To determine the efficacy and tolerability of Lactobacillus rhamnosus (marketed as Antibiophilus) in treating radiation-induced diarrhea

Patients in the treatment group were instructed to use Antibiophilus sachets containing 1.5 grams of Lactobacillus rhamnosus. Patients in the control group used identically appearing placebo sachets containing 700 mg corn starch, 797 mg microcrystalline cellulose, 1.37 mg iron oxide, 1.13 mg orange coloring agent, and 1 mg caramel aroma. Both groups used the sachets three times per day and were asked to document the date and time of any rescue medication.

Patients were between 19–75 years old and had developed diarrhea within 4 weeks of receiving radiation therapy to the abdomen. The experimental group contained 102 patients, and the control group contained 103 patients.

This was a randomized, double-blind, parallel group study.

• The primary endpoint to assess efficacy was the time to and frequency of rescue medication for diarrhea. 
• Secondary endpoints were the number of bowel movements and diarrhea grading (0 for no diarrhea, 1 for mild, 2 for moderate, and 3 for severe).

• A greater percentage of patients in the control group (48%) required rescue medication compared to the experimental group (35%), but the difference was not statistically significant (p = 0.064).
• The control group experienced a greater average number of bowel movements per day (3.2) compared to the experimental group (2.4), but the difference was not statistically significant (p < 0.10).
• Diarrhea was graded at a higher severity for the control group (1) compared to the experimental group (0.7), but the difference was not statistically significant.
• Although the results suggested a superior efficacy for diarrhea treatment in the experimental group, the results failed to show a statistically significant difference for any of the measured variables. Despite this lack of statistically significant differences, the authors concluded that antibiophilus therapy yielded a favorable benefit-to-risk ratio.

• The study population was limited to patients who were already experiencing diarrhea. The study did not provide any data regarding prevention of diarrhea.
• The endpoints were based on patients' subjective reports.

This study involved a large sample. Although the results suggested a superior efficacy for diarrhea treatment in the experimental group, the results failed to show a statistically significant difference for any of the measured variables. 

To investigate the effects of yoga on patients with breast cancer to help them cope with the treatment process and reduce social isolation

Patients were given eight sessions of classical yoga twice a week in a physical therapy department. Each session lasted one hour, including warm up and breathing exercises, asanas, relaxation, and medication. Study data were collected before and after treatment. All sessions were taught by one yoga physiotherapist, and all assessments were done by another yoga teacher.

• The study reported on a sample of 20 female patients.
• Mean patient age was 41.6 years (SD = 6.17 years).
• All patients had breast cancer and had received chemotherapy. At least six months had passed since completion of chemotherapy.

• Single site
• Outpatient setting
• Turkey

Patients were undergoing the transition phase of care after initial treatment.

A prospective trial with a pre/post-test design was used.

• State-Trait Anxiety Inventory
• Visual analog scale for satisfaction
• Nottingham Health Profile (NHP): for quality-of-life measure

State and trait anxiety significantly declined from baseline after the yoga intervention (p = 0.001). All NHP parameters improved after the yoga sessions, including energy level, pain, sleep, emotional level, social adaptation, and physical skills.

Participation in yoga sessions was associated with reduced anxiety and improved quality-of-life scores after initial cancer treatment in these patients with breast cancer.

• The study had a small sample size, with less than 30 participants.
• No demographic information to describe the sample other than age was provided, so relevant sample characteristics are not known.
• It is not clear if yoga sessions were done in groups or individually.
• There was no comparison or control group, and it has been shown that anxiety and other symptoms tend to decline over time, so it is not known if changes seen here were due to time or the intervention as well.
• The measure used for quality of life is somewhat questionable, as the instrument is not generally used to measure quality of life, and application in cancer survivors was not discussed.

Findings suggest that yoga may be helpful for patients with cancer to reduce stress and improve overall fitness and ability to relax.

To evaluate the preventive effect of topical corticosteroids on radiodermatitis

Patients were randomized to use betamethasone or  a moisturizer (Essex) as a control. Patients in the steroid group applied the betamethasone once daily and the moisturizer once daily. Those in the control group applied the moisturizer twice daily. Creams were applied to the irradiated area four hours before or directly after radiation therapy and again in the evening. Creams were applied every day during radiation therapy and for two weeks after the completion of radiation therapy. Symptoms were reported weekly by patients. Radiation Therapy Oncology Group (RTOG) assessment was conducted at the end of radiation treatment.

• N = 202   
• MEDIAN AGE = 63 years
• FEMALES: 100%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer. Sixty-seven percent also received chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Two percent in each group were smokers.

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

PHASE OF CARE: Active antitumor treatment

Double-blind, randomized, controlled trial with active control

• Visual analog scale (VAS) for symptoms of burning and itching
• RTOG grading

For all patients receiving either conventional or hypofractional radiation therapy, those in the corticosteroid group had a significantly lower incidence of radiodermatitis above grade 1 (p < 0.0001). Symptoms of burning and itching were also less prevalent in patients receiving the steroid at the end of treatment and one week later. There were no differences in outcomes based upon skin type. Compliance with the intervention was greater than 95%.

A potent topical steroid was effective in reducing radiodermatitis severity and symptoms among women treated with radiation therapy for breast cancer.

A topical steroid was effective in reducing radiodermatitis. Long-term effects of extended use of strong topical steroids are unknown. Nurses can suggest topical steroid use to reduce symptoms and severity of radiodermatitis.

To determine if treatment with betamethasone+Essex^® cream can decrease acute radiation dermatitis in patients with breast cancer receiving radiation as compared to two emollient creams.

Patients with breast cancer receiving radiation therapy were randomized 2:1:1 to three treatment groups—betamethasone+Essex cream, Essex cream, or Canoderm^® cream. Study creams were applied to the treated skin twice daily for five weeks starting the first week. Treatment continued for two weeks following completion of radiation. Physician/nurse examinations occurred weekly for the first five weeks of treatment.

• N = 102  
• MEDIAN AGE = 62 years
• AGE RANGE = 28–90 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Surgery for breast cancer, planned 3D radiation to 50 Gy
• OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Ryhov County Hospital, Jonkoping, Sweden

• PHASE OF CARE: Active antitumor treatment

• Randomized, double-blinded

The Fitzpatrick skin type scheme I–IV  was used to classify patients as to skin type. Radiation dermatitis was scored using the Radiation Therapy Oncology Group (RTOG) scoring system. A colorimeter measured the redness of the skin at specific areas around the areola. Dryness of skin was measured using a Corneometer^®, with scores averaged using five specific locations. Itching, burning, and skin irritation were patient-scored using a visual analog scale (VAS) of 0–10. Quality of life was determined via the Dermatology Life Questionnaire Index on the first and fifth weeks of treatment. Post-radiation follow-up was by phone with symptoms assessed using VAS.

This study found that prophylactic treatment with betamethasone cream was superior to moisturizing cream for control of acute radiation dermatitis. Because prolonged treatment with topical steroids is known to be able to harm skin integrity, use was limited to seven weeks.

• Measurement validity/reliability questionable
• Other limitations/explanation: RTOG scoring of skin toxicity has not been tested for validity and reliability.

Because up to 90% of patients with breast cancer treated with adjuvant radiation have some degree of skin reaction, assessing and treating according to evidence-based practices is important. This study shows use of prophylactic steroid cream to reduce the severity of skin reaction in this group of patients.

To compare the antiemetic efficacy of second-generation 5HT3 receptor antagonists (RAs) (i.e., palonosetron) with older 5HT3 RAs (i.e., granisetron, azasetron, ramosetron) for controlling acute and delayed chemotherapy-induced nausea and vomiting (CINV) in addition to their effects on patients’ appetites

In this study, 103 patients receiving various chemotherapy regimens with highly emetogenic chemotherapy (HEC) (four regimens) or moderately emetogenic chemotherapy (MEC) (six regimens) were included. One 5HT3 RA (either granisetron, azasetron, ramosetron, or palonosetron) plus dexamethasone and/or aprepitant (a three-drug combination) was administered to 42 patients.

• N = 103
• MEDIAN AGE = 61.6 years
• MALES: 39.8%, FEMALES: 60.2%
• KEY DISEASE CHARACTERISTICS: Various cancers (most common were colorectal and breast)
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving HEC (42 patients) or MEC (61 patients); experienced anticipatory CINV 24 hours before chemotherapy administration

• SITE: Single site                
• SETTING TYPE: Inpatient                    
• LOCATION: Ambulatory therapy center in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective, comparative clinical trial

• Patient diaries were completed on days 1–5 using a 100 mm Visual Analog Scale (VAS) to assess CINV severity, the presence of daily vomiting episodes, and the effect of nausea on appetite level on a four-category scale (normal, appetite diminished because of nausea, food portions decreased because of nausea, and almost no food intake because of nausea).
• The efficacy endpoints were complete response (CR, no emetic episodes and no rescue therapy) and total control (TC, no emetic episodes, no rescue therapy, and no nausea and no appetite loss).

Palonosetron was more effective in controlling delayed CINV than other conventional 5HT3 RAs (i.e., granisetron). Palonosetron also was safe and was not associated with any severe adverse drug reactions.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Measurement/methods not well described
• Other limitations/explanation: No stratification of chemotherapy emetogenicity; various chemotherapy regimens; used more than one 5HT3 RA and different forms (i.e., oral, injection) of antiemetics; antiemetic doses and administration frequency not listed

Palonosetron was recommended as a 5HT3 RA over older 5HT3 RAs. The efficacy of palonosetron in the delayed phase was confirmed. In this study, patient appetite also improved.

To determine the effect of foot massage on pain after breast surgery and to provide guidance for nurses in nonpharmacologic interventions for pain relief

Patients were placed in the control or experimental group. The control group only received pain medications. In addition to receiving pain medications, the experimental group was given a 20-minute foot massage at the first complaint of pain. Pain and vital signs were assessed 5, 30, 60, 90, and 120 minutes after the first complaint of pain in both groups. The time periods were in sync between groups in regard to the first complaint of pain.

• N = 70 (sample size was calculated by power analysis)
• AGE = ≤ 18 years (40% between 41–60 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast surgery patients (included were excision of mass with either SLNBx or ALND, simple mastectomy, or modified radical mastectomy without surgical complications)
• OTHER KEY SAMPLE CHARACTERISTICS: No communication or mental disabilities; no expanders were placed during surgery; had at least one drain placed during surgery; no history of hypertension or need to take blood pressure on the foot;  had to express a pain level of four or higher

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: General department of breast surgery at a University Hospital in Istanbul Turkey between February 2007 and April 2008

• PHASE OF CARE: Active antitumor treatment

Quasi-experimental, nonrandomized, controlled, comparison study

• McGill Pain Questionnaire Short Form (MPQ-SF) including the visual assessment scale (0–10 cm line)

Foot massages with conventional pain medications can be effective in decreasing pain in patients after breast surgery. Nurses can easily use foot massage in patients without risk factors to decrease their pain. Nurses should provide nonpharmacologic techniques such as foot massage to decrease pain in patients after breast surgery.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results: Placebo effect of positive expectations that pain will be eliminated by an intervention can itself decrease pain
• Key sample group differences that could influence results: Four different types of surgery were included.
• Findings not generalizable
• Other limitations/explanation: The assessment of pain is very subjective.

Foot massage could be a practical addition to conventional pain management strategies to assist nurses in controlling postoperative pain. Foot massage is efficient, taking little time and costing little money. The initial cost of training could be quickly off set by the increase in patient satisfaction and better pain control. Including massage training in nursing schools would decrease the cost to institutions. Additional research in the use of massage in other patient populations is needed to help quantify massage as a pain management technique and nursing standard.

To evaluate the efficacy of aprepitant combined with conventional antiemetic therapy in patients receiving moderately emetogenic chemotherapy

5-HT₃ receptor antagonists were given 30 minutes prior to chemotherapy. Aprepitant was given orally at 125 mg on day 1 and 80 mg on days 2 and 3. Dexamethasone was given by infusion 30 minutes prior to chemotherapy. Patients were followed for five days. Results in these patients were compared to a control group that received only 5-HT₃ and dexamethasone.

• The study consisted of 52 patients.
• The mean age was 68.2, with a range of 34-83.
• The majority of the sample (73%) was male, and 27% was female.
• All patients had lung cancer.
   

The study was conducted at a single inpatient site in Japan.

All patients were in active antitumor treatment.

This was a retrospective study.

• The Common Terminology Criteria for Adverse Events was used.
• Complete response (CR) was defined as complete suppression of vomiting and no rescue medication.
• Food intake was measured.
• Chemotherapy completion rate was monitored.

• The CR for control of vomiting was 96% in controls and 100% in the group that was given aprepitant. 
• Complete suppression of nausea was reported as 89% among controls and 96% in the aprepitant group (p = 0.0043). 
• The amount of food intake was greater in the aprepitant group. 
• Completion of planned chemotherapy was higher in the aprepitant group (73.3% versus 88.2%, p = 0.042).

The addition of aprepitant to standard antiemtic therapy in patients receiving moderately emetogenic chemotherapy was associated with less nausea and vomiting and better food intake.

• The study had a small sample of fewer than 100 patients.
• A risk of bias exists because no control group, blinding, or random assignment was included.
• Rescue medications used were not described.  
• Whether differences in completion of the planned chemotherapy were related to chemotherapy-induced nausea and vomiting (CINV) or other toxicities was not clear.

Neurokinin 1 (NK1) receptor antagonists have been recommended for highly emetogenic chemotherapy (HEC); however, less evidence is available regarding their use with moderately emetogenic regimens (MEC).  This study suggests that the addition of NK1 to MEC is beneficial for reduction of CINV in this group of patients. Nurses can advocate for maximal symptom control to prevent CINV, one of the most severe adverse effects of chemotherapy.

To evaluate the efficacy and safety of aprepitant added to standard antiemetic regimens in high-dose chemotherapy for allogeneic hematopoietic stem cell transplantation

• N = 88  
• AVERAGE AGE = 47 years (control), 53 years (aprepitant)
• MALES: 57.1% (control); 60.9% (aprepitant), FEMALES: 42.9% (control); 39.1% (aprepitant)
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, T-cell leukemia, lymphoma, myelodysplastic syndrome; sources of stem cells were related donors, placenta stem cells, bone marrow, unrelated donors, and cord blood
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapies included cyclophosphamide, busulfan, fludarabine, and melphan as well as total body irradiation.

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Kyushu University Hospital in Japan

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

Retrospective medical record review of electronic medical records

• Adverse effects were recorded by nurses in the medical records.

The use of aprepitant with granisetron was highly effective in decreasing vomiting and nausea in patients receiving hematopoietic stem cell transplantations. There was no increase in adverse events. There were therapeutic outcomes.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Selective outcomes reporting

The combination of granisetron and aprepitant was highly effective for chemotherapy-induced nausea and vomiting in patients receiving hematopoietic stem cell transplantations. Nurses should know that the combination did not increase side effects or affect engraftment.

To determine the effectiveness and safety of aprepitant in Japanese patients with hematologic malignancy receiving multiday chemotherapy

All patients were given 3 mg IV granisetron 30 minutes before chemotherapy. Corticosteroids were administered as part of the chemotherapy regimen.  In the aprepitant group, 125 mg was given orally on day 1; on following days, patients received 80 mg aprepitant daily. 

Data were collected via retrospective electronic medical records review for comparison of outcomes between those who received aprepitant versus those who did not. Nausea, vomiting, and adverse events were monitored daily and recorded in the medical record.

• The study consisted of 82 patients.
• The mean age was 47.5.
• The sample was 42.7% male and 57.3% female.
• All participants had hematologic malignancies.  Stem cell transplant patients were excluded.  All patients were receiving moderately or highly emetogenic chemotherapy in multiday regimens.

The study was conducted at a single inpatient site in Japan.

All patients were in active antitumor treatment.

This was a retrospective comparison.

Measurement tools were the Common Terminology for Adverse Events version 4.0 and complete response calculation.

• With aprepitant, the complete response (CR) rate for chemotherapy-induced nausea and vomiting (CINV) control was 76%, compared to 50% in those who did not receive aprepitant (p = 0.013). 
• The percentage of patients without any vomiting was significantly higher with aprepitant (p = 0.002).
• No significant differences were found between groups in prevalence of nausea. 
• Patients treated with regimens containing cytarabine had more CINV (p = 0.028).  In those patients receiving cytarabine 4 g/m² or more per day, CINV was poorly controlled for all patients. 
• Few adverse effects were found with aprepitant with the most common being malaise.

The study showed aprepitant to be safe and effective for CINV prophylaxis in this group of Japanese patients. Analysis suggested that cytarabine at a dosage of 4 g/m² or more per day should be considered highly emetogenic.

• The study had a small sample of fewer than 100 patients.
• A risk of bias exists because no blinding or random assignment was done.

This study adds to the body of evidence that demonstrates the safety and effectiveness of aprepitant for multiday chemotherapy by demonstrating effects in Japanese patients.

To evaluate the antiemetic effect and safety of aprepitant in combination with 5-HT3 receptor antagonist in patients undergoing autologous peripheral blood stem cell transplantation (auto-PBSCT)

This was a retrospective evaluation of patients who received conditioning high-dose chemotherapies prior to auto-PBSCT for hematologic malignancies comparing 26 consecutive patients who received antiemetic therapy that included both aprepitant and granisetron (the aprepitant group) between April 1, 2010, and January 31, 2010, and 22 patients who received granisetron alone (control group) between January 1, 2008, and March 31, 2010, before the introduction of aprepitant. In both groups, IV granisetron 3 mg was started 30 minutes prechemotherapy on day 1 and then repeated every 12 hours while receiving chemotherapy. In the aprepitant group, 125 mg of aprepitant was administered orally 60–90 minutes preadministration of the first moderately to highly emetogenic anticancer drug on day 1 and aprepitant 80 mg PO was given the following two days. Rescue medication including metoclopramide or hydroxyzine was used for breakthrough nausea or vomiting. A corticosteroid was not administered in either group for emetic control.

• N = 48              
• MEDIAN AGE = 52 years (range = 20–66 years)
• MALES:  58%, FEMALES:  42%
• KEY DISEASE CHARACTERISTICS: Patients with non-hodgkin lymphoma, multiple myeloma, hodgkin lymphoma, and leukemia. Conditioning regimens: MCEC (ranimustine 200 mg/m², carboplatin 300 mg/m², etoposide 500 mg/m², cyclophosphamide 50 mg/m²) or melphalan (100 mg/m²) +/– bortezomibor; LEED (etoposide 500 mg/m², cyclophosphamide 60 mg/m², melphalan 130 mg/m²). 
• OTHER KEY SAMPLE CHARACTERISTICS: Japanese descent

• SITE: Single-site  
• SETTING TYPE: Not specified  
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

Retrospective study design with a historical control.

Nausea, vomiting, and other adverse events (ADEs) were monitored twice daily (morning and evening), mainly by nurses, and recorded into EMRs. Primary endpoint was achievement of complete response (CR, defined as no emesis with only grades 1–2 nausea using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) during and until five days after the last chemotherapy dose was administered. Secondary endpoints included percent of patients without vomiting, percent without severe nausea, and the frequency of other ADEs. Severity of ADEs was classified by CTCAE version 4.0.

The percentage of patients who achieved CR in the aprepitant group was significantly higher than in the control group (42% versus 4.5%, p = 0.003). The percentage of patients without vomiting was higher in the aprepitant group (57%) versus the control group (4.5%; p < 0.001), and the percentage of patients without severe nausea was higher in the aprepitant group (58% versus 23%, p = 0.02) in the control group. There was no significant increase in ADEs when adding aprepitant to the antiemetic regimen.

The prophylactic administration of aprepitant significantly enhanced the effectiveness of antiemetic therapy without increasing the frequency and severity of ADEs in Japanese patients receiving high-dose chemotherapy prior to auto-PBSCT for hematologic malignancies.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions that would influence results are not described.
• Measurement/methods not well described
• Other limitations/explanation: The study design is limited in that it is a purely retrospective comparison of a very small group. There is limited of description of data collection. There was no report on the use of rescue medication in any of the analyses.

This study suggests that the addition of aprepitant to a 5-HT3 as prophylaxis for CINV in HEC regimens results in significant improvement in the control of CINV. This comparison of treatment regimens before and after the availability of aprepitant validates the added benefit of including a neurokinin 1 receptor antagonist to 5-HT3 in HEC regimens for improved CINV prophylaxis. Also, this antiemetic regimen did not incorporate the use of steroids, demonstrating a good level of efficacy with a 5-HT3 in addition to neurokinin 1 receptor antagonist.