Low energy helium neon laser in the prevention of oral Mucositis
Introduction:
Effectiveness
of cancer therapies designed to improve cure rates and to extend survival time,
including chemotherapy and radiotherapy is tempered by side effects that may
become life threatening. Oral complications are one such side effect category
and include chemotherapy and radiation therapy related stomatitis (oral
mucositis) and associated pain, xerostomia and oral infection.1
Stomatitis
(oral mucositis) is an inflammation of the mucous membranes of the oral cavity
and oropharynx characterized by tissue erythema, edema, and atrophy often
progressing to ulceration. The clinical significance of radiation therapy related stomatitis is
widely recognized.1Stomatitis is virtually universal when radiation
therapy includes the oropharyngeal area, with the severity dependent upon the
type of ionizing radiation, volume of irradiatd tissue, dose per day,
cumulative dose and duration of radiation therapy.1
Radiation therapy for head and neck cancers has a range of sequelae in the oral
cavity. This includes caries, mucositis, trismus, xerostomia,
osteoradionecrosis and secondary oral and fungal infections.2
Radiotherapy-induced
oral mucositis represents a therapeutic challenge frequently
encountered in cancer patients. This side effect causes significant
morbidity and may delay the treatment plan, as well as increase
therapeutic expenses.3
Side effects of
radiation therapy to the head and neck may be noted as early as the first week.4
A syndrome of pain, swelling and tenderness after irradiation of major
salivary lands begin a few after small doses of radiation are given. The pain
may be severe.5 Severe reduction in the volume of saliva and the
alteration of its composition may cause serious complications. Dryness of mouth
and difficulty in swallowing and mastication are common
The changes in salivary flow, volume and viscosity may be related to vascular
damages to the salivary glands and may persist for years. The recovery of a
normal production of saliva will depend on the characteristics of each patient
and the salivary gland irradiated percentage. Many investigators have
observed, however that within hours of low dose radiation therapy, dryness of
mouth and the elevation of serum amylase develop.5
The xerostomia appears soon after the beginning of the RT,
becoming more evident after 20Gy doses. Initially, the saliva becomes thicker
and its elimination rate decreases6
This xerostomia may be
irreversible, although there is a tendency of recovering up to 50% of the
initial salivary volume, if both the irradiated parotid volume and the final
irradiation dose remain in the lowest possible values(7-11).
Research
findings to date based upon animal, human and most notably cellular studies
have enhanced the establishment of low intensity laser treatment as an effective means of biostimulation for
the wound healing process. The most popular laser in studies on cell
irradiation to date has been the helium – neon laser with a wavelength of
632.8nm. Using embryonic foreskin fibroblasts and adult human skin fibroblasts
, Boulton and Marshall (1986) reported an increase in cell proliferation
following irradiation with a He-Ne laser. Lyons et al 1987
have found out that laser irradiation stimulates the production of collagen by
fibroblasts, which in turn is an important component of scar tissue formation.
Myofibroblasts are modified fibroblasts that are directly involved in
granulation tissue contraction. A study by Pourreau Schneider et al (1990)
found that He-Ne laser irradiation of fibroblasts transforms the cells into
myofibroblasts , which the author suggests may set into motion the acceleration
of the wound healing process which is typically observed in clinical practice
after He-Ne laser treatment12.
Iijima K et al observed that
repeated irradiation with low power He-Ne laser is an effective and safe
therapy for post herpetic neuralgia. They have irradiated 18 patients with
severe postherpetic neuralgia. The efficacy of low power He-Ne laser was
evaluated using a four grade estimation visual analog scale and modified McGill
pain questionnaire after every 10 of as many as 50 irradiations. The efficacy
rate using a four grade estimation at the end of 50 treatments was 94.4%. VAS
decreased from 6.2 before irradiation therapy to 3.6 after 50 treatments.13
Maiya GA,
Sagar MS & Fernandes Donald has reported that low energy He-Ne laser was
effective in preventing and treating oral mucositis among head and neck cancer
patients receiving radiotherapy. The patients with carcinoma of oral cavity
with stages II-IV a being uniformly treated with curative total tumour dose of
66 Gy in 33 fractions over 6 wk were selected for the study. The patients were
divided based on computer generated randomisation into laser (study group) and control
groups with 25 patients in each group. Both study and control groups were
comparable in terms of site of the lesion, stage of the cancer and histology.
The study group patients were treated with He-Ne laser (wavelength 632.8 nm and
output of 10mW) and control group patients were given oral analgesics, local
application of anaesthetics, 0.9 per cent saline and povidine wash during
the course of radiotherapy. All patients
tolerated the laser treatment without any adverse effect or reactions. The result
showed a significant difference in pain and mucositis
Use
of the low-energy helium-neon laser (LEL) appears to be a simple atraumatic
technique for the prevention and treatment of mucositis of various origins.
Preliminary findings, and significant results obtained for chemotherapy-induced
mucositis in a previous phase III study, prompted a randomized multicenter
double-blind trial to evaluate LEL in the prevention of acute radiation-induced
stomatitis. Irradiation by LEL corresponds to local application of a
high-photon-density monochromatic light source. Activation of epithelial
healing for LEL-treated surfaces, the most commonly recognized effect, has been
confirmed by numerous in vitro studies. The mechanism of action at a molecular
and enzymatic level is presently being studied. From September 1994 to March
1998, 30 patients were randomized. Technical specification: 60 mW (25 mW at Reims, 1 patient), He-Ne, wavelength 632.8 nm. The trial
was open to patients with carcinoma of the oropharynx, hypopharynx and oral
cavity, treated by radiotherapy alone (65 Gy at a rate of 2 Gy/fraction, 5
fractions per week) without prior surgery or concomitant chemotherapy. The
malignant tumor had to be located outside the tested laser application areas (9
points): posterior third of the internal surfaces of the cheeks, soft palate
and anterior tonsillar pillars. Patients were randomized to LEL or placebo
light treatment, starting on the first day of radiotherapy and before each
session. The treatment time (t) for each application point was given by the equation
: t (s)=energy (J/cm2)2surface (cm2)/Power (W). Objective
assessment of the degree of mucositis was recorded weekly by a physician
blinded to the type of treatment, using the WHO scale for grading of mucositis
and a segmented visual analogue scale for pain evaluation. Protocol feasibility
and compliance were excellent. Grade 3 mucositis occured with a frequency of
35.2% without LEL and of 7.6% with LEL
Carlos et al has
conducted a study to verify if the use of InGaAIP laser with 685 nm wave length
can reduce the xerostomy incidence, the oral mucositis severity and the pain
related to mucositis in patients with head and neck cancer submitted to
radiotherapy.
Sixty patients presenting head and neck carcinoma were submitted to
radiotherapy with daily doses of 1.8 to 2.0 Gy and a final dose of 45 to 72 Gy.
The salivary volume was evaluated in the first and fifteenth days, at the end
of the treatment and after 15 and 30 days. The oral mucositis was evaluated on
a weekly basis. Twenty-nine patients were submitted to radiotherapy without
laser and 31 were submitted to radiotherapy and laser with daily doses of 2
joules/cm² in predetermined areas of the oral mucosa and the parotid and
submandibular glands. In the group submitted to radiotherapy and laser the
incidence of mucositis (p < 0.001) and pain (p < 0.016) was
significantly lower and the salivary volume (p < 0.001) was kept
higher during and after the treatment.
The group of patients submitted to radiotherapy and laser had lower incidence
of xerostomy, oral mucositis and pain when compared to the group treated with
radioteraphy without laser, producing statistically significant results.
Need for the study:
Helium
neon laser and its ability to improve salivary flow is not studied yet. There
are not many studies done on helium neon lasers and the degree of salivary flow
which helps to prevent oral mucositis in India. Although nurses are taking
care of such patients every day, nurse’s role is hidden within. Keeping all
these in mind, the researcher has decided to undertake this study collaborating
different categories of personnel.
Purpose of the study:
The overall purpose of the study is
to test whether helium neon laser increases the salivary flow which is already
reduced due to the effect of radiotherapy. If the salivary flow increases with
helium neon laser it will help to considerably reduce oral pain and oral
mucositis. In further studies, the mechanism of action of increase in salivary
flow can be studied.
Assumptions:
The researcher
assumes that
- helium neon laser increases salivary flow
- Helium neon laser will reduce the incidence of oral
mucositis and oral pain.
- Patients will willingly participate in the study.
Problem statement:
A study to
determine the effectiveness of low energy helium neon laser in the prevention
of oral complications of cancer therapy among cancer patients admitted to a
selected hospital in India.
Objectives:
- To determine the incidence of oral mucositis among
patients undergoing radiation therapy.
- To assess the severity of oral mucositis among
patients undergoing radiation therapy as measured by mucositis grading
scale.
- To correlate the dose of radiation and the severity
of oral mucositis.
- To find out the effectiveness of low energy helium
neon laser in reducing the severity of oral mucositis among patients
undergoing radiation therapy as
measured by mucositis grading scale.
- To determine the incidence of oral pain among
patients undergoing radiation therapy.
- To assess the severity of oral pain among patients
undergoing radiation therapy as measured by visual analog scale.
- To correlate the dose of radiation and the severity
of oral pain.
- To determine the effectiveness of low energy helium
neon laser in reducing the severity of oral pain among patients undergoing
radiation therapy as measured by
visual analog scale.
- To determine the incidence of salivary dysfunction
among patients undergoing radiation therapy.
- To assess the severity of salivary dysfunction among
patients undergoing radiation therapy as measured un stimulated salivary
flow
- To correlate the dose of radiation and the severity
of salivary dysfunction.
- To determine the effectiveness of low energy helium
neon laser in reducing the severity of salivary dysfunction among patients
undergoing radiation therapy as
measured by un stimulated salivary flow
- To determine the association between oral
complications of cancer therapy and selected demographic variables ;age,
gender, associated chronic illnesses
Definition of
terms:
Oral complications of cancer therapy
In this study
oral complications of cancer therapy refers to salivary dysfunction, oral pain
and the development of oral mucositis following radiotherapy.
Cancer therapy
In this study,
cancer therapy refers to radiotherapy used to treat head and neck cancer
patients.
Cancer
In this study,
cancer refers to cancers of the head and neck region.
Variables:
Dependent
variable: Helium neon laser therapy of
632.8nm wavelength
Independent
variables: Oral mucositis, oral pain, salivary dysfunction.
Selected
demographic variables: age, gender, associated chronic illnesses
Hypotheses:
- There will be significant difference in the severity of
oral mucositis among patients undergoing radiation therapy who are treated
with low energy helium neon laser and not treated with helium neon laser as
measured by mucositis grading scale at 0.05 level of significance.
- There will be significant difference in the severity
of oral pain among patients undergoing radiation therapy who are treated
with low energy helium neon laser and not
treated with helium neon
laser as measured by mucositis grading scale at 0.05 level of
significance.
- There will be significant difference in the severity
of salivary dysfunction among patients undergoing radiation therapy who
are treated with low energy helium neon laser and not treated with helium
neon laser as measured by mucositis grading scale at 0.05 level of
significance.
Research methodology:
Research
approach: The study uses survey approach and evaluative approach.
Research
design: Experimental.
Population:
Head and Neck Cancer patients undergoing radiotherapy.
Sample
size:100
Sampling
techniquePurposive sampling.
Sampling criteria:
The study was
performed in a group of
- Voluntary patients aged above 21 years,
- Bearing head
and neck carcinomas and not submitted to previous RT in the affected
region.
- Patients whose
the irradiation fields include the salivary glands.
- The patients with hospital numbers bearing odd
numbers will be denominated "control", receiving RT without
laser
- Patients with hospital numbers bearing
even numbers will be submitted to RT and laser therapy.
Exclusion
criteria:
Head
and neck cancer patients who receive combination treatment.
Data collection instruments:
Patient
profile, oral mucositis grading scale, visual analog scale for pain, Scale to
assess the salivary flow.
Ethical considerations
Plan for data analysis: t test, chi –
square, anova, odds ratio and path analysis for relationship
Work plan
Conceptual framework:
This
study incorporates the quality caring model developed by Deffy J.The
Quality-Caring Model exposes and demonstrates the value of nursing within the
evidence-based practice milieu of modern health care. It favors a process, or
way of being, that challenges modernist conventions and highlights the power of
relationships. By reaffirming the nature of nursing's work as
relationship-centered, the blended model describes the 2 dominant relationships
that comprise professional encounters. Relationships characterized by caring
are theorized to influence positive outcomes for patients/families, health care
providers, and health care systems.
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