Censabella, S., Claes, S., Orlandini, M., Braekers, R., Thijs, H., & Bulens, P. (2014). Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: Reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol. European Journal of Oncology Nursing, 18, 499–504.
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.
Retrospective study
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.
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.
Celio, L., Frustaci, S., Denaro, A., Buonadonna, A., Ardizzoia, A., Piazza, E., … Italian Trials in Medical Oncology Group. (2010). Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: A randomized, multicenter, phase III trial. Supportive Care in Cancer,19, 1217–1225.
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 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.
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.
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.
Celio, L., Denaro, A., Agustoni, F., & Bajetta, E. (2012). Palonosetron plus 1-day dexamethasone for the prevention of nausea and vomiting due to moderately emetogenic chemotherapy: Effect of established risk factors on treatment outcome in a phase III trial. The Journal of Supportive Oncology, 10(2), 65–71.
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 was conducted at multiple sites (not specified) in Italy.
This was a prespecified, posthoc analysis of a randomized, multicenter, phase III trial.
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.
Celio, L., Agustoni, F., Ricchini, F., Dotti, K., Niger, M., & Braud, F.D. (2013). Palonosetron plus dexamethasone in highly emetogenic chemotherapy: Pooled data from two phase III trials. Future Oncology, 9(10), 1451–1458.
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.
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.
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.
Celio, L., Bonizzoni, E., De Braud, F., Agustoni, F., & Aapro, M. (2016). Should clinicians always administer dexamethasone beyond 24 h after chemotherapy to control delayed nausea and vomiting caused by moderately emetogenic regimens? Insight from the re-evaluation of two randomized studies. Supportive Care in Cancer, 24, 1025–1034.
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).
Secondary analysis of two phase 3, randomized, controlled trials
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.
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.
Centers for Disease Control and Prevention, Infectious Disease Society of America, & American Society of Blood and Marrow Transplantation. (2000). Guidelines for preventing opportunistic infections among hematopoietic stem cell transplant recipients. MMWR Recommendations and Reports, 49, 1–125, CE1–CE7.
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.
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
Other Recommendations
Food-Related
Environmental
Pet Safety
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.
Caviggioli, F., Maione, L., Forcellini, D., Klinger, F., & Klinger, M. (2011). Autologous fat graft in postmastectomy pain syndrome. Plastic and Reconstructive Surgery, 128, 349–352.
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 was a prospective, longitudinal intervention with experimental and control groups.
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.
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.
Cavezzi, A., Paccasassi, S., & Elio, C. (2013). Lymphedema treatment by means of an electro-medical device based on bioresonance and vacuum technology: Clinical and lymphoscintigraphic assessment. International Angiology, 32, 417–423.
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.
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.
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.
Cauwels, R.G., & Martens, L.C. (2011). Low level laser therapy in oral mucositis: A pilot study. European Archives of Paediatric Dentistry, 12, 118–123.
To study the capacity of pain relief and wound healing of low-level laser therapy (LLLT) in chemotherapy-induced oral mucositis in a pediatric population
Children were treated using a GaAIAs diode laser with 830 nm continuous wavelength an output of 150 mW. Laser was applied every 48 hours until complete healing of the lesion occurred.
The study was conducted at a single site in Belgium.
The study used a convenience sample.
Fifty episodes of oral mucositis were included. Pain scores improved after each session with only one exception.
The LLLT appeared to be effective for pain relief in this population.
Castaman, G., Bona, E.D., Schiavotto, C., Trentin, L., D'Emilio, A., & Rodeghiero, F. (1997). Pilot study on the safety and efficacy of desmopressin for the treatment or prevention of bleeding in patients with hematologic malignancies. Haematologica, 82, 584–587.
To determine if desmopressin use is effective to prevent bleeding episodes for patients with thrombocytopenia due to bone marrow failure or idiopathic thrombocytopenic purpura (ITP)
Desmopressin was delivered as 0.4 microgram/kg diluted in 100 mL of NS infused over 30 minutes. Bleeding time was assessed (using standard procedure) before the start of infusion and at one and four hours postinfusion. It is not clear how patients were chosen for inclusion in this study but all had a bleeding event.
All of the patients had a favorable response after one infusion of desmopressin. Bleeding time slowed during infusion and stopped usually within one hour. No nasal packing was required. Patients were able to have scheduled dental procedures, none required platelet transfusions, and no significant side effects were noted from the desmopressin. None of the patients had evidence of disseminated intravascular coagulation.
The findings of this pilot study are interesting to consider for hematologic malignancy groups of patients who receive multiple platelet transfusions and are at risk to become refractory to platelets. Further experimentation is needed to validate the results found here, but on a case-by-case basis, desmopressin infusion could be helpful to decrease bleeding time in thrombocytopenic patients.
At this time, this pilot study does not warrant a change in practice due to its severe limitations of generalizability. There needs to be randomized, clinical trials before a change in practice can be endorsed.