To investigate the effect of Rikkunshito on ghrelin secretion and on cisplatin-induced anorexia in humans

Ten patients were randomly divided into two groups. Both groups received S-1 (80 mg/m²/day orally split into twice-a-day dosing after meals) plus chemotherapy for 21 consecutive days followed by a 14-day rest period. The total daily dose of S-1 was determined based on body surface area (BSA): 80 mg (BSA < 1.25 m²), 100 mg (BSA 1.25–1.5 m²), or 120 mg (BSA > 1.5 m²). Cisplatin 60 mg/m² was administered IV on day 8. All patients were administered 16 mg of dexamethasone and 3 mg of granisetron IV one hour before cisplatin infusion and 8 mg of dexamethasone on days 9 and 10. Group A was started on Rikkunshito for the first course of chemotherapy, followed by a second course of chemotherapy without Rikkunshito. Treatment with Rikkunshito was reversed for group B. During the intervention period, patients took Rikkunshito 7.5 g (2.5 g three times per day by mouth) before each meal on days 1–21. Patients in the control period did not take anything. Blood samples to assess acylated ghrelin levels were collected before and three hours after administration of the cisplatin. Patients were hospitalized after the administration of cisplatin and monitored for five days. The amount of oral intake of each meal was observed and scored, and the average oral intake during five days was calculated.

• The study reported on 10 patients (5 in each arm).
• Mean patient age was 61.8 years, with a range of 50–72 years. (Median age was not calculated in the article.)
• The sample was 80% male and 20% female.
• All patients had gastric cancer: 40% had recurrent disease, 60% had unresectable disease.
• Patients had an Eastern Cooperative Oncology Group performance status score of 0–1 and may have had up to one prior chemotherapy regimen.

• Single site
• Inpatient setting
• Japanese study, suggesting it was done in Japan

• Patients were undergoing active treatment.
• The study has clinical applicability for late effects and survivorship.

A crossover design was used.

Anorexia, nausea, and vomiting were scored according to National Cancer Institute common toxicity criteria.

During the Rikkunshito-on period, there was no significant decrease in the plasma concentration of acylated ghrelin between before and after administration. During the Rikkunshito-off period, the average concentration of plasma-acylated ghrelin three hours after cisplatin administration decreased from preadministration levels but not statistically significantly.

The average oral intake in the Rikkunshito-on period was significantly larger than that in the Rikkunshito-off period (p = 0.0496). The grade of anorexia was significantly lower in the Rikkunshito-on period than in the Rikkunshito-off period (p = 0.0441), and the average oral intake in the Rikkunshito-on period was significantly larger than that in the Rikkunshito-off period. The grade of nausea was not significant; however, the grade in the Rikkunshito-on period tended to be lower. The difference in grade of vomiting was not significant. The time to treatment failure rates during the Rikkunshito-on period were not different. Hypertension, edema, hypokalemia, pseudohyperaldosteronism, hepatic toxicity, and transaminitis have been previously reported but did not appear to be more significant in the Rikkunshito-on or -off period for this study.

Rikkunshito might prevent anorexia induced by cisplatin, and the prophylactic administration of Rikkunshito was felt to be effective in chemotherapy with cisplatin. Patients could continue their treatment on schedule.

• The study had a small sample size, with less than 30 participants.
• The trial was nonrandomized; crossover design may cloud what led to benefit.
• The authors have taken a combination herbal product and assumed that any positive effects in this study are due to ghrelin levels. Previous studies cited by the authors have had mixed results regarding the effect of ghrelin on cachexia and anorexia. The positive effects seen may not be related to effect of Rikkunshito on ghrelin at all but rather due to other effects of one of more of the herbs in Rikkunshito. The presence of multiple herbs in this product may be a confounder.

Rikkunshito may be effective at preventing anorexia induced by cisplatin, but the small sample size makes it unlikely that this data can be generalized. Additional studies are necessary.

To evaluate the effects of prophylactic compression therapy using stockings and sleeves combined with oral goshajinkigan, mecobalamin, and lafutidine on the prevention of nab-paclitaxel-induced peripheral neuropathy (PN)

The control and treatment groups received 260 mg/m² one time every three weeks from June 2012 to April 2013. Patients in the prophylactic treatment group wore stockings and sleeves from the beginning of nab-paclitaxel infusion, continuing for total of 24 hours. The treatment group also received prophylactic goshajinkigan (7.5 g per day), mecobalamin (1,500 mcg per day), and lafutidine (20 mg day) over the course of treatment. Assessments for side effects, including PN grade, were first conducted by a pharmacist then by a physician. If a subject proceeded to chemotherapy, a third set of tests were conducted by a nurse. For the treatment group, the nurse confirmed use of compression stockings and sleeves prior to chemotherapy.

• N = 14 
• AGE RANGE = 42–76 years
• MALES: Not provided, FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: Recurrent breast cancer; metastatic or locally advanced
• OTHER KEY SAMPLE CHARACTERISTICS: Previous treatment with taxanes; prior treatment lines; no other data provided

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Nagasaki Harbor Medical Center, Nagasaki, Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care, palliative care

Parallel-group trial

• National Cancer Institute'sCommon Terminology Criteria for Adverse Events (NCI-CTCAE)
• Various assessments for side effects including PN (not well described)

After the first cycle of chemotherapy, there was a significant difference in presence of PN (all grades) between groups. PN occurred in five out of seven subjects in the control group versus one out of seven subjects in the treatment group. The average grade of PN improved over cycles one through four in the treatment group.

In this small, nonrandomized trial, the grade of PN during one to four cycles of nab-paclitaxel therapy at 260 mg/m² was lower in the treatment group receiving compression therapy and prophylactic medications than the control group.

• Small sample (< 30)
• Baseline sample/group differences of import
• 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
• Selective outcomes reporting
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: This study had a small sample size, and sample characteristics were not well described. The design also was not well described, and there was no explanation of randomization techniques, inclusion and exclusion criteria, or measurements and methods. There was no explanation of baseline PN or the presence of other neurologic symptoms, and other medications previously or currently taken by participants were not reported. The total dose of ​nab-paclitaxel for both groups was not reported, and the mean dose of nab-paclitaxel was significantly greater in the treatment group with no explanation for this difference between samples. The total number of cycles completed for each group was not reported. There was no explanation of the method of administration for the prophylactic medication regimen. Compliance and tolerance rates were not reported. There was no report of any adverse side effects for the sample. The results reported appear incomplete and selectively done for the time period of collected data. Figure 1 depicting grade of neuropathy and number of cycles includes only four cycles for study period June 2012 to April 2013. Assumptions for statistical analysis not reported as met. There is a suggestion that this treatment supports the protection of peripheral nerves, but this assumption cannot be made based on this study as there is no discussion on the main effect on PN and the interaction of the combination of treatments in the treatment group. Citations are missing for the data reported in many places.

Combination prophylaxis with compression sleeves and stockings and medication (goshajinkigan 7.5 mg day, mecobalamin 1,500 mcg per day, and lafutidine 20 mg per day) needs additional investigation of its use for the treatment for nab-paclitaxel-induced PN. The safety, efficacy, benefit, and generalizability for appropriate target populations of this regimen also requires additional study in large, randomized, controlled trials. This study report had numerous flaws and limitations.

There is an emerging problem of growing multi-drug resistant gram-negative rods (MDR-GNRs), and rapid and sensitive detection is difficult. There is no consensus regarding the list of drug-resistant bacteria to target for infection control and infection control policies for multi-drug resistant gram-negative organisms (DR-GNRs) often lack strong evidence to identify the minimum interventions needed to reduce their transmission. The authors were trying to determine if horizontal transmission can be prevented by detecting and appropriately controlling targeted drug-resistant bacilli before they acquire resistance.

In January 2005, a prevention policy against MDR-GNR infection was implemented. After isolating strains that met the defined criteria, contact precautions were implemented. Active interventions, including approval for specific antibiotics prior to use and regulating the prescription of certain antimicrobials, were not applied. The preintervention period (January 1, 2003 to December 31, 2004) was compared to intervention period (January 1, 2005 to December 31, 2010).

• N = 1,287,296 total inpatient days
• OTHER KEY SAMPLE CHARACTERISTICS: No exclusion criteria; active sampling from asymptomatic patients was not conducted; data included dates of detection, types of culture samples, inpatient or outpatient status, names of the detected strains, and results of susceptibility testing; inpatient days of care were defined as the sum of each daily inpatient census for the month

• SITE: Single site    
• SETTING TYPE: Multiple settings    
• LOCATION: Shizuoka Cancer Center, Nagakute, Aichi, Japan

• PHASE OF CARE: Multiple phases of care

Retrospective study (pre- and postintervention) based on the examination of a bacterial testing database

MDR-GNRs were defined as gram-negative bacilli that were insensitive to at least three of the specified classes of antimicrobials, metallo-beta-lactamase-producing bacilli, and extended spectrum beta-lactamase (ESBL)-producing bacilli. Strains of MDR-GNRs were isolated at least 48 hours after admission, and only newly detected stains were included and excluded cases in which the same strain was later detected in the same patients. Each species was included if multiple strains were isolated from the same patients.

The overall incidence density rate of all multi-drug resistant nonfermenting gram-negative bacilli over the eight-year study period (2003–2010) was 0.31 per 10,000 patient days. Rates did not increase significantly between the preintervention period (0.15 per 10,000 days) and the intervention period (0.35 per 10,000 days). The overall incidence rate of MDR enterobacteriaceae infections was 0.49 per 10,000 days. However, the preintervention period was 0.19 per 10,000 days, and the intervention was 0.56 per 10,000 days, representing a statistically significant decrease.

The study increased the detection of enterobacteriaceae bacteria with an increase in ESBL-producing organisms, but no significant change in detection rate of MDR non-glucose-fermenting bacilli was found. Contact precautions were implemented to limit the emergence of MDR-gram negative bacilli, but the efficacy of these policies was deemed uncertain.

• Retrospective study
• No active surveillance of asymptomatic patients
• Incidence measurements based solely on clinical cultures and may be insufficiently sensitive because asymptomatic patients may have been missed

MDR-GNRs are an emerging worldwide problem. Nurses have a significant responsibility to ensure proper precautions are taken as quickly as possible when these organisms are detected. Nurses should ensure that the patient is properly educated, but more importantly, should implement contact precautions and ensure that other healthcare providers are following these precautions. 

To evaluate the effects of a psychoeducational program on quality of life (QOL) among patients treated for colorectal and anal cancer

After patients were discharged post-initial surgery, they were invited to participate in the program. Patients completed a baseline assessment and then were randomized to the study program or usual care. Patients in the control group received standard care, including a phone call on postoperative day 3, a follow-up surgical visit after one month, and an appointment with the social worker/counselor if desired. Control group participants were offered the educational program after the end of the study. The intervention included seven meetings with informational lectures delivered once weekly in groups of about 10 patients. Caregivers could attend educational sessions. Lectures were followed by group discussion among patients only to reflect on the topic among peers and speak about worries and experiences. Study assessments were done at 1, 6, and 12 months after study entry.

• N = 86   
• MEAN AGE = 66 years
• MALES: 62.8%, FEMALES: 37.2%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Colorectal or anal cancer, most were stage I or II 
• OTHER KEY SAMPLE CHARACTERISTICS: The majority were retired and currently married.

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

• PHASE OF CARE: Multiple phases of care

• Randomized, controlled trial with wait-list control–longitudinal repeated measures

• Short Form 36 Health Survey (SF-36)

At one month, the intervention group reported better overall mental health status (effect size = 0.51, p = 0.01). Bodily pain score were more positive in the intervention group at six months (p = 0.01), but not significantly different from that of control patients at any other time point, although among the intervention group, average pain scores improved over time, while among controls remained essentially stable.

The psychoeducational program evaluated here was associated with better mental health status and bodily pain subscale scores over time.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• At baseline, those in the intervention group had significantly higher reported general health and social functioning and better pain scores.
• Repeated measures design with possible testing effects

The psychoeducational program tested here appeared to have positive health-related QOL benefits for participants. Ongoing research is needed to identify the most beneficial timing, amount, content, and format of educational and counseling for short- and long-term benefit to patient with various cancer types and treatment regimens.

To compare functional outcome and quality of life (QOL) in patients who received surgical resection for rectal versus colon cancer, and to review the efficacy of the use of probiotics in bowel function afterwards.

A questionnaire was sent to 193 patients with non–stage IV colon cancer. Some patients with stage III disease received adjuvant chemotherapy over the six-month postoperative period, but no patients were undergoing chemotherapy when the questionnaire was administered. Seventy-seven respondents agreed to take probiotics. Patients received a probiotic that contained Bacillus natto and Lactobacillus acidophilus as the principal ingredients.

Patients took three tablets after meals TID for a total of nine tablets. The questionnaire was readministered three months after probiotic initiation.

• The study reported on a sample of 77 patients with colorectal cancer, divided into right-side, left-side, and rectal groups.
• Patient age ranged from 52 to 77 years across all study groups.
• The final sample comprised 35 men (right side: n = 11; left side: n = 12; rectal: n = 12) and 26 women (right side: n = 7; left side: n = 9; rectal: n = 10).

• Single site
• Multiple settings
• Japan

• Patients were in the late-effect and survivorship phases of care.
• The study has clinical applicability to older adult care.

 This was a questionnaire-based study with a cross-sectional design.

• Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) in Japanese
• European Organization for Research and Treatment of Cancer (EORTC) Cancer Core Quality of Life Questionnaire (QLQ-C30) in Japanese
• Functional outcome was scored using the Wexner Fecal Incontinence Score and questions specific to bowel function.

• Functional outcomes (related to defecation frequency and anal pain), Wexner score, and social function on the QLQ-C30 were worse in the rectal group.
• The right-side group had a tendency toward softer stools and more frequent nighttime defecation than the left-side group.
• Global QOL, constipation, and diarrhea on the QLQ-C30 was improved in the rectal group.
• Frequency of defecation, role of emotion on the SF-36, and constipation on the QLQ-C30 were improved in the left-side group.
• Defecation, frequency, feeling of incomplete evacuation, and global QOL on the SF-36 were significantly improved in the right-side group.
• Patients who were receiving probiotics had a statistically significant reduction in frequency of stools per day (0.4 change; p < 0.05), and 50% fewer patients with right-side colon disease experienced the feeling of incomplete defecation after probiotic use (p < 0.05).
• Specific aspects of QOL scores showed mixed results, with some improving and some subscale scores worsening.

Some improvements were observed in all groups after the administration of probiotics. Changes in defecation and related symptoms differed according to disease location over time. The role of probiotic use cannot be determined from this study report.

• The sample size was small (fewer than 100 patients).
• Risk of bias existed because the study lacked a control group, blinding, and random assignment.
• Unintended interventions or applicable interventions that may have influenced the results were not described.
• Changes over time were not compared between patients who received probiotics and those who did not. As bowel habits and problems can be expected to change over time after surgery and according to tumor location, the impact of probiotic use cannot be determined based on this study.

The study did not provide sufficient evidence to demonstrate the efficacy of probiotic use for managing bowel symptoms in patients after colorectal surgery. However, the study showed differences in bowel symptoms based on initial tumor location and surgical area.

To evaluate the feasibility of intraoperative antimicrobial prophylaxis compared to conventional prophylaxis in patients undergoing elective open gastrectomy

Procedures for prophylaxis were conducted in two stages during six months. In the first stage, patients received four IV doses of cebazolin 1 g at 12-hour intervals beginning 30 minutes before surgery. In the second cohort, patients received the same agent at three-hour intervals beginning 30 minutes before surgery until the end of surgery. Perioperative care was conducted in a standard approach in both cohorts.

• N = 423   
• MEAN AGE = 63.5 years
• AGE RANGE = 27–88 years
• MALES: 65.2%, FEMALES: 34.8%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All were undergoing gastrectomy for gastric cancer. Ninety-eight percent had a ASA score of 1 or 2.
• OTHER KEY SAMPLE CHARACTERISTICS: Median operation time was four hours.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Cohort comparison—prospective

The definition of surgical site infection (SSI) was based on the Centers for Disease Control and Prevention surveillance system.

The overall SSI rate was 9.2%, and all were treated successfully with antibiotics. No statistically significant difference existed between cohorts.

Provision of antimicrobial prophylaxis immediately before and during the operative procedure appears to be feasible and sufficient for the prevention of SSI in patients undergoing gastrectomy.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Provision of antibiotic prophylaxis to reduce SSI 30 minutes before and during the surgical procedure may be sufficient. This study is limited by its design. Additional research is needed to determine the most effective timing and duration of antibiotic prophylaxis for SSI prevention in patients undergoing various types of surgical procedures.

To test the effects of a brief psychosocial intervention (BPIC) delivered using CD-ROM on psychosocial and behavioral outcomes in patients with cancer undergoing adjuvant treatment

Participants viewed a 15-minute CD-ROM education program and received a booklet as well as 20 minutes of health education in the first session. A follow-up 15-minute telephone session was delivered one week later. The program focused on health education, coping, and stress management.

• The study reported on a sample of 71 patients with cancer.
• Of the sample, 29.6% were younger than age 50, and 36.6% were older than age 60.
• The sample was 62% female and 38% male.
• Breast cancer was the most frequent diagnosis, followed by lung cancer. A variety of other cancer diagnoses were included.
• More than 50% of the patients were receiving chemotherapy only, and 37% were receiving chemotherapy plus radiation therapy.
• The majority of patients were married (90%), not employed (80%), and had a high school or higher education level.

• Single site
• Outpatient setting
• Korea

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• Mental Adjustment to Cancer (MAC) Scale
• Hospital Anxiety and Depression Scale (HADS)
• Self-care behavior was assessed with a 20-item tool developed by the author (Cronbach’s alpha = 0.79). Each item was rated 1–7, with higher scores indicating better self-care behavior.

There were no differences between groups for helplessness, hopelessness, anxiety, or depression. There were significant differences in fighting spirit (p = 0.005) and self-care behaviors (p < 0.001) between the two groups. The scores increased in the experimental group but declined in the control group.

Findings support effectiveness of the intervention in improving fighting spirit and self-care behaviors; however, the intervention had no significant effect on anxiety or depression.

• There was a high rate of nonresponders for postintervention measures, which limits the power to detect differences between groups.
• Findings were done four weeks after the initial study session, so long-term benefits are unknown.

Mean anxiety and depression scores at baseline were relatively low, suggesting very limited potential for these outcomes to be significantly improved.

STUDY PURPOSE: To evaluate the effects of spiritual interventions in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 15
• TOTAL PATIENTS INCLUDED IN REVIEW = 827
• SAMPLE RANGE ACROSS STUDIES: 24–120 patients

PHASE OF CARE: Multiple phases of care 

APPLICATIONS: Palliative care

Primary outcomes were spiritual well-being and meaning of life. Anxiety and depression were secondary outcomes. Nine studies examined effects on depression, and six examined effects on anxiety. Seven studies were randomized, controlled trials. There was a moderate effect on spiritual well-being. A large effect size was seen for anxiety (d = - 0.87, p = 0.02), and a moderate effect size for depression was found (d = - 0.62, p = 0.001). The largest effect sizes were seen in studies that were not randomized, controlled trials. Interventions were categorized as religious or existential. Religious interventions had an impact on depression, and existential interventions had an effect on anxiety. There was substantial heterogeneity. This article reports numerous subgroup analysis results based on type of intervention, the intervention provider, and other variables. In the majority of cases, interventions were provided by nurses.

The findings of this meta-analysis suggest that religious and existential spiritual interventions have a positive and at least moderate effect on anxiety and depression as well as spiritual well-being and meaning of life.

The review included nonpeer-reviewed doctoral dissertation results, and an analysis showed a probable publication bias, suggesting that studies with negative findings may not have been retrievable. There was substantial heterogeneity and a varied risk of bias across studies. The highest effect sizes were seen in nonrandomized, controlled studies, which also had the highest risk of bias and heterogeneity. Most studies were of patients at the end of life, so findings may not be applicable to patients at other stages of care.

The findings of this meta-analysis suggest that spiritual interventions, particularly at the end of life, can be beneficial in reducing anxiety and depression and increasing a sense of spiritual well-being and meaning of life. Nurses traditionally recognize the importance of the spiritual dimensions of care, and these findings support that view. The findings must be viewed with caution given the limitations of these results. However, spiritual interventions are low-risk and, as shown here, can be delivered by nurses who already have relevant proficiencies such as engagement, caring, support, and communication.

To evaluate the effects of combined aerobic and strength exercise on physical performance and symptoms in patients who are hospitalized while receiving myeloablative therapy

Patients were randomly assigned to the exercise intervention or usual care. Usual care patients were allowed to undergo physical therapy as medically indicated according to standard practice. The intervention group included ergometer endurance training for 10–20 minutes and resistance exercises for main muscle groups for 20 minutes. Exercises were done five days per week during the entire hospital stay, and training intensity was individually adjusted based on spiroergometry at study entry. Training was suspended if patients experienced fever, infection, thrombocytopenia (platelet < 20,000) cardiac arrhythmia, or life-threatening clinical complications. Neutropenic patients wore masks when they left their rooms. Follow-up assessment was done at 12 months.

• N = 48
• MEAN AGE = 52 years
• MALES: 70.8%, FEMALES: 29.2%
• KEY DISEASE CHARACTERISTICS: Most frequent diagnoses were acute myeloid leukemia (AML) and non-Hodgkin's lymphoma (NHL)

• SITE: Single-site  
• SETTING TYPE: Inpatient  
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

Randomized controlled trial

• Spiroergometry oxygen consumption measurement
• European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) scale
• Modified Fatigue Impact Scale (MFIS)

The median duration of exercise training was 15 days with the median hospital stay being 21 days. The control group’s lung function as measured by oxygen consumption increased. Treatment group oxygen consumption and expiratory minute ventilation volume was significantly higher at the end of the study compared to controls (p < .05). EORTC physical functioning was significantly higher in the treatment group compared to controls (p = .04). There were no other differences in symptoms between groups. The treatment group complained of fatigue for fewer days than those in the control group (p = .04). Self-report of overall condition at 12 months indicated no significant difference between groups. There were no exercise-related adverse events.

This study demonstrated that exercise training during myeloablative chemotherapy is feasible, well-tolerated, and may improve physical performance during treatment.

• Small sample (< 100)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: High drop-out rate

Findings suggest that exercise training during hospitalization for myeloablative chemotherapy is generally well-tolerated. The study was underpowered to show any effect on symptoms of fatigue; however, exercise training was associated with improved physical performance measures. Nurses can advocate for exercise programs for this group of patients.

To evaluate the effectiveness of various interventions to manage the skin effects of cetuximab.

All 31 patients developed the typical acneform rash that occurs from six to 20 days after the first dose of cetuximab. Emollients were recommended for grade 1 acneform eruptions. For patients who developed grade 2 reactions, the same topical treatment as for grade 1 was used, with the addition of topical antibiotic treatment: 1% solution of clindamycin BID for two to three weeks until pustules ceased. The H1 antihistamine loratadine was recommended to relieve itching.

All patients were advised to wash with bath oil or shower with tepid water, avoid sun exposure, and use sunscreen products with high sun protection factor. For grade 1 rash, patients were advised to use topical preparations for moisturizing that contain dexpanthenol (e.g., Bepanthen^® cream or lotion), applied BID. For grade 2 rash, patients used the same topical preparation, plus a topical antibiotic treatment. Finally, for grade 3 rash, treatment with cetuximab was discontinued until the reaction resolved and a combination of emollients, topical antibiotics, and systemic antibiotics was given.

• The study reported on a sample of 31 patients with metastatic colorectal cancer who were treated with cetuximab as third-line or further-line treatment after failure with irinotecan.
• Mean patient age was 56.3 years (range 36–76 years).
• Nineteen patients were men, and 12 were women.

Institute of Oncology in Ljubljana, Slovenia

This was a descriptive study on the effectiveness of various interventions for dermatological toxicities related to cetuximab.

Skin toxicity was evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.

• Of 31 patients in this study, 6 had grade 3 rashes, 16 had grade 2 rashes, and 9 had grade 1 acne-like rashes.
• The authors reported the numbers of patients who used various treatments, but did not report the effectiveness of emollients for grade 1 or grade 2 rashes. They stated, “Generally, for treatment of skin reactions (relief of pain, discomfort, and healing) for the patients experiencing Grade 1 acneform eruptions, the skin should be treated with emollients and moisturizers (containing dexpanthenol) to ensure a maximal hydration of the skin for at least two weeks.”

Grade 3 skin rash was generally manageable with emollients, topical antibiotics, and systemic antibiotics. The effectiveness of emollients on grade 1 and 2 rashes was not reported.

• This was a descriptive study, not a randomized controlled trial.
• The sample of patient reports was small.
• Treatment was based on expert opinion.
• A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.