The intervention consisted of three parts:

1. A computer-based nursing intervention that provided assistance with symptom management and information about disease and treatment
2. Emotional counseling and support
3. Coordination of services.

The research team created this computer-based intervention for 38 symptoms that may occur during chemotherapy. The computer-based nursing intervention was a menu-driven computer program that guided clinical assessment, problem identification, selection of interventions, and measurement of outcomes. It was designed based on current literature, oncology nursing practice standards, and practice guidelines for cancer symptom management. Each symptom or problem had a problem-specific list of appropriate interventions. Emotional support and counseling consisted of the nurse using active listening and teaching of active communication techniques to patients and their caregivers to enhance communication between patients, caregivers, family, and healthcare providers. The intervention occurred over 18 weeks and consisted of nine visits (five in person and four via telephone). Visits took approximately one hour. Telephone encounters took about 20 minutes.

Dyads were recruited within 56 days of chemotherapy initiation. After completion of baseline telephone interviews, dyads were randomly assigned to groups. Data were collected via telephone interviews at three time points during the six-month study: time 1 = entry into study, time 2 = nine weeks or halfway through the intervention, and time 3 = 24 weeks or one month after the intervention.

• The study reported on a sample of 109 dyads (patient and identified caregiver).
• Patients were newly diagnosed with breast, colorectal, or lung cancer and were undergoing chemotherapy.
• The intervention group had 55 dyads, and the conventional care group had 54 dyads.

A randomized controlled trial (RCT) design was used.

• Medical Outcomes Study 36–Short Form (SF-36)
• Center for Epidemiologic Studies–Depression-20 scale (CES-D-20)
• State-Trait Anxiety Inventory (STAI)–state anxiety
• Statistical analyses: t tests and repeated ANOVA for SF-36, CES-D-20, and STAI
• Reliability analyses were completed using Cronbach’s alpha for scales of each time (baseline, time 2, and time 3).

Role emotional, mental health, and mental component scores were significant for the group-by-time intervention (p = 0.1). The intervention did not have a significant effect on anxiety when examining the date from the three time points. However, a trend toward group-by-time interaction (p = 0.09) occurred between baseline and time 2, favoring the intervention group. Pair-wise comparisons of the means showed that the intervention group improved (lower anxiety scores) from baseline to time 2 (p = 0.09), whereas the standard care group remained unchanged. Time 3 data were collected approximately four weeks after completion (24 weeks following enrollment), and any effect the intervention had may have been lost by time 3. Additional analyses were performed on baseline and time 2 data only.

The study was a strong RCT with a good sample size.

• New computer-based nursing intervention was created.
• The intervention was administered by three advanced practice nurses.
• The intervention was time-intensive.

To evaluate the most efficient topical hydrating treatment in the prevention of cutaneous radio-induced effects in breast cancer

Topical treatments used in comparison were Pure Vitamin E; Omega 3, 6, and 9; Betaglucan; sodium hyaluronate; Ixoderm; and Xderit. Patients started using the skin emollients at the start of therapy until three months after completion of therapy. They were not allowed to use any other ointments during the course of therapy.  Any patient who developed a grade 2 or higher skin toxicity stopped the topical treatment and were treated with cortisone creams.

• The study sample (N = 100) was comprised of feamle patients with breast cancer.
• In the study sample, 53% had prior chemotherapy and 75% were receiving hormonal agents during and after radiation therapy.

The study took place in across multiple outpatient sites in Italy.

Patients were undergoing active antitumor treatment.

The study used an observational design.

The Radiation Therapy Oncology Group and European Organisation for the Research and Treatment of Cancer skin toxicity grading scale was used.

There were no grade 2 or 3 toxicities. No differences in toxicities associated with individual agents used could be determined because of the number of different agents used and the small number of patients observed.

 No conclusions can be drawn from this report regarding any comparisons of topical agents used.

• The sample size was small, with less than 100 patients.
• The groups had important differences.
• The study had a risk of bias due to no control group, no blinding, and no random assignment.
• Measurement methods were not described.
• Variation in patients regarding the combination of chemotherapy and radiation therapy could influence results.
• No description of total radiation therapy dosages. 
• No patient demographics provided.

 The study does not add much to evidence regarding prevention or management of radiodermatitis.

115 patients with symptomatic chemotherapy-induced peripheral neuropathy (CIPN) were randomized to the order of receiving oral gabapentin or placebo for six weeks separated by a two week “washout” period and crossing over to the other treatment group for six weeks. Gabapentin doses (300 mg capsules) and identical placebo doses were escalated over three weeks to a target dose of 2,700 mg of gabapentin per day, or nine placebo capsules per day.

• N = 115
• n = 57 assigned to receive gabapentin first
• n = 58 assigned to  receive placebo first.
• 115 adult patients with longer than one month duration of symptomatic CIPN who reported scores of 4 or higher for average pain on a 0–10 numeric rating scale (NRS), or a score of 1 or higher on the Eastern Cooperative Oncology Group (ECOG) neurosensory (ENS) toxicity item (possible ENS scores are 0–3, with 1 defined as mild paresthesias [loss of deep tendon reflexes]).
• Fifty percent of the participants were receiving chemotherapy at study entry. 
• Exclusion criteria included preexisting neuropathy and use of antidepressants, opioids, adjuvant analgesics, topical analgesics, and/or amifostine at baseline.
• Stratified random assignment was used with stratification on type of chemotherapy and whether patients were receiving chemotherapy or had completed chemotherapy.

The study was a phase III randomized, double-blind, placebo-controlled crossover trial.

Primary outcomes were pain and neuropathy symptoms measured by NRS (0 = no pain and 10 = worst pain possible) and the ENS (0 = none and 3 = severe objective sensory loss or paresthesias that interfere with function). These self-report data were collected weekly in reference to a single day

Secondary measures included:

• Tthe World Health Organization (WHO) classification scale for neuropathy-related symptoms
• The Short Form-McGill Pain Questionnaire
• The Brief Pain Inventory-Short Form
• The Subjective Global Impression of Change
• The Symptom Distress Scale
• The Profile of Mood States (POMS) Short Form
• And a quality of life uniscale.

These data were collected at baseline, 6, 8, and 14 weeks.

No differences were noted between groups at baseline, 6, or 14 weeks in the average pain NRS and the ENS. However, worst pain was lower in the placebo followed by gabapentin group at 14 weeks (p = 0.05). The only significant difference between the groups was in the McGill Pain Rating Index, which showed lower pain in the gabapentin group at the end of the first six week treatment period (p = 0.03).

Gabapentin did not improve symptoms of CIPN.

• A mixed sample of varying cancers, treatments, and time since chemotherapy could confound results.
• Patients with greater severity of pain may benefit from gabapentin. However, these patients were excluded from the study as they were taking opioids prior to the start of the study.
• Forty percent of the participants between the two groups were lost to follow-up (115 started treatment and 68 completed treatment).
• Because the eight-week results were not presented, it is not possible to determine if the groups were equivalent at the beginning of the second treatment period. Data on the POMS total and subscale scores were not included. 
• The means presented  at baseline did not include scores from participants who dropped out of the study.
• The authors noted that using separate tests at each time point without adjusting the alpha level to compensate may have contributed to the inconsistent findings among the pain instruments. 
• The ENS instrument considers that all parasthesias involve pain through subjective report and this may then increase or decrease depending on the amount of error in self report and can prove to be problematic when interpreting the results.

To investigate the impact of dietary counseling or nutritional supplements on morbidity and quality-of-life outcomes in patients with cancer during and three months after radiotherapy (RT)

Group 1 patients received individualized dietary counseling based on regular food groups. Group 2 patients consumed two cans of a high-protein liquid supplement per day in addition to their usual diet. Group 3 patients (control) were instructed to maintain their ad lib intake.

This prospective study design allowed for comparison of the effects of the interventions across the study arms over time. Evaluation took place at three points: baseline, at the end of RT, and three months later. Several types of outcome variables were measured, including nutritional status indicators.

• The study evaluated 111 patients with colorectal cancer referred for preoperative radiotherapy plus 5-fluorouracil//folinic acid administered on the first and last five days.
• The sample included 66 males and 45 females.
• Patient age range was 32–88 years.
• Patients were stratified by cancer stage and then randomized (n = 37 in groups 1, 2, and 3).
• All patients completed the study.

• Single radiation oncology department
• Lisbon, Portugal

The study was a prospective, randomized, controlled trial.

• Nutritional assessment
• Patient-Generated Subjective Global Assessment: to assess symptoms, weight change, alterations in food intake, functional capacity, components of metabolic stress, and physical examination findings
• Anthropometrics: height and weight
• Nutritional requirements and dietary assessment
• World Health Organization formulas
• Diet history: 24-hour food questionnaire
• European Organization for Research and Treatment Cancer Quality of Life questionnaire (EORTC QLQ-C30)

Protein 3 energy intake: at three-month time point, group 1 maintained nutritional intake and groups 2 and 3 returned to baseline. After RT and at three months, rates of anorexia, nausea and vomiting, and diarrhea were higher in group 3. At RT completion, 211 QOL function scores improved in group 1, 3 out of 6 function scores improved in group 2, and all scores worsened in group 3.

Researchers concluded that both interventions positively influenced outcomes. Three months after RT, dietary counseling was the only intervention to sustain a significant impact on patient outcomes.

• The study was limited to patients with colorectal cancer.
• The sample was of mixed disease stage (45 were stage I/II, 66 were stage III/IV), although patients were stratified for this.
• Measurement of outcomes was complicated by the fact that patients were receiving active treatments with RT.
• This type of dietary intervention is available to patients by referral to a registered dietitian. Expertise is required, which may be cost-prohibitive or not available at various settings.

This study examined the effects of individualized dietary counseling in a high-risk group. Whether individualized dietary counseling in other cancer groups will produce the desired outcome of increased appetite needs to be examined.

To determine the effect of daily bathing with chlorhexidine on nosocomial infection rates

Nosocomial infection rates were compared before and after the implementation of a daily chlorhexidine bathing. A solution of 4% chlorhexidine gluconate was diluted in 10 parts water to 1 part cleanser and was used to rinse all body surfaces except the face.

• N = 330
• AGE RANGE = 0–21 years
• MALES: 54.9%, FEMALES: 45.2%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Individuals with fever on admission were excluded from the analysis.

• SITE: Single site
• SETTING TYPE: Inpatient
• LOCATION: New Orleans

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Pediatrics

• Retrospective cohort comparison

• Infections were recorded based on the presence of a fever for more than 24 hours and/or the presence of positive cultures in bodily fluid.
• The presence of a fever with no positive cultures was considered presumed infection.
• The infection rate was quantified as incidence density per 100 days.

The infection rate was lower in the study group compared to historical controls only in those aged 12–21 years (p = 0.008). This age group also showed a higher prevalence of neutropenia (p = 0.039) in the study group. Overall, no significant differences existed in infection rates between study groups.

The results did not show an overall reduction in infections with daily chlorhexidine bathing, although some benefit was seen among older adult patients.

• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Differences in the rate of neutropenia between study cohorts existed.

The findings did not provide definitive evidence that daily chlorhexidine bathing reduces hospital-acquired infections; however, the rates among older adult patients, who also had a higher prevalence of neutropenia, improved. Chlorhexidine bathing is a simple and potentially low cost intervention that may have some benefit for neutropenic patients. Further research in this intervention is warranted.

To evaluate the effect of sublingual fentanyl on breakthrough cancer pain in opioid-tolerant patients; to assess how well patients tolerate sublingual fentanyl

The study included an open-label titration phase, a two-week double-blind efficacy phase, and a long-term open-label safety phase of up to 12 months duration. Sublingual orally disintegrating tablet (ODT) fentanyl was given at 100 mcg and titrated in the open-label phase to a maximum dose of 800 mcg until patients identified a single effective and tolerable dose. In the double-blind phase, patients received seven doses of the study drug and three doses of placebo. The study drug and placebo were identical in appearance. Patients took doses in a randomly assigned sequence. Rescue medication could be administered if needed after two hours. Patients were followed on a daily basis by telephone to monitor use of the study and rescue medications and the incidence of adverse events during the titration phase. Thereafter, investigators monitored patients in person on a monthly basis and at two weeks after monthly by-telephone evaluations. Patients maintained an electronic daily diary. Pain intensity  and pain relief were recorded immediately prior to treatment and at 10, 15, 30, and 60 minutes after use.

• The sample was composed of 66 patients in the double-blind phase and 72 in the long-term phase.
• Mean patient age was 55 years (SD = 11.5 years). Age range was 21–80 years.
• Of all patients, 45.8% were male and 54.2% were female.
• Authors did not report specific diagnoses.
• Of all patients, 84% were Caucasian.

• Multisite
• Outpatient

• Phases of care: end of life, palliative care
• Clinical applications: late effects and survivorship

Randomized placebo-controlled phase III trial

• Eleven-point verbal rating scale, to measure pain severity
• Five-point verbal scale, to measure pain relief
• Patient Global Evaluation of Medication
• Evaluation of adverse events by clinicians

Overall, patients received the study drug for an average of 51 days. Median dose of ODT fentanyl was 600 mcg. A median of three doses were taken per day. The most common treatment-related complications were nausea (12.2%), vomiting (5.3%), and somnolence (4.6%). One patient developed stomatitis, which may have been related to the study drug. Sublingual ODT fentanyl was significantly more effective (p < 0.006) than placebo at all time points and was most effective at 60 minutes (p = 0.0004). Pain relief was significantly better with ODT fentanyl than with placebo (p = 0.0007) at 15 minutes after use and at 30 and 60 minutes.

Sublingual ODT fentanyl was effective in the management of breakthrough pain, and patients tolerated the medication well.

• The study had a small sample, with fewer than 100 patients.
• Authors did not discuss the use of rescue medications.
• Authors provided no information about baseline pain levels. Duration or diagnosis was provided to determine generalizability of findings.  No information is provided regarding background pain management or total opiod doses. The follow-up period was relatively short, and a large number of cases were lost to follow-up.

In this study ODT fentanyl was effective in treating breakthrough pain; therefore, ODT fentanyl may be an appropriate means to manage this problem. The study reported one case of stomatitis, which may have been related to this drug. Nurses should be aware of the potential of stomatitis occurring with a patient's use of ODT fentanyl. The follow-up period in the present study was relatively short. Longer use of ODT fentanyl may pose greater risk of stomatitis.

To assess the efficacy of and determine the side effects related to the use of sublingual fentanyl spray for the treatment of breakthrough cancer pain  

The study involved an open-label titration period followed by a treatment period of up to 26 days. The primary efficacy measures were  summed pain intensity difference at 30 minutes (SPID₃₀), total pain relief at 30 minutes (TOTPAR₃₀), and patient global evaluation of medication study at 30 minutes. Efficacy was observed 5–60 minutes postdose and for side effects throughout. Patients were randomly assigned to the study drug or placebo. After the treatment period, a follow-up assessment was done 30 days after treatments. The fentanyl sublingual spray was titrated from 100 mcg to up to 1600 mcg until an effective dose was reached. Rescue medication was the medication the patient had for breakthrough pain before the study.

• The sample was composed of 130 patients, 98 in the placebo-controlled period. The final assessment was based on 90 patients.
• Mean patient age was 65 years.
• Of all patients, 46.9% were male and 53.1% were female.
• All patients had 1–4 episodes of breakthrough pain daily, which was partially controlled by means of at least five morphine equivalents of opioid.
• The most common cancers in the sample were breast, skin, lung, and head and neck cancers.

• Single site
• Inpatient and outpatient
• Center for Clinical Research, Winston-Salem, North Carolina, United States

• End-of-life care
• Clinical applications: end-of-life and palliative care, elderly care
   

Randomized, double-blind, placebo-controlled study 

• Summed pain intensity difference at 30 minutes (SPID₃₀)
• Total pain relief at 30 minutes (TOTPAR₃₀)

Of 130 patients, 98 entered the double-blind period. Relative to placebo, fentanyl sublingual spray significantly improved mean SPID scores from 5 minutes (p = 0.0219) through 60 minutes (p < 0.0001), including the primary endpoint at 30 minutes (p < 0.0001). The most frequent effective dose was 800 mcg. Side effects reported were nausea, hyperhidrosis, and peripheral edema; however, investigators did not consider any of these effects to be related to the treatment. Side effects occurred in about 4% of patients. Degree of pain relief and speed of pain relief were significantly higher with the study drug (p < 0.0001).

In this study fentanyl sublingual spray was well tolerated and effective in treating breakthrough of cancer pain.

Proper patient assessment prior to recommendation of the treatment is highly important. Oral hygiene is important during treatment with fentanyl spray. Keep an eye on side effects to ensure the comfort of the patient.

To evaluate the efficacy of fentanyl buccal soluble film (FBSF), at doses of 200–1200 mcg, in the management of breakthrough pain (BTP) in patients with cancer who are receiving ongoing opioid therapy

In phase 1, patients were screened, for up to one week, to assess tolerance of FBSF. In phrase 2, the titration phase, patients started with 200 mcg dose that was increased in a stepwise fashion (200, 400, 600, 800, 1200 mcg) until the patient experienced pain relief. Patients were discontinued from the study if a satisfactory dose could not be determined. If a satisfactory dose was achieved for two BTP episodes, patients proceeded to the double-blind phase. The double-blind phase lasted up to two weeks. Each patient received nine doses of FBSF (six of study medication and three of placebo). A computer determined the order of administration. Patients were allowed to use usual rescue medication if they did not receive adequate pain relief in 30 minutes. Study medication was allowed every four hours.

• The safety population consisted of 151 patients; 82 patients were in the efficacy population (double-blind phase).
• The study comprised 394 FBSF-treated episodes and 197 placebo-treated episodes.
• In the safety population, mean patient age was 57.1 years. In the efficacy population, mean patient age was 56.8 years.
• In the safety population, 56% were female and 44% were male. In the efficacy population, 55% were female and 45% were male.
• In regard to diagnosis, the conditions that follow were represented in the sample at the cited percentages: breast cancer, 23%; lung cancer, 17%; colorectal cancer, 11%; gastroesophageal cancer, 7%; pancreatic cancer, 6%; head and neck cancer, 5%; nociceptive pain, 50%; neuropathic pain, 32.5%.

• Multisite
• Outpatient
• Thirty centers in the United States

Randomized placebo-controlled, double-blind, multiple-crossover study

• A 0–10 scale (0 = no pain, 10 = worst pain), to measure pain intensity (PI)
• A 0–4 scale (0 = no relief, 4 = complete relief), to measure pain relief
• A measure of pain intensity difference (PID): baseline pain intensity – pain intensity at assessment point
• The sum of pain intensity difference (SPID): sum of PI differences 30 minutes postdose
• A five-point scale of global satisfaction (poor–excellent), with measures taken at the time of rescue-drug administration and 60 minutes postadministration of study drug
• LSM (least-squares mean) ± SEM (standard error mean) = outcome

• For both groups, PI baseline mean was 6.9 and median was 7.0.
• LSM was greater for FBSF-treated episodes than for placebo-treated episodes (47.9 ± 3.9 versus 38.1 ± 4.3) (p = 0.004).
• Results revealed statistically significant separation from placebo at 15 minutes postdose (p < 0.05) through 60 minutes postdose [the last time point assessed (p < 0.001)].
• PID values for FBSF-treated episodes were greater at all time points and significant at 30 minutes (p < 0.01) through last assessment (p < 0.01).
• The percentage of episodes with 33% or 50% decrease in pain was significant compared to the percentage of those episodes related to placebo.
• Satisfaction was greater with FBSF compared to placebo (mean 2.0 versus 1.5, respectively; p < 0.001).
• Mean (± SEM) number of episodes when rescue medication was used was significantly lower after treatment with FBSF than with placebo (30% ± 3.5% versus 44.6% ± 4.4%, p = 0.002).
• Twenty-three patients, or 15.2%, experienced serious adverse events, but according to investigators no event was related to the study drug. Treatment-related adverse events in the titration phase included the conditions that follow, at the cited percentages of patients affected: nausea, 9%; vomiting, 9.3%; somnolence, 6%; dizziness, 4.6%; headache, 4%. Adverse events in the double-blind phase phase included the conditions that follow, at the cited percentages of patients affected: nausea, 9.9%; vomiting, 9.9%; headache, 1.2%.
• Overall satisfaction was higher for FBSF, although a placebo effect did exist (67.1% for FBSF and 47.1% for placebo).

FBSF was more effective than placebo for the treatment of breakthrough pain in patients with cancer. The treatment was well tolerated.

• The study had a small sample, with fewer than 100 participants.
• Not all patients completed all measures.

FBSF shows favorable and safe results for the treatment of breakthrough pain, but the treatment remains investigational.

To examine the effects of inpatient and outpatient rehabilitation (i.e., physical therapy, psycho-oncological treatment, patient education, medical treatment, group sessions) on quality of life and psychosocial outcomes

Patients who had radical prostatectomy participated in inpatient and/or outpatient rehabilitation within 14 days after completion of acute oncology treatment

• N = 714   
• AGE = 57 years (SD = 4.4)
• MALES: 100%  
• KEY DISEASE CHARACTERISTICS: Prostate cancer stages T1–4, pN0, M0; average KPS 79 (SD = 8.7)
• OTHER KEY SAMPLE CHARACTERISTICS: Patient who had radical prostatectomy aged 18–64 years and were employed. Excluded those with excessive psychological or physical distress or cognitive limitations as assessed by rehabilitation physicians, those who were unable to speak and read German, and those who were diagnosed with a second cancer requiring treatment.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Four clinics in Germany

PHASE OF CARE: Transition phase after active treatment

• Quasiexperimental repeated measures design with convenience sampling from inpatient and outpatient treatment areas
• No blinding

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-C30: Two items for subjective cognitive function
• EORTC QLQ-Prostate-specific 25 (PR25)
• Hospital Anxiety and Depression Scale (HADS)

Subjects reported similar cognitive function scores at baseline and one year after rehabilitation. Cohen’s d  was 0.51 and 0.54 respectively (both p < 0.001). They reported higher cognitive function at the end of rehabilitation (F [df 1.8, 1238.2] = 138.1, p < 0.001). Quality of life was higher at a one-year follow-up (p < 0.001). Anxiety was lower at the end of rehabilitation for inpatient and outpatient rehabilitation groups (p < 0.001). Depression was lower at end of rehabilitation and sustained at a one-year follow-up (p = 0.008).

The effect of structured rehabilitation on outcomes in this study was unclear, and no clear differences in outcomes based on whether patients received inpatient or outpatient rehab services were observed.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Intervention expensive, impractical, or training needs
• Subjective cognitive function measure was limited; objective measures of cognitive function were not used.  
• Because rehabilitation was given as part of standard medical care, many other factors could have influenced the results.

Rehabilitation, whether provided in an inpatient or outpatient setting, improved patients’ perception of quality of life, depression, anxiety, and cognitive function by the end of rehabilitation. Perceived improvements in quality of life and depression persisted at one year after treatment.

To evaluate the role of benzydamine in the prevention of mucositis in patients receiving more than 50 Gy of radiation therapy

Patients were stratified according to receiving radiotherapy or radiotherapy and chemotherapy, and then randomly assigned to control or treatment with benzydamine. All patients were advised to use saline mouth rinses, and those in the treatment group also used 0.15% benzydamine hydrochloride rinse. Both groups were to rinse and gargle with the mixture four to six times daily. Patients were examined weekly until four weeks after completion of the treatment.

• N = 120   
• AGE RANGE = 19–90 years
• MALES: 87.5%, FEMALES: 12.5%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All had head and neck cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Radiotherapy dosages ranged from 56–70 Gy.

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

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE) toxicity, version 4
• World Health Organization (WHO) mucositis grading scales

Patients receiving radiotherapy alone who used benzydamine had a lower prevalence of grade 3 mucositis compared to controls (p = 0.038); however, control patients receiving only radiotherapy also had a longer duration of radiation treatment (p = 0.042, 56 versus 44 days). No significant difference in mucositis outcomes occurred among those receiving both chemotherapy and radiation. Control patients in this group had a longer duration of radiation therapy.

Benzydamine prophylaxis appears to be effective to reduce the severity of oral mucositis among patients receiving radiotherapy alone for head and neck cancer. Effects for patients receiving both chemotherapy and radiation therapy were not seen.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Measurement/methods not well described
• Exact measure used in analysis and timing of measurement used not stated
• In both treatment types, patients in the control group had a significantly longer duration of radiation therapy.

Oral rinses with benzydamine were helpful to reduce the prevalence of severe mucositis among patients receiving radiation therapy for head and neck cancer. It is unclear if benzydamine can also be helpful for patients receiving combination chemotherapy and radiation therapy.