Rajiv Gandhi University of Health Sciences



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

“A STUDY TO ASSESS THE EFFECTIVENESS OF GINGER TEA IN REDUCING CHEMOTHERAPY INDUCED NAUSEA AND VOMITING AMONG WOMEN WITH REPRODUCTIVE SYSTEM CANCER IN SELECTED INSTITUTES OF ONCOLOGY AT MYSORE”.

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

Mrs. ASHARANI G.S

1st YEAR M.Sc NURSING

OBSTETRICS AND GYNAECOLOGICAL NURSING

GOPALA GOWDA SHANTHAVERI MEMORIAL COLLEGE OF NURSING

T.N. PURA ROAD, NAZARBAD

MYSORE-570 010

KARNATAKA

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

PROFORMA FOR SYNOPSIS REGISTRATION OF SUBJEECT FOR DISSERTATION

|1.1 |Name of the Candidate and Address | Mrs. ASHARANI G.S |

|1. | |M.Sc. NURSING 1ST YEAR, |

| | |GOPALA GOWDA SHANTHAVERI |

| | |MEMORIAL COLLEGE OF NURSING, |

| | |T.N PURA ROAD, NAZARBAD, |

| | |MYSORE – 570 010 |

|2.2 |Name of the Institution |Gopala Gowda Shanthaveri Memorial College Of Nursing, Mysore. |

|2. | | |

|3. |Course of study and subject |1st Year M.Sc Nursing, |

|3. | |Obstetrics and Gynaecological Nursing. |

|4. |Date of admission to course |11-08- 2012 |

|4. | | |

|5. |Title of the Topic: |

|5. |“The effectiveness Ginger Tea In Reducing Chemotherapy Induced Nausea And Vomiting Among Women With Reproductive System Cancer” |

|6. |Brief resume of the intended work: | |

|6. |6.1 Need for the study |Enclosed |

| |6.2 Review of literature |Enclosed |

| |6.3 Objectives of the study |Enclosed |

| |6.4 Operational definitions |Enclosed |

| |6.5 Hypotheses of the study |Enclosed |

| |6.6 Assumptions |Enclosed |

| |6.7 Delimitations of the study |Enclosed |

| |6.8 Pilot study |Enclosed |

| |6.9 Variables |Enclosed |

|1.1 |Materials and methods: |

|7. |7.1 Source of data collection: data will be collected from women with reproductive system cancer in selected institutes of oncology at Mysore. |

| |7.2 Method of data collection: This study will be conducted after obtaining permission from the concerned hospital authorities. Subjects will be selected |

| |according to selection criteria of the study. Consent will be obtained from patients with reproductive system cancer. Chemotherapy induced nausea and |

| |vomiting will be assessed with standardized nausea and vomiting assessment scale for both groups. Experimental group will be provided with oral |

| |administration of ginger tea and for control group the ginger tea will not be provided. The effectiveness of ginger tea in reducing chemotherapy induced |

| |nausea and vomiting will be assessed in experimental group and comparing the effectiveness of ginger tea administration among experimental and control |

| |group. |

| |7.3 Does the study require any interventions or investigations to the patients or other human being or animals? |

| |YES. Oral administration of ginger tea will be given to the women with reproductive system cancer |

| |7.4 Has ethical clearance been obtained from your institutions? |

| |YES, ethical committee’s clearance has been obtained. |

|2.2 |List of references |Enclosed |

|8. | | |

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

|1. |Name of the candidate and Address |Mrs. ASHARANI G.S |

| | |M.Sc. NURSING 1ST YEAR, |

| | |GOPALA GOWDA SHANTHAVERI MEMORIAL COLLEGE OF NURSING, |

| | |T.N PURA ROAD, NAZARBAD, |

| | |MYSORE- 570 010 |

|2. |Name of the institution |Gopala Gowda Shanthaveri Memorial College Of Nursing, Mysore. |

|3. |Course of study and subject |1st year M.Sc nursing |

| | |Obstetrics and Gynaecological Nursing. |

|4. |Date of admission to course |11-08-2012 |

|5. |Title of the topic |“The effectiveness Ginger Tea In Reducing Chemotherapy Induced Nausea And Vomiting Among Women |

| | |With Reproductive System Cancer” |

6. BRIEF RESUME OF THE INTENDED WORK:

INTRODUCTION:

The Most Important Thing In Illness Is Never To Lose Heart.

-Nikolai Lenin

The World Health Organization defines health as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. The state of positive health implies the notion of perfect functioning of the body and mind. It conceptualizes health biologically, as a state in which every cell and every organ is functioning at optimum capacity and in perfect harmony with the rest of the body. The maintenance and promotion of health is achieved through different combination of physical, mental and social well-being. Health care is a multitude of services rendered to individuals, families or communities by the agents of the health services or professions, for the purpose of promoting, maintaining, monitoring or restoring health.1

The term “disease” literally means “without ease” (uneasiness) – disease, the opposite of ease-when something is wrong with bodily function. Webster defines disease as “a condition in which body health is impaired, a departure from a state of health, an alteration of the human body interrupting the performance of vital functions”.1

Disease is often used more broadly to refer to any condition that causes pain, dysfunction, distress, to the affected person, it sometimes includes injuries, disabilities, disorders, syndromes, infections, isolated symptoms, deviant behaviours and atypical variations of structure and function. Diseases usually affect people not only physically, but also emotionally, as contracting and living with many diseases can alter one's perspective on life. Severity of diseases will have impact on sufferer’s abilities to lead normal everyday lives.1

The reproductive organs in females are those which are concerned with copulation, fertilization, growth and development of the fetus and its subsequent exit to the outer world. The organs are broadly divided into external genitalia, internal genitalia and accessory reproductive organs. External genitalia includes vulva, vaginal orifice, bartholin glands and skene’s glands .Internal genitalia includes vagina, uterus, fallopian tubes and ovaries. The breasts are large, modified sebaceous glands, bilateral and in female constitute accessory reproductive organs as the glands are concerned with lactation following childbirth.2

Cancer is an iceberg disease which affects all communities worldwide. Approximately 10 million people were diagnosed with cancer and more than 6 million die of the disease every year. In India, it is estimated that there are approximately 2-2.5 million cases of cancer at any given point of time and around 7-9 lakhs new cases are detected each year nearly half of these cases die each year.3

The term cancer is used to refer malignant neoplasm. It is a disease of the cells in which the normal mechanisms of the control of growth and proliferation have been altered. Cancer is invasive, spreading directly to surrounding tissue as well as to new sites in the body, disease process that begins when an abnormal cell is transformed by the genetic mutation of the cellular DNA. Cancer is not a single disease with a single cause; rather, it is a group of distinct diseases with different causes, manifestations, treatments and prognosis.4

Cancers can occur in any part of the female reproductive system like in the vulva, vagina, cervix, uterus, fallopian tubes, ovaries or breasts these cancers are called gynaecological cancer. Gynaecological cancers can directly invade nearby tissues and organs or spread through the lymphatic vessels and lymph nodes (lymphatic system) or bloodstream to distant parts of the body.5

Many times women with early stages of cancer have no symptoms and screening test is used to find a disease before the women has any symptoms. There are screening tests for some reproductive cancers like mammogram-x-ray test used to find breast cancer and pap smear-lab test of cells taken during pelvic exam to check for cancer. For this reason, it is important to see a health care provider about any symptoms experienced. The treatment depends on the type of cancer. Reproductive cancers are often treated with surgery, chemotherapy (medicine to kill cancer cells), hormone therapy (medicine to block hormones that are related to cancer growth) or radiation therapy. One or more of these treatments may be used together.6

Over the past several decades, the use of chemicals as a systematic therapy for cancer has been evolving. In the 1970’s chemotherapy was established as an effective treatment modality for cancer. Nausea and vomiting are the most commonly observed side effects of chemotherapy.7

The likelihood that nausea and vomiting will develop after chemotherapy treatment depends on several factors. Two of these factors are sex and age, with female patients and younger patients being at greater risk. In addition, patients who have a high pre-treatment expectation of severe nausea are more likely to have nausea after chemotherapy.8

According to the results of a study that was presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO), use of ginger supplements in combination with conventional antinausea drugs reduces chemotherapy-induced nausea to a greater extent than antinausea drugs alone. Chemotherapy-Induced Nausea and Vomiting (CINV) is a common and potentially serious side effect of cancer treatment. Chemotherapy induced nausea and vomiting is severely debilitating and not only interferes with quality of life but also resulted with disruption of the treatment schedule. In an effort to further control chemotherapy induced nausea vomiting researchers continue to explore new approaches to treatment including complementary and alternative treatments such as dietary supplementation.9

The plant was mentioned in Emperor Shen Hung's Pen Tsao Ching (The Classic Book of Herbs), which he wrote in 3000 BC that ginger was generally safe and clinical trials have showed that side-effects were very rare. Ginger was also valued since earliest times for its important healing properties, it has enjoyed an excellent reputation in ancient Indian, traditional Chinese and Western medicine. Ginger was used by the ancient greeks to prevent nausea after feasting. Recent studies suggested that it may help people with chemotherapy-induced nausea as well.10

6.1 NEED FOR THE STUDY:

Cancer is a general term that is used to describe a group of more than 200 diseases, which can affect any part of the body, with significant associated death and disability. Worldwide, the number of new cancer cases per year is expected to top 15 million and the number of deaths could grow to as many as 12 million by 2020. At least 70% of these deaths will be in economically developing countries, where survival rates (20–30%) are often less than half those in the USA and other developed nations (more than 60%).11

Gynecologic cancer is the cancer of the female reproductive system, which includes cervical cancer, endometrial/uterine cancer, ovarian cancer, vaginal cancer, vulvar cancer, breast cancer and peritoneal cancer. In the last two decades, considerable gains have been made in the detection and treatment of these cancers. When detected in early stages, most gynecologic cancers have a good cure rate.12

Cancers of the female reproductive tract and breast has a high incidence amongst Indian women. Cancer registries have also highlighted that more than 70% of cancers in females occur in the age group of 35-64 and that these cancers exercise an adverse influence on the productive role of women in our society. Over 70% of patients report for diagnostic and treatment services at an advanced stage of disease, resulting in poor survival and high mortality rates. More than 50% were compliant to treatment protocol, less than 30% default during adjuvant therapy and 20% default after the preliminary investigation. Overall 30% complete follow up in the regional institutes and 70-80% in private comprehensive care centers for five years. 13

Each gynecologic cancer is unique, with different signs, symptoms, risk factors and prevention strategies. Every year, more than 80,000 women in the U.S are told they have a gynecologic cancer and more than 25,000 women die from a gynecologic cancer.14

Most people associate chemotherapy with horrible side effects, like hair loss and nausea and vomiting. It is difficult to predict exactly what side effects will be experienced by a person while having chemotherapy. Nausea and vomiting are common side effects of chemotherapy these side effects may affect around half of all people being treated.15

A randamized clinical trial study was conducted to determine the effectiveness of ginger, comprises of 100 women (mean age = 51.83 ± 9.18 years) with advanced breast cancer who were initially assigned to standard chemotherapy protocol were randomized to receive ginger (1.5 g/d in 3 divided doses every 8 hours) plus standard antiemetic regimen (granisetron plus dexamethasone; the ginger group) or standard antiemetic regimen alone (control group). The duration of treatment with ginger was specified to 4 days from the initiation of chemotherapy. Prevalence, score and severity of nausea and vomiting were assessed using a simplified form of Rhodes index in the first 6 hours, between 6 to 24 hours and days 2, 3 and 4 post chemotherapy and study concluded that addition of ginger (1.5 g/d) to standard antiemetic therapy (granisetron plus dexamethasone) in patients with advanced breast cancer effectively reduced the prevalence of nausea in 6 to 24 hours of post chemotherapy and significantly lower prevalence of nausea was observed in the ginger group.16

Chemotherapeutic medicines usually target cells that quickly divide. Since the normal cells in the blood, hair and the lining of the gastrointestinal tract, also divide very quickly, chemotherapy can also damage or kill these healthy cells leading to side effects such as nausea and vomiting (64%), transient elevation of serum transaminases (68%), proteinuria (36%), fever (37%), hematuria (31%), dermatologic rash (25%), edema (20%), Flu-like syndrome (19%), alopecia (14%), diarrhoea (12%), constipation(8%) and thrombocytopenia (5%).17

The researcher conducted a comprehensive review to assess the safety and efficacy of herbal medicines commonly used by patients in an attempt to prevent cancer or treat cancer and its adverse effects associated with conventional cancer treatments. Current evidence suggests that ginger is effective in treating chemotherapy-induced nausea and vomiting.18

Ginger is one of the most highly consumed dietary substances in the world. An article regarding Ayurvedic medicine and anesthesia showed that in Ayurveda, ginger is commonly prescribed for nausea, vomiting, motion sickness, sore throat, respiratory congestion, hypoglycaemia and vertigo. The symptoms of seasickness were far lesser in those volunteers who received 1g of ginger prior to the travel. One gram of ginger per day in four divided doses offered great symptomatic relief and ginger reduces the chemotherapy-induced nausea and vomiting significantly. There were many mechanisms that were postulated for the antiemetic action of ginger because the herb was commonly used as a food component one can assume it to be safe.18

As soon as the ginger is taken it starts to promote the secretion of saliva in the mouth and then it promotes the secretion of various digestive juices or enzymes. This helps to neutralize the stomach acids. The phenols in the ginger help to relax the stomach muscles and to sedate the tissues of the stomach, this reduces the over activity of the stomach which in turn reduces nausea and pain. At the same time the phenols increases the movement inside the intestines and this helps to move digested food and toxins through the digestivesystem.19

The study is currently being conducted by private practice oncology groups despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience post chemotherapy nausea and vomiting. Delayed post chemotherapy nausea and anticipatory nausea were poorly controlled by currently available antiemetic agents. Study suggested that ginger (Zingiber officinale) have beneficial effects on nausea and vomiting associated with motion sickness, surgery and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of chemotherapy nausea.20

The researcher had observed patients suffering from chemotherapy induced nausea and vomiting. Hence the researcher felt that, the current study may explore the effect of ginger tea to reduce chemotherapy induced nausea and vomiting among women with reproductive system cancer , which would enable them to have a good compliance towards the treatment regimen , nutritional status and quality of life.

6.2 REVIEW OF LITERATURE:

A prospective observational study was conducted to determine the incidence of acute and delayed chemotherapy-induced nausea and emesis (vomiting) (CINV) among adult patients receiving highly (HEC) or moderately (MEC) emetogenic chemotherapy for the first time. Physicians and nurses accurately predicted the incidence of acute and delayed CINV after HEC patients receiving aprepitant. Acute nausea and emesis were observed in 22.2% and 0% respectively of MEC patients and delayed nausea and emesis in 33.3% and 22.2% of MEC patients respectively and the incidence of acute nausea and delayed nausea and emesis after MEC by 15, 28 and 18 percentage points, respectively. The result of the study revealed that acute nausea and emesis were observed in 14.3% and 2.4% respectively of HEC patients receiving aprepitant, and delayed nausea and emesis were observed in 14.3% and 7.1% of these patients respectively.21

A prospective observational study was conducted with the aim of this study was to analyze the impact of CINV associated to moderate/highly emetogenous chemotherapy regimens on patients' Quality Of Life (QoL). The study comprises of 202 patients from nine university hospitals were selected and found most frequent cancer site was breast (44 %) followed by lung (16 %) and 76.3 % were receiving highly emetogenous chemotherapy. Despite the use of antiemetic prophylaxis, patients experienced significant nausea and vomiting during 31 % (3.2 % during acute, 15.0 % during delayed phase and 13.2 % during both phases and 45.1 % (5.1 % only during the acute phase, 23.5 % only during the delayed phase and 16.5 % during both phases) of the cycles, respectively having 44.5 % (nausea) and 39.3 % (emesis) of the cycles an impact on patient’s QoL .The results of the study showed that the detrimental effect of CINV on patient’s QoL despite the use of antiemetic prophylaxis .22

A study was conducted to explore the use of protein meals with ginger for the treatment of the delayed nausea of chemotherapy and consists of twenty-eight (28) patients with cancer receiving chemotherapy for the first time were assigned to 1 of 3 groups. For 3 days beginning of the day after their chemotherapy, control group patients continued with their normal diet, Protein Group patients consumed a protein drink and ginger twice daily and high protein group patients consumed a protein drink with additional protein and ginger twice daily. Patients recorded in a diary each day whether they had experienced nausea, gastric activity was assessed in patients before and after ingestion of a high protein meal and ginger, a significant decrease in gastric dysrhythmia occurred after ingestion of the protein and ginger. And the study concluded that high protein meals with ginger reduced the delayed nausea of chemotherapy and reduced use of antiemetic medications. Protein with ginger holds the potential of representing a novel, nutritionally based treatment for the delayed nausea of chemotherapy.23

A randomized, double-blind controlled study was conducted to assess the effectiveness of ginger in chemotherapy induced nausea, study included 644 cancer patients receiving chemotherapy, mostly for breast cancer patients, all patients received standard antinausea drugs like zofran or kytril with their chemotherapy, but in addition they got either placebo (dummy) capsules or capsules with 0.5 grams, 1 gram or 1.5 grams of ginger. The study assessed nausea using a 7-point scale during the first day of the patients 2nd and 3rd chemotherapy cycles, all doses of ginger relieved nausea significantly better than placebo. The most effective doses were 0.5 and 1 grams per day. Study concluded that ginger is a potential nausea remedy for chemo patient doses of half gram to one gram of ginger daily will help to relieve nausea in patients going through chemotherapy.24

A double blind randomized study was conducted to investigate the effectiveness of ginger as an additional antiemetic therapy in patients receiving chemotherapy and cancer patients were randomly assigned to either ginger root powder capsules or placebo capsules as an additional antiemetic to ondansetron and dexamethasone. Chemotherapy-induced nausea and vomiting were evaluated with the Edmonton’s symptom assessment scale and national cancer institute criteria. Acute moderate to severe nausea was observed in 28/30 (93.3%) cycles in control group as compared to 15/27 (55.6%) cycles in experimental group (P=0.003). Acute moderate to severe vomiting was significantly more in the control group compared to the experimental group [23/30 (76.7%) vs. 9/27 (33.33%) respectively (P=0.002)]. Delayed moderate to severe nausea was observed in 22/30 (73.3%) cycles in the control group as compared to 7/27 (25.9%) in the experimental group (P ................
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