran
This is a randomized clinical trial and placebo-controlled study for patients undergoing chemotherapy for leukemia. Patients were randomly assigned to receive either zinc sulfate or placebo.
There is significant difference in the incidence of mucositis during the 14 days of the study, 9 patients (25%) in the experimental group (zinc sulfate) and 19 (54%) in the control group (placebo) showed incidence of mucositis was 2.1 times higher in the control group. Onset of mucositis occurred on days 5.83 (SD = 3.37) (zinc sulfate) and 4.58 (SD = 2.47) (placebo), t test showed no difference between these two groups regarding the onset of mucositis (t = 0.95, p = 34). There is no confirmation of mucositis occurring later in the zinc sulfate group in comparison to the control group. The severity of mucositis was milder in the experimental group compared to the control group on 4th, 7th, and 14th day. RM-ANOVA indicated significant difference between mean score objective evaluation of mucositis the two groups (F = 7.83, p = 0.07). Results also showed significant difference between the two groups' mean score of subjective evaluation of mucositis (F = 5.79, p = 0.01)
The results of the study show that zinc sulfate is helpful in preventing mucositis in patients with leukemia undergoing chemotherapy. The current study does not support any significant difference between the two group in delaying onset of mucositis. The severity of mucositis was milder in the zinc sulfate group in comparison to the control group.
Using zinc sulfate at the dose of 50 mg three times per day for 14 days helped to prevent and decrease the severity of mucositis in the leukemia population undergoing chemotherapy. This along with standard of care oral hygiene could be an effective treatment to prevent and decrease the severity of mucositis. Additional research is needed.
Jiang, C., Wang, H., Xia, C., Dong, Q., Chen, E., Qiu, Y., . . . Chen, T. (2018). A randomized, double-blind, placebo-controlled trial of probiotics to reduce the severity of oral mucositis induced by chemoradiotherapy for patients with nasopharyngeal carcinoma. Cancer, 125, 1081-1090.
The purpose was to evaluate a probiotic combination on the severity of oral mucositis in patients with nasopharyngeal cancer who are undergoing concurrent chemotherapy and radiation therapy.
Probiotic combination (Bifidobacterium longum, Lactobacillus lactis, and Enterococcus faecium) three capsules BID from the beginning of treatment to end of treatment, up to 7 weeks.
PHASE OF CARE: Active anti-tumor treatment
RCT, double-blind, placebo controlled
Mucositis was measured with the CTCAE, version 4.0, by two senior radiation oncologists daily. Routine blood analysis, biochemical analysis, and lymphocyte immunity were measured before and after treatment.
Patients in the intervention group showed a significant reduction in the severity of OM. The incidences of grade 0, 1, 2, and 3 OM in the placebo group and the probiotic combination group were 0% and 12%, 0% and 55%, 54% and 17%, and 46% and 16%, respectively. Additional genomic and biochemical analysis results reported.
The probiotic combination significantly reduced oral mucositis. Blood test results found that this reduction may be due to improvements in immunity. The optimal dose and schedule still needs to be explored.
Probiotics have the potential to improve outcomes related to oral mucositis in patients receiving combination chemotherapy and radiotherapy for nasopharyngeal cancer. Additional research is needed to identify the ideal dose and schedule for this treatment.
Riley, P., Glenny, A.M., Worthington, H.V., Littlewood, A., Fernandez Mauleffinch, L.M., Clarkson, J.E., & McCabe, M.G. (2017). Interventions for preventing oral mucositis in patients with cancer receiving treatment: cytokines and growth factors. Cochrane Database of Systematic Reviews, 11, CD011990.
PHASE OF CARE: Active anti-tumor treatment
Although authors concluded that KGF is beneficial in the prevention of oral mucositis in adults who are receiving (a) radiotherapy to the head and neck with cisplatin or fluorouracil, or (b) chemotherapy alone for mixed solid and hematologic cancers, the results are not conclusive. Could conclude likely effective but not established
The analysis showed inconsistent effect of KGF (keratinocyte growth factor). Because of the concern of cost and benefit, this is not strong evidence enough to recommend.
Hansen, P.B., & Penkowa, M. (2017). Bismuth adjuvant ameliorates adverse effects of high-dose chemotherapy in patients with multiple myeloma and malignant lymphoma undergoing autologous stem cell transplantation: A randomised, double-blind, prospective pilot study. Supportive Care in Cancer, 25, 1279–1289.
To study the effects of oral bismuth in patients prior to autologous stem cell transplantation on reducing the adverse effects of high-dose chemotherapy, including mucositis, neutropenia, and bacteremia.
Randomized, double-blind controlled study either to intervention or placebo group. Bismuth or placebo was 1,000 mg × 2 orally daily for 5 days, followed by 10 days with a daily dose of 500 mg × 2 orally. The first 5 days of bismuth or placebo treatment were prior to the start of chemotherapy regimens, which started on day −3 (multiple myeloma) and day −7 (lymphoma) before ASCT (day 0). The 10 days on the lower dose of bismuth or placebo also started on day −3 (multiple myeloma) and day −7 (lymphoma). On day +4, all patients received 6 mg pegfilgrastim to reduce neutropenia.
Laboratory results: Hemoglobin, leukocytes, differential count, thrombocytes, and reticulocytes. Stomatitis, diarrhea, fever, febrile neutropenia and documented infections based on the Common Criteria for Adverse Events, version 3.0.
Results showed a reduction in grade 2 stomatitis, febrile neutropenia, and infections caused by high-dose chemotherapy. Bismuth reduced significantly the incidence of grade 2 stomatitis, as it occurred only in 2 of 13 patients (15%, two-tailed p = 0.001)
Oral bismuth is shown to be effective in certain patient groups. Oral bismuth may be effective in reducing high-dose chemotherapy effects of mucositis, neutropenia, and infections. The study indicates that there may be a gender difference in side effects; therefore, more studies are warranted to determine the impact of gender differences of treatment and prevention of cytotoxic effects of the treatment.
Small sample (< 100)
First study to use this intervention in hematologic inpatients. More research is needed on the preventative properties of oral bismuth.
He, M., Zhang, B., Shen, N., Wu, N., & Sun, J. (2018). A systematic review and meta-analysis of the effect of low-level laser therapy (LLLT) on chemotherapy-induced oral mucositis in pediatric and young patients. European Journal of Pediatrics, 177, 7-17.
Low sample sizes
LLLT is effective to reduce mucositis and associated pain in pediatric patients with cancer overall. Despite of the deliveries of LLLT vary among the studies, it has been consistent to show the reduction of mucositis in pediatric population.
Peng, H., Chen, B.B., Chen, L., Chen, Y.P., Liu, X., Tang, L.L., . . . Ma, J. (2017). A network meta-analysis in comparing prophylactic treatments of radiotherapy-induced oral mucositis for patients with head and neck cancers receiving radiotherapy. Oral Oncology, 75, 89-94.
TOTAL REFERENCES RETRIEVED: 112 randomized clinical trials were identified. 10 excluded that did not adopt the required criteria to evaluate oral mucositis, 28 studies or conference abstracts that did not provide a detailed number of responders and non-responders, 2 trials that recruited patients with previous chemotherapy, 5 studies that only evaluated mucositis-related pain, and 10 studies with the intention of treatment. 57 studies were eligible.
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Randomization procedure, establishment of sample size, adoption of blinding in the study design, allocation of concealment if intention-to-treat analysis was followed, loss to follow-up, and dropout. Used the revised Jadad/Oxford quality scoring system to quantify study quality.
PHASE OF CARE: Active anti-tumor treatment
Abbreviations: SOC–standard oral care; ABS–antibiotics + SOC; AIS–anti-inflammatory + SOC; AVS–aloe vera + SOC, CAS–coating agents + SOC, CHS–Chinese herbs + SOC, GCS–granulocyte-macrophage colony–stimulating factor + SOC, GFS–growth factor + SOC, GS–glutamine + SOC, HS–honey + SOC, LS–laser + SOC, PS–placebo + SOC; NMT–non-medication treatment
Radiotherapy-induced oral mucositis in patients with head and neck cancer can be debilitating. This network meta-analysis compared prophylactic treatments in patients receiving postoperative radiation with or without chemotherapy. Low-level laser therapy in addition to standard of care may be more effective in reducing oral mucositis than standard care alone.
Limited information provided in the printed lack of control for or limit use of chemotherapy; not clear what constituted low-level laser therapy or the details regarding the other treatments.
Oral mucositis has been identified as a complex process; nurses should remain astute to changes in the oral cavity with the various treatments for cancer as well as changes over time. Interventions effective with a specific cancer treatment may not be universally effective. Study results should be read with a critical review process
Lakhani, R. (2017). A randomised double blind clinical trial to assess the effectiveness of topical application of aloe vera gel versus base gel on radiation-induced mucositis in patients receiving radiation therapy for head and neck malignancy in a selected hospital in Mumbai. Nursing Journal of India, 108, 187.
This study aims to evaluate the time of onset and severity of mucositis in the treatment arm (aloe vera gel) versus the control arm in patients receiving head and neck radiation. Additionally, this study describes demographic variables that impact the severity of mucositis in patient undergoing radiation therapy of the head and neck. Secondary outcomes also included a comparison of hospitalization rates, need for analgesia, antifungals, and antibiotics, as well as nutritional support rates, rates of treatment interruption, and weight loss. Quality-of-life differences between groups was also assessed.
Randomized, double blind control study
Patients in the treatment group had later onset of mucositis (p < 0.05). The treatment group also had decreased severity of mucositis (p < 0.005). The treatment group had less weight loss and less need for supportive medications. The QOL measures were more favorable for the treatment group (p = 0.000 for OMWQ, p = 0.001 for FACT-HN). There was no difference between groups in hospitalization rates or the need for nutritional support.
There is some discrepancy about oral pain results; the text says it was better in the treatment group but the p value listed is 0.243.
The author does not tell the reader anything about the statistical testing that was done, which limits the ability to interpret the results. The tables and charts are not completely labeled so they are hard to interpret as well.
Aloe vera gel may help decrease the time to development and severity of radiation-induced mucositis in patients with head and neck cancer.
Benitez-Rosario, M.A., Rosa-Gonzalez, I., Gonzalez-Davila, E., & Sanz, E. (2018). Fentanyl treatment for end-of-life dyspnoea relief in advanced cancer patients. Supportive Care in Cancer, 27, 157–164.
The purpose of the study was to assess the effects of subcutaneous or IV fentanyl on dyspnea in patients with advanced cancer.
Subcutaneous or IV fentanyl for breathlessness at rest or with minimal exertion for patients with (a) decline in renal function and escalating doses transdermal fenatanyl/ or other opioid, and (b) alternative to transdermal fentanyl at discharge
PHASE OF CARE: End-of-life care
APPLICATIONS: Pediatrics, elder care, palliative care
Retrospective cohort study
Breathlessness was measured on a 0-4 scale, other symptoms were measured with ESAS, MMSE/Pfeiffer, and Likert scales
Total percent of responders to fentanyl was 76%. Fentanyl efficacy was not statistically related to age, gender, cancer type, previous opioid treatment, steroid and midazolam doses, and PPS. The median fentanyl dose in responders was 25 mcg/h (interquartile range = 12–70). It was significantly related to age (37 versus 12 mcg/h, for ≤ 75 versus > 75 years, respectively; p = 0.02). There was not a significant difference between fentanyl doses of responders and non-responders. 36, 23, and 15 patients had sustained improvements in dyspnea over 48, 72, and 96 hours. Fentanyl had no significant toxicity.
Subcutaneous and IV fentanyl may be associated with dyspnea relief in patients with advanced cancer. No severe adverse effects were noted.
Subcutaneous and IV fentanyl may be related to dyspnea at rest relief in patients with advanced cancer. Additional research is need to confirm these results.
Brighton, L.J., Miller, S., Farquhar, M., Booth, S., Yi, D., Gao, W., . . . Maddocks, M. (2018). Holistic services for people with advanced disease and chronic breathlessness: A systematic review and meta-analysis. Thorax, 74, 270-281.
Interventions represented 18 different services. Most services enrolled people with thoracic cancer, involved palliative care staff, and comprised 4–6 contacts over 4–6 weeks. Commonly used interventions included breathing techniques, psychological support, and relaxation techniques. Meta-analyses demonstrated reductions in Numeric Rating Scale distress due to breathlessness (n = 324; mean difference (MD) = −2.30, 95% CI [−4.43, −0.16], p = 0.03) and Hospital Anxiety and Depression Scale (HADS) depression scores (n = 408, MD = −1.67, 95% CI [−2.52, −0.81], p < 0.001). Statistically non-significant effects were observed for Chronic Respiratory Questionnaire (CRQ) mastery (n = 259, MD = 0.23, 95% CI [−0.1, 0.55], p = 0.17) and HADS anxiety scores (n = 552, MD = −1.59, 95% CI [−3.22, 0.05], p = 0.06). Patients and caregivers valued tailored education, self-management interventions, and expert staff providing person-centered, dignified care. There was no observable effect on health status or quality of life, and mixed evidence around physical function.
Evidence suggests an effect of integrative palliative care on the affective domain of breathlessness, and on psychological outcomes of anxiety and depression. Services were highly valued by patients and caregivers, who appreciated the education to help them understand their breathlessness, the provision of useful self-management interventions, and the provision of expert dignified care which centered on the person. No effect on overall health status or quality of life using generic measures and mixed evidence around any effect on physical function was identified
Integrative palliative care may provide a benefit to patients with advanced cancer.