Effectiveness Not Established

Aloe Vera

for Mucositis

Aloe vera is a fleshy green cactus plant. A gel made from the plant is used as a complementary therapy for dry skin, cuts, and burns. Aloe vera gel may provide a protective effect on skin with increasing cumulative uses. It is described as having anti-inflammatory and antibacterial properties. It may reduce vasoconstriction as well as leukocyte and platelet aggregation at the site of injury. It is known to improve wound oxygenation, increase the rate of collagen formation, and decrease the amount of dead tissue at the wound site. Aloe vera preparations have been studied for radiodermatitis and mucositis.

Research Evidence Summaries

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

  1. Using block randomization, subjects were assigned to a treatment or control arm
  2. 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.”
  3. 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.

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Mansouri, P., Haghighi, M., Beheshtipour, N., & Ramzi, M. (2016). The effect of aloe vera solution on chemotherapy-induced stomatitis in clients with lymphoma and leukemia: A randomized controlled clinical trial. International Journal of Community Based Nursing and Midwifery, 4, 119–126. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876780

Study Purpose

To assess the effect of aloe vera solution on stomatitis and its pain intensity in patients undergoing chemotherapeutic procedures

Intervention Characteristics/Basic Study Process

In a randomized, controlled clinical trial, 64 patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) undergoing chemotherapy were randomly divided into a control and intervention group. The intervention group was asked to wash their mouths with 5 mls of aloe vera solution for two minutes twice a day for 14 days. The control group used the ordinary mouthwashes recommended in hematologic centers.

Sample Characteristics

  • N = 64   
  • AGE = Control: 47.78 years (SD = 18.28 years), intervention: 46.25 years (SD = 18.17)
  • MALES: 100% 
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-induced stomatitis

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Shahid Motahari Clinic

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled clinical trial patients were randomly divided into a control and an intervention group.

Measurement Instruments/Methods

  • World Health Organization stomatitis intensity survey checklist
  • Visual analog scale (VAS), a standard tool for measuring pain intensity

Results

Aloe vera solution mouthwash significantly reduced the intensity of stomatitis and its pain in the intervention group compared to the control group. On day one, no difference existed; on the other days, there was a significant difference (days 3–14: p = 0.001 for stomatitis intensity, p = 0.001 for pain).

Conclusions

Aloe vera solution might improve patients’ nutritional status, reduce stomatitis and its pain intensity, and lead to satisfaction.

Limitations

  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results
  • Study participants were all male.
  • No mention of the type of chemotherapy or specific protocols uses
  • No information about use of pain medication or oral care procedures

Nursing Implications

Aloe vera mouthwash can be useful in preventing and treating stomatitis in patients with chemotherapy-induced stomatitis without any side effects.

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Su, C.K., Mehta, V., Ravikumar, L., Shah, R., Pinto, H., Halpern, J., … Quynh-Tu, L. (2004). Phase II double-blind randomized study comparing oral aloe vera versus placebo to prevent radiation-related mucositis in patients with head-and-neck neoplasms. International Journal of Radiation Oncology, Biology, Physics, 60, 171–177.

Intervention Characteristics/Basic Study Process

Patients were given 20 mL aloe vera solution or placebo to swish and swallow four times per day beginning on the first day of radiation therapy (RT) and continuing throughout the treatment course. The  solution consisted of 94.5% aloe juice, 5.0% pear juice concentrate, 0.4% lemon-lime flavor, and 0.1% citric acid. The placebo solution was taste-matched with identical astringency, consistency, and ingredients, except that the aloe vera juice was replaced with water.

Sample Characteristics

The study reported on 58 patients with stage II-IV M0 head and neck cancer who were scheduled to receive radiation of at least 50 Gy to at least one site; 28 patients were given aloe vera, and 30 were given placebo.

Setting

The study was conducted from February 1999 through March 2002.

Study Design

This was a double-blind, placebo-controlled, randomized trial.

Measurement Instruments/Methods

  • Researchers recorded incidence and duration of mucositis.
  • Secondary endpoints were quality of life (QOL), weight loss, use of pain medications, need for IV hydration, oral infections, and duration of treatment interruptions.
  • The toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and patient-completed QOL questionnaires were completed every two weeks.

Results

  • The aloe vera arm recorded a lower maximal mucositis severity grade; however, the difference was not statistically significant.
  • Incidence of grade 2 or worse mucositis was not statistically significant between the groups. The treatment group had lower QOL scores, but the differences were not significant.
  • Both arms had similar outcomes for other dimensions.
  • The authors concluded that the addition of aloe vera did not improve tolerance to head-and-neck RT; decrease objective measurements of mucositis; or improve QOL ratings of health, soreness, or well-being.

Conclusions

Findings were not significant.

Limitations

This study did not accrue adequate patients according to statistical analysis.

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Guideline / Expert Opinion

Edmonds, K., Hull, D., Spencer-Shaw, A., Koldenhof, J., Chrysou, M., Boers-Doets, C., & Molassiotis, A. (2012). Strategies for assessing and managing the adverse events of sorafenib and other targeted therapies in the treatment of renal cell and hepatocellular carcinoma: Recommendations from a European nursing task group. European Journal of Oncology Nursing, 16, 172–184.

Purpose & Patient Population

PURPOSE: To review effective strategies to assist nurses in caring for patients receiving sorafenib, with the focus on those adverse effects the group felt were most difficult to manage—hand-foot syndrome, diarrhea, fatigue, and oral complications

TYPES OF PATIENTS ADDRESSED: Patients receiving sorafenib for renal cell or hepatocellular cancer

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

DATABASES USED: PubMed, Cochrane Library, and hand-searching of the Clinical Journal of Oncology Nursing and American Society of Clinical Oncology website     

KEYWORDS: Side effect general terms, and specific terms for each side effect (e.g., altered taste, hand-foot syndrome); disease-related search terms included renal cancer, cancer of the kidneys, hepatocellular carcinoma, and liver cancer

INCLUSION CRITERIA: Evidence base included wider literature regarding the management of similar adverse events in patients with other types of cancer and other types of antitumor therapy. No other specific criteria were stated.

EXCLUSION CRITERIA: Not stated
 

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment            
  • APPLICATIONS: Late effects and survivorship

Results Provided in the Reference

Out of 2,469 initial citations retrieved, 37 were included for review. No specific quality evaluation of citations was done due to the nature of the literature, with few clinical trials. No description of the group process used is provided. Findings from citations reviewed were outlined and a review of the literature was provided, but no actual synthesis of evidence exists. Noted is that most evidence in this area is from experience.

Guidelines & Recommendations

Recommendations for mucositis include oral care, amifostine, and antibiotic paste for prophylaxis. For symptom management, recommendations include ice chips, topical lidocaine solutions, sage tea and baking soda oral rinses, and topical solution containing aloe vera, and advising patient to avoid tobacco, alcohol, and spicy foods, mucosal coating agents (e.g., Gelclair®), hydrolytic enzymes, and treatment interruption. For diarrhea, recommendations are patient education, loperamide, diphenoxylate, cholestyramine, probiotics, tincture of opium, and antidiarrheal agents, and avoidance of lactose, high roughage, fatty and spicy foods, fruit juice, and caffeine. For hand-foot syndrome, recommendations include use of emollients, wearing gloves, and avoiding constrictive footwear, hot water, urea- or salicylate-containing creams, and treatment interruptions. For fatigue, recommendations include encouraging activity, maintaining normal work and social schedules, providing supportive care, and considering antidepressants, methylphenidate, sleep medication, and treatment-free intervals.

Limitations

This review adds nothing new to the limited body of evidence in this area, and does not include a huge body of literature related to the management of fatigue and diarrhea symptoms. Most evidence reviewed was of low quality and expert opinion. No process by which the group evaluated the evidence strength in order to make full recommendations is described, and the result is generally a listing of previously documented opinions related to the management of these symptoms.

Nursing Implications

This review provides recommended assessments and management approaches that are at the level of expert opinion only.

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