Giacomelli, I., Scartoni, D., Fiammetta, M., Baki, M., Zei, G., Muntoni, C., . . . Livi, L. (2015). Oral lapacho-based medication: An easy, safe, and feasible support to prevent and/or reduce oral mucositis during radiotherapy for head and neck cancer. Nutrition and Cancer, 67, 1249–1254.
To demonstrate the benefits and tolerance of a multicomponent herbal oral agent for mucositis in patients with head and neck cancer receiving radiation or combination therapy
Orasol plus solution (a mixture of lapacho, hyaluronic acid, green tea, calendula, erisiom, propolis, marigold, plantain, and mauve) was administered to patients from the first day of radiotherapy until the end of therapy. It was given at a dose of 10 ml three times daily. The authors indicated that it can be swallowed, but did not state how patients were instructed to use it.
Of the patients, 47.5% developed grade 1, 27.5% developed grade 2, and 10% developed grade 3 mucositis. Median Gy doses to the oral mucosa were lowest in those with grade 1 mucositis. Six patients did not develop mucositis. None of these patients was receiving radiation and chemotherapy. The prevalence of grade 2 or greater mucositis was higher among smokers (p < 0.02). One patient developed itching and one developed glossitis. Twenty-five percent needed an increase in dosage or additional analgesic therapy.
The herbal nutritional supplement tested here may have some benefit for the prevention of severe mucositis in patients with head and neck cancer during therapy. Additional research is needed to establish any benefit.
Very few interventions have been shown to be effective for the prevention and treatment of oral mucositis in patients receiving cancer treatment. The substance tested here appeared safe, and findings suggest that it may be beneficial; however, numerous study design limitations exist. Further research with this agent is needed to determine efficacy.
Ghosh, S., & Dey, S. (2010). Comparing different antiemetic regimens for chemotherapy induced nausea and vomiting. International Journal of Collaborative Research on Internal Medicine and Public Health, 2, 142–156.
To compare the efficacy and safety of ondansetron, granisetron, and palonosetron used with equal dosage of dexamethasone with moderately emetogenic chemotherapy (MEC) to highly emetogenic chemotherapy (HEC)
The study was conducted in a single outpatient setting at Bankura Smmilani Medical College and Hospital in India.
All patients were in active treatment.
This was a double-blind, randomized controlled trial.
Study findings suggest that palonosetron may be more effective for CINV prevention and control with MEC. Palonosetron, as pointed out in this article, is much more expensive than the other medications used, so considering its use in the type of chemotherapy treatment where it appears to be more effective makes sense. Differences in efficacy seen over time suggest that the same drug may have the same efficacy in a patient over the course of therapy. Consideration might be given to studying this issue and the potential of switching drugs at various points.
Ghoreishi, Z., Esfahani, A., Djazayeri, A., Djalali, M., Golestan, B., Ayromlou, H., . . . Darabi, M. (2012). Omega-3 fatty acids are protective against paclitaxel-induced peripheral neuropathy: A randomized double-blind placebo controlled trial. BMC Cancer, 12, 355.
Investigate omega 3 fatty acids in reducing the incidence and severity of paclitaxel-induced peripheral neuropathy
Patients were randomly assigned to receive omega 3 fatty acid supplements at a dose of 640 mg three times daily, or an identical gelatin placebo capsule. All patients received the intervention throughout treatment and for one month after chemotherapy treatment. Patients were evaluated prior to chemotherapy and one month after completion of chemotherapy. Evaluations were done by a single neurologist.
PHASE OF CARE: Active antitumor treatment
Double-blind, placebo-controlled, randomized trial
70% of patients receiving omega 3 fatty acid supplements did not develop peripheral neuropathy, compared to 40% in the placebo group (odds ratio = 0.3, .95% CI = 0.10–0.88, p = .029). There was a non-significant trend toward lower severity of symptoms in those receiving omega 3 fatty acids. No significant differences existed between groups in individual nerve conduction study results. Significant differences did exist between groups in serum EPA and DHA concentrations (p < .005) with higher levels in the experimental group. No relationship existed between serum concentrations and peripheral neuropathy scores.
Findings suggest that oral supplementation with omega 3 fatty acids may have a protective effect for development of peripheral neuropathy in patients receiving paclitaxel.
Findings suggest a neuroprotective effect of omega 3 fatty acid supplementation. These are promising results, which warrant further research in well-powered studies and in the context of other types of neurotoxic chemotherapeutic agents.
Gholizadeh, N., Mehdipoor, M., Sajadi, H., & Moosavi, M.S. (2016). Palifermin and chlorhexidine mouthwashes in prevention of chemotherapy-induced mucositis in children with acute lymphocytic leukemia: A randomized controlled trial. Journal of Dentistry, 17, 343–347. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5136413/pdf/JDS-17-343.pdf
To assess the effectiveness of palifermin in preventing mucositis in children with acute lymphocytic leukemia (ALL) undergoing chemotherapy
A clinical trial of 90 children with ALL who were randomized to receive chlorhexidine or palifermin. One group received 60 mcg/kg palifermin as an IV bolus once daily three days before and three days after chemotherapy. The other group received chlorhexidine mouthwash administered once daily three days before and three days after chemotherapy.
Randomized, controlled trial
The World Health Organization (WHO) Oral Toxicity Scale was used for grading mucositis. The data were analyzed with two-way ANOVA.
The group that used the palifermin had a decreased incidence and severity of chemotherapy-induced mucositis.
Palifermin reduced oral mucositis in children with ALL.
In this study, palifermin has reduced the severity of mucositis in children with ALL who received induction and intensification chemotherapy.
Ghalayani, P., Emami, H., Pakravan, F., & Nasr Isfahani, M. (2014). Comparison of triamcinolone acetonide mucoadhesive film with licorice mucoadhesive film on radiotherapy-induced oral mucositis: A randomized double-blinded clinical trial. Asia-Pacific Journal of Clinical Oncology. Advance online publication.
To determine whether improved pain control and/or ulcer management of oral mucositis in patients with head and neck cancer receiving postoperative radiation therapy can be achieved with licorice mucoadhesive film or triamcinolone acetonide mucoadhesive film
When patients reached a World Health Organization (WHO) grade 2 or 3 mucositis rating, they were randomized according to a balanced block randomization to receive either triamcinolone (T) (.5 mg triamcinolone acetonide in film) or licorice (L) (.18 mg polyphenols as pyrogallol extracted from licorice root) in addition to the standard of care. The standard of care included frequent mouth rinses using boiled water, regular brushing and flossing, scaling, and the removal of plaque and tartar during radiation therapy. The films were applied to the upper lip four times per day. The intervention continued for four weeks or until the cessation of mucositis. The use of analgesics was not permitted before or during the study. Two investigators rated the severity of the mucositis, and data were collected on a weekly basis. Compliance was measured by counting unused films.
Double-blinded, prospective, randomized, controlled trial
There was a significant difference in the mean value of the mucositis scores for the T and L interventions when compared to the control group (p < .05) although there was no difference between the two intervention groups. No statistically significant difference was achieved (p > .05) between interventions in reducing pain during radiation therapy. However, each was statistically significant (p < .05) in reducing pain during radiation therapy when compared to the standard of care alone. A slight additional reduction in pain was noted in the L group, but it was not significant.
Both triamcinolone acetonide mucoadhesive film and licorice mucoadhesive film reduced the mean mucositis score and the pain associated with mucositis during radiation therapy when compared to the group that only received standard of care. However, there was no significant difference between the two interventions for mucositis scores or pain scores when compared to each other.
Although there is not enough evidence to recommended the use of this intervention, this study is a good starting point for nurse research to continue working toward finding additional, better ways to treat and prevent oral mucositis and its complications in patients undergoing cancer treatment.
Ghadiany, M., Rahimi, H., Rezvani, H., Mohammad Alizadeh, A., Zamani, N., Mehdizadeh, M., & Foratyazdi, M. (2016). Prophylaxis of neutropenic fever with ciprofloxacin in patients with acute myeloid leukemia treated with intensive chemotherapy. Asia-Pacific Journal of Clinical Oncology, 12, e11–e15.
To compare outcomes between patients with acute myeloid leukemia (AML) who did or did not receive prophylactic ciprofloxacin 500 mg twice per day for neutropenic fever
Administration of prophylactic ciprofloxacin 500 mg twice daily for the prevention of neutropenic fever
PHASE OF CARE: Active antitumor treatment
Retrospective, medical record, cross-sectional evaluation
Outcome measurements included rate of neutropenic fever episodes, microbiologic findings, patterns of resistance, and mortality. Independent variables included demographic data, type of AML, and administration or absence of the intervention (prophylactic ciprofloxacin). Administration of granulocyte–colony-stimulating factors were also included in the analyses.
No statistically significant differences were found in any of the outcome variables between patients who received prophylactic ciprofloxacin compared to patients who did not receive the prophylactic treatment. Specifically 80% of the treatment group and 82% of the control had neutropenic fevers. Although mortality rates were lower among those who received the prophylactic ciprofloxacin compared to those who did not, the differences were not statistically significant.
There is no benefit of prophylactic ciprofloxacin for the prevention of neutropenic fever among patients undergoing induction chemotherapy for AML. These findings aligned with other similar studies with the exception of one that the researchers found in the literature.
Understanding the ineffectiveness of prophylactic ciprofloxacin for the prevention of febrile neutropenia in patients undergoing induction chemotherapy for AML can aid in treatment decisions and promote the use of more effective interventions.
Gewandter, J.S., Mohile, S.G., Heckler, C.E., Ryan, J.L., Kirshner, J.J., Flynn, P.J., . . . Morrow, G.R. (2014). A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): A University of Rochester CCOP study of 462 cancer survivors. Supportive Care in Cancer, 22, 1807–1814.
To determine the effectiveness and safety of the topical application of a combined 2% ketamine and 4% amitriptyline (KA) cream for reduction of chemotherapy-induced peripheral neuropathy (CIPN) in patients who have completed chemotherapy
One week prior to enrollment, subjects completed a seven-day daily pain, numbness, and tingling diary over the past 24 hours. Subjects answered the question for any of the three symptoms in either their hands or feet. At enrollment, subjects were instructed to use a measuring device for application of 4 g of either KA or placebo cream twice daily to each area of hands or feet with any pain, numbness, or tingling. The seven-day daily pain, numbness, and tingling diary for pain over the past 24 hours, by numeric rating scale (NRS), was completed at three and six weeks after enrollment. A secondary analysis for pain using NRS was done at baseline, three, and six weeks.
No therapeutic effect was observed with the application of KA cream to the affected areas on hands or feet for reduction of pain, numbness, and tingling (p = 0.363). Secondary analysis for pain alone did not show a statistically significant difference between groups comparing means at 95% CI (KA cream, 4.64; placebo, 4.68). Patients in the treatment regimen group of prior taxanes, regardless of receiving study treatment with either KA or placebo, reported a reduction in pain, numbness, and tingling at six weeks (p = 0.042). No statistically significant adverse events were reported for the KA treatment group compared to the placebo group.
This study showed no therapeutic benefit for the topical application of KA cream for CIPN.
Further studies need to be done to investigate if any combination or separate topical compound targeting specific nociceptive pathways has a therapeutic benefit for CIPN.
Gergich, N.L.S., Pfalzer, L.A., McGarvey, C., Springer, B., Gerber, L.H., & Soballe, P. (2008). Preoperative assessment enables the early diagnosisand successful treatment of lymphedema, Cancer 112, 2809–2819.
To investigate the efficacy of a surveillance method for the diagnosis and management of subclinical lymphedema in patients with early-stage breast cancer
Diagnostic criteria for lymphedema included a volume increase of 3% in the affected upper limb compared with the patient’s preoperative measurement and with consideration of the contralateral limb volume changes. When lymphedema was diagnosed, garments were prescribed for daily wear. No activity limitations were placed for the duration of the intervention. At follow-up, when limb volume decreased, women were advised to continue wearing the garment only when completing strenuous exercise or activity, during air travel, with symptoms of heaviness, or if visible swelling appeared. Time points of evaluation were the preoperative visit and 1, 3, 6, 9, 12, and 18 months postoperatively.
The study took place at the National Naval Medical Center Breast Care Center in Bethesda, MD.
The study used a case-control design.
The time to onset of lymphedema averaged 6.9 months postoperatively. The subclinical lymphedema group had significantly higher upper-limb volume than the control group when the compression intervention was introduced. After the intervention, a statistically significant mean 48 ml volume decrease was realized (p < 0.0001) in the subclinical lymphedema group with activity-related garment wear only compared with 2.3 ml decrease in the control group. The mean duration of the intervention was 4.4 weeks. Volume reduction was maintained at an average follow-up of 4.8 months after the intervention.
Preoperative assessment in the context of a prospective surveillance model enables the early detection and management of subclinical lymphedema. An early intervention protocol reduces the affected limb volume to near baseline measures and prevents progression to a more advanced stage of lymphedema for at least the first year postoperatively.
The study does not use a randomized controlled design.
Preoperative baseline measurement is vital to successfully diagnosing subclinical lymphedema. However, currently, physical therapists in clinical practice rely on an impairment-based model for diagnosing and treating lymphedema. The paradigm is inadequate and a shift in the current practice pattern in favor of surveillance models is necessary. Further research is warranted to confirm the long-term clinical and cost effectiveness of this surveillance model compared with a traditional impairment-based model in treating breast cancer-related lymphedema.
Gerber, P.A., Meller, S., Eames, T., Buhren, B.A., Schrumpf, H., Hetzer, S., ... Homey, B. (2012). Management of EGFR-inhibitor associated rash: A retrospective study in 49 patients. European Journal of Medical Research, 17(1), 4.
To compare the effectiveness of three established rash-management strategies in EGFR-inhibitor (EGFRI) associated rash development
Rash severity was assessed during the initial presentation to clinic by applying the EGFR-Induced Rash Severity Score (ERSS). Three different EGFRI rash-management strategies were compared, and each targeted the inflammatory and/or the infectious characteristics of the rash. In stage 1 of the study, 21 patients (ERSS 10.3 to 77.9) were treated topically with mometasone furoate cream (a topical anti-inflammatory) twice daily. In stage 2 of the study, 23 patients (ERSS 12.5 to 67.1) were treated topically with nadifloxacin 1% cream (a potent topical fluoroquinolone antibiotic) once daily in the morning, in combination with prednicarbate 0.25% cream (a topical glucocorticosteroid) once daily in the evening. In stage 3 of the study, five patients (ERSS > 50) received topical nadifloxacin and prednicarbate 0.25% cream in combination with the systemic retinoid isotretinoin 10–20 mg/day. Rash severity was reassessed after three weeks of specific therapy to manage the dermatologic reaction.
Retrospective, uncontrolled, comparative study
Patients' EGFRI-associated rash severity improved significantly with all three dermatological treatments, which are aligned with recent expert recommendations: topical mometasone furoate cream (p = 0.00009); nadifloxacin 1% cream and prednicarbate 0.25% cream (p = 0.03); and nadifloxacin 1% cream and prednicarbate 0.25% cream plus systemic isotretinoin (p = 0.015).
In summary, the results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions, including topical glucocorticosteroids, topical antiseptics/antibiotics, and systemic retinoids. Topical mometasone furoate cream was the only therapy that resulted in a complete resolution of all rash symptoms in one patient.
Nurses should consider treating mild to moderate EGFRI skin rashes with basic skin care measures in combination with topical glucocorticosteroids or combined regimens using glucocorticosteroids and antiseptics/antibiotics. Nurses should be aware that more severe or therapy-resistant rashes may respond with the addition of systemic retinoids.
Gerber, B., Koppel, J., Paul, M., Nguyen-Kim, T.D., Frauenfelder, T., Nair, G., . . . Manz, M.G. (2014). Efficacy of anti-fungal but not anti-bacterial prophylaxis in intensive primary AML therapy: a real-world, retrospective comparative single-centre study. Swiss Medical Weekly, 144, w13985.
To assess the effect of primary prophylaxis with posaconazole and levofloxacin on the incidence of invasive fungal infections (IFI) and bacteremia
This was a retrospective, single-center study that evaluated two groups of adult patients with acute myeloid leukemia/acute promyelocytic leukemia (AML/APL) and high-grade myelodysplastic syndrome (MDS) receiving intensive chemotherapy. The primary endpoint was IFI and bacteremia with secondary endpoints of overall survival at day 100 and at two years, time from the initiation of chemotherapy to the onset of IFI, the use of intravenous and oral antifungal and antibacterial therapy, and total duration of antifungal and antibacterial medication.
Retrospective
IFIs were significantly less common in the prophylaxis group after the first chemotherapy cycle (33.3% versus 65.8%; p = 0.0088). IFIs were significantly less common in the prophylaxis group after the last chemotherapy cycle (53.9% versus 88.9%; p = 0.0021). Chemotherapy cycles that were complicated with bacteremia occurred at a rate of 34.6% with prophylaxis and 32.3% in the nonprophylaxis group; p = 0.8. Positive blood cultures were 50 and 43, respectively, with a nonsignificant trend to more gram-negative infections in the nonprophylaxis group (42% versus 14%; p = 0.073) and to more gram-positive infection in the prophylaxis group (86% versus 58%; p = 0.092). Overall survival at 100 days and at two years, as well as the use of antiviral medications, did not differ between the two arms. Fewer fever days (5.6 versus 9.2; p = 0.00032) and less cytarabine toxicity (18.3% versus 35%; p = 0.025) were observed in the prophylaxis arm.
This single-center retrospective study of posaconazole prophylaxis was efficient in reducing the possible IFIs with a number needed to treat to prevent one IFI of only three. This institution had a relatively high rate of IFIs when compared to published data. Posaconazole for prophylaxis was cost-effective. There was no benefit seen in the use of levofloxacin in preventing bacteremia.
Oncology nurses should be aware of facility policies relating to the use of prophylaxis for IFI and bacteremia and should understand the local climate that may affect the rate of IFIs. This facility used posaconazole and levofloxacin as prophylaxis agents. Other agents exist and are currently in use that may produce different outcomes.