To determine if postoperative use of a transanal drainage tube after anterior resection surgery for rectal cancer would prevent anastomotic leakage and bleeding

In this study, patients were divided into either a transanal drainage tube (TDT) or the non-transanal drainage tube (NTDT) group. A 26 Fr tube was placed during surgery proximal to the anastomosis site. Then, an air leakage test and anastomotic bleeding test were performed. If either test were positive, then corrective surgical measures were employed prior to completion of the surgery. The tube was secured to the patient with a skin suture and connected to draining. The tube was removed approximately five to six days postoperatively. The study accepted patients from January 2007 through May 2011.

• N = 158
• AGE RANGE = < 60 years (66 patients); > 60 years (92 participants)
• MALES: 56.9%, FEMALES: 43.1%
• KEY DISEASE CHARACTERISTICS: Tumor characteristics including tumor diameter, distance of tumor from anal verge, tumor location, histopathological grade, TNM stage, tumor stage, regional lymph node involvement, and distant metastasis were matched and did not reach statistical significance (p < 0.05). 
• OTHER KEY SAMPLE CHARACTERISTICS: Patients in both the TDT and NTDT groups were also matched as to other comorbid illnesses. These included hypertension, diabetes, ischemic heart disease, chronic obstructive pulmonary disease, colorectal adenomatous polyps, breast cancer, and anal fistula.  

• SITE: Not stated/unknown  
• SETTING TYPE: Inpatient  
• LOCATION: The First Affiliated Hospital, Guangzhou University of Traditional Chinese medicine, Guangzhou, People’s Republic of China

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

The study design was a nonrandomized, prospective trial.

A functional definition of anastomotic leakage and anastomotic bleeding were used. The anastomotic leakage definition addressed the drainage of stool, exudate, and gas from the abdominal and rectal drains or a rectovaginal fistula. Leakage was also considered present if peritonitis was present. Leaks were confirmed by CT scan, sigmoidoscopy, rectal examination, or laparotomy. Anastomotic bleeding was defined as continuous rectal bleeding from the rectal drain with a hemoglobin drop that no other cause could explain. Bleeding was confirmed by sigmoidoscopy, rectal examination, or laparotomy.

The use of a transanal tube to reduce bleeding in patients undergoing an anterior resection was not clinically significant. The study findings did not reach statistical significance, possibly due to the small population. However, the TDT group had 0% bleeding occur while the NTDT group experienced a 2.6% bleeding rate (p = 0.236). Of note, when anastomotic leakage was also considered, the TDT complication rate was 2.5% and the NTDT rate was 11.7%, which was clinically significant (p = 0.029).

Anastomotic bleeding is considered a complication of anterior resections. Physiological changes that occur postoperatively include a tight contraction of the anal sphincter, inflammation, pain, and trauma from the surgery. Placement of a transanal tube may be considered a mechanism for addressing some of these changes occurring postoperatively, therefore reducing bleeding.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable

Educational opportunities exist for nurses to instruct patients preoperatively regarding the possible placement of a transanal tube postoperatively, with the rationale for its use to ease the postoperative recovery. Standardization of instruction for nursing staff regarding \"normal\" versus abnormal amounts and types of bleeding/drainage from tubes is necessary.

Capecitabine is hypothesized to cause overexpression of COX-2 in tumor and healthy tissue, inducing hand-foot syndrome (HFS). This prospective clinical trial will address whether the addition of a COX-2 inhibitor plus capecitabine can decrease or ease HFS.

Patients were randomly assigned to adjuvant treatment with capecitabine plus oxaliplatin or capecitabine alone, with or without celecoxib. The COX-2 inhibitor dose was 200 mg/m² BID in combination with capecitabine for 14 days. Adverse events were monitored continuously during treatment and for 30 days after the last dose of study drug. The intensity of adverse events was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

• The study reported on  a sample of 101 patients with colorectal cancer.
• Patients were aged 18 years or older.
• The sample was 56% male and 43% female.
• Patients were postcurative surgery and eligible for adjuvant chemotherapy with capecitabine-based therapy.

• Single site
• Outpatient
• Republic of China
   

Patients were undergoing the active treatment phase of care.

This was a randomized, prospective phase 2 clinical trial.

HFS was evaluated according to the NCI CTCAE, version 4.0.

• Patients in the capecitabine plus celecoxib group had a significantly reduced frequency of HFS higher than grade 1 (p < 0.001) and grade 2 (p = 0.024) compared to patients in the groups without celecoxib.
• No significant differences existed between groups in grade 3 HFS.

Celecoxib was safe and convenient for patients receiving chemotherapy and reduced the incidence of lower grade HFS.

• The study was a phase 2 trial and was not placebo controlled.
• The study was no blinded.
• Why lower grade HFS would be affected whereas no differences occurred in higher grade HFS between groups is unclear. This raises questions over the reliability of HFS toxicity grading. The authors stated the incidence of HFS in this study was higher than that reported elsewhere, which may have been caused by the fact that they defined grade 1 HFS as any slight pigmentation change.
• Who did the grading was not described.

In the correct population of patients, COX-2 inhibitors can be suggested. Additional research in this area is warranted.

To evaluate the efficacy of self-manual lymph drainage (MLD) added to physical exercise for the prevention of lymphedema and scar formation

Self MLD for a total 30 minutes, three sessions a day, after incision closure and suture removal was divided into three steps: Surgical incision scar (10 minutes a session), activate lymph nodes (10 minutes a session), ,stimulate lymph drainage (10 minutes a session). All patients were to continue active remedial exercises for six months following surgery. Women with breast cancer scheduled for surgery were randomly assigned to physical exercise (control) or self MLD plus exercise, with measurements for limb circumference and shoulder abduction recorded 24 hours before and after surgery at week 1, and at 1, 3, 6, and 12 months; evaluation of scar formation was conducted after suture removal at week 1, and at 1, 3, 6, and 12 months.

• N = 1,000   
• AGE: 538 younger than 50 years, 462 50 years or older
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Women with breast cancer scheduled for modified radical mastectomy
• OTHER KEY SAMPLE CHARACTERISTICS: Age, pathological subtypes, differentiation, tumor node metastasis, ER/PR, HER 2 status, lymph node metastasis

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Sun Yat-sen University Cancer Center, Guangdong Shen, China

PHASE OF CARE: Multiple phases of care

• Randomized, controlled trial

• Limb volume circumference at wrist, 8 cm above and below elbow and 8 cm below shoulder joint
• Vancouver Scar Scale (VSS)
• Maximum shoulder abduction

Fewer patients in the MLD group had scar contracture (p < 0.05, MLD versus PE). Prevalence of upper limb lymphedema was lower in the MLD group at various time points (p < 0.05, MLD versus PE). Maximum shoulder abduction was better in the MLD group (p < 0.05, MLD versus PE).

The findings suggest that self-administered MLD with exercise was more effective in preventing lymphedema than exercise alone.

• Risk of bias (no blinding)
• Selective outcomes reporting
• No discussion of subject withdrawals or loss to follow-up was provided. No assessment of patient adherence to exercise and self-administered MLD was reported. Whether patients had additional radiation or chemotherapy during the 12-month period of the study was unclear.

Patient education regarding the lymphatic system, self MLD, combined with physical exercise and adherence to the therapeutic routine may help in preventing scar formation, shoulder dysfunction, and upper extremity lymphedema.

To evaluate the effect of swallowing training on dysphagia and depression in postoperative patients with tongue cancer

• N = 58  
• MEAN AGE: 40-81 years
• MEDIAN AGE: 56.6 years
• MALES: 43 (75%), FEMALES: 15 (25%)
• KEY DISEASE CHARACTERISTICS: 9 patients had stage 1 cancer, 23 had stage II, 21 had stage III, and 5 had stage IV.
• OTHER KEY SAMPLE CHARACTERISTICS: 12 had floor-of-tongue cancers, 27 had side-of-tongue cancers, 6 had near-the-throat cancers, and 13 had top-of-tongue cancers. Eleven patients underwent segmental mandibular resection, and the remaining underwent resection of the mandibular rim only. Extent of tongue resection varied from 10%-75%.

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Guangzhou, China

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Palliative care 

• Prospective study

• Zung Self-Rating Depression Scale (SDS)
• Water-swallowing test (WST)

The WST and SDS scores were significantly lower in the less than 50% tongue resection and rehabilitation group, and also in the early tumor stage group as opposed to the advanced stage group. There was no significant differences in WST and SDS based on age, flap defect rehabilitation, neck dissection, or range of mandibulectomy. WST levels and SDS scores before swallowing training were significantly greater than after training (WST: p = 0.027, SDS: p = 0.034). In all cases, lower WST scores were associated with lower SDS scores.

Improved swallowing may reduce severity of depression. Improving functional outcomes, such as eating, is a significant quality-of-life issue.

• Small sample (less than 100)
• 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)
• Possible selection bias (58/128 patients were assessed, but there was no criteria for inclusion or exclusion in the study)
• Gender bias (75% men)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Findings not generalizable

This is an important issue for nurses in developing and implementing interventions to improve quality of life and survivorship. Swallowing retraining can potentially be effective for both swallowing and depression associated with the disease process.

To compare the incidence and severity of hand-foot syndrome (HFS) in patients who received capecitabine with and without celecoxib.

Patients were randomized to receive oral celecoxib 200 mg BID or no intervention. Sampling was stratified based on the specific chemotherapy regimen used. Patients were educated on how to prevent side effects of therapy and monitored weekly with telephone calls and monthly clinic visits.

• The study reported on a sample of 139 patients with colorectal cancer.
• Mean patient age was 58 years.
• The sample was 60% male and 40% female.
• Some patients received oxaliplatin as well as capecitabine.

• Single site
• Outpatient
• China

Patients were undergoing the active antitumor treatment phase of care.

This was a randomized, prospective trial.

National Cancer Institute (NCI) common toxicity criteria (CTC), version 4

• The incidence of grade 1 to 2 HFS was lower in the celecoxib group (p < 0.05).
• The mean number of chemotherapy cycles before development of HFS was 4.336 in the celecoxib group versus 5.852 in the control group (p < 0.001).
• No adverse events were associated with use of celecoxib.

Celecoxib as used in this trial may delay the onset and severity of HFS in patients receiving capecitabine-based chemotherapy. In addition, celecoxib was not associated with adverse events.

• No subgroup analysis was conducted between patients who received the two different chemotherapy regimens included; therefore, whether those differences would have affected results is unclear.
• The timeframe and sample characteristics of this study were similar to those of another publication from this group that stated a different sample size and method of HFS rating. Whether this study incorporated the same group of patients is unclear.
• Risk of bias existed in the study design because of the lack of blinding and an appropriate attentional control condition.

Use of anti-inflammatory medications such as celecoxib may help delay the onset and severity of HFS in patients receiving capecitabine-based chemotherapy. In addition, no adverse events were reported with use as long as six months.

To review the evidence regarding efficacy of topical treatments to prevent and manage radiodermatitis through meta-analysis and systematic review

Databases searched were Cochrane, MEDLINE, PubMed, and Web of Science. Keywords used were radiodermatitis, skin reaction, prevention, treatment, erythema, and desquamation, among others. Studies were included in the review if they

• Were randomized controlled trials
• Evaluated topical versus non-topical agent therapy
• Reported incidence of grade 2 or higher radiodermatitis for prophylactic trials and incidence of wound healing for treatment trials
• Were written in English.
   

Seventy-three references were retrieved. Study quality was rated using the Jadad Scale.

• The final number of studies included was 20, with 14 prevention trials and 6 treatment trials.
• The sample size ranged from 33–340 across studies.

Effect of topical agents for prevention showed no significant differences across all trials between intervention and control groups (relative risk [RR] = 0.90)  There was no significant difference across control and intervention groups for topical agent use in wound healing (RR = 1.01). There was high heterogeneity in both analyses. All topical agents were considered together, with no analysis of different types of agents.

Findings suggest that overall, the use of topical agents is not effective for either prevention or treatment of radiodermatitis. The findings are similar to those of other systematic reviews in the topic that have shown there is insufficient evidence in this area to recommend any particular topical agent.

• The analysis considered all types of agents, from enzymes to steroids in a single analysis. 
• Given the varied mechanisms of action, the appropriateness of the study is questionable. There is, however, insufficient evidence to do meta-analysis within interventions, because many have only been tested with one study.

There is a continued need for well-designed research in the area of prevention and management of radiodermatitis.

To assess the effectiveness of Tai Chi in managing cancer-related fatigue

Patients were randomized to the Tai Chi or low-impact exercise groups. Tai Chi was taught by instructors in the community and via DVD. Patients were enrolled during hospitalization for chemotherapy. Sessions were conducted for 12 days during each course of chemotherapy every other day across four courses of treatment. Study assessments were conducted prior to the first and third courses of chemotherapy and at the end of the fourth course.

• N = 91
• MEAN AGE = Not reported. Forty-four percent were aged over 60 years.
• MALES: 74.7%, FEMALES: 25.3%
• KEY DISEASE CHARACTERISTICS: All had lung cancer; the majority had stage III or IV disease.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had sixth grade or less of education.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

• Randomized, active, controlled trial

• Multidimensional Fatigue Inventory-Short Form (MFI-SF)

Fatigue scores increased in all patients. At six weeks, general and physical fatigue subscale scores were lower in the Tai Chi group (p < 0.05). Vigor scale scores were higher in the Tai Chi group (p < 0.05). These scores were also better in the Tai Chi group at 12 weeks (p < 0.05). No other differences existed between groups. 

Tai Chi was beneficial for patients with lung cancer to reduce treatment-related fatigue while undergoing chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%  
• Whether exercise and Tai Chi sessions were done with instructors or self-managed in the home is unclear. Similarly, whether sessions were done in individual or group settings is unclear.
• Compliance with sessions was not evaluated.

The findings suggest that Tai Chi can be an effective intervention to combat fatigue during cancer treatment with chemotherapy. Exercise has been shown to be an effective intervention, and patients who did Tai Chi experienced less fatigue than those doing low-impact exercise. This study had multiple limitations, so the strength of this finding is limited. Additional research is warranted to provide strong support for this intervention.

To review the evidence regarding the effects of Chinese herbal medicine on side effects of chemotherapy in women with breast cancer.

Databases searched were Cochrane Library, EMBASE, LILACS, SIGLE, and Chinese Biomedical Disk. Handsearching of key medical journals and references lists of retrieved articles was also performed.

Search keywords were Chinese medicine, plants, drugs, botanical, herbal medicine, and additional search terms related to herbal medicine as well as breast cancer treatments. A full listing of search terms was provided.

Studies were included if they included

• Women with breast cancer receiving chemotherapy as adjuvant or palliative treatment. 
• Single and compound herbal treatments. 
• Randomized clinical trials with chemotherapy-induced side effects.

Patients were excluded if they had other cancers as well as breast cancer (except for skin cancer).

In total, 88 references were retrieved. The authors allocated trials to quality categories described in the Cochrane Reviewers' Handbook and assessed quality according to criteria from Schultz (1995); studies were categorized as having a low, moderate, or high risk of bias.

• The final number of studies included was seven.  
• The sample range across studies was 48 to 120 patients (N = 541).
• All patients had breast cancer and were receiving chemotherapy. 
• All studies were performed on Chinese patients in a mix of settings.

Patients were undergoing multiple phases of care.

Trial duration ranged from 14 to 84 days. Treatments were varied with different herbal concoctions; most included radix ginseng along with other substances. The authors did not provide the findings for all outcomes of interest. A few studies measured quality of life, and several attempted to evaluate the effect on thrombocytopenia and white blood cell volumes and types. Some studies used inappropriate statistical methods. The quality of the included trials was poor.

The nature of the evidence in use of Chinese herbal medicine was not sufficient to draw any conclusions.

The study included a small number of studies with relatively small samples and poor quality.

The evidence reviewed did not provide clear implications for the incorporation of findings into practice. Further well-designed research is needed.

STUDY PURPOSE: To compare the effects of different regimens of NK₁-based antiemetic treatment for patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)

TYPE OF STUDY: Meta-analysis and systematic review

TOTAL REFERENCES RETRIEVED: 1,796

• FINAL NUMBER STUDIES INCLUDED = 35 
• TOTAL PATIENTS INCLUDED IN REVIEW = 18, 889
• SAMPLE RANGE ACROSS STUDIES: 16–1438
• KEY SAMPLE CHARACTERISTICS: All were receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) treatment regimens.

PHASE OF CARE: Active antitumor treatment

Regimens using various NK₁s showed equivalent antiemetic effect in the overall, acute, and delayed phases. In patients receiving HEC, almost all triple-drug regimens showed significantly higher complete response rates when compared to duplex antiemetic regimens. In patients with MEC, the only NK₁ that showed better antiemetic effect than duplex regimens was aprepitant. Palonosetron-based regimens did not show any difference from first generation 5-HT₃s for CINV complete response rate. No differences in outcomes were observed with differing doses of dexamethasone as part of a triple-drug regimen.

This analysis provides some key information regarding the specific selection of agents and regimens used for CINV control among patients receiving MEC and HEC. Consistent with other evidence, CINV was best controlled with a triple-drug regimen rather than a duplex regimen. The findings suggest that varied doses of dexamethasone do not reduce efficacy.

No quality evaluation

The findings suggest that a standard triple drug regimen is more effective for CINV control with HEC regimens compared to duplex regimens. The findings also suggest that differences in dexamethasone dosing does not appear to alter antiemetic effectiveness. Regimens with reduced use of corticosteroid may be needed for patients with diabetes or low tolerance for side effects of steroids.

To evaluate transcutaneous electroacupuncture (TEA) on chemotherapy-induced nausea and vomiting (CINV) as well as serotonin and dopamine levels among patients with cancer

• N = 72
• AGE = Not stated
• MALES: 60% (43), FEMALES: 40% (29)
• KEY DISEASE CHARACTERISTICS: Not stated
• OTHER KEY SAMPLE CHARACTERISTICS: All were naïve to chemotherapy or received only moderate to highly emetogenic chemotherapy; scheduled to receive moderate or highly emetogenic chemotherapy (cisplatin > 50 mg/m², cyclophosphamide > 1,500 mg/m², or carmustine > 250 mg/m²)

• SITE: Single site
• SETTING TYPE: Inpatient
• LOCATION: Zhejiang Provincial Hospital of Traditional Chinese Medicine

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Nausea and vomiting: Patients recorded the date and time of emesis or retching, the degree of nausea (none, mild, moderate, or severe), and the use of rescue medications (name, dose, and time) in a diary.
• Serotonin and dopamine
• Safety measures: Vital signs, 12-lead electrocardiogram (EKG), blood tests (white blood cell count, aspartate transaminase, alanine transaminase, and creatinine clearance), and urinalysis

Vomiting was significantly improved in the treatment group compared to the control group at 48 hours only (p = 0.046). No difference was noted at 24 hours (p = 0.9) or 72 hours (p = 0.68). Nausea was significantly better for the treatment group than the control group at 48 hours (p = 0.001) and 72 hours (p = 0.025) but not at 24 hours. Serotonin and dopamine were not different at baseline but were significantly reduced in the treatment group when compared to the control group at 48 hours (p = 0.03) and 72 hours (p = 0.02). No safety issues were noted in any patients. Laboratory results and EKG tests were normal.

Transcutaneous electroacupuncture was effective at improving delayed nausea and vomiting and had no significant safety issues.

• Small sample (< 100)
• Other limitations/explanation: Sample characteristics were not adequately reported, and no differences between the groups were noted. The authors did not report if any subjects withdrew from the study.

The needleless system of transcutaneous electroacupuncture made administration easy and compliance rates high.