To ascertain the value of topical ascorbic acid solution (ASC) in prevention of radiation dermatitis

Exactly half of the patients (42) were randomized to ASC solution on left side of head with control lotion on right and the other half (42) were randomized to the reverse. At initiation of radiotherapy (RT), patients applied topical solutions (10% aqueous solution of L-ascorbic acid [L-ASC] and vehicle), twice per day prior to and throughout the course of RT, to left and right sides of the head.

Radiotherapist, principal investigator, supervising nurses, and patients were blinded as to the contents of the solutions.

• The sample size was 65 participants with a diagnosed primary brain tumor with cancer metastatic to the brain (median age = 49 years; age range = 1–76 years).
• The sample included 43 men and 41 women
• The dose of radiation ranged from 14–70.3 Gy (median = 50 Gy).

The study was held at Duke University but included 10 cases from two United Kingdom facilities.

This was a quasiexperimental, double-blinded study; patients were used as their own controls.

Skin scores were done in accordance with the skin reaction criteria adopted by the RT committee of the CNS Cancer Consortium.

• Ten patients (15%) preferred ascorbic acid.
• Twenty patients (31%) preferred the placebo.
• Thirty-five (54%) preferred neither.

No discernible benefit exists to ascorbic acid lotion in the manner in which it was used in this trial for the prevention of radiation dermatitis.

• Twenty patients were entered in the trial but were not evaluable, and reasons for exclusion were not discussed.
• Likely differences in skin responses based on age were not examined and reported. The study included a wide range of ages.
• The study had a relatively small sample size.

To compare the effects of two topical skin preparations (an essential oil mixture versus standard care using RadiaPlexRx) on the skin of patients with breast cancer during radiation therapy 

Patients were randomly assigned to a control group applying RadiaPlexRx (hyaluronic acid and mannan polysaccharides) or an experimental group using a mixture of four essential oils (frankincense, lavender, geranium, and helichrysum) in a base of jojoba, aloe vera, tamanu, and evening primrose oils. All patients applied their ointment three times daily during treatment until one month after treatment. An RN who was blinded to the participant assignment performed a baseline skin check and weekly skin assessments during radiation treatment at week one through week six, and at the patient’s four-week follow-up visit. Patients completed a skin diary, quality of life index, visual analog scale (VAS) to rate pain, and a patient satisfaction questionnaire at several points during and after treatment.

• N = 24  
• AGE = 18 years or older 
• FEMALES (%): 100
• KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis, status post lumpectomy, receiving radiation therapy for breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients had to be able to read and speak English, could not have an allergy or sensitivity to the oils in the mixture above, and could not be pregnant or lactating

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Large Midwestern cancer center

PHASE OF CARE: Active antitumor treatment

Experimental, pilot study, randomization to control group or experimental group

Skin toxicity grading by an RN using the acute radiation morbidity scoring criteria per Radiation Therapy Oncology Group (RTOG, 2009), a patient skin diary, a visual analog scale (VAS) for pain, a patient satisfaction questionnaire, a quality of life index, and skin type using the Pathak scale. Measurement points were at baseline, weekly during treatment (weeks one through six), and at a one-month follow-up visit (or week ten).

The authors reported that their pilot study showed no statistical difference in skin toxicity, pain, quality of life, or satisfaction in patients undergoing breast radiation and using either the essential oil mixture or RadiaPlexRx ointment on their skin.

The findings might support the application of an essential oil mixture as another potentially more cost-effective option for standard of care skin treatment during radiation therapy to the breast. The use of natural, organic ingredients might be well accepted by patients desiring \"natural\" treatment over traditional medications.

• The authors noted the limitation of the inability to truly blind subjects regarding their assigned skin preparation because of the strong smell associated with the essential oil mixture. The subjects and/or researchers may have known which topical emollient the subject was applying. 
• Missing data from half of the subjects were reported but were not related to measures used. A multiple imputation method was employed for twenty datasets. 
• Potential limitation: The study eligibility criteria required patients to speak English.

A larger sample size, inclusion of other cancer diagnoses, and non-English–speaking patients might provide more useful data to support the application of essential oil mixtures as an equivalent of the standard of care in treating the skin of patients undergoing radiotherapy.

To determine whether a therapist-led psychoeducational intervention is effective in reducing anxiety, depression, and radiation therapy-related patient concerns

Patients in the control group received usual care. The intervention group received two face-to-face therapist consultations, one prior to radiation planning and one prior to treatment. Therapists received training in how to prepare patients for radiotherapy planning and treatment, focusing on procedure and sensory and side effect information, as well as training in eliciting and responding to emotional cues. Study measures were obtained at baseline and after each intervention time point. Intervention delivery was recorded, and content analysis was completed to determine intervention fidelity by two reviewers from a randomly selected set of 40 recorded sessions.

• N = 102
• MEAN AGE = 54.6 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All participants were diagnosed with breast cancer and were receiving radiation therapy. About 73% of participants were receiving concomitant chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Slightly greater than half of participants were employed part- or full-time, 25% had some college-level education, and one third had less than 10 years of formal education. The majority of participants were married.

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Australia

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Concerns about radiotherapy scale (reliability = .91)
• Knowledge of radiotherapy scale (reliability = .86)
• Patient preparedness and understanding index: Single-item Visual Analog Scale (VAS) 

Analysis showed statistically significant intervention effects for anxiety after the first intervention, (p = .0009) but a small size of effect (beta coefficient = –.145). There was no significant effect seen after the second intervention session. There was no effect on depression scores. Knowledge scores increased more on average for the intervention group between baseline and the first intervention session (p < .05) and related concerns dropped more in the intervention group over the same time period (p < .01).

The provision of a psychoeducational intervention was effective in increasing patients’ knowledge, reducing radiation therapy-related concerns, and reducing anxiety in women receiving radiation therapy for breast cancer.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Other limitations/explanation: Baseline HADS scores were not provided, so it is not clear whether any patients had clinically-relevant anxiety or depression or if there was a floor effect in measurement.  Usual care was not well-described, so it is not clear how much or what type of information usual care patients received.

The provision of this type of education and supportive intervention may reduce anxiety and improve patient knowledge prior to beginning radiation therapy.

To evaluate the efficacy and safety of palonosetron and dexamethasone as an antiemetic regimen

• Eligible patients received palonosetron plus dexamethasone infusion as an antiemetic treatment: 0.25 mg palonosetron admixed with 8 mg dexamethasone in 50 ml infusion solution prior to chemotherapy.
• Patients self-recorded efficacy data in diaries and were contacted on day three at home to review diary completion and inquire about other possible antiemetic treatments.
• Patients then returned to the clinic between days 6 and 8 after chemotherapy for final study procedures.

The study consisted of 33 patients.

The study was conducted at three sites.

This was a nonblinded, open-label, phase II study.

• Patients used a four-point Likert-type scale to rate nausea intensity.
• The number of emetic episodes and use of rescue medication also were documented in patient diaries.

• Twenty-nine (91%) patients had no emetic episodes during the acute interval, 26 (81%) had no emesis during the delayed interval, and 23 (72%) had no emesis during the overall interval.
• Emesis-free rates for the acute, delayed, and overall intervals for the historic population were 79%, 72%, and 66%, respectively.

No significant differences were found in any of the outcomes of interest between groups. The report stated that the addition of dexamethasone increased in benefit in the acute interval by 12%, but this was not significant.

The study refers to a historic population as the control rather than having a control group. The historic control is not described other than that patients received palonosetron without concomitant dexamethasone.

To compare two treatment methods for postmastectomy lymphedema: complex decongestive therapy (CDT) and modified CDT (MCDT) combined with intermittent pneumatic compression (IPC)

Patients were randomly assigned to a treatment arm. The CDT group alone served as the control group while the experimental group received MDCT combined with IPC. Edema volume (difference between affected and unaffected arms) was recorded initially, at the final session of phase I, and at the end of the three months follow-up. Treatment was administered five days a week for 10–15 sessions. The experimental group included skin care, 45 minutes of manual lymph drainage (MLD), remedial exercises, and compression applied by multilayered, short-stretch bandages. Lymph drainage was stimulated in the trunk with 10–15 minutes of MLD on the abdomen; chest; and axillary, inguinal, and cervical lymph nodes followed by a four-chamber pneumatic sleeve and intermittent pneumatic compression pump at 40 mm Hg pressure for 30 minutes.

• The study sample (N= 112) was comprised of female patients with postmastectomy lymphedema (defined as 10% or greater increase in the volume of affected arm compared to that of the contralateral arm).
• Mean age was 53.4 years in the control group and 52.7 years in the experimental group.
• Of 112 patients, two in the control group and one in the experimental group were excluded because of low follow-up compliance.

The study took place in the Outpatient Lymphedema Clinic of the Iranian Center for Breast Cancer.

The study has clinical applicability for patients with breast cancer associated with lymphedema.

The study used a randomized controlled trial design.

Volume of edema was measured by water displacement method and performed by a blinded investigator not engaged in treatment.

CDT alone or in combination reduced edema volume. CDT alone provided better results in both treatment phases. Limb volume measured at three months post-treatment showed 16.9% volume reduction by CDT alone and 7.5% reduction by MCDT plus IPC.

Further studies are needed to evaluate a multimodal approach to lymphedema. These findings do not support a significant improvement with IPC.

Qualified lymphedema specialists are needed to care for this group of patients and to work with medical device companies to evaluate equipment and techniques. Patient education and support is needed for compliance.

To detect an 8% difference in surgical site infections between patients receiving single- or multiple-dose antibiotics with gastric surgery

All patients received IV cefazolin immediately after induction. After surgery, patients randomly were assigned to receive no additional antibiotics or five additional doses every 12 hours. Patients were stratified according to type of surgery and were followed for 30 days after surgery.

• N = 325  
• MEAN AGE = 68 years
• AGE RANGE = 33–91 years
• MALES: 72%, FEMALES: 28%
• KEY DISEASE CHARACTERISTICS: All had gastric cancer; 97% had total gastrectomy; 38 patients had laparoscopic procedures.

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

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

• RCT

• Centers for Disease Control and Prevention definitions of surgical infections were followed.

Overall surgical site infection incidence was 9.1% in the single-dose group and 6.2% in the multiple-dose group. This difference was not statistically significant. Analysis showed that risk of infection was higher in cases with greater blood loss, body mass index of 25 kg/m² or higher, and older age.

No significant difference was seen in post-operative infection rates between those who received single- versus multiple-dose antibiotic prophylaxis.

• Risk of bias (no blinding)

This study showed no statistically significant difference in surgical site infections with single- versus multiple-dose antibiotic prophylaxis. However, this may be questioned—particularly in high-risk patients—if the approximate 3% difference is clinically meaningful. Further research regarding optimal prophylaxis in the highest-risk populations would be helpful.

To assess the effectiveness of prophylactic fluoroquinolone prophylaxis in pediatric patients with neutropenia

Levofloxacin was begun as part of standard prophylactic antimicrobial regimens at doses of 10 mg/kg/d for patients aged 5 years or younger from the beginning of conditioning until a documented fever. Additional prophylactic measures were oral acyclovir, oral fluconazole, and oral TMP-SMX. Prophylaxis was continued until neutropenia resolved with an absolute neutrophil count greater than 500, fever, or other signs of infection. Outcomes of those on levofloxacin were compared to historical controls. All other prophylaxis was the same in both controls and those in the study group.

• N = 96   
• MEDIAN AGE = 4 years
• AGE RANGE = 1.1–17 years
• MALES: 68.8%, FEMALES: 31.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All were undergoing hematopoietic cell transplantation.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Egypt

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Cohort comparison with historical controls

• Fever-free days
• Confirmed bacterial infection by microbiologic samples

Those receiving levofloxacin had a longer duration of fever-free days (p < 0.001), and the relative risk for febrile episodes in control patients was 2.1 (95% confidence interval [1.4, 3.2]). Frequency of documented infection was similar in both groups, but the frequency of gram-negative infections were less in the experimental group (6% versus 15%). This difference was not statistically significant. No difference in prevalence of resistant organisms was observed. The duration of empiric antibiotic use was lower in those receiving levofloxacin prophylaxis (p < 0.001), as was the use of empiric antifungal agents (p < 0.001). No signs of levofloxacin toxicity were observed in any patients.

Levofloxacin prophylaxis in pediatric patients undergoing cell transplantation was associated with the delayed onset of fever and less use of antibiotic and antifungal administration. Insufficient data existed to evaluate the potential effect of prophylaxis on the emergence of resistant organisms.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Decisions to use antibiotics and antifungals empirically was not based on any standard guideline.  
• Comparison to historical controls introduces the potential of history threats to validity.

There have been concerns about the use of quinolones in pediatric patients in general, and concerns that routine antibiotic prophylaxis can result in the emergence of resistant organisms within institutions. The findings from this study revealed that levofloxacin use in children was not associated with toxicities and did delay onset of fever and slightly lower rates of confirmed infections in neutropenic children undergoing hematopoietic cell transplantation. Additional research in pediatric patients is needed to fully evaluate the benefits and potential effects in terms of the emergence of resistant organisms.

Researchers studied the long-term efficacy of stellate ganglion block (SGB) treatment in reducing hot flashes (HF) and improving sleep disturbances in breast cancer survivors.  

Female breast cancer survivors who were experiencing HF and sleep disturbances were enrolled to undergo SGB treatment. A pilot study was conducted on nine patients before the main study enrolled 25 patients for the SGB treatment. In the pilot study, patient assessments occurred at baseline (one week before SGB) and four weeks after treatment. In the main study, patients were assessed at baseline and at weeks 1, 4, 12, and 24 after treatment.

• The pilot study enrolled nine women, and the main study enrolled 25.
• Median age was 53 years (range 34–69).
• Patients were included if they
  • Were women
  • Had nonrecurrent, early stage, postmenopausal breast cancer diagnosed more than five years prior
  • Had a Karnofsky Performance Scale score (KPS) greater than 80%
  • Had severe treatment-resistant HF.
• Patients were excluded if they had a change of antihormonal therapy for breast cancer within eight weeks of the first SGB, blood clotting disorders, use of anticoagulatants (other than low-dose aspirin), any acute infections, cardiac disorders, and an American Society of Anesthesiologists (ASA) classification score greater than three, as determined by an anesthetist.
• Previous use of systemic therapy for climacteric symptoms was recorded, but simultaneous use of these agents was not allowed.

• Single site   
• Outpatient
• University Hospital, Leuven, Belgium

• Patients were undergoing the transition phase of care after initial treatment.
• The study has clinical applicability for late effects and survivorship.

This was a prospective, single-arm, nonrandomized trial.

The Climacteric Symptom Form, HF diary, and Pittsburgh Sleep Quality Index (PSQI) were used to assess the efficacy of SGB on HF and sleep quality. 

This study was divided into two parts:  a pilot study of nine patients and the main study of 25 patients. All patients completed the treatment intervention (SGB) and the assessment to week 24.

• Pilot study:  Five of nine patients had a unilateral SCB; the remaining four had the block bilaterally. Three patients reported no change in HF or sleep quality. Six reported improvement in either the severity of their HF or in sleep quality. All patients required a bilateral SGB to maintain the improvement. 
• Main study: This study showed a decrease in the HF score of 64% (95% confidence interval [CI] [49, 74]) at week 1 and 47% at week 24 (95% CI [27, 62]). The odds ratio for improved sleep quality at week 24 compared with baseline was 4.26 (95% CI [1.86, 9.77]). Thus, SGB seemed to maintain its positive effect on sleep quality over time.

SGB appears to be effective in reducing the number of HF and improving sleep quality in women with early stage breast cancer who are experiencing HF and are resistant to other therapies. The HF gradually returned over time, whereas the improvement in the sleep quality was maintained over 24 weeks. The study demonstrated excellent patient compliance and noted very few side effects other than treatment-induced Horner’s syndrome (ptosis, miosis, anhidrosis, and enophthalmos) that lasted less than six hours.

• The study lacked an appropriate control group.
• The study had a small sample size. The article contains both the data from the pilot study of nine patients and the main study of 25 patients.
• Terminology used in this article was difficult to interpret, and statistical applications for results were confusing.
• There was no consistency to performing a unilateral versus bilateral SGB or to the timing of the second SBG.

The treatment was reported to be safe and very well tolerated, and the side effects were minimal. Further investigation is warranted to identify feasibility in community practices as well as further identification of the appropriate patient population for this intervention.

To test the analgesic effect of CAM2028 with benzydamine compared with CAM2028 without benzydamine (the FDA-approved prescription formula of episil) over an eight-hour period. During treatment with CAM2028, phospholipid and triglceride lipid components self-assemble with a volume of water (saliva) to form a bioadhesive and protective liquid crystalline lining of the oral mucosa. Additional objective of the study was to assess the safety and tolerability of a single-dose of the combined formulation.

1. All patients were receiving radical or postoperative radiotherapy to a significant part of clinically visible oral and/or pharyngeal mucosa at two or more anatomic sites.
2. Trial began during weeks 3 to 4 of radiotherapy and took place over a maximum duration of 12 days.
3. Treatment randomly was assigned after a radiotherapy treatment period of seven days.
4. Patients must have received at least one third of the planned total dosage of radiation.
5. At screening, participants were required to exhibit symptomatic oral mucositis (WHO grade 2 or above). 
6. Likert score of at least 6 was required at screening and before each treatment.
7. Patients were treated with randomized study medication on treatment days 1 and 3 and returned for a final follow-up evaluation on day 5.
8. At the first treatment visit, each patient was randomly allocated to one of two sequences: CAM2028-benzydamine on day 1 followed by CAM20208-control on day 3 or CAM2028-control followed by CAM2028-benzydamine.
9. Patients were assigned a random number and received trial medication sent from the study coordinating center with the corresponding number.
10. List of random numbers was generated at the coordinating center using the permuted bloc method.
11. Treatment allocation was concealed from the investigators, staff at the trial sites, trial monitors, data analysts, managers, and the patients.
12. Patients were given the trial medication after undergoing radiotherapy.
13. One milliliter of the medication was applied to the oral mucosa using a syringe, and patients were instructed to swirl the medication around in the mouth for approximately 15 seconds and then spit. Procedure was repeated after five minutes.
14. On each treatment day, oromucosal pain was assessed by the patient using the Likert scale, done before dosing and at 5 and 30 minutes, and one, two, three, six, and eight hours post dose.

• N = 38 participated (All completed the trial, and no patients discontinued.)
• MEDIAN AGE = 52 years (range = 2–72 years)
• MALES: 84.2%, FEMALES: 15.8%
• KEY DISEASE CHARACTERISTICS: Newly diagnosed head and neck cancer

• SITE: Five oncology centers
• LOCATION: Bulgaria

• PHASE OF CARE: Treatment
• APPLICATIONS: Mucositis

Crossover, double-blind, placebo-controlled, single-dose, randomized, proof of concept trial

• World Health Organization (WHO) 5 grade toxicity scale for oral mucositis
• Likert scale of 0 to 10 for pain

All patients completed the trial. With both treatments, patients experienced a mean 40% decrease in pain intensity at six hours. Both treatments resulted in significant pain relief within five minutes of application that was evident during the entire eight-hour assessment period. At no time did mean pain ratings or pain intensity difference differ statistically between the two treatments. The mean AUC of pain intensity over time did not differ between the two treatments. All of the analyses of pain intensity outcomes showed a statistically significant clinical center effect, with one center reporting larger pain intensity difference values than others. No reason was offered for this difference.

The similar treatment effects of CAM2028 with or without benzydamine suggest that benzydamine did not contribute additionally to the reduction of oral mucositis pain compared with the unmedicated CAM2028 control. CAM2028 resulted in immediate and significant pain relief with a duration that was maintained for up to eight hours.

• Small sample (< 100), split between five centers, and no mention of how many at each center
• No mention of how the outcome assessor was trained to do the assessments of the mucositis, or who did the assessment
• Women were over-represented in the group receiving placebo first.
• One center reported larger pain intensity difference than the others. No reason was offered for this difference.

• Results differences between centers needed further evaluation.
• No patients received chemotherapy in this study, so only applicable to radiotherapy treatment.
• No mention of whether radiation techniques were different between the centers.
• Study does not tell us who monitored the application of the medications.
• CAM2028 may not be a suitable vehicle with which to combine benzydamine.
• Other formulations for extended delivery of benzydamine need to be investigated and studied.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

The studies included 11 quantitative and one qualitative study. Their findings showed positive effects on sleep in two studies, one of which was a single-arm, nonrandomized study. Positive effects were shown on anxiety in three studies, one of which was single-arm. Four studies showed positive effects on depression, one of which was single-arm. Five studies did not show acupuncture to have any effects. It was noted that acupuncture methodology was inconsistently reported. There also was a lack of data such as standard deviations and change scores.

This review showed mixed results for the effects of acupuncture on sleep, depression, and anxiety. The current evidence has several study design and reporting limitations.

• There was inconsistent reporting of methods and statistical results.
• There was no quality evaluation of individual studies.
• No information was provided regarding whether baseline anxiety or depression scores were clinically significant.
• In many trials, the practitioner delivering the intervention was not reported.

There is no strong evidence to support the use of acupuncture for the treatment of anxiety, depression, or sleep disturbances.