Nicolatou-Galitis, O., Dardoufas, K., Markoulatos, P., Sotiropoulou-Lontou, A., Kyprianou, K., Kolitsi, G., … Velegraki, A. (2001). Oral pseudomembranous candidiasis, herpes simplex virus-1 infection, and oral mucositis in head and neck cancer patients receiving radiotherapy and granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwash. Journal of Oral Pathology and Medicine, 30, 471–480.
Patients were given a mouthwash of 400 mcg granulocyte-macrophage colony-stimulating factor (GM-CSF) dissolved in 1 mL sterile water, added to 200 mL drinking water, to treat grade II–IV mucositis. Patients were instructed to use the mouthwash once a day after the end of the second week of therapy. They were instructed to use as a mouthwash and then swallow in fragments within one hour.
Physicians used the following grading system.
Patients used the following grading system.
The authors stated that because 20 out of 46 patients with initial mucositis of grade II and III completed RT with grade I mucositis, the mouthwash was beneficial. However, additional research is needed.
Nicolatou-Galitis, O., Sarri, T., Bowen, J., Di Palma, M., Kouloulias, V.E., Niscola, P., . . . Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO). (2013). Systematic review of amifostine for the management of oral mucositis in cancer patients. Supportive Care in Cancer, 21(1), 357–364.
STUDY PURPOSE: To review available literature from 1966 to December 31, 2010 to define clinical practice guidelines for the use of amifostine for prevention and treatment of oral mucositis in patients with cancer
TYPE OF STUDY: Systematic review
DATABASES USED: MEDLINE
KEYWORDS: Extensive list provided (anti-inflammatory agents) including amifostine, antitumor necrosis factor (TNF), non-steroidal anti-inflammatory drugs, TNF inhibitor, etc.
INCLUSION CRITERIA: Detailed information is provided in a different section of the journal. Studies relevant to the management of radiation and/or chemotherapy-induced oral mucositis using anti-inflammatory interventions including amifostine
EXCLUSION CRITERIA: Articles that did not report on intervention and mucositis outcomes, animal or in vitro studies, non-English articles, methodologic quality, and anti-inflammatory agents other than amifostine
TOTAL REFERENCES RETRIEVED: 908
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Only articles that investigated amifostine specifically were selected. Levels of evidence were based on the Somerfield criteria, and study methodology was evaluated on the Hadorn criteria. These were integrated into guideline categories—recommendation, suggestion, or no guideline possible.
PHASE OF CARE: Active antitumor treatment
No guideline, suggestion, or recommendation for mucositis prevention with amifostine was possible in any of the following groupings.
Conflicting results, insufficient data, and major Hadorn flaws did not allow any guideline related to the use of amifostine for oral mucositis prevention. New well-designed trials are necessary that include timing of amifostine infusion prior to radiotherapy, consistent dose of amifostine, and cancer therapy intensity and modality.
Too many studies may have been eliminated up front.
Because no guidelines are recommended by this review, nurses who continue to administer amifostine for mucositis prevention carefully should document the results and look for ways to participate in well-designed trials. Nurses may consider advocating against the use of amifostine outside of research until guidelines can be established for its use.
Nicholson, A.B. (2006). Methadone for cancer pain [Cochrane review]. In The Cochrane Library, Volume 4, 2006. Oxford, UK: Update Software.
To determine the effectiveness and safety of methadone analgesia in patients with cancer pain; to assess the adverse effects associated with methadone analgesia for the treatment of cancer pain
Databases searched were Cochrane Pain, Palliative & Supportive Care Group Trials Register; The Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CancerLIT; CINAHL; National Research Register; CenterWatch clinical trials listing service; Current Controlled Trials; National Institutes of Health Clinical Trials Databases; BioMed; Glaxo Wellcome Clinical Trials Register; National electronic Library for Health (NeLH); System for Information on Grey Literature in Europe (SIGLE); Dissertation Abstracts OnDisc; Index to Theses (ASLIB Index); Proquest Digital Dissertations; Cochrane Database of Systematic Reviews (CDSR); and Database of Abstracts of Reviews of Effects (DARE).
Evidence suggests that methadone is an analgesic with an efficacy similar to that of morphine and with side effects that are similar to those of morphine. Although methadone is similar to morphine, the pharmacokinetics and pharmacodynamics of methadone make dose titration difficult. Methadone presents the risk of drug accumulation to toxic levels. There is a significant danger that the effect of methadone accumulation leading to delayed onset of adverse effects has not been represented. The majority of studies involved were single-dose comparisons or pertained to short-term use. Such comparisons fail to reproduce clinical practice; such studies do not reveal delayed adverse effects. One study, which compared methadone to morphine over 28 days, reported an increased rate of withdrawal from the methadone group. Withdrawal was due to side effects. Author drew no conclusion regarding the relative merits, in the management of various pain syndromes, of methadone compared to those of other opioids. The additional study found methadone to be as effective as morphine in the treatment of neuropathic pain, but not superior to morphine.
Few studies presented complete data sets regarding pain. No meta-analysis was possible.
Niazi, T. M., Vuong, T., Azoulay, L., Marijnen, C., Bujko, K., Nasr, E., . . . Cummings, B. (2012). Silver clear nylon dressing is effective in preventing radiation-induced dermatitis in patients with lower gastrointestinal cancer: results from a phase III study. International Journal of Radiation Oncology, Biology, Physics, 84, e305-e310.
To compare the efficacy of silver clear nylon dressing to standard skin care for the prevention and treatment of radiodermatitis in patients with anal canal and rectal cancer receiving chemoradiation therapy (XRT).
Patients were randomized to receive the silver dressing beginning on day 1 of radiation treatment or standard of care if radiation-induced dermatitis developed. Standard care involved using sulfadiazine cream at the time of development of grade 1 dermatitis. Patients wore the dressing 24 hours/day, seven days/week, except during XRT delivery. This was continued until two weeks after completion of XRT. The primary study outcome was skin toxicity at the last day of XRT. Skin toxicity was rated by multiple observers from digital photographs of the perineal skin area.
Patients were undergoing the active antitumor treatment phase of care.
Skin scoring system grade 0–4: grading by all 10 observers was calculated as the average score x10.
All patients completed XRT without major toxicity. There were four treatment breaks in the standard care arm and three in the silver dressing arm. On the last day of treatment, the mean dermatitis score was 2.53 for the standard arm and 1.67 for the silver dressing arm. When adjusted for age, there was no significant difference between groups in terms of severity of radiodermatitis.
There were no clear differences between study groups that indicated a substantial benefit for use of silver dressings.
*Dressings were provided free of charge; however, they are generally expensive. Measurement methods were unclear; the authors stated calculation of dermatitis severity using all 10 observer scores but then reported analysis only of average findings in each group. Findings showed no significant difference or meaningful size of effect; however, the authors concluded that the dressing was beneficial, which showed bias in the reporting.
The study did not provide strong support for the efficacy of silver nylon dressing to prevent radiation-induced dermatitis with radiation to the perineal area and skin.
Browning, C. (1997). Lymphoedema: Prevalence, risk factors and management: A review of research. Kings Cross, Australia: NHMRC National Breast Cancer Center.
DATABASES USED: Detailed review of evidence undertaken using a MEDLINE search from 1985–1996. Additional references were retrieved from a survey of references in each article and from unpublished and in-press research from key researchers in the area.
INCLUSION CRITERIA: English language; sample size of 20 or more participants; lymphedema related to breast cancer treatment; if other patients were included, at least 20 participants needed to be patients with breast cancer, and data for these patients were reported separately
EXCLUSION CRITERIA: Animal studies and non-English articles were excluded. Articles were excluded if their data were already published, if they were lymphedema-physiology based, if they discussed measurement techniques only, or if they were review articles.
In this review, all studies reported significant improvement. There was no comparison or control group.
Studies were limited by the lack of a control group, and careful patient selection appears key. Not all women benefited, and risks of surgery were not reported.
Not Recommended for Practice
Ng, W., & Della-Fiorentina, S. (2010). The efficacy of oral ondansetron and dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy—A retrospective audit. European Journal of Cancer Care, 19, 403–407.
To determine the efficacy of 8 mg oral ondansetron plus 8 mg oral dexamethasone as prechemotherapy antiemetic regimen for patients receiving moderately emetogenic chemotherapy (MEC)
Patients who received treatment with MEC were given a standard oral regimen of 8 mg ondansetron and 8 mg dexamethasone. Patients were instructed to take these medications one hour prior to their scheduled treatments. Nursing staff assessed compliance prior to chemotherapy treatment. Nursing staff assessed each patient on day one after chemotherapy treatment.
The study was conducted at a single, outpatient site in Australia.
Study participants were in active treatment, receiving palliative care.
This was a retrospective, descriptive audit.
Common Terminology Criteria for Adverse Events (CTAE v3.0) was used to measure severity of acute nausea and vomiting.
The use of 8 mg oral ondansetron and 8 mg oral dexamethasone as antiemetics for MEC offers comparable efficacy to other regimens for control of acute emesis; however, this regimen does not adequately control acute nausea, particularly in anthracycline-based regimens.
Although 8 mg oral ondansetron and 8 mg oral dexamethasone provided adequate rates of relief of acute CINV in nonanthracycline-based chemotherapy regimens, they alone are not adequate for anthracycline-based regimens.
Ng, C.G., Boks, M.P., Roes, K.C., Zainal, N.Z., Sulaiman, A.H., Tan, S.B., & de Wit, N.J. (2014). Rapid response to methylphenidate as an add-on therapy to mirtazapine in the treatment of major depressive disorder in terminally ill cancer patients: A four-week, randomized, double-blinded, placebo-controlled study. European Neuropsychopharmacology, 24, 491–498.
To test the effectiveness of major depression treatment using add-on therapy methylphenidate to mirtazapine compared with the addition of placebo to mirtazapine in terminally ill patients with cancer (prognosis of living less than three months)
Four-week, randomized, double-blind, placebo-controlled trial
Symptom relief by day 3 was noted among patients with the add-on therapy. Scores on the depression scale and severity of illness were improved by day 3 and day 14, respectively.
Early patient screening for depression among patients in palliative care is highlighted. Improved depression scores were noted by day 3 and improved the severity of illness by day 14. Consider add-on therapy with a fixed dose of mirtazapine and adding methylphenidate as described for patients with cancer with major depressive disorders in palliative care. Whether or not the rapid antidepressant effect of methylphenidate outweighs the potential for significant adverse effects needs to be individually determined for each patient.
Nguyen, T.N., Nilsson, S., Hellstrom, A.L., & Bengtson, A. (2010). Music therapy to reduce pain and anxiety in children with cancer undergoing lumbar puncture: A randomized clinical trial. Journal of Pediatric Oncology Nursing, 27, 146–155.
To evaluate the effect of music in children with cancer who undergo lumbar puncture (LP)
Children were randomized to use either earphones with music (intervention group ) or earphones without music (control group) using iPods. The researcher and physician were blinded to participant group assignment. Immediately prior to the LP procedure, heart rate, blood pressure, oxygen saturation, and respiratory rate were obtained, and pain and anxiety scores were recorded. Directly after the procedure was finished, anxiety was remeasured. Self-reported pain was obtained before, during, and after LP. Physiologic parameters were recorded throughout the procedure. No local anesthetics or other analgesics were administered, which was usual care. Ten children in each group were chosen to be interviewed as well immediately after the LP procedure.
A double-blind, randomized controlled trial design was used.
Pain scores during LP were significantly lower for the music group (p < 0.001), 2.35 compared to 5.65 in controls. Pain scores after the procedure were also lower for the music group (p < 0.003). Anxiety scores after 10 minutes of music before LP were lower for children in the music group (p < 0.001). Anxiety after LP was also lower in the music group (p < 0.001) compared to controls; however, pre- and post-differences in anxiety in both intervention and control groups were minimal. Heart rate and respiratory rate were significantly different between the two groups, with lowered heart (p = 0.012) and respiratory rate (p = 0.009) during the procedure. In interviews, most of the children in the music group indicated that listening to their favorite music helped them feel calm and took their minds off the procedure.
Use of music as a distraction may be helpful to reduce pain and anxiety in children undergoing lumbar puncture.
This study does not provide convincing support for effectiveness of listening to music to reduce anxiety, but it appeared to reduce pain during the procedure. Music provision is a potentially low-risk and low-cost intervention that may be helpful to reduce pain and anxiety in children who are undergoing uncomfortable procedures. Further study of the use of music in combination with other forms of distractions and methods to combat pain are indicated. It is not clear if providing music via use of iPod and earphones is the best approach, as children in this study did indicate that the earphones were somewhat uncomfortable, and use of earphones for multiple patients could be a potential source for transmission of infection.
Nguyen, D.T., Shayani, S., Palmer, J., Dagis, A., Forman, S.J., Epstein, J., & Spielberger, R. (2015). Palifermin for prevention of oral mucositis in allogeneic hematopoietic stem cell transplantation: A single-institution retrospective evaluation. Supportive Care in Cancer, 23, 3141–3147.
To evaluate possible differences between the severity and duration of oral mucositis (OM) and other clinical end points previously found to be associated with OM in patients who received palifermin compared to those who did not
A retrospective chart review of 99 consecutive patients who received an allogeneic hematopoietic stem cell transplantation (AHSCT) with palifermin from December 2006 to December 2009 was conducted, and 30 patients who received AHSCT from January to December 2005 served as control group (this group was treated before palifermin became standard of practice). Palifermin was administered for three consecutive days with the third dose 24 hours before the initiation of fractionated total body irradiation and three additional doses after the completion of the conditioning regimen (days 0–2). All patients received a comprehensive oral care regimen, and oral assessments were conducted every three days by a certified respiratory therapist.
OM developed in 95% of patients in the palifermin group and all 30 patients in the control group. Severe OM developed in 34% of the palifermin group and 80% of the control group (p < 0.0001) with the median duration of OM 13 days with palifermin and 18 days with the control. The median duration of sever OM was not found to be different between groups. The median duration patient-controlled analgesia use was shorter in the palifermin group as was the use of opioids. No significant difference in the duration of total parenteral nutrition use was found.
Palifermin reduced the incidence of severe OM and the overall duration of OM in this study. This supported the use of palifermin.
This study supported palifermin use in this population. However, additional studies providing evidence on quality of life and patient-reported outcomes are needed.
Ng, C.G., Boks, M.P., Roes, K.C., Zainal, N.Z., Sulaiman, A.H., Tan, S.B., & de Wit, N.J. (2014). Rapid response to methylphenidate as an add-on therapy to mirtazapine in the treatment of major depressive disorder in terminally ill cancer patients: A four-week, randomized, double-blinded, placebo-controlled study. European Neuropsychopharmacology, 24, 491–498.
To evaluate whether adding methylphenidate to mirtazapine in the treatment of depression in terminally ill patients with cancer will cause an earlier antidepressant response compared to patients receiving mirtazapine and a placebo
Patients initially were interviewed by a psychiatrist to confirm the diagnosis of major depressive symptoms using the Mini-International Neuropsychiatric Inventory. Patients were randomized and double-blinded (1:1) to receive either methylphenidate (MPH) or a placebo with mirtazapine (MTZ). Patients taking MTZ received a fixed dosage while MPH was first dosed at 5 mg BID then increased, if needed, after day 3. Outcomes were assessed at baseline and at six subsequent follow-up visits during the double-blind treatment on days 3, 6, 9, 14, 21, and 28. Assessments included the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression–Severity scale.
Randomized, double-blinded, placebo-controlled study
Although this was a small-scale study and the dropout rate was high, this study has implications for a small subset of patients. The addition of MPH to the standard treatment of depression may improve the response rates of terminally ill patients with cancer, beginning as early as three days after starting treatment. MPH must be used with caution due to side effects.
Psychosocial assessment, which includes depression, is extremely important to the nursing profession. For those who care for terminally ill patients with cancer, having options to improve quality of life for a patient suffering from depression can have significant clinical implications. Using MPH may be one option to consider when seeking quick results in treating a major depressive disorder in terminally ill patients. MPH must be used with caution due to potential side effects, and the need for further research in this population is indicated.