Patients were given oral paroxetine 20 mg daily beginning seven days after the initiation of the first cycle of chemotherapy for newly diagnosed breast cancer and continued until seven days following their fourth cycle of chemotherapy or placebo. Randomization was stratified by type of chemotherapy regimen to achieve a balanced design.

• The sample was comprised of 94 women with breast cancer initiating at least four cycles of chemotherapy for breast cancer.
• Mean age was 51.2 years (range 31–79). 
• Of the patients, 89% were Caucasian, 28% were significantly depressed at baseline, and 5% had a hemoglobin less than 11 g/dL.
• There were no significant differences between the intervention and placebo control groups in age, mean baseline measures of fatigue, depression, or general health status.
• The difference in baseline hemoglobin between the intervention group (12.3 g/dL) and the placebo control group (12.9 g/dL) was statistically significant (p < 0.05).

Patients were recruited from a university medical center and two of its affiliated hospitals.

Patients were undergoing the active treatment phase of care.

The study was a multicenter, randomized, double-blind, placebo-controlled trial.

• Fatigue Symptom Checklist (FSCL)
• Multidimensional Assessment of Fatigue (MAF) Fatigue Inteference subscale, Question 1
• Profile of Mood States (POMS) Short Form Fatigue/Inertia subscale 

Controlling for baseline fatigue scores, there were no statistically significant differences in fatigue or fatigue interference between the treatment and control groups. There was no relationship between anemia and fatigue at baseline, although changes in anemia over the course of the study were modestly but significantly correlated with one measure of fatigue.

• No power analysis was provided; it was unclear if the study was appropriately powered to detect a difference in fatigue.
• Anemia was not included as a covariate in the analyses.
• Six patients withdrew due to side effects, such as nausea and headache.

There were costs related to drug acquisition.

To test whether providing information about the expected efficacy of acupressure bands would enhance their effectiveness in reducing nausea

• Chemotherapy naïve patients completed baseline questionnaires then received acupressure wristbands.
• Patients were randomized to the following groups.
  • 1: neutral handout and neutral compact disk (CD)
  • 2: acupressure-enhancing handout and neutral CD
  • 3: neutral handout and acupressure-enhancing CD
  • 4: acupressure-enhancing handout and acupressure-enhancing CD
• Patients were instructed to use the acupressure wristband and CD as needed during chemotherapy to prevent or alleviate nausea.
• Patients recorded antiemetic use, severity of nausea and vomiting, and wristband and CD usage in diaries.

• The study consisted of 74 participants.
• Mean age was 51.5 years with a range of 28–74.
• All participants were female patients with breast cancer.
• The majority of patients were White (93%), married (76%), had graduated from high school (99%), and had graduated or attended college (66%).
• The majority of patients were receiving doxorubicin-based chemotherapy (82%). The remaining were receiving docetaxel combined with either cyclophosphamide or carboplatin.

The study was conducted in a single outpatient setting. The location was not stated.

All patients were in active treatment.

This was a double-blind, four-arm, randomized, clinical intervention study.

• Patients reported their experiences in diaries.
• A nausea tool developed by Burish and Carey was used to measured nausea and vomiting on a 7-point Likert-type scale. No reliability or validity information was provided.
• Patients rated nausea expectancy on a 5-point Likert-type scale.
• Patients rated wristband effectiveness expectancy on a 5-point Likert-type scale.
• A study data questionnaire was used to gather demographic and clinical information.
• A feedback questionnaire evaluated the use of and recommendations for the acupressure wristband and CD.

• Results indicated that 15% of the sample experienced vomiting.
• The interaction of high-versus-low levels of nausea expectancy and neutral-versus-enhanced intervention showed a statistically significant difference for peak nausea (p = 0.030) but not for average nausea (p = 0.084).
• Patients who received the neutral materials took more antiemetic than patients who received the acupressure enhancing materials (p = 0.003).
• Expected nausea correlated with average nausea (p = 0.014) and peak nausea (p = 0.002).

Patients with enhanced information required less antiemetics and had less nausea than patients with neutral information. Managing expectations may facilitate chemotherapy-induced nausea and vomiting (CINV) management.

• The sample size was small with fewer than 100 patients.
• Differences in the types of chemotherapy and antiemetic medications and providers' discussion about nausea could have affected the study outcomes.
• The placebo effect of nausea intervention could have modified patients' expectations and response to the treatment.

This study illustrates the need for nurses to assess and be aware of patient’s nausea expectations during chemotherapy. Patients with high expectations may benefit from information or discussion of the expected benefits of interventions on reducing nausea.

Patients receiving doxorubicin and cyclophosphamide were randomized to one of three arms.

• Active acustimulation
• Sham acustimulation
• No acustimulation

Participants were told to wear the assigned band and adjust the acustimulation dial to increase or decrease the acustimulation; they could wear the band as frequently as desired over five days.

• The study consisted of 96 patients.
• All patients were women with breast cancer on the second cycle of chemotherapy.
• Patients’ mean age was 49.5 years.
• The majority of patients were white (n = 87).
• The majority of patients (93%) took some type of antiemetic following treatment.

All participants were treated at outpatient centers at one of four Rochester, NY, area cancer centers.

The study design was a randomized, three-arm trial.

• Demographic information and details of prior nausea and vomiting experience were recorded.
• Five-point Likert-type questions were assessed at the time of randomization following a one-minute trial of the band.
• Patient report diaries were used to measure nausea and emesis over the five-day period.
• The severity of nausea and vomiting episodes, as well as antiemetics, were recorded.
• Quality of life was measured with the Functional Assessment of Cancer Therapy Scale-General.

No significant differences were found in any study measures among the three treatment conditions.

The study does not support the use of acustimulation bands as an adjunct to antiemetics in female patients with breast cancer.

• Only women were included in the study.
• The band could be viewed as a reinforcer (negative conditioning effect) and reminder of an unpleasant state.
• Patients with brain metastases, bowel obstructions, or cardiac pacemakers, or those undergoing concurrent radiation therapy or interferon therapy were excluded.

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.