Cancer is one of the most leading diseases that cause death to millions today. Research, campaigns, test, fundraisers, and marathon are endless when it comes to finding the ultimate cure for it. Even though surgical removal of infected body parts has been favorable in certain situations (ex. mastectomy), it is still not guaranteed the disease will not recur with a more vigorous attack. Although there is no definite cure of cancer, treatments such as chemotherapy and radiation have been proven to treat cancer by treating the affected cells or organs of the body, or shrinking them for surgery, or causing them to disappear. In the midst of treatment, symptoms and adverse affects can occur. One such side effect is oral mucositis (sores in the mouth).
It can cause pain, discomfort, and difficulty in eating, drinking, and swallowing, which ultimately leads to poor appetite, weight loss, dehydration, weakness, and potentially infection. It has been determined that Sulfacrate was one of the most commonly used supportive medications for this symptom. There are other preventative and managing measures used such as aloe vera, amifostine, intravenous glutamine, granulocyte-colony stimulating factor (G-CSF), honey, laser and antibiotic lozenges containing polymixin/tobramycin/amphotericin (PTA). This systematic research review, conducted by Worthington et al. (2013), attempted to determine the most effective intervention for preventing oral mucositis for patients undergoing cancer treatments.
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"Critique of Interventions for Preventing Oral Mucositis".
Objective of Study
The primary objective of the study was clear and unambiguous. The objective was to determine the most effective prophylactic therapy for the oral mucositis in patients with cancer and receiving therapy.
Search Method
Worthington et al. (2013) described electronic searches of Cochrane Oral Health Group and PaPaS Trials Registers, CENTRAL, MEDLINE via OVID, EMBASE via OVID, CINAHL via EBSCO, ANCERLIT via PubMed, OpenSIGLE, and LILACS via the Virtual Health Library were conducted by two authors. The search for studies was extensive including both computerized and printed from multiple resources. Authors of eligible trials were also contacted to identify trials and obtain additional information. Studies about patient with cancer and receiving chemotherapy, radiation, or targeted therapies that has or are at risk for developing oral mucositis were elgible to be included to study in the review. Most of the exclusions were due to these criteria, including studies with limited information and lack of support findings not related to oral mucositis. Only randomized control trials (RCTs), so the study has an evidence of level I.
Sample and Method
After searching through the above-mentioned databases, including the required criteria, the test population was clearly stated to result in 131 randomized controlled trials with 10,514 participants. Descriptions of all studies included were clear and complete, including sample, methodology, risk of bias, results, and assessment of quality of evidence from those studies. With this amount of studies and participants, it is appropriate and well enough to represent the target population (cancer patients with oral mucositis).
Worthington et al. (2013) did not clearly state whether or not minorities or other race and/or ethnicities were included in the study; however, the locations of the studies were the following: 32 in Europe, 20 in the USA, 7 in China, 5 in India, 4 in Canada, 3 in Brazil and Japan, 2 in Iran, Israel, Thailand, Taiwan and Turkey, and 1 in each of the following countries: Argentina, Egypt, Hong Kong, Malaysia, Mexico, South Africa, South Korea, and Uruguay. Thirty-six trials were multicenter studies.
To decrease the risk of bias, various age groups, different cancer types (leukemia, head and neck, other solid tumors and mixed), and cancer treatment (specific, for example 5-fluorouracil (5-FU)) were other variables used in the review. The independent variable was the intervention or interventions studied, typically including symptom therapy, placebos, and no treatment. The dependent variables were assessment of oral mucositis in patients with cancer or who were at risk of developing oral mucositis while going through therapy. The independent variables consisted of more than forty different interventions including, cryotherapy, keratinocyte, aloe vera, amifostine, glutamine (intravenous), granulocyte-colony stimulating factor, honey, laser, Polymixin/Tobramycin/Amphotericin (PTA) lozenges/paste, and sucralfate.
The studies included used either the criteria published by either the World Health Organization (WHO) or European Organization or Research and Treatment of Cancer (EORTC) to assess the mucositis. These included 5-point Likert-type scales ranging from 0 (normal) to 4 (severe), which are similar to the WHO scale and which describe the visible changes to the mucosa. At the highest levels on these scales, participants could not tolerate solid foods and suffered significant pain. Studies also varied in how often the mucositis was assessed ranging from every 5 days or up to 90 days or the end of cancer therapy (Worthington et al. 2013). The studies used time frames that varied from a few days up to a year after intervention treatment to determine effects of the interventions. In assessing the value of the various interventions, Worthington et al. (2013) used the results reported closest to 28 days after intervention for inter-study comparisons.
Worthington et al. (2013) reported that all 131 studies provided clear descriptions of the interventions, including the dose and method of administration for both test and control groups. The control group received no treatment in 36 studies, and a placebo in 87 studies. A variety of types of placebos were used, including placebos matched to the intervention in terms of taste and appearance, or other types of placebos such as water, albumin, glycine, sugar solution, or polycal, saline. More than 40 different types of interventions were included in these 131 studies.
Studies also varied in terms of the risk of bias. In terms of adequacy of the randomization process used to place participants into groups, only 27 of the studies included were assessed as using adequate randomization, and four more gave few details about the randomization process but were judged to be likely adequately randomized based on the studies’ settings in major cancer centers. Other sources of bias were also clearly assessed in Worthington et al. (2013). Specifically, the review assessed the degree to which patients, intervention care personnel, and assessing personnel were each appropriately blinded, and the degree to which there was adequate allocation concealment. Even more importantly, the review assessed whether there was incomplete reporting of results in the study, another source of bias in research. Other types of bias were assessed, including gender imbalances, age imbalances, and conducting interim assessments prior to complete collection of data that resulted in either early publication of results (if in favor of intervention) or early termination of the project (if in favor of control or placebo groups).
Worthington et al. (2013) presented a very clear chart that indicated the areas and degree of bias by number of papers with low, medium, or high risk of bias in various categories noted. In describing the studies included in this review, Worthington et al. (2013) also provided a clear understanding of the types of studies and the details of how they were conducted.
Overall Findings
The overall findings of Worthington et al. (2013) were that ten interventions offered at least some benefit to patients suffering from oral mucositis as a result of treatment for cancer. Results were presented clearly, comparing each intervention with placebo or control based on the studies of that intervention. As one example, Worthington et al. (2013) described the intervention using chlorhexidine vs. either a placebo or no treatment and clearly explained the results from the nine trials using that particular intervention. Worthington et al. (2013) also provided details of the number of participants (total) in those nine studies, the degree of bias of those studies, and an overall statement of results, in this case, that no evidence was found that chlorhexidine was an effective treatment for mucositis. This type of analysis was repeated for each one of the 40+ interventions studied in the trials reviewed.
The ten interventions found to have some potential benefit (and the strength of the evidence and risk of bias) were: allopurinol (weak inconsistent evidence, unclear bias); aloe vera (weak unreliable evidence, unclear bias); amifostine (weak unreliable evidence, significant bias risk in eight of 11 trials); benzydamine (weak unreliable evidence, unclear bias); cryotherapy (ice chips) (some evidence, substantial risk of bias); G-CSF (weak evidence, unclear or high risk of bias); honey (weak unreliable evidence, high risk of bias); keratinocyte GF (some evidence, generally unclear risk of bias); low energy laser (weak evidence, some risk of bias); PTA antibiotic pastille or paste (weak evidence but only two trials; low to unclear risk of bias); sucralfate (some evidence for prevention and improvement, unclear bias, a few with low risk).
Worthington et al. (2013) concluded that cryotherapy and keratinocyte growth factors had some evidence of benefit for patients with mucositis (each with at least 6 trials and at least 550 for each of the two interventions), but that the studies reporting those results had either high or uncertain risk of bias. The other eight interventions suffered from less evidence (2 to 5 trials, and 90 to 350 total participants). Furthermore, the interventions were tested with various types of cancer or therapy. For example, Worthington et al. (2013) reported that aloe vera, PTA antibiotics, and honey were investigated solely in patients receiving radiation therapy for head and neck cancers. Thus, the generalizability of these treatments in other types of cancers or treatments may be unknown.
Summary of Review
Worthington et al. (2013) concluded that while mucositis is an important issue for clinicians and patients, there exists insufficient evidence to support a broadly accepted preventative or curative intervention for mucositis. Evidence exists for a variety of potential treatments, but no strong evidence exists that any one is compelling. Based on the evidence summarized in this report, I agree that no one single intervention dominates. To some degree, the evidence quality is based on the type of cancer and the type of cancer therapy each patient experiences. Thus, there is no one-size-fits-all intervention for mucositis.
The implications for my nursing practice is that treating patients with mucositis developed from cancer treatments should take into account the preferences of the patient as well as the type of cancer an cancer therapy the patient has. For example, a patient with naturalistic preferences or has an extremely limited budge may strongly prefer to use ice chips, aloe vera, or honey for their mucositis, particularly if they have head or neck cancer. A patient with the same kind of cancer who strongly believes in the power of antibiotics and has good drug coverage in their insurance may prefer PTA antibiotics. There is no one single best answer. This review also drives home the critical importance of high-quality, large-scale reviews to generate adequate evidence to drive an evidence-based practice approach to mucositis in patients receiving cancer therapy.
