Kautio, A.L., Haanpaa, M., Leminen, A., Kalso, E., Kautiainen, H., & Saarto, T. (2009). Amitriptyline in the prevention of chemotherapy-induced neuropathic symptoms. Anticancer Research, 29, 2601–2606.
The purpose of the study was to determine if amitriptyline would be effective in treating chemotherapy-induced peripheral neuropathy (CIPN) compared to placebo.
Patients were allocated to amitriptyline or placebo groups. Treatment was started at 25 mg per day, and doses were elevated 25 mg per week up to a maximum dose of 100 mg per day if tolerated. Treatment was continued until the end of the neurotoxic chemotherapy. Follow-up visits were performed every two months and patients were asked to maintain a diary in which they graded neutopathic symptoms by a visual analog scale twice a week. The primary end point was the appearance or progression of neuropathic symptoms based on diary data.
The study was conducted in an outpatient, single-site setting in Helsinki, Finland.
The study was designed as a double blind, randomized, placebo-controlled parallel group.
Measurements include the National Cancer Institute's Common Terminology Criteria for Adverse Events, the European Organisation for the Research and Treatment of Cancer C30 quality-of-life measure, and a visual analog scale for symptom grading.
The median follow-up was at 19–21 weeks. Seventy-four percent of patients were on the highest dose of amtriptyline, which was well tolerated. Tiredness was the most frequent reason for dose reduction. In addition, no differences were noted in intensity of neuropathy between groups. In the majority of cases, the intensity of neuropathy was mild at grade 1. Neuropathy was seen in 76% of patients after nine cycles of treatment. Because of a lack of effect, the study was discontinued earlier than planned.
The study did not demonstrate any effect by amitriptyline on the prevention or treatment of CIPN.
The findings from this study do not support the use of amitriptyline for the prevention and management of CIPN.
Kaushal, J., Gupta, M.C., Kaushal, V., Bhutani, G., Dhankar, R., Atri, R., & Verma, S. (2010). Clinical evaluation of two antiemetic combinations palonosetron dexamethasone versus ondansetron dexamethasone in chemotherapy of head and neck cancer. Singapore Medical Journal, 51(11), 871–875.
To compare the antiemetic effectiveness of palonosetron plus dexamethasone (PD) versus ondansetron plus dexamethasone (OD) for patients with head and neck cancer receiving moderately emetogenic chemotherapy (MEC)
Patients with head and neck cancer who were receiving a standardized MEC regimen (60 mg/m² IV docetaxel, 300 mg/m² IV carboplatin, and 600 mg/m² IV 5-flurouracil) were randomly assigned to one of two groups. During the first cycle of chemotherapy, group one received palonosetron plus dexamethasone (PD) as antiemetic prophylaxis therapy and group two received ondansetron plus dexamethasone (OD) as antiemetic prophylaxis therapy. For the second cycle, the groups crossed over and group one received OD as antiemetic prophylaxis therapy and group two received PD as antiemetic prophylaxis therapy. The efficacy of the antiemetic prophylaxis medication combinations was evaluated at each of the two cycles of chemotherapy by recording the intensity of nausea and the frequency of vomiting. These outcome variables were evaluated during three phases of treatment: the acute phase beginning at chemotherapy administration and ending 24 hours after, the delayed phase beginning 24 hours after chemotherapy administration and ending five days after, and overall for the five days following chemotherapy administration.
The study was conducted at a single outpatient site at a large medical center in India.
All patients were in active treatment.
The study used a randomized, crossover design.
Patients recorded each instance of emesis over the five-day, post-chemotherapy period and the intensity of their nausea using a four-point, descriptive ordinal scale ranging from no nausea to severe nausea.
No significant differences were found between groups for any of the study outcomes (emesis frequency and nausea intensity) in any of the treatment phases (acute phase, delayed phase, and overall).
No difference was found in antiemetogenic efficacy between the PD and OD groups.
The study sample was small with fewer than 100 patients.
As a second-generation 5-HT3 antagonist, palonosetron, may be more effective in preventing and reducing chemotherapy-induced nausea. Some studies have demonstrated that palonosetron is more effective at reducing chemotherapy-induced nausea and vomiting (CINV), while other studies, such as this one, have not. More research must be done before any formulary changes can be proposed.
Kaushal, P., Atri, R., Soni, A., & Kaushal, V. (2015). Comparative evaluation of triplet antiemetic schedule versus doublet antiemetic schedule in chemotherapy-induced emesis in head and neck cancer patients. ecancermedicalscience, 9, 567.
To compare the efficacy of triplet versus doublet antiemetic therapy in patients receiving mitoxantrone, etoposide, and cytarabine (MEC) chemotherapy
Patients were randomized to receive either palonosetron, dexamethasone, and aprepitant, or ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) control.
Complete response (CR), defined as no vomiting and no rescue medications, was seen in 86.7% of those on triplet therapy and 60% of those on doublet therapy in the acute phase (p < 0.05). In the delayed phase, the CR was 83.3% and 53.3% of those on triplet and doublet therapy respectively (p < 0.05). The authors cited the WHO cost effective and strategic planning guidelines to note that because triplet therapy was more effective, it was cost-effective.
The findings showed that triplet therapy was associated with higher CR rates for CINV prevention than doublet therapy (without an NK1) for patients receiving MEC.
A growing volume of research exists to compare antiemetic regimens with and without NK1s, likely because of the cost of NK1 medication. This study showed that triplet therapy containing NK1 was effective for the control of CINV in a greater proportion of patients than doublet therapy. CINV is a debilitation side effect of chemotherapy. Nurses can advocate for the use of the interventions that are most effective for symptom control among patients receiving MEC and HEC.
Kaufman, M., Singh, G., Das, S., Concha-Parra, R., Erber, J., Micames, C., & Gress, F. (2010). Efficacy of endoscopic ultrasound-guided celiac plexus block and celiac plexus neurolysis for managing abdominal pain associated with chronic pancreatitis and pancreatic cancer. Journal of Clinical Gastroenterology, 44(2), 127–134.
To evaluate the efficacy of endoscopic ultrasound-guided (EUS) celiac plexus block (CPB) and celiac plexus neurolysis (CPN) in alleviating chronic abdominal pain due to chronic pancreatitis (CP) or pancreatic cancer
The initial search retrieved 588 articles. Authors selected nine studies for analysis (six of CP pain, three of pain due to pancreatic cancer). The report provides no data regarding quality rating. Of the six studies of CP, three were full articles and three were abstracts. Of the three studies of pancreatic cancer, one was an abstract. Across most studies, methods and procedures were similar. Because current expert consensus precludes the use of absolute alcohol in CPN of patients with CP, due to the potential for inducing fibrosis and limiting future surgical options, authors excluded from the meta-analysis partial data from one study. In this study investigators had used bupivacaine and alcohol in 5 of 19 patients.
EUS CPB for CP was associated with a reduction of abdominal pain in 51% of patients but not with consistent elimination of the need for narcotic analgesics. However, in one study 47% of patients withdrew from narcotics. EUS CPB in CP patients offered temporary relief, up to 48 weeks, in some studies, but short-term pain relief may not indicate long-term effect. EUS CPN for pancreatic cancer pain was associated with a 73% reduction in pain. However, two of three studies reported that narcotic use did not change significantly post-CPN. Analysis of the patients with pancreatic cancer pain showed that the location of the tumor and the timing of EUS CPN were significant factors in the efficacy of the treatment and in pain and narcotics use.
Evidence suggests that EUS CPB is somewhat effective in managing the pain of appropriately selected patients. The evidence is not strong, however, and most effects appear to be temporary. EUS CPB is not an effective single method of pain control; EUS CPB may be useful only as a method of achieving temporary relief from acute flares.
Katzer, K., Tietze, J., Klein, E., Heinemann, V., Ruzicka, T., & Wollenberg, A. (2010). Topical therapy with nadifloxacin cream and prednicarbate cream improves acneiform eruptions caused by the EGFR-inhibitor cetuximab–A report of 29 patients. European Journal of Dermatology, 20, 82–84.
To evaluate the clinical efficacy of nadifloxacin and prednicarbate cream for treatment of cetuximab-induced acneiform eruptions
Patients who had acneiform eruptions of varying severity were treated with nadifloxacin 1% cream and prednicarbate 0.25% cream once daily for six weeks. Patients continued their usual use of sunscreens, cleansers, and antihistamines. The severity of eruptions was scored at baseline and after one, two, and six weeks of treatment.
Investigator developed skin score calculated from percentage body involvement, percentage facial involvement, and skin lesion scoring on a 3-point scale for erythema and other lesion characteristics.
A significant reduction in skin score was seen at all time points (p < .05). Subjective symptoms such as pruritus, pain, and tenderness were reported to be improved. The treatment was well tolerated. Two patients reported mild burning and erythema following application of the nadifloxacin cream.
The combination of topical quinolone and corticosteroid was effective in reducing acneiform eruptions in this group of patients.
The combination of topical quinolone and steroid may be helpful in treating EGFR-inhibitor associated acneiform rash. This study had several methodological limitations, so it does not provide strong support. Further research in this combination is warranted.
Katz, E., Dugan, N.L., Cohn, J.C., Chu, C., Smith, R.G., & Schmitz, K.H. (2010). Weight lifting in patients with lower-extremity lymphedema secondary to cancer: A pilot and feasibility study. Archives of Physical Medicine and Rehabilitation, 91(7), 1070–1076.
To assess the feasibility of recruiting and retaining cancer survivors with lower-extremity lymphedema in an exercise intervention study and to determine preliminary estimates of the safety and efficacy of the intervention
Patients participated in slow, progressive weight lifting two times weekly, supervised for two months, then unsupervised for three months. Participants were instructed in warm-up, stretching, breathing, weight training and additional stretching exercises by a certified fitness professional. Exercises were performed using variable resistance machines, free weights, and ankle weights.
The study has clinical applicability for late effects and survivorship.
The study used a pre-post design with no control.
All but one person attended at least 81% of supervised sessions. Five patients did not complete the study because of cellulitis that occurred early in the study, progression of cancer, and inconvenience. There were no significant differences in lower-limb volume. Strength increased and the six-minute walk increased.
The study was too small to draw any conclusions, and the number of drop outs for various reasons makes the feasibility of this approach for patients with lower-limb lymphedema questionable.
The sample size was small, with less than 30 participants.
The study is one of few that begins to address lower-limb lymphedema. Further study on the safety and potential benefits of exercise and weight training for this condition are needed.
Katz, M.R., Irish, J.C., & Devins, G.M. (2004). Development and pilot testing of a psychoeducational intervention for oral cancer patients. Psycho-Oncology, 13, 642–653.
The intervention involved a 95-page teaching booklet, What to Expect From Your Oral Cancer Surgery: A Guide for Patients and Families. The booklet included information about oral cancer, treatments, and effective coping strategies. Contents were divided into preparing for surgery, postoperative care, and returning home.
In the intervention group, the booklet was given to patients pre- and postoperatively by a nurse experienced in caring for patients with head and neck cancers. The preop session was 60–90 minutes of individual teaching before admission to the hospital for surgery. The predischarge session was 60–90 minutes of individual teaching several days prior to expected discharge from the hospital.
In the control group, patients received standard level of care, which included a preop meeting with the surgeon for consent to treatment as well as a brief description of the illness and treatment. Also included in the preadmission information was a tour of the ward and a team visit from the physician, dietitian, social worker, speech therapist, and enterostomal nurse. No information about coping or emotional difficulties was provided routinely. Measurements were taken at baseline, predischarge, and three months follow-up.
A randomized controlled trial design was used.
The authors reported significant improvement in anxiety scores within the intervention group from time 1 to time 3 (t = 2.88, df = 9, p = 0.018).
Katranci, N., Ovayolu, N., Ovayolu, O., & Sevinc, A. (2012). Evaluation of the effect of cryotherapy in preventing oral mucositis associated with chemotherapy: A randomized controlled trial. European Journal of Oncology Nursing, 16, 339–344.
To assess the effect of oral cryotherapy on development of oral mucositis associated with infusion of fluorouracil (5-FU) with leucovorin
Patients were randomized to cryotherapy or usual care. Prior to randomization, patients completed a study questionnaire, and 60 patients, who had similar characteristics, were selected for randomization. Ice chips were given to patients in the treatment group 5 minutes before and throughout treatment for a total of 30 minutes of continuous use. Mucositis assessment was done on days 7,14, and 21 after chemotherapy.
This was a single-site study conducted in an outpatient setting in Turkey.
Patients were undergoing the active antitumor treatment phase of care.
This was a randomized controlled trial (RCT).
The World Health Organization (WHO) mucositis grading scale was used to assess mucositis severity.
On days 7 and 14, more patients in the experimental group did not have mucositis (p < 0.05). On day 21, patients in the experimental group tended to have lower-grade or grade 0 mucositis, but the difference was not significant.
Findings demonstrated a short-term benefit of cryotherapy in patients receiving 5-FU.
Findings suggest that short-term cryotherapy may be beneficial for patients receiving bolus 5-FU; however, longer-term effectiveness may not be seen.
Kastler, A., Alnassan, H., Pereira, P.L., Alemann, G., Barbe, D.A., Aubry, S., . . . Kastler, B. (2013). Analgesic effects of microwave ablation of bone and soft tissue tumors under local anesthesia. Pain Medicine, 14, 1873–1881.
To evaluate the probability and usefulness of ablation on pain when performed via local anesthesia
Lesions targeted included spinal, sacral, and extraspinal. A visual analog scale was used to evaluate pain from 0–10 pre- and post-procedure, after one week, at 3 months, at 6 months, and at 12 months. Only three patients had data at 12 months.
The mean ablation time was 4.09 minutes, with an average of 4.2 cycles and mean ablation power of 60 W. Pre-procedure pain score was 7.2 (SD = 0.97). Post-procedure, mean visual analog scale scores were 1.64 on day 0, 1.82 on day 7, and 2.05 by the end of one month. At three months, the mean pain score was 2.13, and at six months, it was 2.36. One patient had no pain relief by one month, and follow-up was discontinued. One patient had a soft tissue abscess at the ablation site, which was drained. No other major or minor complications were found.
Microwave ablation of bone lesions may have some promise for relief of bone pain in patients with cancer.
This study suggests that microwave ablation of painful bone lesions may be feasible and may substantially reduce bone pain. This was an extremely small sample. Further well-designed studies are warranted.
Kasseroller, R.G., & Brenner, E. (2010). A prospective randomised study of alginate-drenched low stretch bandages as an alternative to conventional lymphologic compression bandaging. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 18(3), 343–350.
To determine whether a difference exists between conventional and alginate bandaging in regard to lower-volume increase or re-filling of the lymphedema when the bandages are applied in periods with reduced decongestive therapy.
The study included an A group and a B group who received 22 days of treatment with manual lymphatic drainage (MLD) including three inpatient weekends. On inpatient weekends low-stretch compression dressing and alginate semi-rigid bandaging were compared. Patients using low-stretch compression dressings (Group A) had bandages applied Friday evening after MLD and then again on Saturday and Sunday after receiving intermittent pneumatic compression (IPC); patients were instructed to not remove bandaging during sleep. Group B used alginate semi-rigid bandages and also were bandaged after MLD on Friday. Patients were instructed to not remove this bandage for the entire weekend. IPC took place in this group with the bandage remaining in place. Volumes were measured prior to bandaging on Friday and then again on Monday prior to MLD.
The study used a randomized controlled trial design.
There was a statistical difference between the two groups in terms of volume depletion on days 1–5 (p = 0.010). Days 5–8 had a significantly smaller difference (p = 0.001) and days 8-12 was insignificant. Days 12–15 had a significant statistical difference (p=0.001), days 15–19 not significant, and days 19–22 significant (p = 0.003). All significance was in favor of Group B, although the overall statistics were not significant. In terms of tolerance, Group B using the alginate semi-rigid bandage had a statistically significant difference in comfort on the second (p = 0.0004) and third (p = 0.024) weekends.
Although there was no significant difference in volume depletion for women from Group A to Group B, there was a statistically significant difference in the overall comfort of patients in Group B with the semi-rigid bandaging, which can directly impact the women’s quality of life during treatment for lymphedema.
The sample size was small (N < 100).
Some positive changes in women with lympedema rely solely on patient education and compliance with exercise. Patient education and physical therapy must be included in after surgery.