To determine the effectiveness of triclosan in the management of radiation-induced oral mucositis.

To compare the effectiveness of triclosan mouth rinse with conventional sodium bicarbonate mouth rinse.

The trial group was comprised of 24 patients who were randomly allocated into two groups of 12 patients each. Patients in Group I were administered sodium bicarbonate mouth rinse and constituted the control group. Group II was the study group who was given triclosan mouth rinse. Allocation into arms was done with the help of a random number table.

The patients in the control group were advised to prepare sodium bicarbonate mouth rinse by dissolving 2 g of sodium bicarbonate powder, available with the chemist in lukewarm water. The triclosan mouth rinse used in the study was provided to the patient as a ready-made commercial mouth rinse.

Upon noticing the early signs of oral mucositis, patients were advised to begin using the mouth rinses. They were instructed to swish the mouth three times a day during the rest of the course of radiation treatment and continue the same regimen for six weeks following the completion of radiotherapy.

A weekly follow up of grading and mucositis (WHO grading), evaluation of body weight, food intake, and pain (visual analogue scale) were made during the radiation treatment period and post-radiation treatment period. Acute exacerbation of signs and symptoms, which could be attributed to reaction of the mouthwash, was also monitored during treatment.
 

The study was comprised of 24 patients. The median age in the control group was 65.9 years, and in the study group, the median age was 63.67 years.

Males (%): 29.1 in study group and 20.8 in control group. Females (%): 20.8 in study grup and 29.1 in control group.

Key Disease Characteristics: Histopathologically confirmed cases of oral squamous cell carcinoma, selected for external beam radiotherapy.

Site: Single site

Setting Type: The study was conducted in the radiation oncology department of a regional cancer center, Trivandrum in association with the Department of Oral Medicine and Radiology, Dental College.

Location: The center is locaed in Kerala, India.

Phase of Care: Active treatment

Twenty-four patients who underwent radiation therapy for oral cancer and subsequently developed oral mucositiis were included in the study.

WHO Grading scale for mucositis

Visual analogue scale for pain

Both the groups were statistically identical. All 24 patients in both groups passed through grade 3 mucositis on the last day of radiotherapy. However, 10 patients in the control group and only one patient in the study group entered to grade 4 mucositis. A definite change was noticed in the severity of mucositis, food intake, and weight loss. The control group took more than 45 days to resolve the mucositis, while the study group took only less than 28 days.

No firm conclusions regarding effects of triclosan mouthrinse can be made, due to study limitations.

• Small sample size
• Single institution
• No blinding

The sodium bicarbonate mouthwash was needed to be prepared by the study participants, whereas the triclosan was given to the patients already prepared. This is a definite point that could influence compliance. There is no mention as to who did the oral assessments, one person or several different people. If several, was there consistency between them? Unknown.

There was no mention of compliance measurements of the study participant

Triclosan is used in periodontal therapy as an antibacterial agent; however, further research needs to be done to prove the effectiveness in the management of radiation-induced oral mucositis.

To investigate the efficacy of topical morphine compared to routine therapy (magic mouthwash) in the management of oral mucositis in patients with head and neck cancer

In the study group, 10 ml of morphine sulfate 2% was given every three hours, six times per day for six days while the control group received 10 ml magic mouthwash (240 ml of magnesium hydroxide, 25 ml of 2% viscous lidocaine, and 60 ml of diphenhydramine) on the same schedule. The intervention was initiated when patients with head and neck cancer presented with grade 3 or 4 mucositis from chemotherapy, radiotherapy, or chemoradiotherapy. Patients in both arms were instructed to hold the solution in thier mouths for at least two minutes and to not swallow.

• N = 28  
• MEAN AGE = 49.5 years
• MALES: 36.7%, FEMALES: 63.3%
• KEY DISEASE CHARACTERISTICS: Head and neck cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Adults receiving chemotherapy, radiotherapy, or chemoradiotherapy; World Health Organization (WHO) grade 3 or 4 oral mucositis; no current alcohol or smoking  

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Omid Oncology Hospital in Isfahan, Iran (April–July 2011)

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, controlled study

• A blinded radiation oncologist graded mucositis according to WHO guidelines at baseline, day 3, and day 6.
• Patients were asked if pain or discomfort was relieved by mouthwash, and if so, for how long (less than one hour, one to two hours, or greater than two hours).
• Patients also were asked to grade their satisfaction with treatment (satisfied, tolerable, or intolerable).

No significant difference in treatments were found on the third day. On day 6, there was a significant reduction in mucositis severity in patients in the morphine arm (p = 0.045). The trend in mucositis change showed a decrease in severity in both arms.

Both morphine and magic mouthwash were effective in reducing mucositis severity. However, topical morphine was more effective, and its results were more satisfactory to patients than the magic mouthwash.

• Small sample (< 30)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Other limitations/explanation: This study had a small sample size, and there were not enough patients in the study to make recommendations. There was a single inpatient site, a heterogeneous population, and it was unclear how many different medical oncologists assessed mucositis (inter-rater reliability). This study had a short observation period. It was unclear if mucositis would have improved if saline mouth rinses were used instead of magic mouthwash. The act of performing oral care six times per day might have caused the change in mucositis grade.

More studies in larger populations are needed for this intervention. Its comparison to magic mouthwash was questionable because it is not effective in reducing mucositis severity.

• FINAL NUMBER STUDIES INCLUDED = 8
• TOTAL PATIENTS INCLUDED IN REVIEW = 589
• SAMPLE RANGE ACROSS STUDIES: 33–181
• KEY SAMPLE CHARACTERISTICS: Included patients with hepatitis C. One study in melanoma

PHASE OF CARE: Active antitumor treatment

Analysis showed that antidepressant treatment reduced overall incidence of depressive disorder (OR = 0.42, p < 0.001). Only one trial was done in which patients with a history of depression were excluded.

Prophylactic use of antidepressants was associated with reduced incidence of depression in patients receiving interferon alpha monotherapy.

• There was only one study in patients with cancer.

Depression has been identified as an adverse effect of treatment with interferon alpha. This study showed that pre-emptive treatment with antidepressants can reduce the incidence of this effect. Nurses need to be aware of depression associated with interferon alpha treatment, and assess patients for depression, especially if they have a history of depressive symptoms. Long-term effects in patients with cancer are unknown, since there is limited evidence for this group of patients.

To compare the effectiveness, toxicities, and cost of two granulocyte colony-stimulating factor (G-CSF) preparations

Patients were randomized to two group—one receiving filgrastim and one receiving lenograstim  after one chemotherapy treatment cycle. Patients then crossed over to the opposite preparation for the next chemotherapy cycle.

• N = 29
• AGE RANGE = 2–16 years
• MALES: 62%, FEMALES: 38%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; most frequent were Ewing sarcoma, osteosarcoma, and neuroblastoma

• SITE: Single site 
• SETTING TYPE: Multiple settings 
• LOCATION: Turkey

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care

• Crossover, randomized, two-group trial

Febrile neutropenia was defined as absolute neutrophil count less than .05x10³ cells per µL and oral or axillary temperature above 38.3 degrees centigrade or 38.0 for more than one hour.

No differences were seen in treatments in febrile neutropenia, antibiotic use, rate of infection, use of platelet transfusions, or hospitalization. Cost was significantly lower with filgrastim (p = .002). No differences were seen between treatments in adverse effects. Bone pain was the most frequent side effect, with no significant differences between treatments

Findings suggest that efficacy and side effects of filgrastim and lenograstim are equivalent. Filgrastim use was less costly.

• Small sample (less than 100)
• Risk of bias (no blinding)
• Other limitations/explanation: Patients had a variety of diseases and were getting a wide variety of chemotherapy treatments given the small sample size, which potentially would impact the risk of febrile neutropenia.

Findings show that both of these G-CSF formulations provide similar results but differ substantially in cost. Nurses can advocate for less costly alternatives for care according to patients’ financial situations. The main side effect for patients is bone pain, which needs to be addressed effectively.

Methylphenidate immediate release was administered at 5 mg twice daily and was titrated to effect as much as 20 or 30 mg per day if no response occurred after three and five days, respectively. Doses were given in the morning and at noon to limit insomnia. Treatment was discontinued after one week if no improvement was reported.

• In total, 11 patients were included.    
• Age ranged from 50 to 79 years.
• Men and women were included.
• Patients had various advanced malignancies.
• Ethnicity was not reported.

• Inpatient and outpatient   
• Large university cancer center

Patients were undergoing the end of life phase of care.

The study used a prospective, case series, open-label design; no comparison group was used.

• No formal fatigue measures were used.
• Patients self-reported improvement in fatigue.

Of the 11 patients, two experienced no improvement in fatigue on methylphenidate and one required 30 mg to sustain improvements in fatigue. Eight patients experienced improvements in their self-reported levels of fatigue after treatment with 10 mg daily in a divided dose.

• The study was open-label, with no randomization or control or comparison group.
• The study was a small case series.
• Six patients experienced a side effect, including insomnia (n = 5), agitation (n = 1), anorexia (n = 1), nausea and vomiting (n = 1), and dry mouth (n = 1).

No special training is required to deliver the intervention. Costs are related to drug acquisition.

To determine if tranexamic acid and cryoprecipitate led to a reduction in blood loss and red cell transfusions in patients with peritoneal malignancies having surgery, and to see if the effect of the change in practice would lead to change in coagulation parameters or incidences of thrombosis

For the group in 2011, the standard protocol for cytoreductive surgery with hyperthermic intraperitoneal peroperative chemotherapy included using fresh frozen plasma (FFP) pre-emptively two hours into surgery, as well as for significant blood loss guided by laboratory values. Red blood cells, platelets, and cryoprecipitate were also transfused per laboratory values, per protocol. Following the CRASH-2 study, in 2013, a new protocol was devised to administer tranexamic acid at the beginning of surgery, with a repeated dose four hours into the procedure. If hemorrhage starts before 2 L of blood loss, cryoprecipitate is given with pre- and post-coagulation laboratory values. Laboratory tests were conducted throughout the surgery with intervention as appropriate.

• N = 201 
• AGE = 55 years
• MALES: 35%, FEMALES: 65%
• CURRENT TREATMENT: Chemotherapy, surgery
• KEY DISEASE CHARACTERISTICS: Peritoneal malignancy treated with cytoreductive surgery combined with hyperthermic intraperitoneal peroperative chemotherapy

• SITE: Single site  
• SETTING TYPE: Inpatient     
• LOCATION: United Kingdom

PHASE OF CARE: Active antitumor treatment

Prospective trial with a matched historical comparison group

• Two-tailed student t test using Excel
• P < 0.05 was significant. 
• The outcomes were measured by evaluating the fibrinogen, hemoglobin, prothrombin time, activated partial thromboplastin time, and platelets before and during the surgery.

The new protocol, using tranexamic acid, led to maintained average fibrinogen levels, a statistically significant increase in hemoglobin levels during and just following surgery, and a statistically significant reduction in blood loss. No significant reduction in FFP was observed and no difference in deep vein thrombosis existed in the two groups.

The patients given tranexamic acid and cryoprecipitate during cytoreductive surgery had higher fibrinogen levels and a decrease in blood loss—higher hemoglobin levels and fewer red cell transfusions. No higher arterial or venous thrombosis were observed in this group compared to the prior group.

• Risk of bias (no control group)            
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Measurement/methods not well described                  
• Measurement validity/reliability questionable
• Findings not generalizable
• Data samples from two different time periods, with changes in practice and issues of data; new protocol gives clearer direction to the team caring for patient 
• Because the newer protocol added tranexamic acid and cryoprecipitate together, it is unclear how they determined which was effective.

Nurses caring for patients with peritoneal cancer undergoing cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy should be aware of tranexamic acid and cryoprecipitate use to reduce blood loss.

APPLICATIONS: Palliative care

Interventions included pain education, culturally sensitive online support and education, and coaching versus controls. Meta-analysis of pooled results from these three studies did not show a significant overall effect on pain intensity. Interventions across studies varied in terms of frequency, duration, and intensity.

This analysis did not demonstrate a significant impact of psychosocial/psychoeducational types of interventions on pain intensity among disadvantaged patient groups. There is insufficient evidence to draw any firm conclusions.

• Few studies were included.
• Generally high risk of bias in included studies

No firm conclusions can be drawn regarding the effectiveness of psychosocial interventions for pain management among disadvantaged patient groups. There is a lack of research in this area. Findings here point to the need to develop and test these types of interventions for potentially vulnerable patient populations.

The purpose of this study was to evaluate the potential effect of carbamazepine for chemotherapy-induced nausea and vomiting (CINV) for moderately or highly emetogenic chemotherapy (MEC or HEC). The secondary aim was to evaluate side effects of this treatment and its influence on quality of life.

The standard antiemetic regimen was given to all patients, which includes ondansetron IV 8 mg, dexamethasone IV 10 mg, and ranitidine IV 50 mg prior to chemotherapy (day 1). All patients also received dexamethasone PO 4 mg BID on days 2 and 3. In addition to the standard of care, all patients received carbamazepine 200 mg PO four times per day on the third day before chemotherapy, BID on the second day before chemotherapy, and three times a day on the day before chemotherapy. Patients continued taking carbamazepine 200 mg PO three times per day until the fifth day after chemotherapy. Patients recorded data on days 1–6. Rescue therapy was given as needed and included 5-HT3RA, phenothiazines, butyrophenones, and domperidone.

• N = 7  
• AGE = 48 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer, highly emetogenic chemotherapy regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score for all 10 women was 0, first cycle of chemotherapy

• SITE: Single-site    
• SETTING TYPE: Outpatient  
• LOCATION: Brazil

• PHASE OF CARE: Active antitumor treatment

Prospective, descriptive study

• Functional Living Index-Emesis (FLIE) questionnaire
• Patients recorded all episodes of vomiting on diary cards starting with chemotherapy and for six days after.  
• Complete response was defined as the absence of any events of vomiting and no use of rescue medications.

Ten patients signed informed consent, three subjects could not complete the study due to adverse events (two had vomiting prior to chemotherapy and one experienced severe somnolence). The remaining seven patients had no response to the treatment, and there was no documented impact on quality of life as measured by the FLIE. The study was therefore discontinued.

The study was closed after seven subjects completed the protocol without any positive response for CINV. Carbamazepine was not found to be effective for CINV in women treated with highly emetogenic chemotherapy and caused vomiting in 20% of patients prior to the induction of chemotherapy.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Subject withdrawals ≥ 10%

Because the study was closed due to a 0% efficacy for CINV in this small sample of women with breast cancer, carbamazepine should not be recommended for CINV treatment at this time.

To evaluate the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) with emetogenic therapy in adult patients in India

Enrolled patients were randomized into one of two groups receiving either ramosetron 0.1 mg (group 1) or ondansetron 4 mg (group 2). Tablets were taken in the morning beginning one hour before chemotherapy and continuing for five days. Medications that could influence CINV were not permitted during the trial. Rescue medications were used at the discretion of the investigator. Data were recorded for five days.

• N = 214  
• AGE RANGE = 18–75 years
• MALES: 73 (34%), FEMALES: 141 (65%)
• KEY DISEASE CHARACTERISTICS: Multiple cancers, emetogenic chemotherapy regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Any patient who experienced vomiting 24 hours prior to study was excluded  

• SITE: Multi-site    
• SETTING TYPE: Outpatient  
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment

Prospective, open-label, randomized, experimental design

• 4-point criteria adapted from National Cancer Institute Common Toxicity Criteria (NCICTC)
• Patient report of nausea and vomiting
• Investigator Global Assessment of Efficacy (IGAE) 4-point scale
• Adverse events recorded by investigators 

There was no significant difference in nausea and vomiting on day 1 between groups. After day 1, 64.0% of patients in group 1 achieved a complete response compared to 60.0% in group 2. More patients in group 1 as compared to group 2 achieved a complete response in the overall phase (27.2% [95% CI: 35.4%, 19.0%] versus 7.0% [95% CI: 12%, 2%]; difference 20.2% [95% CI: 29.7%, 10.2%]; P < 0.001) . Patients in group 1 reported less severe nausea than patients in group 2 on days 2 (p = 0.019), 3 (p = 0.020), 4 (p = 0.001), and 5 (p = 0.002). Patients in group 1 reported a less severe grade of vomiting on days 3 (p = 0.014) and 5 (p = 0.035).

Patients receiving ramosetron experienced less severe nausea and vomiting in delayed CINV compared to those receiving ondansetron.

• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: The majority of references used for this paper are old.

CINV continues to be a problematic side effect of chemotherapy. Nurses should frequently assess patients for nausea and vomiting in both the acute and delayed phase after administration of chemotherapy, taking note of the severity of both. The use of ramosetron for CINV in Indian patients is as effective as ondansetron and might be preferred for delayed CINV.

To assess the effects of a spiritual care intervention on the quality of life and spiritual well-being of patients with cancer undergoing surgery

A 90-minute spiritual care intervention based on the MATCH (Mercy, Austerity, Truthfulness, Cleanliness, and Holy Name) guideline involving 30 minutes of counseling, reading, and chanting was delivered to patient/caregiver dyads undergoing surgery for cancer daily while in the hospital. Quality of life and spiritual well-being were measured prior to discharge and at one month, two months, and three months.

• N = 107 
• MEAN AGE =  Patients: 51 years (SD = 13), caregivers: 39 years (SD = 12.7)
• MALES: Caregiver information not described
• FEMALES: Caregiver information not described
• CURRENT TREATMENT: Not applicable; patients undergoing surgery
• KEY DISEASE CHARACTERISTICS: Breast cancer (22%), head and neck cancer (54%), mixed and other cancers (24%)

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: India

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Prospective, single-arm, repeated-measures trial

• Functional Assessment of Cancer Therapy-General (FACT-G)
• Functional Assessment of Chronic Illness Therapy—Spiritual Well-being (FACIT-Sp)

Patients and caregivers demonstrated statistically significant improvements in all domains of quality of life and spiritual well-being at all measurements following the intervention.

A spiritual care intervention delivered in a hospital is feasible and has the potential to improve patient and caregiver quality of life and spiritual well-being. Randomized, controlled studies in this area are needed.

• Risk of bias (no control group)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Intervention expensive, impractical, or training needs
• Questionable protocol fidelity
• Low return rate
• Potential for recall bias among both groups surveyed
• No control group
• Caregivers not described
• Little data about the intervention
• Limited data on the specifics of the actual dose or number of days delivered
• Single institution in India
• Unclear how intervention fidelity was maintained
• Unclear if intervention was administered by several people and, if so, how they ensured high interrator reliability

Addressing spiritual concerns may be an important method to positively affect caregiver quality of life and spiritual well-being.