Hyaluronic Acid/Sodium Hyaluronate

Hyaluronic Acid/Sodium Hyaluronate

PEP Topic 
Mucositis
Description 

Hyaluronic acid, also known as hyaluronate, is a carbohydrate substance that is present in connective, epithelial, and neural tissues and is a major component of the intracellular matrix. Sodium hyaluronate is the sodium salt of the same substance. Hyaluronic acid or sodium hyaluronate has been used in patients with cancer as an oral spray for treatment of mucositis and as a topical treatment for radiodermatitis.

Effectiveness Not Established

Research Evidence Summaries

The clinical effectiveness of Gelclair in the management of oral mucositis. (2009). Australian Nursing Journal, 16(9), 30-33.

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Study Purpose:

To evaluate the effect of Gelclair on pain scores in patients with head and neck cancer with oral mucositis receiving radiotherapy.

Intervention Characteristics/Basic Study Process:

During radiotherapy treatment a care plan for management of oral mucosa was commenced after each patient's first treatment. During the study, Gelclair was offered to patients whose pain scores exceeded 5/10. Gelclair was given three times per day, one hour before food, rinsed around the mouth for 1 minute.

Sample Characteristics:

The study was comprised of 33 patients age 18 to 81 years.

Key Disease Characteristics: Confirmed diagnosis of oral mucositis while receiving radiotherapy for head and neck cancer

Setting:

Site: Single site

Location: Perth Radiation Oncology at Royal Perth Hospital, Feb 2008 to Sep 2008

Phase of Care and Clinical Applications:

Phase of Care: Active treatment

Clinical Applications: Elderly care; end of life and palliative care

Study Design:

Case study

Measurement Instruments/Methods:

Data was collected from patient records and interviews conducted by registered nurses.

Results:

Prior to Gelclair treatment, 88% of patients were graded a pain score of 7 or above, which is classified as severe pain; following treatment with Gelclair, 85% of patients reported an improvement in their pain scores. Prior to Gelclair, tx average PS ws 8.33, and post tx PS average was 3.52.

Conclusions:

There is potential diminishing of pain with daily use of Gelclair, but further randomized studies are needed to further assess the potential benefit this product can have on oral mucositis in patients receiving chemotherapy and or radiotherapy.

Limitations:

No appropriate control group

Nursing Implications:

Decreasing the pain from OM with Gelclair could potentially decrease the need for analgesics and decrease the need for hospitalization.

Barber, C., Powell, R., Ellis, A., & Hewett, J. (2007). Comparing pain control and ability to eat and drink with standard therapy vs. Gelclair: A preliminary, double centre, randomised controlled trial on patients with radiotherapy-induced oral mucositis. Supportive Care in Cancer, 15(4), 427–440.

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Study Purpose:

RCT was designed to evaluate pain control and the ability to eat and drink using standard therapy (sucralfate and Mucaine® [Wyeth-Ayerst Laboratories]) versus Gelclair®  (EKR Therapeutics, Inc.) in patients with radiotherapy-induced oral mucositis.

Intervention Characteristics/Basic Study Process:

Patients used medication 30 minutes to 1 hour before eating or drinking.

Gelclair: Patients used undiluted or could mix a single dose in a glass with up to 40 ml of water. Patients swished and gargled for at least one minute to coat the tongue, roof of mouth, throat, and inside of cheeks. If unable to do that, patients used sponge applicators. Patients spat the product out and did not swallow it.

Sucralfate and Mucaine: Patients swished 10 ml in mouth for at least 1 minute to coat all areas, then swallowed the product.  

Study was 24 hours only. Baseline was 1, 3, and 24 hours after initiation of treatment.

Patients in both groups had additional analgesia available throughout the trial.

Patients swallowed standard therapy but not Gelclair.

 

Sample Characteristics:

The sample was comprised of 20 patients (n = 10 in the Gelclair group and n = 10 in the standard [sucralfate and Mucaine] group).

Patients with head and neck cancer received daily radation therapy over a 4–6 week period and showed at least grade 1 oral mucositis and pain not alleviated by paracetamol, co-codamol, or aspirin.

The mean age was 61.1 years (range = 28-79 years).

Three patients were smokers.

 

Study Design:

Double-center, prospective RCT

Single blind trial with the administrating nurse specialist unaware of medication used

Conducted as feasibility study for future sample size calculation

Measurement Instruments/Methods:

Oral mucositis NCI-CTC for radiation

General pain and pain on speaking VAS 0–10

Swallowing assessment was self-recorded (normal to swallowing own saliva only).

Compliance was queried by the researcher.
 

Results:

Using NCI grading, nine patients had grade 3 or 4 (three in the intervention arm and six in the control arm). The remaining 11 patients had grade 1 or 2 (seven in the Gelclair group and four in the standard therapy group).

No observations of relevance with regard to general pain, pain on speaking, or ability to eat and drink for those with higher grades of oral mucositis.

Number of coanalgesics of strong opiate type

One patient was noncompliant for sucralfate and Mucaine.

General pain: No significant difference was observed between the intervention and the control group across time intervals (p = 0.236).

Reduction in pain on speaking was not significant (p = 0.616).

Swallow: Effects of standard therapy appeared to last longer than Gelclair (NS).
 

Limitations:

Because the study was only 24 hours, effectiveness with more severe mucositis is not known.

 

Colella, G., Cannavale, R., Vicidomini, A., Rinaldi, G., Compilato, D., & Campisi, G. (2010). Efficacy of a spray compound containing a pool of collagen precursor synthetic aminoacids (l-proline, l-leucine, l-lysine and glycine) combined with sodium hyaluronate to manage chemo/radiotherapy-induced oral mucositis: Preliminary data of an open trial. International Journal of Immunopathology and Pharmacology, 23(1), 143-151.

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Study Purpose:

Evaluate the efficacy of sodium hyaluronate to decrease pain and severity of oral mucositis

Intervention Characteristics/Basic Study Process:

Patients affected by oral mucositis were consecutively recruited. Patients were instructed to apply the hylauronic based spray on oral lesions 3-4 times per day for 14 days after meals. All patients did mouth care, including oral rinses with 0.12% chlorhexidine gluconate based mouthwash 3 times daily. Patients were evaluated with oral examination and photo recording at baseline, at 24 hours, 72 hours, 7 days, and 14 days.

Sample Characteristics:

The study was comprised of 27 patients with a mean age of 61 (SD = 18.6 years) and a range of 18-96 years. There were 12 femailes and 15 males.

Diagnosis Information: Recent treatment for head and neck cancer, daily radiotherapy, or chemo for neoplasm

Other Key Characteristics: signs of at least grade 1 oral mucositis

Setting:

Mutli-site: University of Naples and University Hospital of Palermo

Study Design:

Open label prospective clinical trial

Measurement Instruments/Methods:

  • WHO mucositis scale
  • Visual Analog Scale (VAS) for pain
  • Clinical resolution index

Results:

Pain scores with VAS reduced over time and was significantly reduced after two hours from spray provision (p  < 0.0001). Similar differences were shown at every other measurement time point as well (p < 0.0001). Patients treated showed improvement of lesion at 72 h (p = 0.0005) and progressive improvement in ability to swallow food and liquids.

Conclusions:

Findings suggest that hylauronic acid/sodium hyaluronate may be helpful for management of oral mucositis.

Limitations:

Small sample <30. No appropriate control group; variety in treatment regimens (chemo versus non-chemo) may skew results. Patients already had mucositis at study entry and were using chlorhexidine, which is contrary to guideline recommendations. It is unclear if this may have affected findings.

Nursing Implications:

May be effective but what are side effects? Does it lead to numbing? What does it taste like? Etc.

Vokurka, S., Skardova, J., Hruskova, R., Kabatova-Maxova, K., Svoboda, T., Bystricka, E., et al. (2011). The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 17(10), CR572-6.

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Study Purpose:

To assess the efficacy, tolerance, and impact on oral cavity microbial colonization in patients with OM post-allogeneic hematopoietic stem cell transplantation.  

Intervention Characteristics/Basic Study Process:

Oral cavity nursing care with benzydamine, chlorhexadine, or saliva solutions was started on the first day of conditioning chemotherapy administration and covered the entire inpatient stay. Gelclair was begun for 22 consecutive patients on the day of the development of OM and continued until the OM resolved when oral cavity nursing care was resumed until the patient was discharged.

Sample Characteristics:

The study was comprised of 37 patients, age 19-68 years.

There were 51 males and 49 females.

KEY DISEASE CHARACTERISTICS: AML, ALL, CLL, CML, HL, NHL, MDS, MM

 

Setting:

SITE: Single site

LOCATION: Stem Cell Transplant Center of Hokkaido University Hospital

Phase of Care and Clinical Applications:

PHASE OF CARE: Active treatment

Study Design:

Prospective observational study in adults with oral mucositis post-allogeneic stem cell transplant in 2008-2009.

Measurement Instruments/Methods:

  • WHO Grading 0-4 daily    
  • VAS for tolerance of oral rinses daily 1-5 scale (1 = tolerable without any problems and 5 = intolerable)  
  • Pain reduction and food intake improved daily, VAS score 1-5 (1 = excellent and 5 = no effect at all).
  • Oral cavity swabs weekly in the AM beginning on admission to the transplant unit and continuing through the post OM phase
     

Results:

There was no difference in the median value of tolerability of the rinses. There was also no difference in the improvement of oral intake. The duration of pain relief was significantly longer in the Gelclair group, and significantly fewer pathogens were found in the Gelclair group compared to the control group. There was significant increase in pathogen colonization after discontinuation of the Gelclair in the post OM phase.

Conclusions:

Gelclair may be helpful in the management of OM and pain in some patients after allogeneic stem cell transplant. Use of Gelclair seemed to have helped protect the mucosa from enterococcus and candida colonization.

Limitations:

Small sample <30

No cost comparison performed.

Nursing Implications:

Further randomized controlled studies are needed to assess the efficacy of Gelclair in the transplant population. There is also further study needed regarding the reduction in incidence of pathogen colonization with the use of Gelclair and to clarify the cost effectiveness of this treatment regimen.

Guideline/Expert Opinion

Buchsel, P.C., & Murphy, P.J.M. (2008). Polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair®): a bioadherent oral gel for the treatment of oral mucositis and other painful oral lesions. Expert Opinion on Drug Metabolism and Toxicology, 4, 1449-1454.

doi:10.1517/17425250802525371
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Purpose & Patient Population:

PURPOSE: Review the benefit of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) for oral mucositis

 

Type of Resource/Evidence-Based Process:

RESOURCE TYPE: Expert opinion

Phase of Care and Clinical Applications:

PHASE OF CARE: Active treatment

Results Provided in the Reference:

Various uses and mechanism of action of hyaluronic gel (Gelclair) are discussed. Six studies/articles are summarized. Only one article provided any significant findings. One other article related to oral mucositis was a case study. The author suggests that Gelclair may be a useful additional therapy to help with pain caused by oral lesions. It may contribute to improved drinking, eating, and swallowing, and may improve nutritional status and quality of life.

Guidelines & Recommendations:

May be effective for pain related to mucositis

Nursing Implications:

A large control trial is needed to increase the strength of recommending Gelclair. Evidence provided here is weak and very limited regarding examination of Gelclair for oral mucositis in patients with cancer.


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