Symptom Monitoring
Symptom monitoring refers to employing a focused and systematic approach to symptom monitoring in order to improve patient-reported outcomes.
Minocycline
Minocycline is a drug that has been traditionally used as an antibiotic and anti-inflammatory. It has been studied in animal models for the prevention of paclitaxel-induced neurotoxicity with some positive results; trials in humans are now underway. Until more results are known, minocycline for peripheral neuropathy should only be used in the context of a clinical trial.
Dexamethasone Mouthwash
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.
Study Purpose
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.
Intervention Characteristics/Basic Study Process
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.
Sample Characteristics
- N = 69
- MEAN AGE: 36.725 years
- MALES: 57%
- FEMALES: 43%
- CURRENT TREATMENT: Chemotherapy
- KEY DISEASE CHARACTERISTICS: AML, ALL, CML
Setting
SITE: Multi-site
SETTING TYPE: Not specified
LOCATION: Nemaze Hospitals affiliated to SUMS, Shiraz, Iran
Phase of Care and Clinical Applications
- PHASE OF CARE: Active anti-tumor treatment
- APPLICATIONS: Palliative care
Study Design
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.
Measurement Instruments/Methods
- IBM SPSS Statistics, version 20
- Kolmogorov-Smirnov test
- Independent t test and chi-square test
- Repeated measures analysis of variance (RM-ANOVA)
Results
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)
Conclusions
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.
Limitations
- Small sample (< 100)
- Risk of bias (sample characteristics)
- Findings not generalizable
- Other limitations/explanation: Length of the study, evaluation of mucositis for a longer time
Nursing Implications
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.
Study Purpose
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.
Intervention Characteristics/Basic Study Process
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.
Sample Characteristics
- N = 99 (2:1 randomization, n = 64 in probiotic group and n = 35 in placebo group)
- MEAN AGE: 50.4 years in treatment group and 51.69 years in placebo group
- MALES: N = 58 (n = 21 [60%] in treatment group, n = 37 (64%] in control group)
- FEMALES: N = 35 (n = 14 [40%] in treatment group, n = 21 [36%] in control group)
- CURRENT TREATMENT: Combination radiation therapy and chemotherapy
- KEY DISEASE CHARACTERISTICS: Nasopharyngeal cancer
- OTHER KEY SAMPLE CHARACTERISTICS: n/a
Setting
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: China
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Study Design
RCT, double-blind, placebo controlled
Measurement Instruments/Methods
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.
Results
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.
Conclusions
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.
Nursing Implications
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.
Purpose
- STUDY PURPOSE: To assess the effects of cytokines and growth factors for preventing oral mucositis in patients with cancer who are receiving treatment.
- TYPE OF STUDY: Systematic review
Search Strategy
- DATABASES USED: Cochrane Oral Health’s information specialist searched the following databases: Cochrane Oral Health’s Trials Register (searched May 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched May 2017); MEDLINE Ovid (1946 to May 2017); Embase Ovid (December 2015 to May 2017); CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to May 2017); and CANCERLIT PubMed (1950 to May 2017). The U.S. National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials.
- YEARS INCLUDED: Through May 2017
- INCLUSION CRITERIA: RCTs
- EXCLUSION CRITERIA:Not a RCT or unclear; stomatitis incidence reported in adverse events table; unclear if mucositis was oral or gastrointestinal; study stopped early with very few participants enrolled; oral mucositis not mentioned and unknown if measured; some participants had oral mucositis at baseline; crossover study with no reporting of first-period data; results reported by cycle assuming independence; survival/cure was primary outcome with mucositis (unclear if oral or gastrointestinal) as a toxicity
Literature Evaluated
- TOTAL REFERENCES RETRIEVED: 3,145
- EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two review authors independently screened the results of electronic searches, extracted data, and assessed risk of bias. For dichotomous outcomes, they reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, they reported mean differences (MD) and 95% CIs. They pooled similar studies in random-effects meta-analyses.
Sample Characteristics
- FINAL NUMBER STUDIES INCLUDED: 35 (published from 1993 to 2017)
- TOTAL PATIENTS INCLUDED IN REVIEW: 3,102
- SAMPLE RANGE ACROSS STUDIES: Fourteen studies enrolled participants with hematological cancers. Eighteen studies enrolled participants with solid cancers: head and neck, colorectal, breast, and sarcoma. The remaining three studies enrolled a mixture of participants with solid cancers and participants with hematological cancers, two of which were 80%-90% solid, and the other study only 3% solid.
- KEY SAMPLE CHARACTERISTICS: All patients being treated for cancer, aged 1 to 87 years old
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Results
- There might be a reduction in the risk of moderate to severe oral mucositis in adults receiving bone marrow/stem cell transplantation after conditioning therapy for hematological cancers (RR = 0.89, 95% CI [0.8, 0.99]; 6 studies; 852 participants; low-quality evidence).
- A possible reduction in the risk of severe oral mucositis in bone marrow/stem cell transplantation after conditioning therapy for hematological cancers, but there is also some possibility of an increase in risk (RR = 0.85, 95% CI [0.65, 1.11]; 6 studies; 852 participants; low-quality evidence).
- Probably a reduction in the risk of moderate to severe oral mucositis in adults receiving radiotherapy to the head and neck with cisplatin or fluorouracil (RR = 0.91, 95% CI [0.83, 1]; 3 studies; 471 participants; moderate-quality evidence).
- Likely that there is a reduction in the risk of severe oral mucositis in adults receiving radiotherapy to the head and neck (RR = 0.79, 95% CI [0.69, 0.9]; 3 studies; 471 participants; high-quality evidence)
- Likely that there is a reduction in the risk of moderate to severe oral mucositis in adults receiving chemotherapy alone for mixed solid and hematologic cancers (RR = 0.56, 95% CI [0.45, 0.7]; 4 studies; 344 participants; moderate-quality evidence)
- Might be a reduction in the risk of severe oral mucositis in this population (RR = 0.3, 95% CI [0.14, 0.65]; 3 studies; 263 participants; low-quality evidence)
Conclusions
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
Limitations
- Low sample sizes
- 13 studies (37%) were at low overall risk of bias
- 12 studies (34%) were at unclear overall risk of bias.
- 10 studies (29%) were at high overall risk of bias
Nursing Implications
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.
Study Purpose
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.
Intervention Characteristics/Basic Study Process
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.
Sample Characteristics
- N = 50
- AGE: 32-73 years
- MALES: 66%
- FEMALES: 34%
- CURRENT TREATMENT: Chemotherapy
- KEY DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma or lymphoma
- OTHER KEY SAMPLE CHARACTERISTICS: Autologous stem cell transplantation candidates
Setting
- SITE: Single site
- SETTING TYPE: Inpatient
- LOCATION: Copenhagen, Denmark
Phase of Care and Clinical Applications
- PHASE OF CARE: Active anti-tumor treatment
- APPLICATIONS: Palliative care
Study Design
- Randomized, double-blind study to one of two groups receiving oral bismuth or a placebo
Measurement Instruments/Methods
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
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)
Conclusions
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.
Limitations
Small sample (< 100)
Nursing Implications
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.
Purpose
- STUDY PURPOSE: To evaluate effect of prophylactic and therapeutic low-level laser therapy (LLLT) in pediatric and young patients with cancer or undergoing HSCT.
- TYPE OF STUDY: Meta analysis and systematic review
Search Strategy
- DATABASES USED: Cochrane Central Register of Controlled Trials, Embase, MEDLINE, Web of Science, China Biology Medicine (CBM), Wanfang Database, and China National Knowledge Infrastructure (CNKI)
- YEARS INCLUDED: (overall for all databases) Years searched was unclear. Included articles were as old as 2007. The newest study was from 2017.
- INCLUSION CRITERIA: The randomized controlled trials and clinical controlled trials. Study participants were younger than age 23 years at diagnosis of any type of childhood cancer or undergoing HSCT. Both prophylaxis and therapeutic use of LLLT were included.
- EXCLUSION CRITERIA: Not specified, but can assume studies that do not fit inclusion criteria were excluded.
Literature Evaluated
- TOTAL REFERENCES RETRIEVED: 202
- EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The authors made reasonable effort to evaluate articles. The authors also used Cochrane Collaboration’s tool for assessing potential risk of bias for each article.
Sample Characteristics
- FINAL NUMBER STUDIES INCLUDED: 8
- TOTAL PATIENTS INCLUDED IN REVIEW: Occurrence of OM after prophylactic LLLT = 213 (ex, 106; con, 107); grade 3 or higher OM after prophylactic LLLT = 173 (ex, 86; con, 87); OM severity after prophylactic LLLT = 96(ex, 44; con, 52); OM severity after therapeutic LLLT = 160 (ex, 79; con, 81); oral pain after therapeutic LLLT = 139 (ex, 70; con 69)
- SAMPLE RANGE ACROSS STUDIES: 16-123
- KEY SAMPLE CHARACTERISTICS: Patients with various solid tumors or lymphoma and leukemia who underwent HSCT
Phase of Care and Clinical Applications
- PHASE OF CARE: Active anti-tumor treatment
- APPLICATIONS: Pediatrics
Results
- After prophylactic LLLT, the OR for developing OM was significantly lower compared with placebo (OR = 0.5, 95% CI [0.29, 0.87], p = 0.01)
- The OR for developing grade III OM or worse was statistically significantly lower compared with placebo (OR = 0.3, 95% CI [0.1, 0.9], p = 0.03)
- The OM severity was statistically significantly lower compared with placebo (SMD = −0.56, 95% CI [−0.98, −0.14], p = 0.009)
- For therapeutic LLLT, the OM severity was significantly reduced compared to routine care (SMD = −1.18, 95% CI [−1.52, −0.84], p < 0.00001)
- Oral pain was also reduced after LLLT over routine care (MD = −0.73, 95% CI [−1.36, −0.11], p = 0.02)
Conclusions
- Prophylactic LLLT reduces mucositis and severe mucositis and decreases the average severity of oral mucositis in pediatric and young patients with cancer.
- Therapeutic LLLT also reduces the average severity of oral mucositis and oral pain.
Limitations
Low sample sizes
Nursing Implications
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.
Purpose
- STUDY PURPOSE: To optimize the prophylactic treatment for radiotherapy-induced oral mucositis in patients with head and neck cancer receiving postoperative or definitive radiotherapy with or without chemotherapy
- TYPE OF STUDY: Network meta analysis and systematic review
Search Strategy
- DATABASES USED: PubMed, Web of Science, Cochrane Library, and Chinese databases (WangFang, National Knowledge Infrastructure)
- YEARS INCLUDED: (Overall for all databases) Authors stated the search was up to May 1, 2017. Supplemental material shows the oldest study included was 1989.
- INCLUSION CRITERIA: Head and neck cancer or carcinoma or neoplasm, nasopharyngeal carcinoma or cancer or neoplasm, radiotherapy and mucositis
- EXCLUSION CRITERIA: Not specified
Literature Evaluated
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.
Sample Characteristics
- FINAL NUMBER STUDIES INCLUDED: 57
- TOTAL PATIENTS INCLUDED IN REVIEW: 5,261 patients randomly assigned
- SAMPLE RANGE ACROSS STUDIES: Not specified in this version of article.
- KEY SAMPLE CHARACTERISTICS: Not specified in this version of article
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Results
- Direct meta analysis findings for grade 0–2 oral mucositis: Abs: SOC, AIS: PS, AVS: PS, CHS: PS, GFS: PS, GS: PS, GS: SOC, HS: SOC, LS: PS, LS: SOC, PS: SOC
- SOC and PS had worse effects and LS had better effects than most of the other treatments; details in supplementary materials
- In the network of 12 treatment arms, LS ranked as best and SOC as least effective in preventing grade 3 and 4 mucositis
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
Conclusions
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.
Limitations
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.
Nursing Implications
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.
Study Purpose
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.
Intervention Characteristics/Basic Study Process
- Using block randomization, subjects were assigned to a treatment or control arm
- For patients in both groups, patients applied a thin layer of gel (presumably to the oral mucosa) three times daily throughout their radiation treatment. Patients were told not to drink/eat anything for 15 minutes. The treatment group applied 10% aloe vera, the control group gel was not specified other than a “base gel.”
- The patients in both groups were assessed on day 1, 8, 15, 22, 29, 36, and “last day.”
Sample Characteristics
- N = 100, 51 in treatment group, 49 in control group
- AGE: Adult, 10 participants were younger than age 40 years, 28 participants were 41-50 years, 31 participants were 51-60 years, and 31 participants were older than age 60 years
- MALES: 85%
- FEMALES: 15%
- CURRENT TREATMENT: Combination radiation therapy and chemotherapy
- KEY DISEASE CHARACTERISTICS: Patients with head and neck cancer undergoing radiation therapy or chemotherapy-radiation therapy
- OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included allergy to aloe vera, diabetes-mellitus, immune suppressants, and HIV-positive patients
Setting
- SITE: Single site
- SETTING TYPE: Multiple settings
- LOCATION: Mumbai, India
Phase of Care and Clinical Applications
- PHASE OF CARE: Active anti-tumor treatment
- APPLICATIONS: Palliative care
Study Design
Randomized, double blind control study
Measurement Instruments/Methods
- Data was collected using an interview schedule and an observational tool
- Primary outcomes: WHO grading of mucositis and VAS oral pain scores
- Secondary outcomes: Amount of antibiotic, antifungal, and analgesia used and on what day of treatment. Number of hospital admissions, nutritional support requirement, treatment interruption, weight loss, QOL: OMWQ-HN, and FACT-HN
Results
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.
Conclusions
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.
Limitations
- Measurement/methods not well described
- Measurement validity/reliability questionable
- Questionable protocol fidelity
- Other limitations/explanation: The statistical analysis is poorly described. Most of the data is reported as frequency and percent of occurrence. Although the onset of occurrence of mucositis is significant (p = 0.043), there is only a difference of either 0.7, but it does not state if this is 0.7 days or hours (the mean is 17.5 in the treatment group, 16.8 in the control group). The authors provide a z score of 1.7 and a df of 98). As far as analgesic requirements, the authors do not provide data. On grades of mucositis, the table only report on the grade on the last day of therapy, and the p value may be representative of all grades; however, grades 1 and 2 are worse in the experimental group and grade 3 is worse in the control group. It is difficult to interpret the data because the x and y axes are not labeled. There is no mention of how compliant patients were with the protocol; therefore, there is potential for poor protocol fidelity (Did the aloe vera feel good and the base solution not? Did it taste better/worse so people didn’t use it? All of this is unknown). It is very hard to delineate the magnitude of group differences across time. Seeing the raw data may help answer these questions.
Nursing Implications
Aloe vera gel may help decrease the time to development and severity of radiation-induced mucositis in patients with head and neck cancer.