Diana College of Nursing, No.68, Chokkanahalli, Jakkur Post, Bangalore-64
Diana College of Nursing, No.68, Chokkanahalli, Jakkur Post, Bangalore-64
Diana College of Nursing, No.68, Chokkanahalli, Jakkur Post, Bangalore-64
SYNOPSIS
hospitals,Bangalore .
1
6. Brief resume of the intended work
Introduction:
“Life is not measure by the breaths we take, but rather by the moments that take our
breath away.”1
Cancer refers to a large group of potentially lethal disorders characterized by abnormal cell
growth and metastasis .Because of its diversity and complexity, cancer has no single treatment
nor it can be attributed to a single etiologic agent. What is currently known about the disease
process, treatment options and methods of prevention changes virtually every day.2
In 1985, a goal of the National Cancer Institute was to reduce the cancer mortality by 50% by the
year 2000. Early detection is the best treatment for cancer. Cancer screening activities promote
early detection of malignancies and premalignant conditions and with early detection come the
greater likelihood of successful treatment. The diagnosis of cancer is a multiphasic process that
includes obtaining a careful history regarding host and environmental risk factors.2
An estimated 12, 84,900 persons were diagnosed with cancer in 2002. More than 8 million
Americans alive today have a history of cancer. It is estimated that 5, 47,000 Americans died of
cancer in 1995. Lung cancer is now the number one killer in both sexes.2
Each year American Cancer Society estimates the number of new cancer cases and deaths
expected in the U.S. in the current year, complies the most recent data on cancer incidence,
2
A more systemic approach is necessary to truly affect a cure in many cases. In 1970s
chemotherapy was established as an effective treatment for cancer. The effect of chemotherapy is
at the cellular level. Chemotherapy disrupts the cell life cycle. The chemotherapeutic agents are
cytotoxic ie, they disable a cell which results in the cell death. As a result both malignant and
It is important to identify and differentiate between the toxic effects of the drugs and the
progression of the malignant process. Any side effects or adverse effects can be identified and
reported so that the drug dosage can be modified or discontinued.4 chemotherapy has got many
side effects. One of its side effects is infection. Infection is the leading cause of death in cancer
patients. Disruption of mucous membrane and skin induced by chemotherapy provides a locus
for infection. Oral complications frequently include mucositis, an inflammation of the oral
mucous surface and xerostomia or drying of the oral cavity. In chemotherapy, epithelial cells in
the oral mucosa slough and become denuded as a result of the cytotoxicity of chemotherapeutic
agents.2
Mucositis is often reported as the most debilitating side effects of cancer therapy. Hospitalization
is required in 16% of patients with mucositis. Mucositis can lead to septicaemia, bacteraemia and
fungemia when the patient is neutropenic. Earlier diagnosis could lead to a change in the
schedule of treatment and alleviating mucositis and its complications.5Thus assessing the nature
frequently encountered in cancer patients. This side effect causes significant morbidity and may
delay the treatment plan, as well as increase therapeutic expenses. Various topical mouth rinses
3
containing corticosteroids,disinfectants,antimicrobial substances,sucralfate,baking soda, or local
anaesthetics are used in the prophylaxis and therapy of chemotherapy or radiotherapy induced
oral mucositis. Various literatures support the use of many agents. In a study conducted the
author reported that saline rinses may be more effective than a regime using a more astringent
mouthwash.6
In an another study, it was reported that cryotherapy, or rapid cooling of the oral cavity using ice,
causes local vasoconstriction and hence reduces blood flow to the oral mucosa. Cryotherapy may
reduce the amount of drug reaching the oral mucous membranes, and may therefore reduce
mucositis caused by local cytotoxic activity of these drugs. Studies support the use of
fluorouracil, but it is not effective for continuous infusions. However, the author concludes that
further work is needed to evaluate the effectiveness of this agent for chemotherapy-induced
mucositis.7
Keeping the above views in mind the investigator had an intense curiosity to evaluate the
effectiveness of oral ice cubes and saline mouth wash on prevention of oral mucositis among
“Cancer does not define me, but how I live and fight with cancer DOES define
me.”
Cancer is a class of diseases characterized by out-of-control cell growth. There are over 100
different types of cancer, and each is classified by the type of cell that is initially affected.
Cancer is a group of more than 200 diseases characterized by uncontrolled and unregulated
4
growth of cells. An estimated 12, 84,900 persons were diagnosed with cancer in 2002. More than
8 million Americans alive today have a history of cancer. It is estimated that 5, 47,000
Americans died of cancer in 1995. Lung cancer is now the number one killer in both sexes.2
Each year American Cancer Society estimates the number of new cancer cases and deaths
expected in the U.S. in the current year, complies the most recent data on cancer incidence,
mortality and survival based on incidence data on cancer from National Cancer Institute, Centres
for Disease Control and Prevention, and the North American Association of Central Cancer
Registries and mortality data from the National Centre for Health Statistics.8
Cancer survival varies between countries. The CONCORD study provided the first opportunity
to estimate cancer survival in 11 states in USA covered by the National Program of Cancer
registries and the study covers the 42% of the US population. This was the first worldwide
Experts say that global cancer rates could increase by 50% to 15 million by 2020. In 2000, 5.3
million men and 4.7 million women died from cancer. It is said that 12.7 million cancer cases
and 7.6 million deaths occurred in 2008. It is estimated that about 9 million new cancer cases are
diagnosed every year and over 4.5 million people die from cancer each year in the world. 10
Researchers say that global burden of cancer continues to increase largely. WHO estimates that
The estimated number of new cancer in India per year is about 7 lakhs and over 3.5 lakh people
die of cancer each year.9 WHO says that India has one of the highest cancer rates in the world. It
indicates 10.6 per 1, 00,000 populations have cancer of gall bladder. It is the world’s highest
rate.12 In India the first report of cancer incidence was done in 1996-1998. A total number of
5
11,700 cases were registered. The most reported malignancies in males were lung cancer
(16.3%), cancer of oral cavity (7.1%), cancer of pharynx (5.7%), and larynx (5.7%). In females
frequently reported were breast cancer (22.7%), followed by cervical cancer (17.5%), gall
bladder (6.45), ovary (5.8%). This data provided information on cancer profile in eastern India.13
It is said that there would be about 1.5 lakh cancer cases at any given time in Karnataka and
about 35,000 new cases are added to this pool each year. Advanced Cancer Registry Program in
Bangalore used data from 105 hospitals and private clinics and it included more than 2, 00,000
patients with confirmed cancer. Among these rates of stomach cancer was high. And the Registry
Increasing the intensity of radiation therapy and chemotherapy in the management of cancer has
increased the incidence of adverse effects, especially oral mucositis. The administration of many
chemo-radiotherapy regimens in patients with cancer may be complicated by toxicities that limit
the clinicians' abilities to deliver the most effective doses of active agents 14. Oral mucositis is a
major dose-limiting toxic effect and the most important cause of morbidity in patients
undergoing chemo-radiotherapy for head and neck cancers, in patients undergoing bone marrow
transplantation and those receiving certain chemotherapeutic agents for a variety of human
malignancies.15
The mouth is a frequent site of complications arising from drug or radiation cancer therapy, with
mucositis, xerostomia, osteoradionecrosis, and local infections being the most common. From
the stand-point of dose limitation, treatment breaks, quality of life, and health economic
outcomes, mucositis is the most significant acute oral toxicity. 16Oral mucositis is a frequently
6
undergoing chemotherapy to treat cancer experience oral mucositis. Oral mucositis can lead to
malnutrition, fluid electrolyte imbalances, and other complications such as sepsis. Side effects
present a major barrier to the administration of doses sufficient to affect a cure. Many treatments
have already discussed regarding the management of this condition. Working knowledge of the
vast number of substances used for the treatment of oral mucositis is mandatory for health care
providers.17
Symptoms of mucositis vary from pain and discomfort to an inability to tolerate food and fluids.
Mucositis may also limit the patients’ ability to tolerate either chemotherapy or radiation. The
mucositis may affect patients’ gums and dental condition, speech, and self-esteem are reduced. It
is therefore extremely important that mucositis be prevented whenever possible or at least treated
The intent of an article is to review preventive strategies and treatment approaches for patients
with established oral mucositis. Many agents of differing mechanisms of action have been used
in the prevention and treatment of oral mucositis induced by anticancer therapies. Currently, no
solutions, drugs and methods used and studied in the prophylaxis and therapy of chemotherapy
or radiotherapy-induced oral mucositis reflects the need of new, more efficient tools in the
management of this complication. Current studies and our increasing understanding of the
etiology and pathogenesis of oral mucositis will lead to new approaches to the management and
Further intensive research through well-structured clinical trials to obtain the best scientific
evidence over the standard therapy of oral mucositis is necessary to attain ideal parameters for
7
radiotherapy and chemotherapy.14 In a study conducted the effect of cryotherapy in prevention of
oral mucositis was evaluated. 60 patients were randomized, the experimental group (30) and the
control group (30). Oral mucositis in the patients was evaluated at 7, 14.and 21 days after
chemotherapy. They found that in experimental group receiving cryotherapy, oral mucositis was
not observed at 7 and 14 days. Similarly, incidence of oral mucositis in experimental group was
The above literatures and the investigators personal experience in the oncology unit motivated
the investigator to undertake this study. As ice cubes can be made readily available and cheaper,
people undergoing chemotherapy may effectively use this in their due course of therapy.
“Not everything that is faced can be changed. But nothing can be changed until it is faced.”
James Baldwin
B. Literatures related to the use of oral ice cubes on prevention of oral mucositis among patients
receiving chemotherapy.
C. Literatures related to the effectiveness of saline mouth wash on prevention of oral mucositis
8
A) Literatures related to chemotherapy induced oral mucositis:
A study was done to assess the incidence and severity of chemotherapy-associated oral
mucositis. The study was done by a retrospective analysis of 150 patients with various solid
tumors. In addition, possible risk factors for the development of mucositis were identified.
Mucositis was scored using the World Health Organization (WHO) criteria. Eighty-seven
episodes of mucositis occurred in 47 (31%) patients. Twenty-six patients each experienced only
one episode, whereas 21 patients had up to eight episodes of mucositis. The 1,281 chemotherapy
cycles that have been analyzed included 87 cycles in which mucositis was observed. In 16
patients (11%) only slight oral mucosal changes were recorded (maximum WHO score 1), while
25 patients (17%) experienced mild to moderate mucositis (maximum WHO score 2), and in 6
patients (4%) mucositis was moderate to severe (maximum WHO score 3). No grade 4 mucositis
developed. The authors concluded that almost one-third of patients receiving chemotherapy for
solid tumors experienced one or more episodes of mild to more severe oral mucositis, indicating
An article on the occurrence of oral mucositis states that the oral and gastric mucosa is frequently
damaged during chemotherapy and leading to mucositis. Mucositis may require that subsequent
chemotherapy doses be reduced. Standard care for oral mucositis is based on effective oral
hygiene, appropriate analgesia, infection management and parenteral nutrition when needed. The
evaluation of new options to treat and prevent mucositis rather than control the symptoms is
therefore an urgent priority. Promising investigational approaches have recently emerged. This
A study conducted was emphasizing mucositis as one of the most common adverse reactions
encountered in radiation therapy as well as in chemotherapy. Mucositis may limit the patients’
9
ability to tolerate chemotherapy or radiation and nutritional status is compromised. It may
drastically affect cancer treatment as well as patients’ quality of life. It is estimated that there is
In a study conducted it revealed that the oral mucositis is a major dose –limiting toxic effect and
the most important cause of morbidity in patients undergoing chemotherapy. The intention of the
study was to review preventive strategies for patients with oral mucositis. Many agents of
different actions have been used and no interventions were completely successful at preventing
A review identified a vast number of interventions that have been investigated to determine their
effectiveness in the prevention or treatment of oral mucositis in cancer patients. The authors
report that further work is needed to evaluate the effectiveness of these agents for prevention of
Cancer therapy induced oral mucositis is described as the most significant and debilitating acute
complication associated with radiation therapy and chemotherapy. Many strategies have been
evaluated to prevent oral mucositis, but the data is confusing since it is often conflicting. The
B) Literatures related to the effectiveness of oral ice cubes on prevention of oral mucositis
A study was conducted to compare the use of plain ice, flavoured ice and standard care to
evaluate the effect on mucositis and to determine patients’ perceptions of the two forms of oral
cryotherapy. Patients were randomized to receive each of the interventions across three cycles of
chemotherapy.-standard care alone, standard care plus plain ice, standard care plus flavoured ice.
Mucositis was assessed by the nurses prior to each of three chemotherapy cycles and 15 days
10
after each intervention. Two assessment tools were used, the Oral Assessment Guide and the
determine their comfort and satisfaction with oral cryotherapy. Patients revealed that they used
standard care alone, they were more likely to experience symptoms of mucositis than when they
used either plain ice or flavoured ice. They concluded that both forms of cryotherapy were
effective in reducing the severity of oral mucositis after chemotherapy and were more effective
Another study was conducted to investigate the effect of oral cryotherapy on the development of
involved 60 patients, 30 of whom were in the study group and 30 in the control group. Ice cubes
at a size of that can be moved easily in the mouth and whose corners have been smoothed in
order that they will not cause irritation to in the mouth has been used in oral cryotherapy in the
study group. Oral cryotherapy was initiated five minutes before chemotherapy and maintained
during venous infusions of etoposide, platinol, mitomycin and vinblastine depending on the
chemotherapy course. The rate of mucositis in study group was 36.7% and control group was
90.0% and the difference was <0.05%. These findings have demonstrated that oral cryotherapy
makes an important contribution to the protection of oral health by reducing the mucositis.25
A study was conducted to evaluate the effect of cryotherapy in prevention of oral mucositis
associated with infusion of 5-fluorouracil (5-FU) with leucovorin. 60 patients were randomized,
the experimental group (30) and the control group (30). Oral mucositis in the patients was
evaluated at 7, 14.and 21 days after chemotherapy. They found that in experimental group
receiving cryotherapy, oral mucositis was not observed at 7 and 14 days. Similarly, incidence of
grades 1, 2 and 3 oral mucositis in experimental group was quite a bit lower when compared to
11
the control group. They concluded that oral cryotherapy has a significant contribution to the
A study was done to assess the appropriate prevention and oral care in head and neck cancer
patients to provide the oral comfort and function for improving the patient’s quality of life.
FU. Patients are instructed to swish ice chips in their mouth for 30 minutes, beginning 5 minutes
before the administration of intravenous infusion. Ice chips producing local vasoconstriction and
decreasing blood flow to the oral mucosa and helps reducing chemotherapeutic drug exposure
An experimental approach with Cross–over Design was done on prevention of mucositis among
cancer patients receiving 5-fluorouracil using plain versus flavoured ice cubes to care their pain
and improve their quality of life with fewer complications. The objectives of the study were to
assess the oral mucosa before and after the treatment, to identify the experiences of patients
during the therapy while sucking the ice cubes and compare the effectiveness of plain ice cubes
versus flavoured ice cubes in preventing oral mucositis. The check list scores of the patients
showed that there is a difference in the experience of the patients while sucking plain ice cubes
and flavoured ice cubes. As a whole the result showed that the flavoured ice cubes were effective
in preventing mucositis and the patients were in favour of the flavoured ice cubes.27
A study was done to review the current research evidence base for oral care procedures utilized
by nurses in order to identify best practice. Saline mouth washes widely advocated in the nursing
literature. Normal saline is not damaging to the oral mucosa and an isotonic solution (0.9%/v) is
12
recommended for mouth care. This study concluded that saline rinses may be effective than a
Mucositis may be a painful, debilitating, dose-limiting side effect of both chemotherapy and
radiotherapy for which there is no widely accepted prophylaxis or effective treatment. The basis
of management is pain relief, prevention of dehydration and adequate nutrition. When tested
vigorously, most antiseptic mouth washes anti-ulcer agents were ineffective. Simple mechanical
A randomized, controlled trial was designed using adult patients who were to have 50% or more
of the mouth irradiated as part of their treatment regimen for head and neck cancer. Forty
patients were assessed weekly during their course of radiotherapy using an oral assessment
guide. Twenty patients used normal saline rinses, and 20 used hydrogen peroxide. The patients
who received the normal saline rinses began advanced oral care than those received hydrogen
A study was conducted on effectiveness of commonly used mouth washes on prevention of oral
mucositis. Daily chlorhexidine mouth wash is often recommended for preventing chemotherapy
induced oral mucositis. Povidone iodine, NaCl 0.9% are also recommended. In this study three
out of five randomized controlled trials were included in a meta-analysis. The results failed to
A study to assess the effectiveness of oral ice cubes over saline mouth wash on oral
Bangalore.
13
6.4 Objectives of the study
1. To assess the severity of oral mucositis among experimental group and control group.
2. To assess the effectiveness of oral ice cubes on severity of oral mucositis before and
3. To assess the effectiveness of saline mouth wash on severity of oral mucositis before
4. To assess the effectiveness of oral ice cubes over saline mouth wash by comparing the
severity of oral mucositis between experimental group and control group after
intervention.
5. To find out the association between severity of oral mucositis among experimental
6. To find out the association between the severity of oral mucositis among control group
before and after the administration of oral ice cubes and saline mouth wash among
14
3. Ice cubes –Refers to the small, roughly cube-shaped chips of ice which is prepared
experimental group, where they will be instructed to swish ice chips in their mouth
4. Saline mouth wash- Refers to 0.9% normal saline and will be administered to the
control group where they will be instructed to rinse their mouth twice with 30 ml of
normal saline.
list.
6. Patients receiving chemotherapy- Refers to both male and female clients who are
in the treatment of cancer with antineoplastic drugs in selected oncology hospitals,
Bangalore.
6.6 Hypothesis
H1: There is a significant difference in the severity of oral mucositis before and after
H2: There is a significant difference in the severity of oral mucositis before and after
H3: There is a significant difference in the severity of oral mucositis between experimental
15
H4: There is a significant association between severity of oral mucositis among
H5: There is a significant association between the severity of oral mucositis among control
6.7 Assumptions
2. The use of oral ice cubes and saline mouth wash may have some effect on severity of oral
16
7. Materials and methods
Bangalore.
Experimental design
hospitals, Bangalore.
group.
control group.
17
Inclusion criteria. The patients receiving chemotherapy :
study.
collection.
cancer.
Section A.
Section B.
receiving chemotherapy.
Section C.
18
Data collection Prior to data collection, permission will be
Phase I
Phase II
Phase III
19
experimental group and the effectiveness of
Data analysis, and Data presentation The collected data will be organized by :
Descriptive statistics:
Inferential statistics:
control group.
20
Analyzed data will be presented in
the findings.
7.3 Does the study require any investigations or interventions to be conducted on patients
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes. Ethical clearance will be obtained from the ethical committee of Diana College of Nursing,
Bangalore. Permission will be obtained from the Principal, Diana College of Nursing, and
Bangalore. Permission will be obtained from the administrative heads of selected hospitals in
21
ETHICAL COMMITTEE
hospitals, Bangalore.
Bangalore-6
Approved
Ethical committee
22
Members of Ethical committee
3 . Prof. Kalaivani. S
5. Prof. Rangappa
Biostatistician, GKVK,
Bangalore
23
List of references
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18. KatranciN. Ovayolu N. Ovayolu O. SevincA. European Journal of Oncology Nursing.
chemotherapy.10September 2011.
19. J.E RaberDurlacher. M.Abu Saris. B.de Koning. N.I Weijl. A H Zwinderman,S.
chemotherapy for solid tumor: A retrospective analysis of 150 cases: vol 8, No.5.7
March 2000:366-371.
http:/www.ncbi.nlm.nih.gov/pmc.
22. Carl. Rosewell Park Cancer Institute, New York. USA; Current Opinion In Oncology
23. Redding SW, Journal of Dental Education. Cancer therapy related oral mucositis.
24. Sue Nikkoletti. Journal of clinical nursing.Comparison of plain ice and flavoured ice
for preventing oral mucositis associated with the use of 5-fluorouracil.issue 6.2006.
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26. Sirikarn Sutthavong. Pornchai Jyansisyanont.Narisa Boonyopastham.Journal of
education. Effectiveness of plain ice cubes versus flavoured ice cubes on preventing
2.pageno:38-40.
1999.13:31.
29. Symonds RP. British journal of cancer. Treatment induced mucositis: an old problem
287.
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9.Signature of the candidate
researchable.
10.Remarks of the guide
Bangalore-64.
Signature
Signature
Signature
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