Each participant took one placebo and a 24 hour-dose of sustained-release morphine daily, 12 hours apart. For one week participants took the active dose in the morning; for one week they took the active dose in the evening. For each participant, the study lasted 17 days. The time of administration was randomized in double-blind manner. The study was completed over 12 months.

The sample was composed of 42 people with advanced cancer who were suffering from opioid-responsive pain and who were taking stable opioid doses. Twenty-six of the 42 completed the study, providing adequate power (80%) for analysis.

Patients in the sample were in five regional palliative care programs in Australia.

Randomized multisite double-blind, placebo-controlled crossover equivalence and effectiveness study that comprised broad inclusion criteria

• 100 mm visual analog scale (VAS), to measure pain during the last two days (steady state) in both arms of the study (Investigators collected pain scores every four hours while the patient was awake.)
• VAS and categorical scales, to measure other pain parameters, quality of sleep, nausea, vomiting, constipation, confusion, and somnolence

• Mean VAS: morning dosing = 16 mm; evening dosing = 14 mm (p = 0.76, difference of adjusted means = 2 mm, 95% CI –2, 6). Data indicate no significant differences in pain control, pain during day, pain-disturbing sleep, or with breakthrough medication use.
• In regard to nausea, authors noted a significant treatment difference but no period or sequence effect. Authors observed no difference, associated with morning or evening administration of morphine, in use of antiemetics.
• Authors observed no significant treatment, period, or sequence effects regarding side effects other than nausea.
• Ten participants indicated a preference for a time period; eight preferred evening administration of morphine.

This study suggests that once-daily sustained-release morphine can be administered, to people with significant opioid-responsive pain and advanced cancer, with equal overall effect in the morning or the evening.

The findings regarding nausea may be a statistical rather than a clinical finding—a Type I error. Of the 42 randomized patients, 16 withdrew. Nine withdrew from the am-pm arm and seven withdrew from the pm-am arm. In the am-pm arm, three cited efficacy as the reason for withdrawal. In the pm-am arm, one cited efficacy as the reason for withdrawal. The difference in withdrawals, am-pm vs. pm-am, was not significant (p = 0.97). Authors questioned whether the study should have been powered to show a smaller difference, though the patients were already optimized on opioids.

Patients in the study population suffered typical end-of-life pain. Future researchers should define a subgroup (e.g., those with poorly controlled pain, those on high doses of opioids, those who are still trying to function at work). Other than in regard to nausea, secondary measures indicated no differences relating to administration time. Future research could assess effects on sleep patterns, quality of life, activities of daily living, and fatigue.

To determine if 15 minutes of therapeutic massage is associated with reduction in patient-expressed levels of pain, fatigue, and emotional and physical distress during hospitalization

Patients were recruited over a three-year period. The same social worker assessed the four domains of distress evaluated; assessments were done pre- and postmassage. All patients served as their own controls. Before the massage, the massage therapist asked the patient which parts of the body to massage. The most frequently chosen area was feet and legs or back, neck, and shoulders. The massage therapist provided each patient with a 10–15 minute Swedish massage. A CD player provided the same music to all patients.

• The sample was composed of 251 patients.
• Mean patient age was 59.4 years. The age range was 20–80 years.
• The percentage of male patients was 30.3%. The percentage of female patients was 69.7%.
• The sample included a broad distribution of cancer sites.
• Of all patients, 68.9% were white, 29.1% were Black; 2% self-identified as belonging to an ethnic group.

• Single site
• Inpatient
• University hospital in Georgia, United States

Observational

The study used MacDonald’s scale, modified, for patient evaluation of massage therapy (rating on a 1–5 point Likert scale, Cronbach's alpha = 0.850).

Authors found significant reductions relating to each of the four dimensions measured. Mean pain scores declined (p = 0.000, effect size = 0.7270), fatigue scores declined (p = 0.000, effect size = 0.714), physical distress declined (p =.000, effect size = 0.756), and emotional distress declined (p = 0.000, effect size = 0.6810). Posthoc analysis did not reveal that the main effect was affected by interactions with possible covariates.

Results demonstrated that massage therapy was associated with reduction of physical and emotional distress, pain, and fatigue in a broad range of hospitalized patients.

• The study did not have an appropriate control group.
• The authors noted that a large proportion of patients refused to participate. Males were more likely to refuse participation than females. This suggests that some patients have preconceptions about massage or privacy concerns regarding human touch. The study may have a risk of bias due to selection bias.
• Postintervention assessments were performed immediately after the intervention. They do not reflect how long perceived benefits lasted.
• The sample consisted of hospitalized patients, but authors provided no information about phase of care or whether patients were hospitalized for comorbid conditions.

Nurses must consider the possibility that patients have preconceptions or privacy concerns regarding massage therapy. Authors suggested that some patients might be more comfortable with the intervention if it were called a back rub rather than a massage. Nurses in settings that offer massage should incorporate information about the intervention and allow patients to discuss their preconceptions and concerns. Findings suggest that a brief massage can relieve distress during hospitalization. Nurses should consider reinstituting the back rub as a standard nursing intervention.

Massage therapists who were specially trained in massage therapy for patients with cancer discussed the massage intervention process with patients and asked them which parts of their body they would like to have massaged. Massage sessions lasted 10 to 15 minutes, using Swedish massage. The most common areas for massage chosen by patients were the feet and leg or back, neck, and shoulder areas. Once patients were enrolled in the study, oncology social workers met with patients to perform a baseline assessment of pretreatment outcomes. After the massage intervention, the oncology social worker met with the patient to assess posttreatment outcomes.

• The study reported 251 patients with cancer (70% female, 30% male).
• Mean patient age was 54.96 years.
• Of the participants, 68.9% were Caucasian, 29.1% were Black, 1.2% were Asian, 0.4% were Hispanic, and 0.4% were Indian.
• Multiple cancer types were included, but the most common type was gynecologic (25%).
• Patients were recruited during a three-year period and were determined to be eligible for the study by their primary nurse.

Patients were hospitalized at a major university hospital in southeastern Georgia.

Patients were undergoing the active treatment phase of care.

The study used a nonrandomized, single-group, pre-/posttest, repeated-measures design.

A modified version of MacDonald’s Patient Evaluation of Massage Experience Scale was used.

The massage therapy intervention resulted in a statistically significant decline in fatigue mean scores (p <  0.001), which was observed between pre- and posttest treatment evaluations.

• The study was not a randomized controlled trial; therefore, no neutral comparison group existed to test for baseline similarities or postintervention differences between groups.
• A substantial number of patients refused to participate, particularly men. This may be a result of preconceived notions regarding massage and human touch. Changing massage nomenclature to “back rub” may be more broadly acceptable in future investigations.
• The study was not a longitudinal design; therefore, it could not be determined how long the observed benefits lasted.

To evaluate the efficacy and tolerability of prolonged-released (PR), fixed-dose oxycodone-naloxone

Patients were prescribed an oral PR oxycodone-naloxone combination for pain control at a dose according to level of pain, age, health status, and previous opioid use.

• N = 206  
• MEAN AGE = 61.3 years (SD = 2.9 years), 89 (43.2%) g5 years or older
• MALES: 47.1%, FEMALES: 52.9%
• KEY DISEASE CHARACTERISTICS: Advanced cancer; moderate to  severe chronic pain
• OTHER KEY SAMPLE CHARACTERISTICS: Constipation

• SITE: Single site  
• SETTING TYPE: Outpatient
• LOCATION: Clinic

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care and palliative care 

• Retrospective, 28-day, observational analysis

• Visual Analog Scale (VAS)
• Bowel Function Index (BFI)

The reported pain at baseline was severe (VAS = 70.9, SD = 7.8, range = 55–94). Less than a fourth of patients reported somatic or visceral pain only. The majority of patients (73.3%) complained of mixed neuropathic and nociceptive pain. At the first visit, 37.6% of patients reported one to four BTCP episodes (mean = 0.9 + 1.2) during background treatment. The mean baseline BFI score was 43.2 + 14.8, indicating that some degree of bowel dysfunction was already present before starting the new PR oxycodone-naloxone treatment. Almost all (97.6%) patients had abnormal baseline BFI values (i.e. > 28.8, 26), and 41% of patients were already taking laxatives.

This combination was a highly effective analgesic in ambulatory outpatients with cancer experiencing chronic pain. Combination PR oxycodone-naloxone was not associated with adverse effects on bowel function and was equally efficacious and well-tolerated in and opioid-naive and -experienced patients and in young and old patients alike.

• Findings not generalizable
• Other limitations/explanation: Retrospective observational design; short time of observation; and the single-center nature of the study

This study may provide useful guidance for the daily management of outpatients with advanced cancer experiencing chronic pain. The long-term effectiveness of fixed-combination PR oxycodone-naloxone deserves additional investigation.

To verify the efficacy of 660 nm laser associated with 780 nm laser in reducing the severity of oral mucositis (OM)

Investigators conducted two interviews before beginning treatment for OM and one interview after the therapies. In the first interview, patients were asked about demographics, medical and laboratory data, and types of food ingested. Oral health status was evaluated, and the oral cavity was examined. Oral hygiene was reviewed.

Following the first interview, participants were divided into one of three groups.

• Group 1 was the control group (CG), which received no laser therapy. The CG used chlorhexidine mouthwashes twice per day for 5 days. 
• Group 2 was irradiated with laser-emitting light in the red region, 660 nm for the treatment of OM. Group 2 received five daily sessions of low-level laser irradiation. 
• Group 3 received five daily laser treatments of laser irradiation with two wavelengths. These patients were irradiated with laser-emitting light in the red region and immediately afterward with laser-emitting light in the infrared region, 660 nm laser with a sequential phase of 780 nm laser.

• The sample consisted of 18 patients ranging in age from 41–90 years.
• The sample was 66.7% male and 33.3% female.
• No significant differences existed between groups.
• All participants were receiving 5-fluorouracil (5-FU) not in combination of other agents.
• Cancer diagnoses were oropharyngeal (n = 8), gastric (n = 3), esophageal (n = 2), maxillary sinus (n = 1), colon (n = 1), colorectal (n = 1), rectal (n = 1), and breast (n = 1).
• Periodontal disease, dental caries, and hematological data (total leukocytes and platelets) were not significantly different among groups.
• In terms of smoking and alcohol use, 13 of 18 participants were smokers or ex-smokers and 15 of 18 participants did not drink alcohol.

This study was conducted in Brazil. The site and setting type were not specified.

• Patients were undergoing the active treatment phase of care.
• This study has clinical applicability for palliative care.

This was a pilot study, prospective trial.

Symptoms of OM were classified according to a system validated by Monopoli et al. and applied by Vera-Llonch et al. The name of the tool was not given. Assessment was performed by a dental surgeon. This system was based on a grading system with the following grades.

• 0 = absence of sites with erythema, ulceration, or pseudomembranes
• 1 = presence of erythema and absence of ulceration
• 2 = presence of erythema, ulceration, or pseudomembrane affecting only one site
• 3 = presence of erythema, ulceration, or pseudomembrane affecting two sites
• 4 = presence of erythema, ulceration, or pseudomembrane affecting three sites
• 5 = presence of erythema, ulceration, or pseudomembrane affecting more than three sites.  

A faces visual scale was used to assess satisfaction with the results of treatment with a happy face meaning \"satisfied\" (i.e., I feel no pain, I am able to eat better, I can speak better, I am satisfied, I like the treatment) and a sad face meaning “dissatisfied\" (i.e., I feel pain, I cannot eat, I cannot speak, I am not satisfied, I don’t like the treatment).

Consistency of food eaten was measured; however, no tool was specified.

The red laser group (Group 2) and the red laser plus infrared laser group (Group 3) had statistically significant differences in comparison to the CG group (Group 1) (p = 0.0190).

Statistically significant changes were found in the consistency of the foods ingested, favoring Group 3 (p < 0.001).

Satisfaction with oral condition was significantly different from the initial to the final evaluation with regard to Groups 1 and 2 (p < 0.001). No statistical difference was found in Group 3 from the initial to the final evaluation (p = 0.491).

A statistically significant difference was found between the CG and the red laser groups in OM scores but not necessarily in the severity of the OM lesions. The addition of laser light emission in the red region with infrared emission was found to be advantageous for the treatment of OM. The study provided support for the use of good oral hygiene alone in reducing the grade of OM.

• The sample size was small, with fewer than 30 patients.
• Even though it was described as a blinded study, it clearly was not.
• The study only included adults and patients receiving 5-FU.
• Information regarding how data was collected, especially in regard to the tools, was lacking.
• The article did not describe how patients were assigned to groups, which was apparently not random.
• Frequency of oral assessment was not described, and values used in the analysis were unclear.

Using good oral hygiene alone is still the cornerstone of OM prevention and treatment. The addition of laser therapy may be helpful. Laser therapy may not be available in all settings. This study did not substantially add to evidence in this area. This study was too small to make definitive decisions regarding laser therapy, but it provides promising results.

To determine the effectiveness of interventions to facilitate uptake of new knowledge by healthcare practitioners, patients, and family caregivers to improve cancer pain management. Primary outcomes of interest were change in behavior or practice of healthcare professionals or patients and caregivers. Secondary outcomes included change in patient quality of life or satisfaction with treatment.

Databases searched were CINAHL, MEDLINE, EMBASE, AMED, Web of Science, Cochrane Database of Clinical Trials and Cochrane Database of Systematic Reviews, National Cancer Institute of Canada, Canadian Cancer Society, American Cancer Society, American Society of Clinical Oncology, European Association for Palliative Care, and other websites.

An extensive listing of specific search terms and operators is provided. Main search terms included pain, analgesia, cancer, practice guidelines, evidence based medicine, and organizational innovation.

Studies were included in the review if they

• Were randomized controlled trials, controlled clinical trials, time series, and pre-post studies that evaluated the effect of knowledge translation interventions on patient outcomes
• Included patients with cancer.

Case reports, cross-sectional studies, or noncontrolled pre-post studies were excluded.

• The initial search yielded 15,625 articles.
• A total of 308 articles were retrieved and reviewed according to inclusion criteria.
• Risk of bias assessment was done using methods of the Cochrane Effective Practice and Organization of Care Group.

A final sample of 26 studies was included: 16 examined interventions for patients only, 4 focused on family caregivers, and 5 investigated effects of interventions targeted to health professionals. One study compared a solo intervention for patients only, and a dyad intervention for patients and their significant others, within the same study.

• Of 26 studies, 25 were rated as having high risk of bias due to lack of blinding in the design, incomplete data, lack of allocation concealment, and other issues. Inter-rater reliability of this scoring showed only slight agreement between raters.

Interventions targeting health professionals (5 studies)

• Findings related to patient outcomes were mixed, with two studies showing decrease in pain intensity and two studies showing no change in patients’ pain.
• Two studies showed significant increases in healthcare professionals’ knowledge and attitudes.

Interventions targeting patients and caregivers (21 studies)

• Most interventions were face-to-face coaching sessions and distribution of printed material. In more than half of the studies, in-person or telephone follow-up was used to reinforce education.
• Eight studies showed significant decrease in patients’ pain intensity with the intervention, and five showed positive change in patient behavior regarding pain control strategies.
• Five studies targeting patients and family caregivers showed mixed results, with two showing improvement in pain intensity and adherence to therapy, and three showing no effect.

Meta-analysis results

     Interventions targeting patients and caregivers

• There was no significant effect of interventions on pain interference with activities.
• In six studies, the effect on usual/average pain showed a tendency favoring the intervention (SMD = 0.43, 95% CI 0.13 – 0.74, effect = 2.76, p = 0.006). These findings are limited by the high heterogeneity among studies.
• There was no significant overall effect of interventions on worst pain, current pain, or overall pain measures in meta-analysis.
• There was a significant effect of the intervention on least pain intensity (SMD = 0.93, 95% CI 0.44 – 0.142, p = 0.0002), but this was from only two studies.

Intervention dose and intensity

• It is noted that the “dose” and intensity of knowledge translation interventions varied greatly. Authors define high- and low-dose parameters and show that those studies with higher dosage of the intervention tended to report significant results on patient outcomes.

Knowledge translation interventions aimed at healthcare professionals have demonstrated change in practitioner behavior and attitude, but have not demonstrated an effect on patient pain outcomes measured. There is some evidence to suggest that higher intensity and “dose” of these interventions, indicating amount of time spent in education, inclusion of follow-up, patient/family contact, and longer duration of follow- up, tend to be more effective.

Knowledge translation interventions aimed at patients and caregivers have been associated with improvement in patients’ least and average pain scores, but not other pain measures. These findings need to be viewed with caution, since studies included showed high heterogeneity, and the timing, dosage, and intensity of the interventions varied.

Educational and knowledge translation interventions regarding pain management that are aimed at the patient and caregiver have been shown to be effective in improving some measures of pain intensity, and have often, but not always, resulted in improved knowledge, attitudes, and skills related to pain management. Elements of success included more intensive education such as involvement of a multidisciplinary team in face-to-face education, locally constructed education materials, standardized approaches, and patient follow-up to reinforce the education. Pain management educational programs should be constructed to include key elements that are likely to improve outcomes.

To investigate the effects of a physical activity intervention for men receiving androgen deprivation therapy (ADT) on physical activity behavior, quality of life (QOL), and fitness.

Patients were randomly assigned to either the intervention or a wait-list control group. Assessments were performed in both groups at baseline, after completion of the 16-week activity intervention, and two and six months postintervention. The exercise program included a home-based portion and weekly group sessions of an individualized program provided by a certified fitness professional. Exercises were tailored to ability but consisted mostly of walking, stretching, and resistance exercises with a Thera-Band. A physioball and Thera-Band were provided to each patient for use in the home-based activity. Home exercise was suggested three to five times per week. Group sessions were conducted weekly for 16 weeks and monthly thereafter until completion of all follow-up measures. These included a group-based workout with individualized feedback, education, and group discussion. Discussion focused on common concerns, goal setting, monitoring behavior, overcoming barriers, role of a positive attitude, social support, relapse prevention, and nutrition.

• One hundred patients were randomized, and 66 completed the study.
• Mean age was 67.6 years (standard deviation = 8.6 years). 
• Patients had any stage of prostate cancer and were expected to receive ADT for at least six months.
• Patients with a high risk of osteoporosis were excluded (long-term steroid use or a T-score less than –2.5 on bone mineral densitometry).
• Of the patients, 88% were married and 61% were retired.
• Patients were recruited between 2004 and 2006 and had physician clearance to participate in the exercise program.

• Single site
• Calgary, Canada

The study used a randomized, controlled, repeated measures design.

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Expanded Prostate Cancer Index Composite (EPIC):  This instrument assesses function and bother in three organ systems:  sexual, urinary, and bowel, and has recently expanded to include possible effects of ADT. The test retest reliability and internal consistency is reported to be high for the urinary, bowel, sexual, and hormonal domain summary scores (r ≥ 0.80; α ≥ 0.82).
• Fatigue Severity Scale (FSS)
• Center for Epidemiologic Studies Depression scale (CESD)
• Godins’ leasure score index (LSI) of Godin’s leisure time exercise questionnaire:  a three-item measure assessment of frequency of exercise
• Fitness assessment, including resting heart rate, blood pressure, six-minute walk, grip dynamometer, and flexibility by testing modified sit and reach
• Body mass index (BMI)
• Baseline bone densitometry
• Variety of bloodwork

• Of the patients, 34% dropped out.
• LSI scores pre- to postintervention showed a significant interaction effect (p = 0.004) with the intervention group reporting increased physical activity and the controls reporting decreased levels.
• No significant changes were seen in QOL measurements.
• Of the patients who dropped out, 67% were in the wait-list control group. In the intervention group, 10 patients withdrew; five of these withdrew for medical reasons.
• Attendance for group sessions was 77.8%, with attendance on average at 12 of 16 sessions.
• At baseline, both groups had similar BMI measures and were considered in the overweight category. After the program, the intervention group had a very slight decrease in average BMI (change of –0.23), whereas the controls showed an average increase to 29.04 (change of 0.75), just below the level that differentiates overweight from obesity.
• In the intervention group, there were nonsignificant improvements seen in depression over time; however, the intervention group had a higher level of depression at baseline than the control group.
• There were no significant changes in fatigue scores over time or between groups.

The physical activity intervention was associated with an overall increase in reported physical activity. There were no significant effects seen in QOL or fatigue.

• The high drop-out rate reduced the statistical power of the study, which may have resulted in an inability to detect significant differences between groups.
• No mechanism was used to evaluate patient adherence to the home-based part of the program.
• The study lacked an attentional control.
• There may have been sample selection bias because individuals interested in or already having a more active lifestyle may be more likely to participate in this type of program, so any results seen cannot be attributed to solely to the program.
• The duration of the intervention may not have been sufficient to see significant changes in the outcome measures.
• The study demonstrated that maintaining involvement and adherence to exercise in this patient population is challenging.
• The findings showed that additional studies of the use of exercise in various patient types should continue because effects and issues seen in this study differ somewhat from those in other patient groups.

Bupropion sustained release was initiated at 100 or 150 mg daily, and the dose was adjusted according to the patient’s response. The final bupropion dose ranged from 100 to 300 mg daily. The modal bupropion dose was 150 mg, and patients were treated and observed for as long as two years.

• The study included 15 patients consecutively referred for assessment due to the presence of fatigue or depression with marked fatigue.
• Age ranged from 37 to 87 years.
• Diagnoses included breast cancer, primary brain tumor, prostate cancer, and lymphoma.
• Patients were excluded if they were receiving erythropoietin treatment, were anemic, had a history of diabetes mellitus, or had an active rheumatologic condition.

• Single site
• Comprehensive cancer center

The study was a single-arm, open-label, case series.

Fatigue was evaluated on the Clinical Global Improvement (CGI) Scale by a clinician not directly involved in the trial.

• The degree of fatigue was rated as very much improved (n = 6), much improved (n = 2), and minimally improved (n = 5).
• One patient showed no change, and another was much worse with respect to fatigue symptoms following bupropion treatment.
• Most patients (n = 13) reported some of the most common bupropion side effects, such as increased anxiety, dry mouth, nausea, insomnia, tremor, and tinnitus. These were rated as mostly mild to moderate.
• Thirteen patients were reported as improved, and eight were rated as much improved or better.
• In all patients, improvement occurred in two to four weeks.

• The study had a single arm, and no random assignment or comparison group was included.
• The trial used an open-label design.
• Clinician-evaluated measures of fatigue may be less sensitive to a change in rating of a subjective symptom, such as fatigue.
• Bupropion should be used with caution in patients at risk for seizure and those receiving concurrent therapies that lower the seizure threshold.

Cost is incurred to acquire the drug.

Adult patients with cancer receiving cyclic chemotherapy for solid tumors or lymphoma who were at risk for temporary, severe neutropenia (absolute neutrophil count [ANC] < 500/mm³) were treated with oral levofloxacin 500 mg or matching placebo daily for seven days during the expected neutropenic period. Treatment began on day 5 for regimens associated with early onset of neutropenia (e.g., docetaxel), day 8 for 14-day and 21-day cycles, and day 15 for 28-day cycles.

Patients were on study for a mean of 4.4 cycles of chemotherapy, with 45% of patients completing six cycles.

784 patients were randomly assigned to the placebo arm and received 3,459 cycles of chemotherapy (mean = 4.4 cycles per patient).

Random assignment of patients in the SIGNIFICANT trial was stratified by age (younger than age 40, 40–59, and 60 years of age and older) and cancer type (breast, testicular, small cell lung, Hodgkin disease, non-Hodgkin lymphoma [NHL], and others).

1,565 adults starting chemotherapy for solid tumors or lymphomas; eligible regimens were known to be associated with a risk of neutropenia (ANC <  500/mm³), but were not routinely given with granulocyte–colony-stimulating factor (G-CSF) support. Many different types of cancer were included.

60 oncology centers in the United Kingdom.

The study was a prospective, multicenter, randomized, double-blind, placebo-controlled trial with secondary univariate and multivariate analysis.

• The primary outcome measure was the incidence of clinically-documented febrile episodes (FEs), defined as a core temperature exceeding 38°C and attributed to infection.
• The original results demonstrated a reduction in FEs in patients receiving levofloxacin. However, the use of prophylactic antibiotics may increase the rate of antibiotic resistance, so the data from a 2005 study by the authors were analyzed to determine which patients benefit most from prophylactic antibiotics. The analysis measured rates of FEs across all cycles, calculated as the proportion of randomly assigned patients experiencing the event at least once during the chemotherapy program (per patient FE rate). The analysis separates events in cycle 1 because chemotherapy dose reductions and possibly antibiotic resistance may affect later cycles. Per cycle FE rates are calculated as the proportion of observed cycles in which an event occurs.
• Rates of hospitalization for the treatment of suspected infection (HTSI) also were analyzed. HTSI occurred in a subset of patients with FEs and also in some patients not meeting the trial criteria for an FE.
   

119 of 784 (15.2%) control group participants had at least one FE during chemotherapy.

Treatment benefit of quinolone prophylaxis was present across all cycles.

As reported in a 2005 article by the authors, the per-patient FE rate was 10.8% (84 of 781) for patients receiving levofloxacin compared with 15.2% for patients receiving placebo (119 of 784), giving a statistically significant reduction in the risk of FE (odds ratio = 0.67; 95% confidence interval [0.5, 0.91]; p =0.009).

For the first cycle only, the per-patient FE rate was 3.5% in patients receiving levofloxacin compared with 7.9%  in controls (odds ratio = 0.42; 95% confidence interval [0.26, 0.66]; p =0.0001),  whereas for non–first cycles, the per-patient FE rate was 7.8% (61 of 781) and 9.8%  (77 of 784), respectively (odds ratio = 0.78; 95% confidence interval [0.55, 1.11]; p = 0.16).

Per-cycle FE rates in cycle 2 and cycles 2–6 indicate that prophylactic benefit is gained in the small number of patients who experience an FE in cycle 1, but not in the much larger group of patients who do not experience an FE in cycle 1.

The data suggest that the benefit of antibiotics is greatest in those who experience an FE in cycle 1 because they are at higher risk of developing an FE in subsequent cycles compared with patients who do not develop an FE in cycle 1.
 

• Secondary analysis
• The primary outcome is the incidence of FEs rather than documented infections, and a reduction in documented infections may be a more meaningful endpoint.
• The sample is at low risk for febrile neutropenia. An important consideration for low-risk patients with short durations of neutropenia is whether quinolone prophylaxis is of greater benefit than the option of outpatient quinolone treatment for fever and neutropenia, should it occur. Both the National Comprehensive Cancer Network and the Infectious Diseases Society of America recommend oral quinolone-based regimens as outpatient empirical therapy for neutropenic fever in adults meeting criteria for low risk for complications.
• Use of quinolone prophylaxis may preclude later use of the regimens as empirical therapy for neutropenic fever in the same patient. Guidelines on outpatient management of adults with neutropenic fever assume that quinolones were not used as prophylaxis and the use of quinolones for prophylaxis precludes their use for treatment.
   

To evaluate the effect of olive oil on radiodermatitis

Patients were randomly assigned to the olive oil group or the control group. Patients treated with olive oil used it three times daily beginning on the first day of radiation therapy (RT) and continued for two weeks after completion of RT. The control group used water in place of the olive oil. Both groups were instructed to gently wash with water alone or mild soap and water. Side effects were recorded by a dermatologist and radiologist who were blinded to the study group assignment.

• N = 94
• MEAN AGE = 55.9 years
• MALES: 93.6%, FEMALES: 6.4%
• KEY DISEASE CHARACTERISTICS: All had nasopharyngeal cancer, and most were stage III.
• OTHER KEY SAMPLE CHARACTERISTICS: All were receiving high-dose RT (total dose = 70 Gy) with weekly cisplatin and docetaxel. Intensity-modulated radiation therapy (IMRT) was used in two Gy daily fractions for seven weeks.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: China

PHASE OF CARE: Active antitumor treatment

Single-blind, randomized, controlled trial

• Radiation Therapy Oncology Group (RTOG) skin scoring
• Visual analog scales (VASs) for itching, pain, and burning (0–10)

Grade I and II skin reactions occurred in 93.6% of those using olive oil and 72.3% of those using water. Grade III reactions were seen in 6.4% of those in the experimental group and 27.7% of those in the control group (p < 0.01). Symptoms from VAS scores were also lower in the experimental group (p < 0.01). No patients developed grade IV skin toxicity.

Olive oil appeared to provide some protection against the development of severe radiodermatitis compared to cleansing and water alone.

• Small sample (< 100)
• Measurement/methods not well described
• Whether all symptoms were on a single VAS score and the frequency of that scoring were unclear. 
• Whether patients were instructed not to use any other skin treatments was not stated.

Prophylactic use of topical olive oil may provide protection from the development of more severe radiodermatitis. Results of this study provide promising results. Further research to confirm these findings would be beneficial.