The objective of this study was to assess the effect of optimizing hub disinfection using alcohol-impregnated port protectors by measuring the rate of central line-associated bloodstream infections (CLABSIs) and contaminated blood cultures (CBCs) in adult oncologic patient population.

The intervention involved switching traditional catheter hub care using alcohol wipes to care using 70% isopropyl alcohol-impregnated port protectors and needless neutral-pressure connectors. The intervention period results were compared to those from historical controls. Data were collected for all types of central lines, including peripherally inserted tunneled catheters and implanted ports. Line insertion techniques followed best practices for draping, skin prep, etc. Port protectors are luer lock-style caps with provide cleaning as they are twisted on and off catheter hubs. A new protector is used each time the port is accessed. Compliance was assessed by weekly observations defined as percentage of patients with catheter protectors in place.

• The sample size was 1,272.
• The age range of participants was 19–92.
• Women made up 51% of the sample; men made up 49%.
• Key disease characteristics were blood and solid cancers.

A single-site inpatient setting in West Virginia

Active antitumor treatment

Observational trial with comparison to historical controls

Observational comparison. Researchers compared CLABSI and CBC rates before and after intervention.

There was a statistically significant decrease in CLABSI rates with the use of alcohol-impregnated port protectors  from 2.3 per 1,000 central line days to 0.3 per 1,000 central line days during the intervention period (RR = 0.14, 95% CI [0.02, 1.07], p = 0.03). The rate of contaminated blood cultures decreased from 2.5% to 0.2% (RR = 0.09, 95% CI [0.01, 0.65], p = 0.002).

The use of alcohol-impregnated port protectors may help to reduce CLABSI rates. Further evidence is needed to make strong conclusions.

• 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(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• There is too much unexplained variability in this study to draw firm conclusions– types of disease and associated risk of infections are not described. 
• Varied types of catheters are included and considered together, although these are associated themselves with different risk of infection. 
• There is no information about total catheter dwell time, and whether these differed. 
• Although specific CLABSI rates may have differed, there is no information or analysis as to whether the rate of catheter removal and change differed. 
• Method of determination of compliance with specifics of use and hub changes is questionable–the fact that a hub is observed to be in place in a single point observation does not say anything about whether or not that is being changed as required for each hub access.

Suboptimal hub disinfection has a great effect on CLABSI rates. The use of alcohol-impregnated port protectors could help prevent CLABSI by eliminating this factor from the equation; however, effect sizes shown here are small. There are numerous limits to the evidence provided here which reduces the strength of the evidence and any conclusions that can be drawn; however, findings are promising. Additional well-designed studies are warranted. It would be useful to have associated cost benefit analysis, and studies comparing this approach to others to determine most cost-effective approaches to reduce CLABSI risk and rates.

The purpose of the study was to evaluate the safety and efficacy of a new rG-CSF in patients receiving chemotherapy for breast cancer.
 

Patients receiving either doxorubicin and docetaxel or docetaxel alone were entered into the study.  Patients were given rG-CSF  5 mcg/kg per day by subcutaneous injection starting on day 2 of each chemotherapy cycle, 24 hours after chemotherapy completion, that continued for either five days or until absolute neutrophil count (ANC) was greater than 1.5 x 10⁹/L. The study duration was 13 months. Severity and incidence of adverse events and antibody formation to the study drug were done. Study endpoints were incidence and duration of febrile neutropenia, duration of fever, chemotherapy cycle delays or dosage reductions, and incidence of antibiotic therapy.

• 50 patients were studied.
• Mean age of the participants was 53.54 years (SD = 10.47).
• All participants were female.
• All had breast cancer; 44% were chemotherapy naïve.

Multiple site in Lithuania.

Active antitumor treatment

Open label phase IV

• Febrile neutropenia defined as axillary temperature greater than 38.5ºC and ANC less than 0.5 x 10⁹/L.
• Common Toxicity Criteria
   

273 cycles of chemotherapy were examined. Mean duration of rG-CSF administration per cycle was 6.3 days. Eight patients withdrew from the study for various reasons. Most adverse events were associated with the chemotherapy. The most frequent grade 3–4 toxicity was neutropenia. Incidence of  grade 4 neutropenia was 47% in cycle 1 and 42% overall in patients receiving docetaxel/doxorubicin and 29% in cycle 1 and 21% overall in patients receiving docetaxel only. Most frequent study drug-related adverse events were bone pain and leukocytosis (21%), headache and musculoskeletal pain (14%), and back pain (7%).  Only bone pain was seen to be of more than mild-to-moderate severity. No neutralizing antibodies were found. Total incidence of febrile neutropenia (FN) was 14%. Mean duration of FN was 2–2.3 days. Mean duration of fever was 2.1–3.6 days depending on chemotherapy group. There was an overall incidence of chemotherapy delays or dosage changes of 1%. Overall, 20% of patients received IV antibiotics.

Overall, the study drug showed similar efficacy to other colony-stimulating factors and appeared to be well tolerated.

• Small sample (less than 100 participants)
• Risk of bias (no control group) 
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Findings were not generalizable
• It is not clear if analysis accounted for study withdrawals as percentages shown assume initial study sample size. Intent to treat analysis is not clearly stated. Open label design and no direct comparison with other formulations. These findings may not be generalizable to patients receiving other chemotherapeutic agents.

 Findings demonstrate effects of another G-CSF formulation.

To investigate if oral cryotherapy during myeloablative therapy may influence frequency and severity of mucositis, nutritional status, and infection rate after bone marrow transplant

Patients were randomly assigned to the cryotherapy treatment group or the usual care control group. A stratified randomization technique was used in regard to the type of transplant. Patients in the cryotherapy treatment group were instructed to suck on ice chips or rinse with ice-cold water during chemotherapy administration. The control group followed usual care without cryotherapy.

• The study reported on 78 patients aged 18 years or older.
• The mean age of the cryotherapy treatment group was 49.8 years (SD = 14.4 years), and the mean age of the usual care control group was 54.3 years (SD = 11.0 years).
• The sample was 58% male and 42% female.
• All patients had been diagnosed with hematologic or oncologic malignances. A total of 11 different diagnoses were represented.
• No significant differences existed between the cryotherapy treatment group and the usual care control group regarding age, gender, or tobacco use; the types of conditioning regimens; or the use of total body irradiation.

The study was conducted at a single-site, inpatient setting in Uppsala, Sweden.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for palliative care.

This was a randomized controlled trial.

• Investigators used an Oral Mucositis Assessment Score (OMAS), which was converted into the World Health Organization (WHO) scale.
• Infection rates were assessed based on neutropenic fever and use of IV antibiotics.
• Nutrition was assessed based on rate of total parenteral nutrition (TPN) and serum albumin.

• Fewer patients in the cryotherapy treatment group experienced grade 3–4 oral mucositis (OM) than in the control group (p < 0.05). However, no statistical difference was found in the severity of mucositis in the subgroup of patients receiving unrelated donor bone marrow transplant.
• No significant differences were found in weight loss between the cryotherapy treatment group and the control group.
• Fewer patients in the cryotherapy treatment group needed TPN and the number of days of TPN were fewer than in the control group. However, these differences were not statistically significant.
• The cryotherapy treatment group maintained better serum albumin levels on days 1–6 (p < 0.01) and days 7–13 (p < 0.009). 
• The cryotherapy treatment group had significantly fewer days of hospitalization (p < 0.05) in the subgroup of patients receiving unrelated donor bone marrow transplant.
• No statistical significance was found between groups related to the number of days with fever, number of positive blood cultures, or use of IV antibiotics.

Oral cryotherapy may be helpful in reducing the severity of mucositis, particularly in patients receiving autologous stem cell transplant (ASCT). Decreasing the severity of mucositis may lead to decreases in the need for TPN and better maintenance of serum albumin levels. Limited statistically significant findings were found in this study; however, it supports positive trends that favor cryotherapy use. Larger, prospective trials need to be completed.

• The sample size was small with fewer than 100 patients.
• The investigators did not clearly describe how the OMAS scale translated into the WHO scale.
• The compliance rate for using the oral cryotherapy for the unrelated  bone marrow transplant group was only three out of eight patients or less than half of the time.

Mucositis carries a high symptom burden for patients undergoing stem cell transplant. Cryotherapy may be one way to curb the effects of oral mucositis. However, this study provided no evidence to suggest that cryotherapy is the definitive way to prevent mucositis or to lessen the intensity of mucositis for all patients across the board.

Patients sucked on ice chips or rinsed with ice cold water during administration of chemotherapy. Treatment started in direct connection with and lasted until the end of the chemotherapy session.

Patients were randomized to oral cryotherapy or standard oral care. Stratified randomization was used with regard to type of BMT.

Eighty patients aged 18 and older scheduled for bone marrow transplantation (BMT). Two patients refused.

Two patients had testicular cancer; all others had hematologic malignancies (11 diagnoses evenly distributed).

Occurred from January 2002 to August 2004

Pain intensity was rated from 0–10.

Mucositis index scores  

Modified version of the Oral Mucositis Assessment Scale (OMAS)

Morphine equivalent of pain medication and duration of medications
 

Of the patients, 71%–100% managed to keep their oral cavity constantly cooled more than half the time, 58%–75% managed to keep their oral cavity constantly cooled all the time, and 7 (18%) found oral cryotherapy unpleasant. Among those seven, four (10%) found oral cryotherapy very unpleasant.

Calculated power analysis was based on days of opioids.

The experimental group had significantly fewer days with IV opioids (0.77 +/– 2.3) and complete treatment response (CTR) (2.44+/– 4.6) t = –2.053; df = 76, p = 0.045. No other differences in opioid use were observed.

Autologous BMT highest mucositis was days 9–11 (days start with chemotherapy)

Allogeneic and unrelated donor transplants peak was days 16–18

Autologous BMT experimental group (n = 62) had significantly lower mucositis score on day 10 (1.6 +/–1.9 versus 4.3 +/–5.7; t = 2.1; df = 45; p = 0.042). The experimental group also had significantly fewer days (0.06 +/– 0.25 versus 1.71 +/– 3.22, p = 0.008) and lower total dose IV opioids.

The allogenic and URD BMT group (n = 16) had significantly lower mucositis scores on day 16 (3.7 +/– 1.8 versus 11.6 +/– 6.8; t = 2.9; df = 11; p = 0.021) but  no different opioid use.

Compliance with regimen (dose of cryotherapy)

Unable to blind cryotherapy; no indication if mucositis assessors were blinded.
 

To determine whether the addition of Caphosol^® mouth rinse to a standard of care that included oral cryotherapy would decrease the incidence of oral mucositis

Patients were randomized with a computer table to the experimental or the control group. All patients received oral cryotherapy (crushed ice in the mouth during treatment), but only the experimental group received Caphosol^®. Patients in the experimental group used Caphosol^® 30 mL to rinse the oral cavity four times per day starting before high-dose chemotherapy and ending on day 21. Data were collected daily from the start of chemotherapy till day 21.

• N = 40  
• MEAN AGE = 50.4 years
• MALES: 23, FEMALES: 17
• KEY DISEASE CHARACTERISTICS: Hematologic malignancies including acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, chronic myelomonocytic leukemia, and myelodysplastic syndrome
• OTHER KEY SAMPLE CHARACTERISTICS: There were no significant differences between the conditioning regimes of the two groups.

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University Hospital, Sweden

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, open-label study

• World Health Organization (WHO) mucositis grading
• Pain was assessed using the Visual Analog Scale (VAS).
• Pain medications, C-reactive protein (CRP) values, lab values, number of total parenteral nutrition (TPN) days, and hospital days were obtained from medical records.

There was no statistically significant difference between the mucositis scores, oral pain, days with TPN, use of opioids, number of hospital days, or lab values.

Adding Caphosol^® to oral cryotherapy did not provide any additional effects.

• Small sample (< 100)
• Risk of bias (no control group)
• Other limitations/explanation: In the experimental group, 15% of patients discontinued the intervention.

Oral mucositis continues to be a major complication of chemotherapy, particularity high-dose chemotherapy. Additional research with larger sample sizes is suggested because of a trend of lower pain levels, mucositis scores, and use of analgesics in patients using Caphosol^®. The 21-day use of Caphosol^® and the discontinuation of Caphosol^® because of taste or nausea are other items that merit additional study.

To evaluate the effectiveness of adding aprepitant to standard antiemetic treatment in patients receiving high-dose chemotherapy prior to stem cell transplantation

• N = 96  
• MEAN AGE = 58.1 years (experimental), 56.5 years (control)
• MALES: 70%, FEMALES: 30%
• KEY DISEASE CHARACTERISTICS: Lymphoma (38 patients) and myeloma (58 patients)
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy regimens, high-dose melphelan, BEAM, BEAC, and BBM

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

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

This was a randomized, blinded study.

Patient diaries were used to record nausea and vomiting. An analysis was made on an intention-to-treat basis, and differences between the groups were then analyzed. Days at the hospital, weight, and use of total parenteral nutrition also were analyzed.

Thirty-eight patients (83%) in the experimental group experienced no vomiting compared to 16 patients (36%) in the control group. This finding was statistically significant. The number of vomiting episodes was also significantly lower in the experimental arm compared to the control arm up to 17 days post chemotherapy. There were no significant differences regarding days of nausea or use of antiemetic rescue medications between the two groups. There were no significant differences noted in days at the hospital, weight and use of TPN between the two groups.

The results also showed that there was a significant difference between patients who expected nausea and those who did not. Patients who did not expect nausea had lower rates of vomiting as well as fewer days of nausea.

The addition of aprepitant to the antiemetic regimen in this patient population was well-tolerated and demonstrated a statistically significant reduction in the rate of delayed vomiting.

• Small sample (< 100)

Delayed CINV is an issue of critical importance for this patient population, and ongoing research to identify and improve symptom control and quality of life is necessary. These findings provide a springboard to conduct additional research with a larger sample size to confirm the positive impact of aprepitant on delayed vomiting.

To determine whether polaprezinc suspension in sodium alginate (P-AG) reduces the irradiation period and time to discharge after completion of radiotherapy in patients with head and neck cancer and improves the overall survival in patients with head and neck cancer who received radiotherapy

• 104 patients who accomplished 70 Gy of irradiation
• 79 patients received P-AG for prevention of oral mucositis (OM) from May 2009 to December 2014, and 25 patients received azulene gargle for prophylaxis from January 2007 to April 2009.
• Physicians checked the incidence and maximal severity of OM associated with radiotherapy every three days using a fiber-optic camera. 
• Pharmacists and nurses monitored OM and oral pain daily and recorded the results on electronic medical charts.  
• OM was graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Pain was evaluated by a numeric rating scale. 
• The overall survival was plotted by the Kaplan–Meier method and compared statistically between the control group and the P-AG group by the Mantel–Cox log-rank test.

• N = 25 (control group), 79 (P-AG group)    
• AGE = 64.5 (49.8–75.6) (control group) and 65.7 (50.8–78) (P-AG group) 
• MALES: 90, FEMALES: 14
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: The control group primary site of cancer was the larynx (36%), followed by the oropharynx/ hypopharynx and epipharynx. The P-AG group primary site was the larynx (43%) and oropharynx/ hypopharynx (43%).
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients in both groups, 40%–45% had no lymph node metastasis. The most common chemotherapy regimen was docetaxel (36%), followed by cisplatin 5-fluorouracil (CDDP/5-FU) and carboplatin in the control group, whereas CDDP/5-FU (34%) followed by carboplatin and docetaxel was provided for the P-AG group.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Gifu University Hospital, Japan

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

• Retrospective study to assess the incidence and severity of OM, the irradiation period, and the time to discharge in patients who received radiotherapy for head and neck cancer

• Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as follows: grade 1 = erythema of the mucosa in oral cavity; grade 2 = patchy ulcerations or pseudomembranes in the oral cavity; grade 3 = confluent ulcerations or pseudomembranes, or bleeding with minor trauma in the oral cavity; and grade 4 = life-threatening consequences in the oral cavity
• Pain was evaluated by a numeric rating scale.
• The Mantel–Cox log-rank test for the overall survival was plotted by the Kaplan–Meier method.

The incidence of grade 3 OM was significantly lower in the P-AG group than in the control group (16.5% versus 52%, p = 0.0003). P-AG also significantly reduced the median duration of radiotherapy (HR = 0.557, 95% CI [0.357, 0.871], p = 0.0149) and median time to discharge after completion of radiotherapy (HR = 0.604, 95% CI [0.386, 0.946], p = 0.028).

P-AG was useful for preventing OM and reducing the irradiation period and median time to discharge after the completion of radiotherapy.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Retrospective study to assess patients who received P-AG (n = 79) for prevention of OM or azulene gargle (n = 25)

Randomized and multi-institutional designs are needed to clarify the beneficial effect of P-AG on the incidence of OM and hospitalization.

The objective of the study was to evaluate tunneled pleural catheters for efficacy of palliation and the rate and predictors for spontaneous pleurodesis.

The study was a retrospective review of all patients (no matter who or where inserted) with at least tunneled pleural catheter inserted at a single institution from September 2007 to September 2009. Catheters were placed by pulmonologists, interventional radiologists, and thoracic surgeons in interventional radiology or bedside. All catheters were placed by Seldinger technique, unless during a video-assisted thoracoscopic procedure (VATs).

A total of 418 tunneled pleural catheters were placed. Forty-two patients had additional contralateral pleural catheters, 13 patients had an additional ipsilateral pleural catheter, and 4 patients had both a contralateral and secondary ipsilateral catheter.

• The study reported on a sample of 355 patients.
• The median age was 63 years, with a range of 16-90 years.
• Of the sample, 42% were males and 58% were females.
• Of the sample, 106 patients (30%) had lung cancer, 62 (17%) had breast cancer, 36 (10%) had gynecologic cancer, 24 (7%) had urologic cancer, 21 (6%) had upper gastrointestinal cancer, 18 (5%) had sarcoma, 18 (5%) had lower gastrointestinal cancer, 18 (5%) had hepatobiliary, and 52 (15%) had other disease.
• Two hundred fifty-three patients (61%) had right effusions, and 165 patients (39%) had left effusions.
• Sixty-nine patients (17%) had undergone previous procedures, and 349 patients (83%) had undergone no previous procedures.
• One hundred and ten patients (26%) had loculated pleural effusions, and 308 patients (74%) had simple, non-loculated pleural effusions.

The single-site study was conducted in both the inpatient and outpatient settings. Two hundred sixty-one patients (62%) were treated in interventional radiology, 107 patients (26%) were treating in the operating room, 37 patients (9%) were treated at the bedside, and 13 patients (3%) were treated in a clinic.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care.
   

The study was a retrospective review.

• Radiographic evaluation of effusions pre- and post-catheter placement
• Computed tomography (CT) scan preferred; chest x-ray when CT not available
• Measured presence/absence of pleural fluid and presence/absence of spontaneous pleurodesis     
• Dyspnea was measured as “absence of symptoms” and “no need for subsequent effusion-directed drainage,” but the exact instrument or method of measurement was not described.
   

Median survival in this series from the time of the first catheter insertion was 3.7 months (range 2.9-4.5 months, confidence interval 95%). Median follow-up was 2.4 months, with a range of 1.0-6.4 months. Three hundred eighty of 418 catheters inserted (91%) did NOT need additional effusions-directed therapies. The successful palliation rate in patients who lived longer than 30 days was 89% (28 of 322 insertions). Spontaneous pleurodesis was achieved in 110 catheters (26%), and accounting for those who died, the probability of successful pleurodesis during the study time was 34%. The catheter complication rate was 4.8% (20 catheters; 5 grade II, 15 grade III).

• Tunneled pleural catheters were considered more cost-effective than talc pleurodesis for patients living less than six weeks. They had complication rates of 4.8% and were less severe than with talc pleurodesis (severe respiratory distress in 1%-9%).
• High rate of palliation (91%) was evidenced by no need for additional interventions for relief of symptomatic pleural effusions.
• The spontaneous pleurodesis rate of 26% is lower than other tunneled catheter studies.

•  No appropriate control group
•  Lack of a definitive symptom assessment scale
•  Lack of control for insertion operator, location, indication, or phase of disease.
   

Tunneled pleural catheters offer an alternative method of pleural drainage and may even induce spontaneous pleurodesis in patients with symptomatic malignant pleural effusions. The process of placing the catheter is minimally invasive, is associated with a low complication rate, and allows for rapid recovery of patients with limited life expectancy. More than 90% of patients receiving this therapy experienced symptomatic relief that did not require additional interventions for treatment of pleural effusions. This therapy option for management of symptomatic pleural effusions may be suggested by nurses familiar with the management of malignant pleural effusions. Studies addressing specific symptom relief would be valuable to validate the effectiveness of this intervention.

To evaluate the effectiveness of palonosetron versus granisetron in standard triplet antiemetic therapy

The regimens used were IV palonosetron or granisetron on day 1 in additional or oral aprepitant (125 mg on day 1 and 80 mg/day on days 2–3), IV dexamethasone 12 mg on day 1 and 8 mg/day on days 2–4. No other antiemetics were used. Patients were randomly assigned to the palonosetron or granisetron regimen. Patients recorded nausea daily in a diary. Rescue medication of metoclopramide, domperidone, or dexamethasone was used as needed.

• N = 827   
• MEDIAN AGE = 63 years
• MALES: 74.6%, FEMALES: 25.4%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All patients had solid tumors and were to receive a cisplatin-based highly emetogenic chemotherapy (HEC) regimen. Multiple tumor types existed; lung cancer was most frequent.

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

• PHASE OF CARE: Active antitumor treatment

• Double-blind, randomized, phase-III trial

• Complete control defined as no emesis, no use of rescue medication, and only mild nausea
• Total control defined as no emesis, no use of rescue medication, and no nausea

CR for delayed phase were higher with palonosetron (67.2% versus 59.1%, p = 0.014). Complete and total control rates were higher with palonosetron, in the delayed phase (p < 0.03).

The use of palonosetron as the 5HT3 in triplet antiemetic therapy was associated with somewhat greater chemotherapy-induced nausea and vomiting (CINV) control in the delayed phase and, as a result, in the overall phase.

• Evaluation was done only in the first cycle of chemotherapy.

Palonosetron was associated with a slightly higher proportion of patients having better CINV control in the delayed phase compared to granisetron. Further analysis is warranted to evaluate the actual cost benefit of different 5HT3 selections.

To investigate the safety and efficacy of fluvoxamine to treat anxiety and depression in patients with gynecologic cancer

For eight weeks patients were treated with escalating doses:

• Week 1: 25 mg once daily
• Week 2: 50 mg once daily
• Week 3: 50 mg twice daily
• Week 4: 50 mg three times daily
• Week 5 and onward: Dosing varied according to each patient's condition. 

Subjects were evaluated at two, four, six, and eight weeks.

• The study reported on a sample of 10 female patients.
• Median patient age was 53 years, with a range of 33–66 years.
• All patients had gynecologic cancers and were diagnosed at least two weeks prior to study entry.
• All patients had a HADS score of at least 11, indicating clinically relevant conditions. Mean HADS score was 19.
• Five patients had a diagnosed adjustment disorder, and five patients had major depression.

• Single site
• Setting not specified
• Japan

Patients were undergoing active antitumor treatment.

Prospective trial design 

• Hospital Anxiety and Depression Score (HADS)
• Short Form 36 Health Survey (SF-36)

Compared to HADS anxiety and depression scores at baseline, the scores were significantly lower after four weeks of treatment (p < 0.05) and remained significantly lower. After eight weeks, researchers noted significant improvements in SF-36 scores for vitality, mental health, and emotional role functioning (p < 0.05). No adverse effects of treatment were reported.

Fluvoxamine treatment of patients with gynecologic cancer who had clinically relevant anxiety and depression appears to reduce anxiety and depression. The small study sample precludes firm conclusions.

• The sample size was small, with fewer than 30 participants.
• The study had risks of bias because it had no control group, no blinding, and no random assignment.
• All patients had, at baseline, significant depression and anxiety, so findings cannot be generalized to patients with levels of these symptoms that are not clinically relevant. The follow-up period was only eight weeks; longer-term safety and efficacy are unknown.

Fluvoxamine as provided appeared to be effective in management of clinically relevant anxiety and depression in women with gynecologic cancer. Studies of anxiety and depression are often done with patients who do not have clinically significant problems in these areas at baseline, often making findings nonsignificant. This study provided some support for effective use of medication in patients with clinically relevant levels of anxiety and depression. The sample was very small, and the study design had multiple risks of bias. To determine which groups of patients can benefit from treatment, larger, well-designed trials are warranted.