To study the dose, level of pain, and toxicity symptoms associated with intermittent subcutaneous methadone injections used to treat cancer pain

Over seven days, patients whose pain was well controlled with oral methadone received subcutaneous methadone via a butterfly needle that was used exclusively for methadone. The conversion ratio, oral methadone to subcutaneous methadone, was 1:1.

• The sample was composed of 10 patients.
• The age range of patients was 46–81 years.
• The sample consisted of two females and eight males.
• All patients had advanced cancer (the study comprised multiple diagnoses), were hospitalized in a palliative care unit, and had achieved pain control (a pain rating of less than 5 on a 0–10 scale) on stable methadone doses.

• Single site
• Inpatient
• Palliative care unit, Spain

• Numeric Rating Scale (NRS), 0–10, to measure the local discomfort of each injection
• Methadone dose used
• Toxicity symptoms

Two of 10 patients withdrew because of nonpainful irritation at the injection site. Compared to the methadone doses other patients were taking, these two patients took significantly higher doses: 40–45 mg, either every 8 hours or every 12 hours. All other patients’ doses were 5–25 mg, either every 8 hours or every 12 hours. Eight patients completed the study over seven days. Pain levels went from 3.3 to 3.5 on a  0–10 scale.

Intermittent subcutaneous methadone administration seems to be a useful alternative when oral administration is not feasible.

The study had a small sample size.

The conversion ratio, oral to subcutaneous methadone, was 1:1. This is not the currently recommended conversion ratio, though patients in the study experienced no increase in toxicity as the result of the 1:1 conversion. However, the duration of the study was only seven days; a longer duration may have resulted in toxicity effects. Higher doses caused local irritation. At even higher doses, clinicians may have to consider other strategies, such as adding dexamethasone to the infusion. If a patient is unable to take oral methadone, alternatives other than subcutaneous methadone—transdermal or buccal administration—are available.

To assess the effects of Multiwave Lock System low-level laser therapy in the management of acute radiation dermatitis

All patients received standard skin care including hydroactive colloid gel thre times daily throughout radiation therapy and self-adhesive silicone foam dressing for dry or moist desquamation. Those in the laser therapy group also received six sessions twice a week starting from fraction 20 of radiation. Results from the laser group were compared to that of a historical control group who had only usual care.

• N = 79   
• MEAN AGE = 55 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer; most had stage I–II disease; slightly more than one-third had chemotherapy prior to radiotherapy.

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

PHASE OF CARE: Active antitumor treatment

Prospective, quasiexperimental with historical control comparison

• Radiation Therapy Oncology Group (RTOG) grading
• Radiotherapy-Induced Skin Reaction Assessment Scale (RISRA)
• Skindex-16

RTOG scores in the control group increased over time but remained stable in the laser group. The difference between groups was significant (p < 0.005). There were no cases of greater than grade 2 skin toxicity. Analysis of change in RISRA scores showed improvement in subjective scores in the laser group (p = 0.023) and less score increase overall in the laser group (p < 0.03).

This type of low-level laser therapy was shown to be beneficial in reducing the severity of radiodermatitis among women being treated for breast cancer.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)

The use of low-level laser therapy may have some benefit for the management of radiodermatitis. The promising findings from this study warrant additional well designed research.

To compare the efficacy of dexpanthenol cream versus hydroactive colloid gel application during breast radiation therapy (RT)

In this retrospective study, one group of patients receiving breast radiotherapy applied dexpanthenol cream three times per day from day 1 through day 12 of radiation. From day 13 to completion, they switched their skin care regimen to hydroactive colloid gel (Flamigel^®). The other group of patients with breast cancer applied only dexpanthenol cream three times per day throughout the entire course of radiation. All patients were women with breast cancer who received a total dose of 66 Gy. Skin assessment was performed by oncology nurses using World Health Organization grading criteria for acute skin toxicity. The occurrence and time to onset of moist desquamation were endpoints for this study.

• N = 483
• MEAN AGE = 57 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving neoadjuvant chemotherapy; hormone therapy allowed; brachytherapy patients excluded

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

• PHASE OF CARE: Active antitumor treatment

Retrospective study

• World Health Organization criteria for grading acute skin toxicity scale, breast size in diameter, chemotherapy administration, and time to onset of moist desquamation

Patients who used the hydroactive colloid gel preparation experienced moist desquamation significantly later than patients who used only the dexpanthenol cream (p < 0.0001); however, breast size had a higher hazard ratio till time to development for patients using the cream than those using the gel. The incidence of most desquamation was significantly lower in the group using the gel (p < 0.0001). The incidence was highest in women with large breasts.

Patients with breast cancer undergoing radiotherapy may benefit from using a hydroactive colloid gel from the beginning of radiation treatment until the completion of treatment for the prevention of moist desquamation. The strength of this evidence is limited because of this study's design. Women with large breasts were at higher risk for the development of moist desquamation.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Other limitations/explanation: This was a retrospective study. There was no follow-up regarding skin reaction and healing time. No subjective assessments were done during treatment (i.e., pain, quality of life, itching). No exact known concentration of ingredients used in either skin preparation was described. The treatments consisted of different vehicles of delivery (oil versus gel). Women who initially used dexpanthenol were then switched to the hydroactive colloid gel; this would have influenced final results.

When applied three times daily, the use of a hydroactive colloid gel may provide healing benefits for the skin of patients with breast cancer undergoing radiotherapy and decrease the time to onset of moist desquamation.

To assess the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) regimens

All patients received a single IV dose of 0.25 mg palonosetron and 8 mg dexamethasone before chemotherapy on day 1. Patients then were randomized to one of two delayed antiemetic regimens: no additional dexamethasone or 8 mg dexamethasone daily on days 2 and 3. Rescue medication of dexamethasone or metoclopramide was allowed as needed. In patient diaries, participants recorded emetic events, use of rescue medication, and maximum nausea experience.

• The study consisted of 332 participants.
• In the palonosetron plus dexamethasone, one-day group, the mean age was 56.9 years (SD = 11.8). In the palonosetron plus dexamethasone, three-day group, the mean age was 57.2 years (SD = 11.3).
• The sample was 65.1% female and 34.9% male.
• Cancer diagnoses were breast, colorectal, lung, or other.
• Patients were chemotherapy naïve.
• Most patients received oxaliplatin or anthracycline plus cyclophosphamide (AC)–based chemotherapy regimens.

The study was conducted in multiple sites in Italy.

All patients were in active treatment.

This was a randomized, open-label, parallel group trial.

Patients recorded the number and time of emetic episodes, use of rescue medications, maximum nausea in the previous 24 hours, adverse events, and use of concomitant medication in patient diaries.

The following were measured.

• Complete response (CR), defined as no emetic episodes, no rescue medication, during days 1–5
• CR in acute and delayed phase
• Complete control (CC), defined as no emetic episodes, no use of rescue medication, no more than mild nausea
• No emesis, no nausea, and no use of rescue medication in overall, acute, and delayed phases
• Severity of nausea on a four-point Likert-type scale.

• No significant differences in CR rate were found between study groups in the overall, acute, and delayed phases.
• During the delayed phase, significantly fewer patients who had received three days of dexamethasone required rescue medication (p = 0.026).
• Overall, 83%–87% of patients achieved CC in the acute phase.
• In the delayed phase, 66.3% who received 1 day of dexamethasone had CR, compared to 75.8% of those who had three days of dexamethasone. These differences were not statistically significant.
• The proportion of patients with no vomiting and no nausea was not different between groups.
• Female gender and AC-containing chemotherapy were associated with worse overall CR rates across all subjects (p = 0.02).
• No clinically relevant differences were found between groups with respect to adverse events.

Palonosetron plus single-dose dexamethasone administered before common MEC regimens was not as effective as palonosetron plus dexamethasone for three days in the prevention of CINV.

• The percentage of patients who received AC chemotherapy (HEC) was 35.2% (subanalysis was done).
• The discussion states that the one-day regimen with palonosetron was more effective; however, data did not support that conclusion.
• Article discussion suggested bias.

For patients receiving non-AC MEC chemotherapy, and especially male patients, single-dose palonosetron and dexamethasone could be an option, considering side effects from multiday use of dexamethasone. However, as the study suggested, the need for rescue medication was higher in this group compared with the three-day dexamethasone regimen during the delayed phase.

To verify whether the noninferiority hypothesis of a dexamethasone sparing regimen can be demonstrated even after adjustment for known risk factors for developing CINV and to assess the impact of the risk factors studied on antiemetic outcome

Chemotherapy-naïve patients received 0.25 mg IV palonosetron and 8 mg IV dexamethasone on day 1. Patients were randomly assigned to no additional dexamethasone (1 day dexamethasone regimen) or 8 mg oral dexamethasone on days 2–3 (3-day dexa regimen). After chemotherapy, rescue medication, including dexamethasone or metoclopramide, were permitted on an as-needed basis.

• The study consisted of 324 patients with a median age of 57.5 years.
• The sample was 35% male and 65% female.
• Cancer diagnoses were primarily breast and colorectal with some lung and other.
• Patients were chemotherapy naïve receiving MEC (additional chemotherapeutic agents of Hesketh-emetogenic level 2 or lower were permitted between days 1–5) with a European Cooperative Oncology Group status of 0–2 (mostly 0–1).
• Patients receiving AC chemotherapy represented 35% of the sample, and 36% of patients had distant metastases.

The study was conducted at multiple sites (not specified) in Italy.

• All patients were in active treatment.
• This study has application to late effects and survivorship.

This was a prespecified, posthoc analysis of a randomized, multicenter, phase III trial.

• Complete response was defined as no emetic episodes and no rescue antiemetics during the overall five-day study period and no nausea in the overall study period.
• Risk factors of age, gender, and alcohol consumption were recorded.

• In the adjusted model (multivariable), only younger age (p = 0.044) was significantly associated with poorer outcomes in terms of CR to antiemetic treatment. As compared with older patients, those under 50 years of age had a probability of achieving complete protection against CINV in the overall five-day study period that was reduced by approximately 13 percentage points.
• No between-treatment differences were found in CR rates according to age, gender, alcohol consumption, and type of MEC regimen.
• No significant differences were found between treatment groups in the rate of no nausea according to each risk factor studied (among younger patients undergoing AC-based chemotherapy).
• The three-day regimen achieved higher nausea control than the one-day regimen (p = 0.075).

The analysis confirmed that the palonosetron plus one-day dexamethasone regimen provides a valid treatment option for prevention of CINV in delayed, non-AC-based MEC. However, these findings are not applicable to younger patients undergoing AC-based chemotherapy as the palonosetron plus three-day dexamethasone regimen achieved statistically better nausea control in this population.

Younger patients were mostly women undergoing AC chemotherapy and, primarily, no history of alcohol consumption.  A 15% margin was set for the noninferiority analysis, which is still a highly clinically relevant difference.

Administration of palonosetron with single-day dexamethasone could be recommended for the patients undergoing non-AC-based MEC for the control of delayed CINV, considering the side effects of dexamethasone. This was a noninferiority analysis, meaning that  researchers accepted a 15% difference in rate of control as no real difference. Nurses need to be aware of the implications of this type of trial and judge whether lack of CINV control in 15% of patients is acceptable.  As the study demonstrated, the palonosetron with three-day dexamethasone regimen is still recommended for the control of nausea, especially for younger patients receiving AC-based chemotherapy.

To compare the effectiveness of palonosetron combined with dexamethasone versus older antagonist-containing regimens in combination with dexamethasone in patients receiving highly emetogenic chemotherapy (HEC)

In both studies, eligible patients were randomly assigned to receive a single IV dose of palonosetron (0.25 mg or 0.75 mg), or an older antagonist (Zofran® 32 mg or granisetron 3 mg) as a bolus given 30 minutes before initiation of HEC on day 1. Prophylactic dexamethasone (20 or 16 mg IV) was administered before the initiation of chemotherapy on day 1. In the Saito et al. trial, one of the trials summarized by Celio et al., delayed dexamethasone was also given daily on days 2 and 3. The primary endpoint for efficacy was the proportion of patients achieving CR (defined as no emetic episodes and no use of rescue antiemetics). Patients recorded daily emetic events, nausea, and rescue medications for five days after starting chemotherapy.

• N = 1411
• MEAN AGE = 55–56 years
• MALES: 43.1%, FEMALES: 56.9%
• KEY DISEASE CHARACTERISTICS: Lung/breast/other malignancies scheduled to receive a single dose of IV HEC

• SITE: Multi-site  
• SETTING TYPE: Multiple settings  
• LOCATION: Japan and western countries

• PHASE OF CARE: Active antitumor treatment

Pooled analysis of multi-center, double-blind, double-dummy, parallel-group, active-comparator trials

Patient daily diary recording emetic events, severity of nausea, and rescue medication use

The proportion of patients achieving CR was significantly higher with the palonosetron versus the control regimen in the overall five-day study period (49.2% versus 37.3%; p < 0.0001), in the acute phase (73.1% versus 69.7%), as well as in the post hoc analysis for the delayed time period (53.6% versus 41.2%; p < 0.0001). For either time period, the incremental improvement observed with the use of palonosetron was approximately 12 percentage points.

The analysis of data from two pooled studies demonstrates the benefit of palonosetron plus dexamethasone, compared to older 5-HT3 receptor antagonists plus dexamethasone, in the prevention of chemotherapy-induced nausea and vomiting (CINV) in HEC during a five-day study period. It also suggests a benefit of palonosetron on delayed nausea or vomiting.

• Risk of bias (no control group)
• Other limitations/explanation: Different doses of dexamethasone were given in standard care group.

This study further supports prior data showing that palonosetron with dexamethasone provides improved protection from overall CINV during HEC, as well as in the delayed phase, over older-generation 5-HT3 receptor antagonists.

To determine the effectiveness of dexamethasone against delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) or anthracycline plus cyclophosphamide (AC)

This reanalysis consisted of of two cohorts of chemotherapy-naïve patients who were included in two phase 3, randomized, controlled trails investigating a dexamethasone-sparing regimen. Participants were randomized to receive palonosetron (0.25 mg IV) plus dexamethasone (8 mg IV) on day 1 of chemotherapy or the same regimen followed by oral dexamethasone on days 2 and 3 in the MEC and AC regimens. Patients were divided according to the effectiveness of prophylaxis against acute CINV as either high- (experienced neither vomiting nor moderate-to-severe nausea) or low-risk (experienced vomiting or moderate to severe CINV).

• N = 624 (237 received MEC and 380 received AC)  
• MEDIAN AGE RANGE = 50–60 years
• MALES: 50.4%, 45.5%, FEMALES: 49.6%, 54.5%
• KEY DISEASE CHARACTERISTICS: Various primary cancers; breast (380); solid tumors, colorectal, and lung most common
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve patients who were included in two randomized clinical studies investigating a dexamethasone-sparing regimen; received either MEC for a solid tumor or AC-containing chemotherapy for breast cancer

• SITE: Multi-site    
• SETTING TYPE: Outpatient

• PHASE OF CARE: Active antitumor treatment

Secondary analysis of two phase 3, randomized, controlled trials

• Patients used a daily diary for five days. Nausea was assessed using a Visual Analog Scale (VAS) or verbal category scale (no nausea; mild = did not interfere with normal daily life; moderate = interfered with normal daily life; and severe = required the patient to be bedridden).
• The primary efficacy endpoint was the proportion of patients with protection against both vomiting and moderate-to-severe nausea.
• The secondary endpoints were protection against delayed vomiting, protection against delayed moderate-to-severe nausea, duration of delayed symptoms (i.e., number of delayed days phase when patients experienced either vomiting or nausea), and maximum severity of delayed nausea (two or more out of the four days was considered severe). The patient’s satisfaction with antiemetic coverage was assessed on day 6 by a satisfaction VAS (a 100 mm line marked “not at all satisfied” at the left-hand end and “totally satisfied” at the right-hand end). 

• Low-risk patients who received MEC: There were no statistically significant differences between the one-day and three-day regimens.  
• Low-risk patients who received AC: The one-day regimen was significantly less effective than the three-day regimen.
• High-risk patients who received AC: The one-day regimen experienced less control than the three-day regimen (statistically significant for no full protection against chronic CINV and moderate-to-severe nausea alone). This improvement was of greater magnitude. Additional dexamethasone doses improved the protection rates against moderate-to-severe nausea on days 2 (p = 0.083), 3 (p = 0.003), and 4 (p = 0.024) postchemotherapy.
• There were no significant differences in the duration of delayed vomiting or nausea in patients receiving MEC who were at a high or low risk. 
• Acute vomiting was an independent predictor for delayed vomiting (p = 0.045), and acute moderate-to-severe nausea independently predicted delayed nausea (p = 0.0007).

The dexamethasone-sparing regimen (three-day) achieved excellent control of delayed symptoms in patients with no acute CINV and for low-risk patients receiving AC, but it was less effective in patients receiving HEC. Additional dexamethasone doses could be offered selectively.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable
• Findings not generalizable
• Other limitations/explanation:  

Patients receiving AC regimens are at an increased risk of experiencing delayed CINV. Some patients might not benefit from a dexamethasone-sparing antiemetic regimen. In this study, the reduction of dexamethasone was less effective for patients at a high risk. Extending the use of dexamethasone could produce adverse effects, so selective dexamethasone prescriptions should be individualized.

To summarize the current data and provide comprehensive evidence-based recommendations for the prevention of opportunistic infections in adult and pediatric hematopoietic stem cell transplant (HSCT) recipients.

This was an evidence-based guideline. Evidence was reviewed by multiple professional groups and panels under Centers for Disease Control and Prevention (CDC) guidance.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for pediatrics.

No results were stated. 

This guideline identified infection risks during preengraftment, postengraftment (30–100 days), and late phase (>100 days) for HSCT recipients, associated with immune system defects, device risks, and incidence of specific viral, bacterial, fungal, and mold infectious risks; very specific prevention strategies per treatment phase for allogeneic and autologous HSCT, as well as for both adult and pediatric patients; information on dosage and timing of prophylactic medication, vaccinations, and other specific medical interventions; recommendations for vaccination and behaviors of household members and close contacts; and recommendations for healthcare workers and environmental infection control practices in transplant centers. It identified phase-specific and life-long behavioral prevention, including food preparation, avoiding specific exposures, pet safety, sexual safety, travel safety, water safety, occupational exposures, and general areas to avoid for patients. 

Evidence Rating System

A - Strong evidence and substantial clinical benefit (strongly recommended)
B - Strong or moderate evidence, but only limited clinical benefit (generally recommended)
C - Insufficient evidence for efficacy or efficacy does not outweigh possible adverse consequences (optional)
D - Moderate evidence against efficacy or for adverse outcome (generally not recommended)
E- Strong evidence against (never recommended)

I - Evidence from at least one well-executed randomized trial
II - Evidence from at least one well-designed clinical trial without randomization, cohort, or case controlled, time series
III - Evidence from opinions of respected authorities

Recommendations With at Least Optional Recommendation Level

Vaccinations

• Pneumococcal vaccination (23-valent) at 12 to 24 months post HSCT in adults and children 2 years and older (BII)
• Haemophilus influenzae type b (HiB) vaccination at 12, 14, and 24 months post HSCT (BII)
• Diptheria vaccination at 14 and 24 months post HSCT if older than 7 years (BII)
• Pertussis revaccination 25 months post HSCT if not immunosuppressed
• Annual influenza vaccination for household contacts, health providers (AI), and recipients (BII)
• Polio: Not recommended for adults.  Others should be vaccinated according to guidelines with inactive. (BII)
• Hepatitis A: Recommended if patients have chronic liver disease or travel to endemic countries and for children older than 24 months living in endemic areas (BII)
• Measles, mumps, and rubella (MMR): recommended for patients older than 12 months, 24 months post HSCT, if they are not immunocompromised (AI)
• Varicella: Candidate testing and history.  Vaccinate household members and health providers who are seronegative four to six weeks before HSCT. (AIII).  Only vaccinate patients if they are seronegative and exposed.
• Live attenuated vaccinations should not be used (EIII).

Other Recommendations

• Candidate testing and sexual partner testing for herpes simplex virus (HSV) (AII)
• Antiviral prophylaxis in seropositive patients (AI)
• Use of condoms in nonmonogamous or seropositive partner relationships (applies to cytomegalovirus [CMV] and HSV prevention (BIII)
• Avoid sharing cups and eating utensils. (BIII)
• Frequent hand washing (AIII)
• Avoid contact with potentially infected respiratory secretions or saliva. (AIII)
• Candidate and partner testing for CMV antibodies (AIII)
• Antiviral prophylaxis for seropositive patients (AI)
• Avoid exposure to dust and construction areas. (AIII)
• Trimethoprim-sulfamethasaxole (TMP-SMZ) prophylaxis for pneumocystis in allogeneic patients and consideration for autologous patients (BIII)
• Antifungal prophylaxis in allogeneic patients (AI)
• Allogeneic patients should avoid contact with outhouses and skin exposure to soil or human fecal contaminants. (BIII)
• Dental evaluation and treatment before conditioning (AIII)

Food-Related

• No raw or undercooked meat or eggs should be eaten for three months post HSCT, and all immunosuppressive drugs should be stopped. (AIII)
• Antimicrobial diet restrictions are included but have no evidence base beyond expert opinion.  These include safe food handling in general, avoiding fruit with rough textures, washing fresh fruits and vegetables well, avoiding fresh-squeezed fruit and vegetable juices, raw honey, deli meats, raw uncooked grain products, unroasted raw nuts or nuts in the shell, and unpasteurized beer (such as homemade).

Environmental

• There is no strong evidence, but most researchers recommend that plants and fresh or dried flowers should not be allowed in patient rooms during hospitalization.
• For children, play areas should be disinfected at least weekly. (BIII)
• No rectal thermometers, enemas, suppositories, or rectal examinations should be used or performed while the patient is immunosuppressed. (DIII)
• Menstruating women should avoid using tampons.
• Patients should avoid exposure to crowded areas while in the hospital.  Wearing a mask when off the unit is not recommended as necessary.
• High-efficiency particulate absorption (HEPA) filtration, positive air pressure rooms, and at least 12 air exchanges/hour are recommended for allogeneic patients (BIII).  This need is not established for autologous patients, and the value of laminar air flow is not established.
• No hospital visitors with respiratory or other infectious symptoms should visit. (AIII)

Pet Safety

• Avoid exposure to animals for the first six months and during immunosuppression (no rating).
• Avoid cleaning litter boxes, cages, or feces; if necessary, wear gloves.
• Frequent hand washing after touching pets or contact with feces is recommended.

This summary is not intended to provide all content from these guidelines.  The reader should refer to the original document for complete information.

Some recommendations are not supported by research data but are provided as best current knowledge in the area.

This was a comprehensive resource, with extensive specific recommendations and identification of the evidence classification of each recommendation.  This is an excellent reference for individuals working with HSCT recipients.

To assess the clinical effectiveness of lipoaspirate graft in the treatment of postmastectomy pain syndrome

At baseline (prior to autologous fat grafting) and after treatment, pain was measured using a visual analog scale, and analgesic and drug intake were recorded. A nontreatment control group completed the same measures. At one year, measures were repeated in both groups.

• The study reported on 113 patients with severe scar retraction and postmastectomy pain syndrome related to breast cancer (treatment group = 72, control group = 41). Sixty-three patients in the treatment group and 35 patients in the control were analyzed.
• Patient age was not reported.
• The sample was assumed to be 100% female due to breast cancer population, but this was not stated.

• Single site
• Milan, Italy

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

The study was a prospective, longitudinal intervention with experimental and control groups.

• Visual analog scale for pain (0–10) at baseline and one year     
• Analgesic use recorded at baseline and one year

In the treatment group, there was a decrease in pain (p < 0.0005). The authors noted that 28 of 34 patients stopped their analgesic therapy at 13 months.

• The study has a small sample, with less than 100 participants.
• The study lacks a randomized control group.
• Information about demographics is missing, making baseline characterization of the groups difficult to ascertain.

More research is needed to determine if autologous fat grafts will benefit women with postmastectomy pain, but this may be a promising area of study.

To assess the efficacy and safety of a medical device based on electric microcurrents and vacuum mechanism on lower limb lymphedema

Ten daily sessions were performed with an electro-sound wave and vacuum medical device. Lymphoscintigraphy was performed before and after treatments, and an independent observer scored the images. Circumference tape measurement and volumetry were also calculated before and after treatment.

• N = 8  
• MEAN AGE = 40.5 years
• MALES: 25%, FEMALES: 75%
• KEY DISEASE CHARACTERISTICS: Lower extremity lymphedema

• SITE: Single site   
• SETTING TYPE: Outpatient   
• LOCATION: Ascoli Piceno, Italy

• PHASE OF CARE: Not provided

• Observational clinical and instrumental study

• Lymphoscintigraphy examination
• Electro-medical device (EMD),
• Visual analog score (1–10)
• Volumetry
• Microsoft^® Excel software

The total limb volumetry decreased from 9,145 cc to 8,714 cc after 10 sessions. There was an 8% reduction in lower limb volumetry. Ankle and midcalf circumference decreased from 27.7 cm to 27.2 cm and 26.2 cm to 25.2 cm, respectively.

The use of a medical device based on bioresonance and vacuum mechanisms appears to be safe and effective at reducing limb volume and lymphoscintigraphy parameters.

• Small sample (< 30)
• Risk of bias (no blinding)

This method of limb volume reduction may be effective. However, this was a small study size, and the results of the study require further validation.