Tummel, E., Ochoa, D., Korourian, S., Betzold, R., Adkins, L., McCarthy, M., . . . Klimberg, V.S. (2016). Does axillary reverse mapping prevent lymphedema after lymphadenectomy? Annals of Surgery. Advance online publication.
To further validate previous findings that an axillary reverse mapping (ARM) technique enabling the preservation of arm lymphatics can reduce the postoperative lymphedema rate in women having sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
ARM was conducted intraoperatively with technetium in the breast and blue dye in the arm. Arm volume displacement measures were conducted preoperatively and every six months. Follow-up ranged from 3–54 months, with an average of 20 months. Lymphedema rates of sample cases were compared to those of a group that did not have ARM.
SNLB mapping was successful in 98.5% of the patients, and ALND lymphatics or blue nodes were identified in 71.8% of the procedures. After SLND, 0.8% had findings of lymphedema, and 6.5% had lymphedema after ALND. In cases where blue lymphatics were identified and able to be preserved, the SLNB lymphedema rate was 1.2%; the lymphedema rate in ALND cases was 6.9%. These rates were compared to reported rates with SLNB ranging from 0%–13%.
ARM may help preserve lymphatic structures and reduce the rates of postoperative lymphedema.
A variety of surgical techniques aimed at reducing postoperative lymphedema are being examined. This study describes one method of ARM that may be beneficial. Further research is needed to determine efficacy with concurrent comparison, the techniques that are most effective, and the role of ARM in overall lymphedema prevention and management.
Tulipani, C., Morelli, F., Spedicato, M.R., Maiello, E., Todarello, O., & Porcelli, P. (2010). Alexithymia and cancer pain: The effect of psychological intervention. Psychotherapy and Psychosomatics, 79(3), 156–163.
To evaluate the impact of psychological intervention on pain perception and levels of alexithymia in patients with cancer
For six months, patients were randomly included in a psychological intervention or control group. The intervention consisted of biweekly 90-minute sessions provided by a clinical psychologist trained in psychotherapy and psycho-oncology. Main aspects included psychoeducation regarding mechanisms of pain, daily management of cancer-related issues, emotional reaction to illness, problem solving, cognitive restructuring of dysfunctional illness-related concerns and beliefs, stress management, and progressive relaxation. Investigators assessed outcomes at baseline and at the end of the study. Authors did not describe the control condition.
Randomized controlled trial
Control patients were significantly younger and had more progressive cancer than those in the intervention group (p = 0.01). In multiple regression analysis, only alexithymia and scores from the physical component of the SF-12 were predictive of pain intensity (p < 0.001). Patients with progressive disease had higher pain intensity, more interference with daily living, and worse pain (p < 0.001). At the end of six months, compared to controls, patients who received the intervention had significantly lower scores relating to pain intensity (p = 0.03), alexithymia (p < 0.001), hypochondriasis (p = 0.016), and disease perception (p = .013) and showed improvement in these problems from baseline (p < 0.007).
Findings of this study showed that the psychological intervention tested seemed to have a positive effect on pain and alexithymia in patients with cancer. Alexithymia was predictive of pain intensity.
Findings suggest that psychological intervention, including cognitive behavioral techniques and progressive relaxation, can be helpful to patients in regard to management of pain; however, limitations of the study design must be considered when interpreting results. The intervention provided was time-consuming and would be associated with cost, which was not discussed. Future researchers should construct well-designed studies to determine the most helpful type and dosage of interventions of this type.
Tuca, A. (2010). Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review. Cancer Management and Research, 2, 1–12.
To evaluate the antiemetic efficacy of transdermal granisetron in chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and highly emetogenic chemotherapy
This was a multisite study conducted in the inpatient setting. The phase II trial was conducted in Germany. The phase III trial was conducted in nine countries.
All patients were in active treatment. Clinical applications of these studies are late effects and survivorship.
In the first trial, patients used a Likert-type scale and visual analog scale (VAS) to measure CINV.
Transdermal granisetron is effective and safe in controlling acute emesis induced by chemotherapy with moderate and high emetogenic potential; its efficacy and safety are fully comparable with those of oral granisetron.
Age, gender, cancer type, and stage were not mentioned.
The transdermal route may bring more comfort to patients. The patch is simple to apply and is maintained throughout chemotherapy without skin problems in most patients. The use of transdermal patch can avoid one of the many venous manipulations necessary in chemotherapy. Also, patches could be helpful in patients with swallowing problems. Nurses need to consider obstacles, including cost and insurance coverage, when selecting antiemetics.
Tsukuda, M., Ishitoya, J., Mikami, Y., Matsuda, H., Katori, H., Horiuchi, C., … Toth, G. (2009). Antiemetic effects of granisetron and dexamethasone combination therapy during cisplatin-containing chemotherapy for head and neck cancer: Dexamethasone dosage verification trial. International Journal of Clinical Oncology, 14, 337–343.
To determine the optimal dose of dexamethasone in combination with granisetron for chemotherapy-induced nausea and vomiting (CINV) control with cisplatin-containing chemotherapy
Patients were randomized to either receive 8 mg dexamethasone before chemotherapy and 24, 48, and 72 hours after chemotherapy during cycle 1, and 16 mg dexamethasone at the same time periods with cycle 2 of chemotherapy (8 mg antecedent group), or dosing of dexamethasone in the opposite sequence. All patients also received 3 mg granisetron with each dexamethasone administration. Physicians had discretion to provide addition treatment in cases of extreme nausea or vomiting. Symptoms were evaluated daily for 5 days.
The study was conducted at a single site in Japan.
All patients were in active treatment.
This was a randomized crossover trial.
Overall efficacy rates ranged from 47.2% on day 5 to 88.9% on day 1. No differences were found at any time point between groups.
No difference was found in antiemetic effect between 8 mg and 16 mg dexamethasone dosing.
The study suggests that lower dosages of dexamethasone may be as effective as higher doses for CINV management. Further research in this area is needed. Lower dosing may help to reduce potential side effects of steroids.
Tsukahara, K., Nakamura, K., Motohashi, R., Sato, H., Endo, M., Katsube, Y., . . . Suzuki, M. (2014). Antiemetic therapy of fosaprepitant, palonosetron, and dexamethasone combined with cisplatin-based chemotherapy for head and neck carcinomas. Acta Oto-Laryngologica, 134, 1198–1204.
To determine the effects of triple-drug therapy on chemotherapy-induced nausea and vomiting (CINV) in patients with head and neck cancer
Thirty men received 53 cycles of chemotherapy, and 11 women 18 cycles of chemotherapy consisting of cisplatin, docetaxel, and 5-fluorouracil. Patients received concomitant radiation therapy except in the induction phase. Prior to each cycle, patients received fosaprepitant at 150 mg/kg, palonosetron at 0.75 mg/kg, and dexamethasone at 10 mg/kg. They also received dexamethasone at 6.6 mg/kg daily for three days after chemotherapy. Each patient received a diary to record their experiences of nausea and vomiting with each cycle.
Prospective, quantitative, nonrandomized, nonblinded trial
A complete response (CR) was defined as no vomiting and no rescue therapy. In the overall phase, 69% (49 of 71) of courses achieved CR. The rate of no vomiting in the overall phase was 90.1%. Nausea in acute phase was reported as no nausea or slight nausea in 91.5% of patients. 87.3% of patients experienced no changes in or slightly reduced food intake, and 85.9% of patients reported good or relatively good general condition in the acute phase. In the delayed phase, no nausea to slight nausea was reported in 56.3% of patients, and 43.7% reported no changes in or slightly reduced food intake. 53.5% reported good to relatively good general condition.
In the overall phase, the majority of patients achieved a CR and reported no nausea or slight nausea. More patients experienced some nausea during the delayed phase than during the overall phase.
Triple-drug therapy should be considered during prophylaxis for CINV in patients with head and neck cancer receiving chemotherapy. Although the majority of patients experienced CR during the overall phase, more patients experienced nausea in the delayed phase. Additional interventions to prevent and treat CINV in the delayed phase may be necessary.
Tsujimoto, T., Yamamoto, Y., Wasa, M., Takenaka, Y., Nakahara, S., Takagi, T., . . . Ito, T. (2014). L-glutamine decreases the severity of mucositis induced by chemoradiotherapy in patients with locally advanced head and neck cancer: A double-blind, randomized, placebo-controlled trial. Oncology Reports, 33, 33–39.
To investigate whether L-glutamine (glutamine) decreases the severity of mucositis in the oral cavity, pharynx, and larynx induced by chemoradiotherapy (CRT)
Patients with squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx, or larynx (HNC) receiving CRT were randomized to orally receive either glutamine (group G) or placebo (group P) at a dose of 10 g three times per day throughout the CRT course.
Double-blinded, randomized, placebo-controlled trial that excluded patients with active mouth or throat soreness before treatment, uncontrolled diabetes mellitus, or severe renal or hepatic insufficiency.
The study demonstrated that glutamine significantly decreased the severity of CRT-induced mucositis in patients with HNC. Patients (group G) receiving glutamine had a decreased the incidence of grade 4 mucositis. The mean duration of supplemental nutrition because of severe mucositis was significantly shorter in group G than in group P (group G, 18 ± 13; group P, 27 ± 11; p = .046). Treatment delay caused by mucositis was observed in zero patients in group G and in 15% of patients in group P. In addition, NRS scores were significantly lower in group G than in group P at weeks 4, 5, and 6 (p = .049, p = .019, p = .032, respectively).
The study showed that glutamine significantly decreases the severity of CRT-induced mucositis in patients with cancer, which in turn will improve quality of life for patients.
This study could not provide conclusive results of glutamine in the prevention and treatment of oral mucositis. The study indicated the need for an integrative and multidisciplinary approach in patient care, which could result in substantial advances in the outcomes of cancer therapy and the improvement in patient quality of life. However, there is no known specific dose for glutamine, and it has not been approved by the U.S. Food and Drug Administration for the treatment of mucositis during chemoradiotherapy.
Tsuji, D., Kim, Y.I., Taku, K., Nakagaki, S., Ikematsu, Y., Tsubota, H., … Daimon, T. (2011). Comparative trial of two intravenous doses of granisetron (1 versus 3 mg) in the prevention of chemotherapy-induced acute emesis: a double-blind, randomized, non-inferiority trial. Supportive Care in Cancer, 20, 1057–1064.
To determine the optimal IV granisetron dose, 1 or 3 mg, in patients with cancer receiving moderately emetogenic chemotherapy (MEC) or high emetogenic chemothrerapy (HEC)
Patients received 1 mg or 3 mg granisetron with adequate dosing of dexamethasone (20 mg IV dexamethasone on day 1 for patients receiving cisplatin-, anthracycline-, and cyclophosphamide-based regimens and 10 mg IV dexamethasone prior to chemotherapy for patients receiving MEC regimens). Granisetron and dexamethasone were diluted and administered 10-30 minutes before chemotherapy. Rescue antiemetic medication was possible, and the usage was recorded. Nausea and vomiting were recorded for seven days.
This was a multisite study conducted at 10 centers located throughout Japan. The setting type was not specified.
Patients were undergoing the active treatment phase of care.
This was a double-blind, randomized, noninferiority trial.
Patient diaries were used to record episodes of acute and delayed nausea, vomiting, use of rescue antiemetics, and bowel patterns.
Results indicated that 1 mg of granisetron was not inferior in effect to a 3-mg dose. The primary endpoint was the proportion of patients with a complete response during the first 24 hours after chemotherapy. For the primary endpoint, 359 patients were evaluable according to the modified intention-to-treat (ITT) analysis. Complete protection was achieved in the modified ITT population, 90.6% and 88.8% for the 3- and 1-mg groups, respectively (p < 0.0001); however, results met the stated margin to demonstrate noninferiority. The secondary efficacy analysis showed that the maximum grade of nausea in the acute phase was similar in both groups (p = 0.61). In addition, no significant difference was found between the two groups in the number of vomiting episodes (p = 0.62). No statistically significant differences were observed in the maximum grade of nausea in the delayed phase (from day 2 to 7; p = 0.67). Adverse events on day 1 as well as on days 2–7 after chemotherapy were mild and not significantly different in both groups. No severe or unexpected adverse events were reported.
This study showed that 1 mg granisetron is not inferior to 3 mg when both doses are combined with dexamethasone, assuming that a 15% difference in complete response rate is accepted.
Findings suggest that lower dose granisetron may be effective for control of acute and delayed CINV.
Tsivian, M., Qi, P., Kimura, M., Chen, V.H., Chen, S.H., Gan, T.J., & Polascik, T.J. (2012). The effect of noise-cancelling headphones or music on pain perception and anxiety in men undergoing transrectal prostate biopsy. Urology, 79, 32–36.
To assess the effect of noise-canceling headphones, with or without music, on patient pain and anxiety associated with routine, office-based transrectal ultrasound-guided prostate biopsy
Patients were randomly assigned to one of three groups: control group (no noise-canceling headphones), headphones group (patients wore noise-canceling headphones), or music group (which listened to Bach's Brandenburg Concertos through noise-canceling headphones). Patients donned headphones immediately before the procedure, after hearing a thorough description of the procedure and getting into position for the procedure.
Randomized controlled trial
Mean VRS scores showed that pain significantly increased from baseline to postprocedure for all groups (control group, 0.79–2.49, p = 0.001; headphones group, 0.89–2.29, p = 0.009; music group, 0.52–2.13, p < 0.001). In no group did anxiety level change from baseline to postprocedure. The music group had the lowest overall mean State-Trait Anxiety score. Blood pressure levels remained fairly stable from baseline to postprocedure. The control group’s mean diastolic blood pressure increased from 82.3 to 88.4, the headphones group’s mean diastolic blood pressure increased from 79.38 to 81.9, and the music group’s mean diastolic blood pressure increased from 82.5 to 84.9. Authors reported that these changes were not statistically significant.
According to this study, music or noise-canceling headphones do not appear to relieve pain perception and anxiety during transrectal prostate biopsy; however, further research is warranted due to the small sample size.
Although this study did not find music or noise-canceling headphones to be effective in decreasing pain perception and anxiety, nurses may want to ask patients if they would like to listen to music in the circumstances outlined. Listening to music may be a distraction and potentially mitigate pain.
Tsimberidou, A.M., Giles, F.J., Khouri, I., Bueso-Ramos, C., Pilat, S., Thomas, D.A., . . . Kurzrock, R. (2005). Low-dose interleukin-11 in patients with bone marrow failure: Update of the MD Anderson Cancer Center experience. Annals of Oncology, 16, 139–145.
Interleukin-11 (IL-11) 10 mcg/kg subcutaneous was given daily for two weeks followed by a two-week rest period for two induction courses. Patients with grade 0–1 toxicity during a course could have a 5 mcg/kg/day dose increase in subsequent courses. If grade 3 toxicity was reached, the dose was decreased by 50%. If grade 4 toxicity was reached, therapy was stopped. Responders could receive maintenance therapy of the same daily dose used in induction (10 mcg/kg) given on alternate days or daily. For grade 3 or lower toxicity, the dose could increase by 5 mcg/kg. Therapy continued as long as there was hematologic improvement without grade 3 or 4 toxicity.
Twenty-seven percent (nine patients—eight patients at 10 mcg dose, one patient at 15 mcg dose) responded. Patients were 56–78 years of age. The median time to response was 0.9 months (higher response rate with patients older than 50 years [P = 0.008], MDS versus AA [P=0.025], and creatinine greater than 1 mg/dl [P = 0.0004]). Lower baseline platelet counts (less than five) took months to respond. The median response duration was three months. Among responders, the median maximum post-treatment platelet count was 137. Five patients showed multilineage response; three were treated with IL-11 alone, and two were treated with IL-11 plus erythropoietin and granulocyte colony-stimulating factor. The most common side effects for grade 1–2 were lower extremity edema, conjunctiva infection, and fatigue. Grade 3 toxicities were arrhythmia and transient ischemic attack. Ten patients had no side effects. Patients on maintenance therapy received a range of 35–70 mg/kg weekly cumulative.
Tsianakas, V., Robert, G., Richardson, A., Verity, R., Oakley, C., Murrells, T., . . . Ream, E. (2015). Enhancing the experience of carers in the chemotherapy outpatient setting: An exploratory randomised controlled trial to test impact, acceptability and feasibility of a complex intervention co-designed by carers and staff. Supportive Care in Cancer, 23, 3069–3080.
To test the feasibility and acceptability of a codesigned (caregiver and healthcare provider) Take Care intervention, and to measure caregiver knowledge, information needs, confidence, and emotional well-being related to intervention efficacy
The Take Care intervention included a 19-minute DVD designed to offer education, information, and support to the caregivers of patients starting chemotherapy. It also included a booklet and a one-hour protocol-guided group (≤ 5) consultation offered prior to the delivery of the first cycle of IV chemotherapy.
Two-phase, mixed-method, pilot randomized, controlled trial with a later purposive subsample of the Take Care group gaining variation in caregiver characteristics and data on intervention feasibility and acceptability (focus groups of six healthcare providers also served later purpose)
There were statistically significant improvements in intervention group caregiver knowledge of chemotherapy and side effects (all nine areas ≤ 0.012), their satisfaction with care in (five of seven items), and in the number of caregivers who felt they had the information they needed or that their informational needs had been met (p < 0.001). No difference between the intervention and control groups was demonstrated in emotional well-being or in caregivers' experience of care except for one item involving the time that staff members spent with care, which was higher for the intervention group (p = 0.014). Confidence in coping showed a trend towards significance after the intervention. In addition, focus group data showed that the intervention was feasible, acceptable, and useful.
The Take Care intervention for the caregivers of patients starting IV chemotherapy showed promise as an acceptable and feasible approach to support and educate caregivers.
The Take Care intervention may provide an acceptable, useful, and feasible approach to meet the educational and support needs of the caregivers of patients receiving chemotherapy the first time. Additional studies reflecting methodologic rigor with United States population groups are warranted to determine if the intervention may be effective in improving caregiver knowledge of chemotherapy and side effects, meeting educational and support needs, and improving caregiver emotional well-being and role satisfaction.