NK2

 

Research NK2

 

Provide a synopsis of one completed nursing research study conducted in the applicant organization that is institutional review board-approved (IRB-approved) or determined exempt by organizational review.   

 

 

Study overview

  • Title of Study: SMAP-AV: Saving Mucosa with Prophylactic Aloe Vera Therapy

    • The Catholic Health Initiatives (CHI) Institute for Research and Innovation Institutional Review Board (CHIRB) approved the research project on April 23, 2019 and determined the project to be a full IRB review that was expedited.

  • Study Start Date: May 22, 2019

  • Study Complete Date: March 14, 2023

 

Research team

  • Elizabeth Bright, RN, OCN, Nurse Navigator in the Cancer Treatment Center, was the Co-Principal Investigator.

  • David Pruitt, MD, Radiation Oncologist in the Cancer Treatment Center, was the Principal Investigator.

 

Study aim

The purpose of this study was to determine whether the prophylactic use of Aloe Vera juice for patients receiving external beam radiation therapy, specifically for those with a biopsy confirming diagnosis of head or neck cancer:

  • Would prevent drastic weight loss (>10%)

  • Would prevent patients in this population from requiring a percutaneous endoscopic gastrostomy (PEG) tube

  • Would lead to patients in this population scoring as 2 or lower on the World Health Organization (WHO) oral mucositis scale during their course of radiation

 

The potential benefit of the study is that patients would experience less severe treatment-related side effects, in particular mucositis and esophagitis, and less drastic weight loss during treatment by using the correct consistency of Aloe Vera juice prophylactically as prescribed during external beam radiation therapy. Aloe Vera products and raw Aloe Vera leaf are widely available for human consumption through grocers and other retailers in America. Aloe Vera juice is like any other vegetable and is sold alongside other produce. It is expected that there is very little risk with ingesting Aloe Vera juice.

 

Significance of the literature review

Key References to Support Significance

  1. 1Puataweepong, Putipun, Mantana Dhanachai, Somjai Dangprasert, Chompron sithatani, Thiti Sawangsilp, Laddawan Narkwong, Parmorn Puttikaran, Tanin Intragumtornchai. “The Efficacy of Oral Aloe Vera Juice for Radiation Induced Mucositis in Head and Neck Cancer Patients: a Double-Blind Placebo-controlled Study.” Asian Biomedicine, no. 4. (August 2009): 375-382.
  2. Sahebjamee, Mahnaz, Reza Bekhradi, Arash Mansourian, Sajjad Ashnagar. “Comparative Efficacy of Aloe Vera and Benzydamine Mouthwashes on Radiation – Induced Oral Mucositis: A Triple-Blind”. Oral Health & Preventaive Dentistry (November 2014).
  3. Ahmadi, Amirhossein. “Potential Prevention: Aloe Vera Mouthwash May Reduce Radiation-Induced Oral Mucositis in Head and Neck Cancer Patients. Chinese Journal of Integrative Medicine no. 18 (August 2012): 635640.
  4. Lonbro, Simon, Gry Bjerg Peterson, Jens Rikardt Andersen, Jorgen Johansen. Prediction of Critical Weight Loss During Radiation Treatment in Head and Neck Cancer Patients is Dependent on BMI no. 24 (May 2016) 2101-2109.

 

Why the Study is Important to Nursing
Improving patients’ experience of care is important to nursing, as patients with head and neck cancer have many difficult side effects that impact their quality of life and lead to treatment delays that can result in their treatment being less effective. Side effects include, but are not limited to, pain, problems swallowing, and required dental procedures before the start of radiation (most commonly total mouth extraction) (Puataweepong et al., 2009; Sahebjamee et al., 2014; Ahmadi, 2012; and Lonbro et al., 2016).

 

The cost of care is relevant for this study. The organization looked at:

  • Pharmaceuticals vs. over-the-counter Aloe Vera juice

    • Mugard: Six bottles, one bottle a week for six weeks of therapy at a cost of $1,200
    • One gallon of Aloe Vera juice at $6.44 at a local grocery store

  • PEG tube placement (an extra surgical procedure) vs. no procedure

    • PEG tube placement – $2,000-$5,000
    • No procedure – $0

  • The cost of daily tube feedings vs. the cost of normal oral nutrition

    • Daily tube feedings – $84
    • Daily oral nutrition - $10

 

What is Currently Known about the Prophylactic Use of Aloe Vera Juice
It is known through previous research studies that patients undergoing radiation therapy who use Aloe Vera prophylactically on the first day of radiation therapy have less discomfort related to mucositis than those who wait until they have those symptoms and are then prescribed medications to help (Sahebjamee et al., 2014).

 

Patients continue to have increased issues with mucositis, increased weight loss, and routine PEG tube placement at hospitals where physicians and nurses are still practicing medicine and providing nursing care in the same way it has always been done. The researchers set out to determine the ideal time for prophylactic Aloe Vera and its ideal consistency.

 

Innovation

This research study was to produce actionable information for nursing, as the proposed mechanism of Aloe Vera juice is to coat the mucosa. This decreases irritation to the lining of the throat, thereby enabling patients to eat and/or drink with less discomfort. Better nutrition then enables patients to maintain caloric intake to prevent weight loss.

 

Pruitt reviewed many local Aloe Vera products. The product chosen for this study has a water-like viscosity; it is manufactured from the inner gel portion of the Aloe Vera plant. The preparation is Aloe Vera juice, made from the Aloe Vera inner gel or filet. The investigators provided Aloe Vera for every patient. The ingredients are water, Aloe Vera concentrate, citric acid, and sodium benzoate as a food preservative.

 

Study design

The study followed a quantitative, descriptive design.

 

The three endpoints for SMAP-AV were:

  • Patients will not lose greater than 10% of their initial body weight during their radiation treatments.

  • Patients will not require a PEG tube.

  • Patients will experience 2 or less on the WHO oral mucositis scale during their course of radiation.

 

Sample description

The type of sample for this study was a cohort.

 

Inclusion criteria:

  • A biopsy-confirmed diagnosis of head or neck cancer

  • Receiving external beam radiation therapy + (plus) or - (minus) chemotherapy, with curative intent at CHI St. Vincent Cancer Center – Hot Springs

  • P16+ (P16 Positive) or P16- (P16 Negative)

  • Smoker or non-smoker

  • Male or female

  • Age 20+

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

  • Stage I, II, III or IV head or neck cancer

 

Exclusion criteria:

  • Vulnerable population, defined as:

    • Adults unable to consent, and/or cognitively impaired

    • Not an adult (infants, children, teenagers)

    • Pregnant women

    • Prisoners

    • ECOG performance status of 3 or 4

    • Recurrent head or neck cancer 30 patients were enrolled in the study.

 

Location of study

The study was conducted at CHI St. Vincent Hot Springs, Cancer Treatment Center, which is an ambulatory care center.

 

Study procedures

Pruitt assessed all oral cavity head and neck cancer patients at the new patient consult. Patients who met the inclusion criteria met again with Pruitt to discuss the research study, read the study protocol, and sign the informed consent if they decided to participate. Every patient then had intensive education sessions with a nurse navigator about the side effects of treatment, directions for taking the Aloe Vera juice, and how to track information in a patient journal. Every patient initially discussed with the nurse navigator the importance of proper nutrition throughout treatment. The nutritionist then met with each patient biweekly to continue discussions of proper nutrition throughout their treatment.

 

At the start of external beam radiation therapy, Bright, the nurse navigator, provided patients with the Aloe Vera juice and verbal and written instructions for its use. The purpose of the Aloe Vera juice is to coat the mucosa of the mouth and esophagus. Bright instructed the patients to take one ounce of the provided 99.8% Aloe Vera juice by mouth after breakfast, one ounce after lunch, one ounce after supper, and one ounce at bedtime. Patients were instructed not to eat or drink for 20 minutes after drinking Aloe Vera juice and that it was not to be consumed within two hours before the prescribed daily radiation therapy or before two hours after completing the therapy.

 

Data collection methods included a clinical nurse or Bright weighing patients at baseline and weekly while undergoing treatment and documenting this in the electronic medical record (EMR). Patients’ weights at one month, three months, six months, and nine months, and one year after radiation therapy treatment, were documented in the EMR and Patient Treatment Documentation Form. Patients saw a registered dietician every other Thursday while under treatment.

 

Nurses informed patients of weight loss and asked them about compliance with the use of the Aloe Vera juice. Patients who began to lose weight were counseled to increase calories and protein intake.

 

Patients were asked to fill out a daily journal of treatment time and to record the time they consumed the Aloe Vera juice. Patients were instructed not to take any Aloe Vera product other than the one provided by the investigator.

 

Results

The results for the three endpoints of the study for the 30-patient sample were as follows:

  • Patients will not lose greater than 10% of their initial body weight:

    • 17/30 patients (57%) lost less than 10% of their initial body weight.

    • 8/30 patients (27%) lost more than 10% of their initial body weight but were not compliant with the use of Aloe Vera juice.

    • 5/30 patients (17%) did not complete radiation In addition:

    • 1 patient had a hospital admission and never resumed treatment.

    • 3 patients quit the study due to discomfort or pain.

    • 1 patient had a cardiac arrest and disease that was not due to the study.

  • Patients will not require a PEG tube:

    • 2/30 patients (7%) had PEG placement during treatment.

    • 1 of the 30 patients (3%) had a PEG placed prior to consult but did not inform the researchers.

    • 3/30 patients (10%) required PEG tube placement after completing treatment.

  • Patients will experience 2 or less on the WHO oral mucositis scale:

    • 2/30 patients (7%) had a WHO oral mucositis score of 3.

    • 28/30 patients (93%) had a WHO oral mucositis score of 0-2 at the completion of radiation.

 

Discussion

The findings for the IRB and FDA-approved research study SMAP-AV were significant for most of the patients: losing less than 10% of their initial body weight, not needing PEG tube placement, and oral mucositis scores of 2 or less on the WHO oral mucositis scale. The results validated the findings from the literature review regarding the need for cost-effective strategies to decrease the discomfort of mucositis for patients undergoing external beam radiation treatment. The results further validated the importance of prophylactic versus reactive use of Aloe Vera juice for this vulnerable patient population.

 

Findings showed that starting the Aloe Vera juice at the first external beam radiation treatment increased the success of the program, rather than waiting until the patient started having problems, which is usually two to three weeks after treatment is started. Pruitt wanted these patients to continue to swallow. However, patients with a PEG tube in place do not force themselves to swallow, primarily because of pain. Patients who drink oral nutritional supplements and continue to swallow during treatment will keep the swallowing mechanism patent. They will then be able to resume eating and drinking sooner after treatment is completed, helping to mitigate post-therapy complications.

 

The researchers reviewed patients’ journals during treatment and after treatment was completed. They found that patients who followed the protocol as directed had better success than those who were not compliant with the four-time daily dose of Aloe Vera juice throughout radiation treatment.

 

The implications of the findings favored the organization continuing the prophylactic use of Aloe Vera juice for patients receiving external beam radiation therapy, specifically for those with a biopsy-proven diagnosis of head or neck cancer.