DOI Link: doi: 10.7314/APJCP.2014.15.9.3951

To evaluate the effects of an electronic antinausea instrument (EANI) combined with hydrochloride palonosetron versus hydrochloride palonosetron alone on nausea and vomiting during the administration of highly emetogenic chemotherapy

The treatment group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy while wearing an EANI (no report of how long the patients wore the instrument). The control group received 0.25 mg of hydrochloride palonosetron injected five minutes before chemotherapy alone.

• N = 120 (60 in control, 60 in treatment)
• AGE RANGE = 23–74 years (no sample characteristics provided)
• MALES: Not reported, FEMALES: Not reported
• KEY DISEASE CHARACTERISTICS: Not reported
• OTHER KEY SAMPLE CHARACTERISTICS: No sample characteristics were reported, but eligibility criteria included patients being treated with highly emetogenic chemotherapy (adriamycin, cisplatin, and epirubicin) with no nausea or vomiting 24 hours before chemotherapy.

• SITE: Not stated
• SETTING TYPE: Not specified    
• LOCATION: People’s Hospital of Taixing City, China

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Vomiting degree was measured and reported as 0 (no vomiting), 1 (one to two emesis events per day), 2 (three to five emesis events per day), or 3 (greater than five emesis events per day).
• Nausea level was measured and reported as 0 (no change), 1 (no change in eating), 2 (obvious reduction in food intake), or 3 (couldn't eat and needed IV nutritional support).  
• Response rate was defined as the degree of vomiting plus the level of nausea divided by the total number of cases.
• There was no report of who recorded nausea and vomiting or how often.

There was a significant difference in the response rate for nausea (90% response in treatment group and 76.7% response in control group, p < 0.05), and there was a significant difference in the response rate for vomiting (95% response in treatment group and 78.3% response in control group, p < 0.05). No significant differences in adverse reactions between the groups and no severe adverse reactions were reported.

The use of an electronic antinausea instrument along with hydrochloride palonosetron appeared to be more effective than hydrochloride palonosetron alone for the treatment of acute nausea and vomiting associated with highly emetogenic chemotherapy.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: The study lacked a great deal of information, which calls into question its validity. There was no information how the randomization was performed, no information on sample characteristics was provided, no information on the EANI device was given, vomiting and nausea classifications were not validated, who determined the vomiting and nausea classifications for each patient was not stated, and there was no report of a statistical analysis. Adverse reactions were reported in the results but were not part of the purpose statement, and it was not described how the information was obtained.

Electronic antinausea instruments may be effective for treating chemotherapy-induced nausea and vomiting, but additional studies are needed to confirm these findings.

To assess the safety and efficacy of fluvoxamine combined with prolonged-release oxycodone for the management of cancer-related chronic pain

Patients with moderate to severe cancer-related pain were randomized to either the control group, which was treated with only prolonged-release oxycodone, or the prolonged-release oxycodone combined with fluvoxamine group. A daily maintenance dose of oxycodone was determined per patient after two weeks. Fluvoxamine began at 50 mg per day and increased by 50–100 mg per day to a maximum of 150 mg twice daily. Patients were assessed three times daily for pain response and dosage adjustment.

• N = 120
• AGE = Not provided
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: Not provided
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had a life expectancy of at least two months at study entry.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: China

Randomized, open-label trial

• Numeric Rating Scale (NRS)
• Opioid consumption

Pain severity declined in both groups. There were no reported significant differences between groups for pain severity or opioid consumption.

The findings of this study did not demonstrate the efficacy of fluvoxamine for chronic pain management.

• Risk of bias (no blinding)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Other limitations/explanation: The timing of measurement and duration were not well described. Although pain was measured every three hours, the exact measure used in the analysis was not stated. There was no information about the duration of the study, total opioid dosages in both groups before and after the intervention, or demographic information. The sample numbers differed between the tables and the body of the article, calling into question the overall validity of the results.

This study did not show any benefit from the addition of fluvoxamine to prolonged-release opioids in the management of moderate to severe chronic cancer-related pain.

DOI Link: doi: 10.1007/s00520-015-2737-2

Applications: Palliative care

Analysis showed improved partial pain response with Chinese medicine compared to sustained release morphine or bisphosphonates (RR = 1.18, p = 0.02)

External application of traditional Chinese herbal medicine was shown here to improve pain response rate in patients with metastatic bone pain; however, the quality of the evidence is insufficient to draw firm conclusions

All studies were deemed to be of low quality. The authors noted that included studies were mainly from Chinese publications, and that it is known that negative results are not published in China. This suggests important publication bias.

There is currently insufficient good quality evidence to demonstrate efficacy of traditional Chinese herbal medicine for pain management. Findings of this meta analysis suggest promise for this type of intervention as adjunctive treatment; however, well-designed research is needed for evaluation of the evidence.

To evaluate the impact of information, provided preoperatively, on the anxiety and knowledge of women undergoing mastectomy for breast cancer; to assess the specific impact of additional, structured preoperative information (delivered by means of educational/informational video) on perioperative anxiety and treatment- and disease-related knowledge in women undergoing mastectomy for breast cancer

Routine information was delivered to both arms of the study. Information was not standardized and included the typical conversation with the attending surgeon, surgical informed consent, and practical information from nurses. The treatment arm provided additional information delivered preoperatively via video; the information was recorded by a breast cancer survivor. Information in the video was obtained from the National Cancer Institute’s website. All patients were prospectively followed for one month (further follow-up was performed according to local treatment protocols) at 24–36 hours, 7 days, and 30 days postoperatively.

• The study reported on a sample of 58 female patients.
• Mean patient age was 60 years in the intervention group and 55 years in the control group.
• Patients had a diagnosis of breast cancer needing mastectomy, with cytologically or histologically proven invasive breast cancer. More than 80% in both arms had IIA and IIB stage disease, and 76% were diagnosed with ductal carcinoma.
• Women were older than 18 years of age and had the physical and psychological ability to use a visual analog scale and to complete requested questionnaires.
• Women were excluded from the study if they were admitted for breast-conserving therapy, neoadjuvant treatment for breast cancer, disseminated breast cancer, vision and/or hearing impairment, previous treatment for other malignancies, medical education, and other factors (geographical and familial) that would interfere with the protocol requirements.

• Inpatient
• Department of Surgical Oncology, Maria Sklodowska-Curie Memorial Institute of Oncology, Krakow, Poland

• Phase of care: active treatment
• Clinical applications: late effects and survivorship

Open-labeled, randomized controlled trial

• To measure anxiety: A visual analog scale (VAS) for anxiety was validated and shown to be the clinical equivalent of the Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI).  
• To measure level of knowledge: Investigators used a VAS (a subjective measure) as well as a self-administered questionnaire (an objective measure) containing specific questions about breast cancer treatment and familial risk.

• Authors noted no significant differences in anxiety levels between the intervention and control arms over all four time points.
• Authors noted no significant differences in subjective or objective knowledge between the intervention and control arms over all four time points.
• The number of patients confirming the association of the participant’s disease with an elevated risk for breast cancer in children or close blood relatives increased in the intervention arm from 40% preoperatively to 70% postoperatively.

Patients who participated in the study showed no evident or significant improvement in perioperative anxiety or treatment- and disease-related knowledge, with the exception of knowledge concerning available primary treatment modalities.

• The study had a small sample size, with fewer than than 100 participants.
• The outcomes of this study may result from having no a priori sample size estimation or power analysis. Interpreting results was difficult.

Patient education, as well as emotional support, should always be important preoperatively and must continue postoperatively.

DOI Link: doi: 10.1200/JCO.2010.32.2750

To determine if early ultrasound-guided celiac plexus neurolysis (EUS-CPN) prevents pain progression in and reduces narcotic use by patients with painful inoperable pancreatic cancer

Eligible for the study were patients referred for endoscopic ultrasound for the diagnosis and staging of suspected pancreatic cancer with new onset of suspected cancer-related pain. If onsite cytopathology results confirmed the diagnosis of adenocarcinoma and the lesion was deemed inoperable, consenting patients were randomly assigned to EUS-CPN or no EUS-CPN. Celiac plexus neurolysis (CPN) was performed during the endoscopic procedure. After the procedure patients returned to the referring physician for ongoing pain management. One month after randomization, a patient could undergo open-label CPN at the physician’s discretion. Investigators assessed outcomes at one and three months after randomization.

• The sample was composed of 98 patients.
• Mean patient age was 66.6 years.
• Of all patients, 52% were female and 48% were male.
• All patients had inoperable pancreatic cancer. Investigators performed subgroup analysis of patients who received chemotherapy and/or radiation therapy for pain management. On average, patients had a pain-duration history of nine weeks. Average pain intensity score at baseline was 4.7 on an 11-point scale.

• Single site
• Outpatient
• Canada

Double-blind randomized controlled trial

• Numeric pain intensity rating scale 0–10
• Total morphine consumption
• Digestive Disease Quality-of-Life Questionnaire-15 (DDQ-15)

• Sixty patients survived to the three-month follow-up point. All subjects randomized were included in intention-to-treat analysis. Pain relief with EUS-CPN was greater at one month (mean difference [MD] of pain scores: –28.9, 95% CI –67 through –2.8, p = 0.09) and three months (MD: –60.7, 95% CI –86.6 through –25.5, p = 0.01). However, the difference in mean change from baseline was significantly lower in the EUS-CPN group after one month (p = 0.01) and three months (p < 0.001).
• Change in morphine consumption was not different between groups at any time point.
• Authors noted no differences between groups in regard to survival or quality of life.
• Secondary analysis related to patients who received chemotherapy or radiation therapy.
  • Among patients who did not undergo chemotherapy or radiation therapy, EUS-CPN was associated with significantly better pain relief at one month and three months (p < 0.001).
  • In patients who underwent chemotherapy or radiation therapy, pain control with EUS-CPN was not significantly different from pain control in patients who did not undergo EUS-CPN.
  • In patients undergoing chemotherapy or radiation therapy, authors noted no difference between groups in morphine consumption.
  • In patients who did not have chemotherapy or radiation therapy, EUS-CPN patients had lower morphine consumption at three months (p = 0.05).

Results show that, compared to pain management with narcotics alone, early EUS-CPN provides greater pain relief. In the sudied patients, this approach was not better than chemotherapy or radiation therapy for pain control. 

• The study had a small sample, with fewer than 100 patients.
• Pain intensity measures used for analysis are unclear. Methods describe use of an 11-point scale and analysis of percentage of change. However, results are reported as mean differences. Presumably the differences are differences in mean percentage of change, but that is not clear.
• Timing of pain intensity measures is not entirely clear. Whether pain measures represent least, average, and worst pain is unclear.
• Authors do not discuss breakthrough pain or its management.

For patients with painful inoperable pancreatic cancer, early EUS-CPN may provide better pain control than do opioids alone. However, this study does not show any difference in overall morphine consumption associated with EUS-CPN. In this group of patients, palliative chemotherapy or radiation therapy appears to achieve pain control similar to the pain control that EUS-CPN achieves. EUS-CPN has not been associated with early or late complications; it may produce fewer side effects and symptoms than chemotherapy or radiation therapy. For this group of patients, nurses can advocate for consideration of EUS-CPN for adjuvant pain management. The advantage of early EUS-CPN is that the procedure can be done at the same time as a staging procedure, limiting the number of invasive procedures that the patient has to undergo.

DOI Link: doi: 10.1188/12.ONF.568-577

To evaluate the safety and efficacy of reflexology.

Patients were randomly assigned to one of three groups:  reflexology, lay foot manipulation, or the control. Certified reflexology providers administered the reflexology intervention in four weekly, 30-minute sessions. Foot manipulation providers were laywomen trained in the procedure. The laywomen delivered foot manipulation according to the relexology schedule. The control group received standard care. Study data were collected at baseline and at 5 and 11 weeks after randomization. Reflexologists and foot manipulation providers collected data after sessions at the planned time points.

• The study was comprised of 243 women with breast cancer.
• Mean age was 55.7 years.
• Most patients had stage III or IV breast cancer, and 79.67% had metastatic disease.
• The majority (83%) of patients were Caucasian, 65% were married or partnered, and 35% were employed. Educational level varied across the groups.
• Patients were excluded if they were in hospice care at the time of study entry.

• Multisite
• United States

The study has clinical applicability for late effects and survivorship.

The study was a three-group, single-blind, randomized, controlled trial.

• Short Form Health Survey (SF-36) Physical Functioning Subscale
• Functional Assessment of Cancer Therapy–Breast (FACT-B)
• Brief Fatigue Inventory (BFI)
• Brief Pain Inventory (BPI)
• State-Trait Anxiety Inventory (STAI)

At baseline, scores regarding anxiety and depression, according to the Center for Epidemiologic Studies Depression Scale (CESD), differed significantly (p < 0.01) across study groups. No differences were found regarding quality of life and symptoms of depression, anxiety, pain, or nausea. Those receiving reflexology reported lower levels of dyspnea than did the other two groups (p ≤ 0.02). Patients getting foot manipulation from laywomen had lower fatigue scores than did the controls (p < 0.01). Further analysis showed that the effect on fatigue was mediated by changes in dyspnea. Eleven percent of those in the foot manipulation group and 10% of those in the reflexology group did not complete all the sessions. The intervention had no adverse effects.

The findings suggested that reflexology may improve the symptoms of dyspnea and that foot manipulation may help reduce fatigue in women with advanced-stage breast cancer. The authors noted no effect of reflexology or foot manipulation on pain, anxiety, symptoms of depression, or nausea.

• The study had important baseline sample and group differences.
• The study had a risk of bias due to the lack of blinding.
• The findings were not generalizable; the study was underpowered in regard to detecting planned differences in patient outcomes.

The findings did not indicate that reflexology and foot manipulation affected pain, anxiety, symptoms of depression, or nausea among women with advanced breast cancer. The study demonstrated that these interventions are safe for the type of patients who participated. Reflexology and foot manipulation are low-risk interventions that may be helpful to some patients. Laypeople and caregivers could be taught these techniques, which may provide a meaningful way for these people to be involved in symptom management.

DOI Link: doi: 10.1188/08.ONF.E90-E99

To examine daily fatigue patterns during the third cycle of chemotherapy in women with breast cancer and predict whether fatigue trajectories differ by exercise or chemotherapy regimens.

Patients completed a daily fatigue diary that included a fatigue rating and items to determine whether they were exercisers or nonexercisers. Patients were asked to complete the diary daily. Weekly telephone calls from an exercise physiologist were used to determine exercise adherence.  Adherence was determined as either a yes or no based on whether the patient exercised at least three days per week for 20 minutes per session and at a “somewhat hard” intensity. Measures obtained during the third course of chemotherapy were used in this analysis.

• Ninety-eight patients (all female) were included.
• Mean age was 49.5 years (standard deviation = 9.3; range 28–72).
• Patients had breast cancer stage III and less.
• Of the patients, 72% were married/partnered, 28% were single, 74% were Caucasian, and 89% were educated more than 12 years.
• Patients were undergoing chemotherapy, with the majority (79%) receiving chemotherapy.

• Multisite  
• Outpatient
• Five cancer centers in the San Fransisco Bay area

Patients were undergoing the active treatment phase of care.

This was a prospective, longitudinal, repeated-measure design primary study; a secondary analysis of these data was performed.

• The fatigue diary had two standard questions, each measured on an 11-point rating scale ranging from 0 (no fatigue/tiredness) to 10 (overwhelming fatigue/tiredness). 
• Determination of exerciser versus nonexerciser status, the Surgeon General’s Guideline for Physical Activity, was used (described as at least three days a week for 20 minutes per session at an intensity of “somewhat hard”).

Average levels of fatigue reported were moderate for the first eight days and mild for the rest of the cycle. Highest levels of fatigue were observed on days 1 to 3 for average and worst fatigue. Five distinct trajectory patterns of cancer-related fatigue (CRF) were identified:  immediate and sharp increase followed by a gradual decline; early peak, a decline, and a sharp increase toward the end of the cycle; small variations among daily scores; chaotic pattern; and step-up evaluation followed by a gradual decline. Nonexercisers had higher average and worst fatigue (p < 0.01). In exercisers and nonexercisers, fatigue declined in severity over time, and the rate of decline was not significantly different between the two groups; however, fatigue levels were consistently higher among nonexercisers.

CRF peaked in the days immediately after intravenous chemotherapy and declined gradually over time. Fatigue tended to be lower in those who exercised as described.

• The study had a small sample size, with less than 100 patients.
• The sample consisted of female outpatients with breast cancer.
• Fatigue was not measured at different times during the day.
• No baseline of fatigue was established prior to chemotherapy.
• The length of the chemotherapy cycle varied depending on the regime.

Nurses should provide anticipatory guidance to patients so that they can plan for the days when they are at most risk for fatigue. Continued exercise during the course of chemotherapy may be helpful in mitigating the severity of fatigue.

DOI Link: http://apjcn.nhri.org.tw/server/APJCN/17/1/17.pdf

To evaluate the effects of a Taiwanese traditional diet including paeony and licorice components on pain in patients with terminal cancer

Patients were randomly assigned to one of three groups: (a) Taiwanese traditional herbal diet (TTHD) group, consisting of analgesic herbs (paeony root and licorice root) and tonic vegetable soup (lilli bulbus, nelumbo seed, and jujube fruit), (b) reference group, receiving the regular hospital diet, (c) and control group, receiving the tonic soup without addition of analgesic herbs. All patients remained on the assigned diet for one week. Pain was assessed via patient self-report questionnaire on days 3 and 10.

• The study reported on a sample of 2,466 patients.
• Patient age ranged from 9 to 89 years; 87% were between 40–79 years old.
• The sample was 50.7% male and 49.3% female.
• A variety of cancer sites were included, with the most common being lung, liver, colorectal, and stomach.
• An estimated 90% of patients had pain that was from medical conditions other than cancer. Most patients had neuropathic pain.
• Patients on any analgesics were excluded from the study.

• Single site
• Inpatient setting
• Taiwan University Palliative Medicine Ward

The study was a randomized, parallel group trial.

• Numeric rating scale using a 100-point scale: without pain, minimal pain, mild but tolerable pain, moderately uncomfortable pain, and extreme pain
• Previous tool validation identified
• No information on reliability

All groups reported significant reduction in mean pain scores on days 3 and 10. Patients in the TTHD group reported a three-point improvement in pain (from 53 to 50), which was significantly greater than that in the reference and control groups (p < 0.01).

In this study, use of traditional Taiwanese analgesic herbs was effective for pain reduction, compared to control and reference groups, in palliative care patients who were not receiving other analgesic medications.

Patients on analgesics were excluded from this study, and authors stated that in 90% of cases, pain was not cancer-related. Application of findings to other groups with cancer-related pain who require substantial analgesic therapy is questionable. Though statistically significant, the clinical relevance of the change in average pain scores is questionable, with a change of 3 points on a 100-point scale. The pain scale is not clearly explained, and it appears its scoring is not a continuous variable, though the statistical analysis and summary data provided treats the data as continuous data.

Findings here suggest that traditional Taiwanese analgesic herbs may be helpful in managing pain in terminally ill patients. There are a number of study report issues that make these findings very limited, so applicability to other patients with cancer-related pain is questionable. Future research in this area should examine use of this approach as adjunctive therapy in concert with other analgesia in patients with pain that is truly cancer-related. Applicability in other cultures is needed.

DOI Link: doi: 10.1177/0148607116651509

To evaluate the efficacy and safety of early supplementary parenteral nutrition (PN) following esophagectomy

Patients who had undergone scheduled esophagectomy (by laparoscopy or open surgery) for esophageal cancer were randomized 1:1 into two groups. The randomization sequence was generated by a computer, and the code was kept in sealed envelopes. Both groups were started on enteral nutrition (EN) within 24 hours after surgery; patients in the EN plus PN group also received supplementary parenteral nutrition (SPN), gradually increased over five days, to meet the full caloric target.

• N = 70   
• AGE = 30–66 years
• MALES: 68%, FEMALES: 32%
• CURRENT TREATMENT: Surgery
• OTHER KEY SAMPLE CHARACTERISTICS: Esophagectomy, nasojejunal tube placement or jejunostomy for postoperative feeding

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Department of Thoracic Surgery of Zhongshan Hospital, China

• PHASE OF CARE: Active Antitumor Treatment
• APPLICATIONS: Elder care

Randomized trial

The full-calorie target for each patient was based on measured resting energy expenditure, as determined by open-circuit indirect calorimetry (IC) (QUARK RMR). IC measurements were performed daily on each patient in both groups. The Chinese version of the Medical Outcome Study 36-Item Short-Form (MOS SF-36) as a surrogate of health-related quality of life assessment was used, and patients were required to fulfill the scale before surgery. Anthropometric parameters were taken. Standard laboratory blood biochemistry parameters were measured. Perioperatively, tumors were staged using the International Union Against Cancer's sixth edition of the tumor node metastasis (TNM) classification of malignant tumors (www.uicc.org) according to postoperative pathological results. The Clavien-Dindo classification was used to grade and record postoperative complications.

Patients in the EN plus PN group but not in the EN group preserved body weight (mean = 0.18, SD = 3.38 kg versus mean = −2.15, SD = 3.19 kg; p < 0.05) and FFM (mean = 1.46, SD = 2.97 kg versus mean = −2.08, SD = 4.16 kg) relative to preoperative measurements. Length of hospital stay, postoperative morbidity rates, and standard blood biochemistry profiles were similar. However, scores for physical functioning (mean = 71.5, SD = 24.3 versus mean = 60.4, SD = 27.4; p < 0.05) and energy/fatigue (mean = 62.9, SD = 19.5 versus mean = 54.2, SD = 23.5; p < 0.05) were significantly higher in the EN plus PN group 90 days following surgery.

Addition of early PN to supplement standard EN did not significantly change the perioperative outcomes of patients undergoing esophagectomy. However, for patients who received SPN, increased calorie and protein intakes were associated with preservation of body weight, FFM, and better health-related quality of life in short-term follow-up. Additional studies with larger sample sizes are needed to confirm these findings.

• Small sample (< 100)
• Key sample group differences that could influence results
• Exclusion criteria study included (a) aged younger than 18 years or older than 75 years, (b) body mass index less than 18 or greater than 30 kg/m², (c) contraindications for EN or PN, (d) preoperative initiation of EN or PN, (e) ongoing infections, (f) preexisting organ failure (e.g., renal dysfunction–required dialysis, noncompensatory chronic obstructive pulmonary disease), (g) treatment with high doses of steroids, and (h) severe metabolic abnormalities (e.g., diabetes, hyperthyroidism, hypothyroidism).

To evaluate the therapeutic effects of RhEGF on mucositis in patients with head and neck cancer receiving RT, with or without chemotherapy

Patients were randomized to 1 of 4 arms, 10, 50, or 100 mcg/mL study drug or placebo. Patients were instructed to spray study drug over the entire oral mucosa and then swallow the residual, twice daily, from the first day through week 5 of RT. Oral intake was restricted for 30 minutes after spraying. All patients gargled with chlorhexidine. No other mucositis treatment was allowed. Pain medication was allowed. Patients were removed from study if RT was interrupted for 3 or more consecutive days. Every week patients mucositis was graded by a radiation oncologist using RTOG scoring criteria. Patients with treatment delay were removed from the study

Sample Size: 100 patients Age Information: 18-77 years Females: 38 Males: 75 Diagnosis Information: head and neck cancer receiving at least 5 weeks of definitive aim RT or postop RT or definitive chemoradiotherapy. Fraction was 2.0 ± 0.25 Gy with 2 dimensional, 3 dimensional or IMRT Other Key Characteristics: exclusions included cytotoxic chemotherapy or RT within 3 weeks of the study or systemic or topical oral corticosteroids within 30 days of the study. Induction chemotherapy or concurrent cisplatin was allowed.

Multisite Korea

Randomized, double-blind, placebo-controlled phase 2. Randomized per institution and concurrent use of chemotherapy.

RTOG grading

RhEGF significantly reduced the incidence of severe oral mucositis at the primary endpoint (64% response with 50 mcg/mL EGF vs 37% response in the control group)(p =.025). Thirteen patients dropped out of the study. Six cases were dropped from the study due to radiotherapy interruption. Response rate ( ratio of patients who did no develop oral mucositis, with grade 2) were 57.7%, 64% and 59.1% for RhEGF groups. Only the group treated with 50mcg/ml had significantly higher response rate than placebo ( p =.0246). There were no significant differences between groups at week 4-5.

The EGF spray may have potential benefit for oral mucositis in patients undergoing RT for head and neck cancer. Phase 3 studies are ongoing to confirm these results.

It is difficult to standardize the administration of topical medications, also unable to penetrate the deep regions of the throat No intention to treat analysis of those removed from the study Variations if patients oral mucosal status and overall medical condition, only 5 weeks of observation, the dose was self-administered by patients and recorded in their log books, eating habits of Koreans differ from those of Western societies The spray did not effectively reach the pharyngeal mucosa, therefore there was no effect on pharyngeal mucositis. Patients had varying RT doses, some had IMRT and some had concurrent chemotherapy – there was no subgroup analysis based on these differences that could be expected to affect rate and severity of mucositis.

Due to topical spray administration, there is a potential for improper amount of drug to be administered. Phase 3 results should be reviewed if completed.