To evaluate the effect of paravertebral blocks on the postoperative pain, nausea, and vomiting of patients undergoing breast cancer surgery with or without axillary staging

Chart review

• The sample was composed of 337 patients.   
• Mean patient age was 59.5 years.
• All patients were female.
• All patients underwent breast cancer surgery and received paravertebral blocks (PVBs). Of all patients, 45.5% (110 patients) had mastectomy; in addition, 13.4% (45 patients) had tissue-expander reconstruction, 53.3% (129 patients) had a sentinel lymph node biopsy, and 33.5% (81 patients) had full axillary dissections.  
• A study was excluded if patients had myocutaneous tissue-flap breast reconstruction simultaneous to mastectomy, had additional surgeries, used continuously delivered postoperative pain medication, had a history of chronic pain, or had a history of needing antiemetics prior to surgery.

• Single site
• Inpatient
• Hospital
   

• Phase of care: active treatment
• Clinical applications: late effects and survivorship

Retrospective chart review

• Scores, 0–10, to measure pain
• Opioid analgesic converter as presented on globalRPh.com

In patients who had undergone breast cancer surgery, PVB had no effect on postoperative pain, nausea, or vomiting.

• The pain, nausea, and vomiting scores of patients who had undergone breast cancer surgery with PVBs were similar to the scores of patients who had undergone breast cancer surgery without PVBs.
• The study demonstrated that PVBs can be easily and safely administered. This study did not show any advantage to doing so.

• The study had a risk of bias due to no appropriate control group.
• The list that follows showed other study limitations.
  • The study was retrospective.
  • Not all charts contained consistently recorded postoperative pain scores; the timing or frequency of pain scores varied greatly.
  • Determining the relationship of pain score to administration of pain medication was difficult.
  • Some pain scores were gathered before administration of pain medication; some, after administration.
  • The study lacked a standard postoperative pain medication regimen.
  • Patients received different types of opioids.
  • Some patients received postoperative NSAIDs. Authors did not consider the effect of the NSAIDs on pain.
  • The study had no means of evaluating whether PVBs were successful in reducing pain.
  • Each cohort included significantly different types of breast and axillary surgeries.
     

This study indicated that PVB might decrease postoperative pain in breast cancer surgery patients with immediate breast reconstruction with tissue expanders. PVB may have an important role in decreasing postoperative pain and opioid analgesic usage in patients electing to have immediate breast reconstruction with tissue expanders.

To evaluate the safety and efficacy of darbepoetin alfa (DA) administration every three weeks at fixed doses with or without intravenous (IV) iron.

The study used 1:1:1:1 randomization to one of four groups, stratified by platinum versus nonplatinum. The primary endpoint was hemoglobin 11 g/dL or greater, with no iron deficiency. The secondary endpoint was incidence of transfusions and change in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score from baseline to end of study. DA was administered every three weeks, and dosages were reduced according to hemoglobin levels. Weekly, 400 µg of IV iron were given, and dosages were reduced as warranted based on ferritin levels. Patients were assigned to one of four groups with or without iron with DA at either 300 µg or 500 µg.

• The study included 128 patients (78 females, 40 males).
• Age ranged from 27 to 97 years. Mean ages for the four arms were 61.7, 54.5, 64.5, and 61.8 years.
• Patients had nonmyeloid malignancies.
• Hemoglobin 10 or less
• Patients had more than eight weeks of planned chemotherapy.

• Multisite
• North America and Europe (Romania and Russia)

FACT-F

DA at 300 µg and 500 µg given every three weeks demonstrated similar benefits, and added IV iron improved treatment response. There were larger increases in hemoglobin level, and increase in hemoglobin level occurred earlier. The proportions of patients with clinically significant increases in FACT-F score were 100% for the DA 300 µg group, 64% for the 500 µg DA group, 66% for those not receiving iron, and 100% for those receiving iron. No evidence existed of a statistically significant interaction between DA dose received and IV iron usage.

Fatigue and hemoglobin levels improved in patients with anemia receiving DA with and without iron.

• No appropriate control group was used.
• Several anaphylactoid reactions to IV iron shed light on a safety issue.
• Efficacy results were pooled and summarized because no evidence was observed of a statistically significant interaction between DA and IV iron usage.

DA cannot be recommended at any dose for cancer-related fatigue.

To test the hypothesis that ginkgo biloba may be helpful for radiation-induced cognitive impairment

120 mg ginkgo biloba was given for 24 weeks and then discontinued for 6 weeks as a washout period. Tests were administered at baseline, 12 weeks, 24 weeks, and 30 weeks after the initial evaluation.

• The study reported on a sample of 34 patients with a median age of 47 years (range 22–82).
• Participants were 32% male and 68% female.
• Cognitive impairment and depressed mood were present in the sample at baseline.
• All participants had brain irradiation six or more months prior to study entry and no evidence of disease progression.

• Single site
• Outpatient    
• North Carolina

Phases of Care: Late effects and survivorship

An open label phase II study design was used.

• Mini mental state exam
• Trail Making Test parts A and B
• Digit Span Test
• Revised Rey-Osterrieth Complex Figure Test
• Verbal fluency (FAS) test
• California Verbal Learning Test II
• FACT-Brain
• Profile of Mood States (POMS)

Trail Making Test (TMT) results improved significantly from baseline to 24 weeks; however, TMT-Part B continued to improve significantly from week 24 to week 30 after ginkgo was stopped. It is unclear if changes seen demonstrate improvement with treatment or learning effect. Scores for immediate and delayed recall on the Rey-Osterreith Figure were better (p < 0.0002), but these were not measured and reported at 30 weeks. There were no other changes in mental function scores. POMS scores improved for overall mood for the first 24 weeks and then began to decline. By 24 and 30 weeks, only 19 patients remained in the study. Most common toxicities reported were cognitive issues and memory problems. Five patients (16%) discontinued treatment because of gastrointestinal symptoms. One patient discontinued treatment because of intracranial bleed in one patient. Another five patients (16%) discontinued treatment because of no perceived benefit.

Findings from the study do not provide clear support for the effectiveness of gingko biloba on cognitive impairment caused by brain irradiation.

• The study had a small sample size with less than 30 participants.
• A risk of bias was possible because there was no control group, no blinding, and no random assignment.
• Findings were not generalizable.
• Subject withdrawals were greater than or equal to 10% of participants.
• There was a potential testing effect in the study.

Findings do not support effectiveness of gingko biloba to improve cognitive function in patients who have impairment associated with brain radiation.

In part A, patients were randomized to receive either PEG plus electrolytes (PEG+E) (n = 60) or lactulose (n = 55) for one month. In part B, 65 patients continued on the treatment for another two months. Patients received PEG+E, irrespective of the laxative they received at the start of part A.

PEG 3350 is an osmotic laxative that opposes the colon’s normal drying action on the feces. The increasing fecal bulk stretches the circular muscle fibers in the bowel wall and triggers myogenic peristalsis. PEG+E provides electrolyte depletion and dehydration that can occur with other laxatives.

Lactulose is metabolized to lactic acid by bacteria in the colon. Those bacteria exert a local osmotic effect, drawing water and electrolytes into the colon from the surrounding tissues to bulk feces.

• The study reported on a sample of 115 patients.
• Patients were included in the study if they were aged 18 to 90 years and had fewer than three stools a week and/or difficult evacuation for at least three months.
• Patients were excluded if they had secondary constipation; were taking concomitant medication that might modify bowel transit; had severe liver, renal, or cardiac impairment; were not likely to comply with treatment; were not able to give informed consent, or were women of childbearing age not using effective contraception.

This was a single-blind, randomized, multicenter study.

The efficacy of PEG+E was evaluated by

• Number of stools per day
• Evacuation score
• Dyschezia index (graded from 0-3)
• Global satisfaction index (analog scale from 0-10)

Part A

• At the end of the one-month period, PEG+E showed consistently and significantly better results in number of stools per day, ease of evacuation, and global satisfaction.
• Sixty percent of PEG+E recipients did not use all their sachets, compared with 40% in the lactulose group.
• In the lactulose group, 23% increased their dosage to three or more sachets per day, whereas 64% of lactulose recipients used two to three sachets per day.
• The use of suppositories and micro-enemas was significantly lower in the PEG+E group than the lactulose group (16% versus 34%).

Part B

• Daily dosage of PEG+E remained stable, with most patients using one to two sachets per day.
• Patients in the lactulose group tended to increase to three sachets per day.
• At the end of three months, the efficacy of PEG+E was significantly better than that produced by lactulose in number of stools per day and ease of evacuation.

Use of PEG+E instead of lactulose doubled the percentage of patients successfully treated at three months. PEG+E was found to be a superior treatment compared to lactulose to treat idiopathic constipation. The study was well designed.

• The objective was to update the 1999 ATS consensus statement on dyspnea based upon new knowledge of neurophysiology and increasing interest in dyspnea as a patient-reported outcome.
• Included were patients who experience dyspnea from any etiology.

A multidisciplinary group of international experts determined the overall scope of these guidelines according to group consensus. This was followed by evidence reviews in key topic areas conducted by committee members with relevant expertise, and all group members agreed on final content.

Databases searched were PubMed and CINAHL (1999- 2009).  

Search keywords were dyspnea, breathlessness, and respiratory sensation, with additional keywords according to specific sections. Reference lists of the articles were hand-searched.

Included were

• Mechanisms underlying dyspnea
• Instruments used to measure dyspnea
• The clinical approach to patients who complain of dyspnea
• The treatment of dyspnea that persists despite maximal treatment of underlying pathologic processes responsible for breathing discomfort
• Topics that should be in the focus of future research.

The exclusion criteria were not clearly described.

• Patients were undergoing multiple phases of care.
• The guidelines have clinical applicability for elder care and palliative care.

• Results were not clearly defined.
• Literature was summarized in a general fashion with strong referencing, but levels and strength of evidence were not noted.

• Evidence describing the pathophysiology and measurement of dyspnea was comprehensive and well referenced.
• Management of refractory dyspnea despite aggressive assessment and attempts to control the etiology was the focus of the treatment section of the document.
• Therapies with strong evidence to support use include opiates, but adverse effects may interfere with acceptance.
• Therapies with limited evidence to support use include oxygen therapy, nebulized morphine, nebulized furosemide, heliox, anxiolytics, pulmonary rehabilitation, inspiratory respiratory muscle training, chest wall vibration, cool air movement on the face, noninvasive ventilation, acupuncture, and acupressure.

• The consensus document does not use systematic review techniques.
• Although dated 2012, key high-level evidence articles used in the ONS PEP review process (Cochrane Reviews) were not included in the references.
• In these guidelines is limited reference to patients with cancer.

These consensus guidelines from a respected professional organization fill an important void in the literature by describing the pathobiology and measurement instruments for dyspnea. The brief review of treatment options provides information for clinicians to consider for patients with refractory dyspnea.

The purpose of the study was to determine if cannabinoids are useful in treating neuropathic pain.

No specific databases were stated. Key words included ajulemic acid, analgesia, cannabidiol, cannabinoid, cannabis, CB1 receptor, CB2 receptor, ∆9-tetrahydrocannabinol, dronabinol, levonantradol, nabilone, neuropathic pain, and Sativex. Studies were included if they directly assessed pain; studies were excluded if they assessed pain indirectly by indices of general effects (i.e., quality of life or improvement in sleep).

The total number of studies initially reviewed was not stated; however, the final sample included 18 clinical studies from 2000–2008, 2 studies from prior to 2000, and 3 major reviews and/or meta-analyses. The method of study evaluation was not reported.

The sample range across studies was not stated, but characteristics included neuropathic pain from a variety of conditions, including cancer-related neuropathy.

Substantial evidence shows that cannabinoids are beneficial in reducing neuropathic pain from a variety of causes, including CIPN. One notable study prior to 2000 included 36 patients with cancer pain. Two of the reviews and meta-analysis also included studies of people with cancer-related pain. The findings from this subset were not discussed.

Cannabinoids can be useful as an adjuvant medication for treatment of neuropathic pain; however, side effects such as somnolence, ataxia, dry mouth, euphoria, and dizziness limit their acceptance and tolerance with patients. The authors concluded that, while cannabinoids are moderately effective for the treatment of neuropathic pain, cannabinoid drugs with less psychoactivity should be developed.

This report was limited by lack of specific information related to the literature search and sample sizes of studies included.

Based on the data presented, use of cannabinoids are likely effective for treating neuropathic pain in patients with cancer; however, their psychoactive side effects may limit their acceptability and tolerability.

Test the effectiveness of a paraprofessionally delivered, telephonic-based, psycho-educational intervention (telephone sessions plus survivorship booklet) to reduce depressive symptoms compared with the control condition (survivorship booklet only)

Intervention was based on the contextual model of health-related quality of life and the cognitive behavioral framework. Participants allocated to the intervention condition received eight 40–50-minute, biweekly, psychoeducational telephone services. Telephonic sessions involved seven domains: basic breast cancer information; managing medical and physical issues, follow-up care, and cancer resources; coping skills and problem-solving training; balancing emotions and stress management; family and social concerns; sexual health concerns; and financial issues and employment concerns. A booster and debriefing session took place one month after completion of telephone sessions.

• N = 199 (intervention = 99 [English language preferred = 45, Spanish language preferred = 54]; control = 100 [English language preferred = 39, Spanish language preferred = 61])
• MEAN AGE = 52.9 years (SD = 10.5 years)
• MALES: NA, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors
• OTHER KEY SAMPLE CHARACTERISTICS: Latino

• SITE: Multi-site  
• SETTING TYPE: Other  
• LOCATION: California cancer registry, hospital cancer registries, and breast cancer survivor support groups

PHASE OF CARE: Late effects and survivorship

Randomized, controlled trial

Center for Epidemiological Studies Depression Scale (CESD) to assess depressive symptoms in addition to demographic and clinical characteristics

A statistically significant decrease in depressive symptoms was seen among Latina patients with breast cancer in the intervention condition compared with Latina patients with breast cancer in the control condition, after controlling for depressive symptoms at T1 and language (p < 0.05). English-language-preferred and Spanish-language-preferred Latina patients with breast cancer in the intervention condition showed an eight-point decrease in depressive symptoms from baseline to follow-up, whereas those in the control condition showed no significant change.

These findings support the success of psycho-educational telephonic intervention in significantly reducing depressive symptoms among Latina patients with breast cancer, regardless of language. This is a great way to address distress among the ethnically diverse population of patients with cancer.

• Findings not generalizable
• Greater than 10% were lost to follow-up; lots of steps taken to assure treatment fidelity

This study represents a novel psycho-educational trial implemented by paraprofessionals. This could be a cost effective approach that would improve distress symptoms in a minority population with cancer. With proper training, nurses and social workers may implement this intervention, which will contribute to better patient outcomes.

STUDY PURPOSE: To examine the literature regarding precautionary and lifestyle behaviors to prevent adverse effects with arm lymphedema secondary to breast cancer surgery

TYPE OF STUDY: General review/\"semi\" systematic

• FINAL NUMBER STUDIES INCLUDED = 26 
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,992
• SAMPLE RANGE ACROSS STUDIES: 12–632 patients
• KEY SAMPLE CHARACTERISTICS: All patient sample studies were of women with breast cancer; none had lymphedema or lymph node removals.

PHASE OF CARE: Late effects and survivorship

Nine studies looked at air travel and risk of lymphedema. No consensus among studies regarding the utility of compression garment use during air travel was found, and no evidence exists to show that its use is of benefit or a risk to patients. Five studies regarding temperature extremes were included. Two studies conducted in China reported benefit from local heat therapies, and one study showed that sauna use may be associated with increased risk. Findings were insufficient to draw firm conclusions. Four studies looked at risk and the use of the affected arm for blood pressure monitoring. Two studies showed some evidence that blood pressure measurement was associated with increased lymphedema. Ten studies looked at venipuncture and lymphedema risk or outcomes. Conflicting reports were seen, and most evidence was of low quality. Eight studies involving the relationship between infection and incident worsening of lymphedema were reviewed. Of these, six suggested a significant relationship between worse lymphedema outcomes and infection, injury, or cellulitis.

Insufficient evidence exists to draw firm conclusions about the necessity of precautionary guidelines for behavior to reduce the potential for incident worsening of lymphedema and related adverse effects, although guidelines are based on sound physiological principles. Studies have shown that skin infections and inflammation are significant risk factors.

• Limited number of studies included
• Mostly low quality/high risk of bias studies
• Included recommendations from hand surgeons and studies unrelated to breast cancer–related lymphedema.
• The strongest evidence was nonrandomized, prospective, observational, or cohort designs, but these were based on patient recollection and other survey data.

This study adds to a growing body of evidence encouraging the questioning of traditional patient teaching for risk reduction behaviors aimed at reducing the risk of incident worsening of arm lymphedema after surgery for breast cancer. Insufficient evidence shows that risk reduction behaviors are effective in reducing risk; however, insufficient evidence supports that elimination of these behaviors is safe for patients. Traditional patient teaching to avoid the use of tourniquets or limb constriction, wounds or punctures, exposure to extreme temperatures, the use of compression garments with air travel, and maintain cleanliness are founded in sound physiological rationale. Such risk reduction behaviors are not overly restrictive and are sensible aspects of patient teaching for self-care.

STUDY PURPOSE: To develop an evidence-based guideline on central venous catheter (CVC) care for patients with cancer

TYPE OF STUDY: Systematic review

DATABASES USED: MEDLINE (PubMed) and the Cochrane Collaboration Library

KEYWORDS: Authors did not state which keywords were utilized.

INCLUSION CRITERIA: As long as the randomized clinical trials included a majority of patients with cancer, they were included for this review. Most recent trials were included as opposed to older trials. Authors searched from 1980–July 2012 in databases that were published in English.

EXCLUSION CRITERIA: No specific exclusion criteria were mentioned by authors. Randomized controlled trials (RCTs) were excluded if patients with CVCs were compared to patients with permanent catheters.

TOTAL REFERENCES RETRIEVED = 133, plus an unspecified number of pre-existing guidelines that were discovered during the search

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: 108 RCTs of patients with cancer and 25 meta-analyses or systematic reviews were found in the search. Several pre-existing guidelines also were discovered during the literature search.

• FINAL NUMBER STUDIES INCLUDED = 133, plus an unspecified number of pre-existing guidelines that were discovered during the search, 108 RCTs, and 25 meta-analyses
• KEY SAMPLE CHARACTERISTICS: Patients with cancer; patients with cancer with CVC access

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

Not enough evidence was found to suggest only one type of CVC for patients or to suggest only one insertion site or approach for tunneled lines. A CVC bundle should be used for line insertion and maintenance. 

Evidence is insufficient to recommend one type of CVC for patients with cancer. The choice of catheter needs to be patient-specific, avoiding femoral lines because of increased risk of infection. Hand hygiene, barrier precautions during catheter insertion and utilization, and chlorhexidine skin antisepsis during insertion are recommended to prevent catheter-related infections. Cultures should be drawn prior to antibiotic administration when an infection is suspected.

• No major limitations identified in meta-analysis

Hand hygiene and maximum barrier protection should be used during any type of catheter manipulation to avoid infection. Routine flushing with normal saline is recommended for patency. Blood cultures should be collected from CVCs prior to antibiotic administration. Tissue plasminogen activator should be used for catheters with patency issues. Routine prophylaxis with anticoagulants is not recommended for catheter-associated thrombus.

To study the effect of acupuncture on hot flashes in men with prostate cancer treated with androgen deprivation

Men with hot flashes occurring at least 3 or more times per day for at least three days before enrollment were enrolled. They completed hot flash diaries with resulting hot flash scores at baseline, daily for at least 6 weeks, and then monthly for 8 months (targeted time was 36 months). Acupuncture was administered by same acupuncturist twice a week for 4 weeks to the same 10 points with electro stimulation applied to 8 of the 10 points per protocol.

• N = 14  
• AGE:  mean 68 years
• MALES (%)  100%     FEMALES (%)  0
• KEY DISEASE CHARACTERISTICS:   Locally advanced prostate cancer
• OTHER KEY SAMPLE CHARACTERISTICS:   Advanced local disease managed with androgen deprivation therapy

The study enrolled men with locally advanced prostate cancer, who had been treated with androgen deprivation therapy as an adjuvant to radiation therapy, radical prostatectomty, or brachytherapy. All men must have had hot flashes occurring at least 3 or more times per day for at least three days before enrollment. Patients could not be receiving medications for hot flashes nor have a history of acupuncture treatment.

• SITE: Single site   
• SETTING TYPE: Outpatient setting   
• LOCATION: United States

PHASE OF CARE: Active Treatment

APPLICATIONS: Late effects & survivorship; Elderly care

Prospective single arm trial

• Hot Flash Diaries    
• Hot Flash Score - calculated as frequency x severity.

Mean initial Hot Flash Score (HFS) was 28.3, which decreased to 10.3 (p= 0.0001) at 2 weeks post-treatment, 7.5 (p = 0.0001) at 6 weeks post-treatment, and 7.0 (p= 0.0001) at 8 months post-treatment. Clinical improvement for each patient was defined as the percent decrease in the mean HFS at each time point. The mean improvement at weeks 2 and 6 was 68.4% and 89.2%.

In this limited sample size, acupuncture appeared to reduce hot flash symptoms experienced by men treated with androgen deprivation for their locally advanced prostate cancer.

• Small sample <30
• The study clearly defined the participant group; however it failed to define further the acupuncture points used within the study. It also did not define which of the 8 out of  10 points had electro stimulation applied in order to determine if these were exact points used in each participant.  
   

Further research is needed in larger sample sizes to determine effectiveness, and  the reproducibility of the study when using multiple providers. The study explored the long term benefits of using acupuncture and suggested (demonstrated) an 80.3% decrease in HFS at the 8-month follow-up.