Patients were randomized to one of three study groups.

• Acupressure bands (Sea-Bands®)
• Acustimulation band (ReliefBand®)
• No band control

The intervention or lack of intervention was used in combination with standard antiemetics for chemotherapy-induced nausea and vomiting.

Patients wore devices (if any) continuously for five days, and those in the acustimulation band group could adjust the intensity of stimulation.

• The study consisted of 739 patients who were chemotherapy-naïve.
• Cancer diagnoses included breast cancer (85%) and hematologic neoplasms (10%).
• The majority of the patients were white (88%) and female (92%).
• Patients were about to receive cancer regimens containing cisplatin or doxorubicin, without concurrent radiation therapy or interferon.
• Patients were excluded from the study if they had pacemakers, bowel obstruction, or symptomatic brain metastases.

The study was conducted at outpatient clinics at 17 geographically diverse member sites of the University of Rochester Clinical Oncology Program.

The study design was a randomized controlled trial.

• Using diaries, patients reported on the severity of nausea and number of vomiting episodes in the morning, afternoon, evening, and night, on the day of treatment and the following four days on a seven-point scale.
• Quality of life was measured using the Functional Assessment of Cancer Therapy Scale-General.
• Demographic data, chemotherapy information, and antiemetics were recorded.
• Efficacy reports of wristband(s) were assessed on a five-point scale prior to treatment.

• Patients in the acupressure group experienced less nausea on the day of treatment compared to controls.
• No significant differences were found in delayed nausea and vomiting among the three groups.
• Pronounced gender differences existed. Men in the acustimulation group had less nausea and vomiting compared to controls. No significant differences existed in women among the three groups, although the reduction in nausea on the day of treatment in the acupressure group approached clinical significance.

A possible placebo effect existed.

This randomized controlled trial used a three-level crossover design (active acustimulation, sham acustimulation, and no acustimulation). All patients received standard antiemetics ordered by the physician. Patients wore a wristband before chemotherapy and as needed. Patients could adjust the stimulation intensity.

• The study consisted of 27 patients (25 women, 2 men).
• The mean age of patient was 49.7 years.
• Most patients were Caucasian, one was African American, and one was Asian.
• Cancer diagnoses were breast (81%), colorectal (11%), ovarian (4%), and lung (4%).
• Patients who had previously experienced moderate or more severe nausea following their first chemotherapy treatment were screened for the study.
• Patients were scheduled to receive at least three more chemotherapy treatments without radiotherapy or interferon.

The study was conducted at three outpatient oncology clinics in the northeastern United States.

The study was a randomized clinical trial using a three-level crossover design (active acustimulation, sham acustimulation, and no acustimulation).

• Using patient diaries, patients reported on the severity of nausea for each period (morning, afternoon, evening, night) on the day of treatment and on the following four days.
• Severity of nausea was assessed on a seven-point rating scale.
• Patients also reported on the type and total number of antiemetic pills taken on days 1–5.

No statistical differences in average severity of nausea were observed between the interventions. A nearly significant difference was found in the severity of delayed nausea reported during active acustimulation compared to no acustimulation.

Findings were positive but not conclusive.

• The sample size was small, and data were missing.
• The study did not account for medication changes (antiemetics).
• The wristband may have caused a placebo effect. Mood elevation may be possible with nerve stimulation and the release of endorphins.

Caution should be used in patients with pacemakers.

Thêta-cream was compared with standard skin care using Bepanthol (Bepanthen) lotion to prevent acute radiation therapy (RT) side effects in skin tissue.

Patients were randomly assigned to use Thêta-Cream (GM Glucan, Hydroxyprolisilan C, Matrixyl) (arm A) or Bepanthol lotion (dexpanthenol) (arm B) during RT. Medication was applied lightly to the treatment field twice daily starting within one week before beginning RT. Patients were requested to wash irradiated skin gently with care to skin marks. No other prophylactic topical treatment was allowed.

• The sample was comprised of 20 women with early stage breast cancer. 
• Mean age was 56 years (range 43–65) for patients receiving Thêta-cream and 52 years (range 38–61) for patients receiving Bepanthol lotion.
• Treatment was given in a supine position with 6 mv photons of a linear accelerator with tangential.

The study was a randomized, blinded, controlled trial.

• All patients had thermo-luminescent dosimeter (TLD) measurements of the actual dose delivered to their skin surface once during their RT series.
• At 0, 30, and 50 Gy, acute skin toxicity was scored with a modified Radiation Therapy Oncology Group (RTOG) scoring system, by a single investigator.
• RTOG scoring was modified to allow for further discrimination of low scores.
• Five aspects of skin toxicity were scored separately with 0 to 3 points.
• Erythema, desquamation, and efflorescence were judged by inspection, elevation of skin temperature in comparison with the contralateral breast by palpation, and itchiness according to patients’ statements.
• Skin toxicity was scored separately for three localizations. The maximal score of each aspect of skin toxicity anywhere in the treatment fields was recorded, and median values were compared between the two groups. Total scores across all areas were calculated as well.
• Patients were asked if they would recommend it for other patients using a visual analog scale.
• The opinion of technical assistants in RT about skin marks was evaluated with a visual analog scale.

• At 50 Gy, there was an insignificant trend in favor of Bepanthol lotion.
• There was no difference for maximal scores in every single aspect of skin toxicity for both groups at 30 Gy.
• No difference was found in patient preference.

In direct comparison with dexpanthenol-containing lotion, no advantage for Thêta-Cream was found.

• The study had a small sample size.
• Patients in the Thêta-Cream group were slightly older and more often had ongoing hormonal treatment.
• Validity and reliability of the modified RTOG scoring system was not discussed.
• The article states random assignment, but the study plan states patients were alternately assigned into two groups without further stratification.

To compare Theta-cream with standard skin care using Bepanthol (Bepanthen) lotion to prevent acute radiation side effects in skin tissue

Patients were randomly assigned to use Theta-Cream or Bepanthol lotion during radiation therapy. Medication was applied lightly to the treatment field twice daily, starting within one week before beginning radiation therapy. Patients requested to wash irradiated skin gently with care to skin marks. No other prophylactic topical treatment was allowed.

• The study sample (N = 20) was comprised of female patients with early-stage breast cancer.
• Mean age was 56 years for the Theta-Cream group and 52 years for the Bepanthol lotion group, with a range of 43–65 and 38–61 years, respectively. 

The study used a randomized controlled blinded trial design.

• All patients had thermoluminescent dosimeter (TLD) measurements of actual dose delivered to skin surface once during their radiation series.
• At 0, 30, and 50 Gy, acute skin toxicity was scored with modified Radiation Therapy Oncology Group (RTOG) scoring; RTOG scoring was modified for further discrimination of low scores.
• Erythema, desquamation, and efflorescence were judged by inspection; elevation of skin temperature in comparison with the contralateral breast by palpation; and itchiness according to patients’ statements.
• Skin toxicity was scored separately for three localizations. The maximal score was recorded and median values were compared between the two groups.
• Patients were asked for subjective content with their skincare regimen and if they would recommend it for other patients using a visual analog scale.

At 50 Gy, there was a insignificant trend in favor of Bepanthol lotion with a median total score of 8 (range 3–14) versus 11 (range 3–15) with Theta-Cream. There was no difference for maximal scores in every single aspect of skin toxicity for both groups at 30 Gy.

In direct comparison with dexpanthenol-containing lotion, no advantage for Theta-Cream was found. There were no differences in skin toxicity between groups using Theta-Cream or Bepanthen.

• The study had a small sample size, with less than 50 patients.
• Patients in the Theta-Cream group were slightly older and more often had ongoing hormonal treatment.
• Validity and reliability of modified RTOG scoring system was not discussed.
• Article states random assignment, but study plan states patients were alternately assigned into two groups.

To manage oral mucositis induced by radiotherapy and to reduce pain by using benzydamine hydrochloride, chlorhexidine, and povidone iodine

Selected patients were divided into study and control groups. The study groups were further subdivided into group 1, group 2, and group 3. Each study group consisted of 25 patients, and the control group also consisted of 25 patients; the three study groups and the control group were given benzydamine hydrochloride, chlorhexidine, povidone iodine, and distilled water, respectively. These rinses were given after two weeks of radiation therapy (RT) at the onset of oral mucositis.

Patients in the study groups as well as the control group were instructed to rinse the oral cavity with 15 ml of their respective rinses for at least 30 seconds, 4 times a day at six-hour intervals. The mouth-rinsing regimen was performed under professional supervision. The samples of mouth rinses were given to the patients without dilution for one week use, one at a time, for convenience. Patients also were given measuring cups to measure the quantity of oral rinses. All patients were examined at the end of every week during the RT for about a six-week period.

• Patients' age ranged from 30–70 years old.
• Patients all had head and neck malignancies (no explanation offered).

The study was conducted at the Radiotherapy Department of Kidwai Memorial Institute of Oncology in Bangalore, Karanataka, India.

Patients were undergoing the active treatment phase of care.

The study did not involve blinding.

• The World Health Organization Grading scale for mucositis was used.
• The Lindquist/Hickey scale was used to evaluate pain.

This study was oorly designed, and the report was confusing and difficult to understand.

• No explanation was given as to how the groups were divided into study and control.
• The authors were unclear as to whether the groups were all given the same mouth rinses or different ones.
• No blinding was involved.
• This was a single institution study.
• No randomization was noted in the report.
• No mention was made of how compliance was tracked during the study.
• No age breakdown was given.
• The authors did not identify who conducted the oral assessments and what training they received to ensure consistency.
• No mention was made of whether opioids were permitted during treatment for pain control.

Several studies have pointed in the direction that benzydamine hydrochloride is effective in the management of oral mucositis. Further well-designed, randomized placebo controlled studies are needed for verification.

During active treatment with chemotherapy, the patient began taking loratadine to prevent pegfilgrastim-induced bone pain with self-reported 100% effectiveness, which continued throughout treatment with chemotherapy regimens that included pegfilgrastim. Loratadine completely eliminated pain that was resistant to NSAIDs.

There are implications for further research identified in this case study. Nurses are positioned to collaborate with other care providers and healthcare disciplines in this research. Oncology nurses working in a variety of settings (e.g., research, academic, outpatient infusion clinic, inpatient hospital unit, etc.) may assist in all aspects of monitoring and evaluation as well as provide direct patient care and supervision.

To evaluate the effects of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy (RT) to the breast or chest wall

Patients were randomized to receive either the emu oil or a cotton seed oil placebo. Patients were instructed to apply the oil two times per day during radiation treatment and for six weeks after completion. The oil was to be applied at least four hours before treatment to avoid any bolus effect. No other creams or oils were to be used. Any additional treatments were to be documented by providers. Patients were assessed at baseline, weekly during treatment, and six weeks later.

• N = 42  
• AGE = 18 years or older
• MALES (%): Not specified, FEMALES (%): Not specified
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer undergoing RT to the breast (breast conservation therapy) or the chest wall (postmastectomy RT)  
• OTHER KEY SAMPLE CHARACTERISTICS: Primary invasive breast carcinoma or ductal carcinoma in situ. The daily treatment dose was between 1.75 Gy and 2.12 Gy. Patients could enter the study before receiving the third RT fraction. Of the patients, 64.7% had a planned total dose greater than 55 Gy, and 64.3% had prior chemotherapy.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Rochester, MN

PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, placebo-controlled trial

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Skindex-16
• Patient diary to record symptoms on 0–10 scale

Patient symptoms reported varied between groups, with some symptoms more severe in the emu oil group and some more severe in the control group. No statistically significant differences in symptoms or skin toxicity scores existed between groups. For most of the study period, those using the emu oil had lower Skindex scores; however, by the end of the trial, their Skindex scores were higher. A higher proportion of those using emu oil had grade 2 and 3 CTCAE scores, although this difference was not statistically significant.

This study did not show any substantial benefit or adverse effects associated with the use of emu oil to prevent radiodermatitis.

• Small sample (< 100)
• Unintended interventions or applicable interventions not described that would influence results
• Providers could use additional supportive interventions, such as hydrocortisone cream, but no information on whether any patients had additional interventions was provided.

Radiation dermatitis is a common dermatologic adverse event, and management of this toxicity requires a wide range of treatment modalities. This study did not provide strong evidence for or against the use of emu oil. Further research is needed to determine efficacy and safety.

RESOURCE TYPE: Consensus-based guideline

This publication has important updates for the nurse regarding the inclusion of oral antineoplastics, radiation emetogenicity, and treatments, and the addition of two new NK₁ receptor antagonists: netupitant and rolapitant. Both require further study before recommendations can be made. Although control of vomiting is markedly improved, nausea remains a challenge.

To determine if dexamethasone is superior to aprepitant in the prevention of delayed emesis in patients with breast cancer receiving chemotherapy that includes anthracyclines and cyclophosphamide

Patients were randomized using computer generated numbers, and blinding was performed by a special company. On day 1, 30 minutes prior to chemotherapy, all patients received palonosetron at 0.25 mg IV in a 30-second bolus and dexamethasone at 8 mg IV diluted in 100 ml of saline IV over 15 minutes. Aprepitant at 125 mg was administered orally one hour prior to chemotherapy. On days 2 and 3, patients randomly received either dexamethasone at 4 mg twice daily or aprepitant at 80 mg daily. Patients receiving aprepitant took a placebo in the evenings, and all pills were placed in identical capsules. On days 1–5, patients could receive either prochlorperazine at 10 mg via a suppository or metoclopramide at 10 mg intramuscularly as rescue medication. Adherence to medications on days 2 and 3 was checked by counting the remaining pills. Data were collected on days 1–6 after chemotherapy.

• N = 551  
• MEAN AGE = 53 years (median = 50 years)
• MALES: < 1%, FEMALES: > 99%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve patients with breast cancer receiving anthracyclines plus cyclophosphamide

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

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, parallel study

• Daily diary to record the number of vomiting episodes, adverse events, rescue medications, and the presence, intensity, and duration of nausea
• Functional Living Index–Emesis (FLIE)
• Visual Analog Scale (VAS) for nausea

There was no significant difference in complete responses between the two groups in the acute (p = 0.39) or delayed phases (p = 1). There were no statistically significant differences in total control (p = 0.27), vomiting (p = 0.39), nausea (p = 0.24), significant nausea (p = 0.10), number of emetic episodes (p = 0.07), maximum severity of nausea (p = 0.26), or duration of nausea (p = 0.13) between the two groups in the delayed phase. Patients receiving dexamethasone experienced more insomnia (p = 0.02) and heartburn (p = 0.03) than those in the aprepitant group. More patients in the aprepitant group reported sedation and anorexia, but these results were not statistically significant.

In patients with breast cancer receiving chemotherapy containing anthracyclines and cyclophosphamide, dexamethasone and aprepitant have similar efficacy for the management of delayed chemotherpy-induced nausea and vomiting (CINV) when the optimal prophylactic treatment for acute CINV is administered. Patients who receive dexamethasone may experience a slight increase in adverse events compared to those taking aprepitant.

Nurses can help patients consider the differences in efficacy, safety, and cost of dexamethasone versus aprepitant when selecting an appropriate pharmacologic intervention for delayed CINV. In addition, nurses can help ensure that patients receive the optimal prophylactic treatment recommended for CINV with chemotherapy regimes that contain anthracyclines and cyclophosphamides.

This Perugia consensus panel was composed of 10 committees that reported findings to a 23-member expert panel from 10 different countries. The panel determined level of evidence and made changes in 2004 guidelines if evidence supported a greater than 10% increase in benefit. Updates were approved by the European Society of Medical Oncology (ESMO) Guidelines Working Group. All author relationships were reported. The panel used MEDLINE and other databases, which were not specified.

Emetogenicity of agents:

• As new agents are developed, often limited recording of common toxicities is provided in order to accurately reflect emetogenic potential.
• Increased use of oral agents and chronic oral administration creates issues regarding whether emetogenicity is defined by a single dose or a full course, and chronic use has blurred the lines between acute and delayed chemotherapy-induced nausea and vomiting (CINV).
• The authors provided an updated list of chemotherapy agents and levels of emetogenicity. Classification of oral agents was provided on the basis of a full course of treatment.

Prevention of acute CINV:

• Minimal risk: No routine prophylaxis
• Low risk: Day 1—dexamethasone or 5-HT₃ receptor antagonists or dopamine receptor antagonist
• Moderate emetogenic chemotherapy (MEC)
  • With anthracycline: Day 1—5-HT₃ receptor antagonist + dexamethasone + aprepitant or fosaprepitant; days 2 and 3—aprepitant
  • Without anthracycline: Day 1—palonosetron + dexamethasone; days 2 and 3—dexamethasone
• Highly emetogenic chemotherapy (HEC): Day 1—5-HT₃ receptor antagonist + dexamethasone + aprepitant or fosaprepitant; days 2 and 3—dexamethasone + aprepitant; day 4—dexamethasone
• Although studies have shown effectiveness of casopitant, the producer discontinued regulatory filings, so this was not recommended for use.
• All 5-HT₃ receptor antagonists were found to show the same efficacy. More studies are needed to determine if palonosetron is more effective with cisplatin-based therapies.

Prevention of delayed CINV:

• Aprepitant should be used to prevent delayed CINV.
• Whether dexamethasone is as effective or if the combination of dexamethasone and aprepitant would be more effective is not known. The optimal dose and duration of dexamethasone is not defined.
• Prevention with multiple-day cisplatin was not clear. Aprepitant + dexamethasone for acute and dexamethasone for delayed CINV was recommended. The possible role of ​neurokinin 1 (NK1) was not clear.

Refractory CINV and rescue:

• Maximally effective prophylaxis should be used.
• The addition of cannabinoids, olanzapine, and nonpharmacologic interventions could be considered.

Prevention of anticipatory CINV:

• The best way to prevent this learned response is maximum effective control of acute and delayed CINV.
• Anticipatory CINV is difficult to control with medication.
• Benzodiazepines are the only drugs identified as effective, but efficacy tends to decrease as chemotherapy continues.

Prevention of CINV with high-dose chemotherapy:

• Complete protection is currently only achieved in a minority of patients.
• Current standard is dexamethasone + 5-HT₃ receptor antagonists.
• Evaluation of the addition of aprepitant is needed.

Radiation-induced nausea and vomiting:

• Risk level and antiemetic guidelines are provided.
• Generally, prophylaxis with 5-HT₃ receptor antagonists + dexamethasone and rescue with 5-HT₃ receptor antagonists are recommended.

Antiemetics in children:

• All pediatric patients receiving MEC or HEC should receive prophylaxis with 5-HT₃ and dexamethasone. Optimal dosing requires further study.
• No studies have evaluated approaches for prevention of anticipatory CINV.
• Metoclopramide, phenothiazines, and cannabinoids have shown only moderate efficacy.

The guidelines provide a clear set of recommendations and review of the relevant evidence strength assessed for various cancer treatment scenarios.

A complete listing of databases used for evidence retrieval was not provided.

Control of emesis has markedly improved in recent years; however, nausea remains a challenge and future research should shift attention to this aspect. Current trials generally define complete response end points that exclude consideration of the experience of nausea rather than vomiting. Trials suggest that some agents are more effective for acute vomiting, others are more effective for delayed vomiting, and some may be more effective for nausea. Identification of these differences and incorporation into the rationale for treatment needs to continue.

Further research is needed in the areas of prevention with high-dose chemotherapy and stem cell support, combined chemotherapy and radiation therapy, and anticipatory nausea and antiemetic use in children. Practitioners need to be aware of the impact of oral therapy and chronic oral chemotherapy treatment on current approaches to antiemetic treatment, timing, and definitions of acute and delayed CINV. Practitioners also need to be aware that current chemotherapy risk determination does not apply to combined radiotherapy and chemotherapy.