Park, J.H., Min, Y.S., Chun, S.M., & Seo, K.S. (2015). Effects of stellate ganglion block on breast cancer-related lymphedema: Comparison of various injectates. Pain Physician, 18, 93–99.
To evaluate the effects of a stellate ganglion block (SGB) and steroids on breast cancer-related lymphedema
Patients were randomly assigned to one of three groups using different substances injected for SGB, (1) bupivacaine alone, (2) bupivacaine and triamcinolone, or (3) triamcinolone alone. Patients were given three consecutive blocks every two weeks. Outcome measurements were obtained at two, four, and eight weeks.
Double-blinded, randomized, controlled study
Forearm circumference was significantly decreased in all groups one month after three treatments. Upper arm measures showed significant reductions at different time points across the three groups, but all showed a statistically significant reduction over time (p < 0.017). Those who received SGB with triamcinolone had a slightly larger reduction in upper arm circumference. There were no differences between groups in quality of life measures.
SGBs may be a viable alternative treatment for breast cancer-related arm lymphedema. The use of a corticosteroid for the block might produce the most effective results.
SGBs may be an effective alternative treatment for breast cancer-related lymphedema. Additional research is needed to confirm these findings.
Park, K.H., Lee, S., Park, J.H., Kang, S.Y., Kim, H.Y., Park, I.H., . . . Seo, J.H. (2017). A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer. Supportive Care in Cancer, 25, 505–511.
To demonstrate that DA-3031 is not inferior to daily filgrastim to manage neutropenia
Patients were randomly assigned to receive daily filgrastim or DA-3031. Daily filgrastim at 100mcg/m2 began 24 hours after chemotherapy was started and continued until absolute neutrophil count was at least 5 x 109, or for 10 days. Those in the experimental group received 6 mg DA-3031 by subcutaneous injection on day 2 of each chemotherapy cycle. Patients received TAC chemotherapy every three weeks up to six cycles. The noninferiority margin set was two days for the duration of grade 4 neutropenia.
PHASE OF CARE: Active antitumor treatment
Open-label, noninferiority, randomized, controlled trial
Mean duration of grade 4 neutropenia was 2.08 (SD = 0.85) days for the filgrastim group and 2.28 (SD = 1.14) days for the DA-3031 group. The difference between groups was 0.2 (SD = 1) days, supporting noninferiority of DA-3031. There were no significant differences between groups in absolute neutrophil coutn recovery time, incidence of febrile neutropenia, hospitalization, or requirement for intravenous antibiotics. There was no significant difference between groups in musculoskeletal symptoms associated with colony-stimulating factor administration. The findings were similar across all chemotherapy cycles. ITT and per protocol analysis were similar.
DA-3031, a once-per-cycle colony-stimulating factor, was not inferior to daily filgrastim.
DA-3031, a pegylated colony-stimulating factor was comparable to daily pegfilgrastim for neutropenia-related outcomes among women receiving TAC therapy. A once-per-cycle colony-stimulating factor can be more practical for patients because it does not require daily injections. Comparative costs of these two approaches was not discussed and may need to be considered in the selection of an approach.
Park, K.H., Sohn, J.H., Lee, S., Park, J.H., Kang, S.Y., Kim, H.Y., . . . Seo, J.H. (2013). A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer. Investigational New Drugs, 31, 1300–1306.
To evaluate the safety and efficacy of once-per-cycle DA-3031 in patients receiving chemotherapy for breast cancer
Patients were randomized to daily injections of filgrastim 100 mcg/m2 beginning 24 hours after chemotherapy until absolute neutrophil count (ANC) was 5x109 after nadir or up to 10 days, or to one of two doses of pegfilgrastim (3.6 mg or 6 mg). The primary endpoint was duration of grade 4 neutropenia.
No significant differences were seen among groups in ANC nadirs or time to recovery. Overall incidence of febrile neutropenia was 9.8%, with no significant differences between groups. The most common adverse event was musculoskeletal pain, with no significant differences between groups, although pain was slightly higher in the 6 mg pegfilgrastim group.
Single-dose pegfilgrastim had similar efficacy and side effects to daily filgrastim.
Daily dosing of filgrastim had essentially the same efficacy and side effects as once-per-cycle pegfilgrastim. Severity of musculoskeletal pain appeared to be slightly higher with the higher dose of pegfilgrastim. Reducing the need for daily injections may be an important consideration for some patients and has been shown to have essentially the same effects. Higher doses may be associated with increased musculoskeletal pain. Although not statistically significant, this can be an important consideration to promote patient quality of care.
Pardo Masferrer, J., Murcia Mejía, M., Vidal Fernández, M., Alvarado Astudillo, A., Hernández Armenteros, M. L., Macías Hernández, V., . . . Mirada Ferre, A. (2010). Prophylaxis with a cream containing urea reduces the incidence and severity of radio-induced dermatitis. Clinical and Translational Oncology, 12, 43–48.
Primary Aim: To evaluate the effectiveness of author-defined intensive use (three times daily [TID] use starting two or three weeks before radiotherapy [RT] and continuing this frequency throughout RT) application of a lotion preparation made of 3% urea, polidocanol, and hyaluronic acid for preventing the appearance of acute radiodermatitis and controlling its severity in patients actively undergoing RT for breast cancer.
Secondary Aim: To study effectiveness, the authors compared the incidence and grade of toxicity with 174 patients with breast cancer treated in the same clinic the previous year. These patients used skin-support measures at the beginning of RT or when radiodermatitis occurred.
Ureadin cream was used TID for two to three weeks prior to the start of external beam RT (EBRT) and continued for the entire treatment period. This use was considered intensive compared to other studies and the standard use schedule of twice daily (BID) cream application at the start of RT or 10 days before starting RT.
This was a prospective, observational study performed over 14 months.
The overall rate of radiodermatitis was 72.4%, with 51% of patients being toxicity grade 1; 20% grade 2, and 1% grade 3. The first case of skin toxicity appeared in third week of treatment; in >87% of patients, radiodermatitis appeared between weeks 5 and 7. The severity of radiodermatitis with the intensive use of the lotion was significantly lower (72.4% vs. 84.5%; p < 0.05). The grade of toxicity was significantly lower in intensive-use patients (p < 0.001), and grade 2 toxicity or higher was significantly lower (21.4% vs. 50%; p < 0.01). Severity of clinical symptoms of pain, itching, redness, desquamation, and impact on QOL was reported as negligible by patients.
For patients with breast cancer who undergo conservative surgery and will receive RT to a dose of 60 to 70 Gy, use of Ureadin on an intensive basis (TID beginning two to three weeks prior to the start of RT) compared to BID use is considered effective at reducing the incidence and grade of skin toxicity during RT and is well tolerated by patients.
Paramanandam, V.S., & Roberts, D. (2014). Weight training is not harmful for women with breast cancer-related lymphoedema: A systematic review. Journal of Physiotherapy, 60, 136–143.
PHASE OF CARE: Late effects and survivorship
APPLICATIONS: Elder care
Weight training exercise with low to moderate intensity (no trials used high-intensity weight training) and relatively slow progression significantly improved upper limb strength (SMD = 0.93, 95% CI 0.73–1.12) and lower limb strength (SMD = 0.75, 95% CI 0.47–1.04) without increasing arm volume or the incidence of breast cancer-related lymphedema. No significant effects were noted for body mass index (SMD = -0.10, 95% -0.31–0.11). Some aspects of quality of life may have improved with weight training. Participants in all trials used pressure garments and received supervision.
Weight training appeared to be safe and beneficial in improving limb strength and the physical components of quality of life in women with or at risk of lymphedema. Pressure garments, supervision, and limiting the intensity of the weight training may be important, but this could not be confirmed with this review.
A potential selection bias of the studies reviewed may exist because no blinding methods were employed among authors and affiliations. Heterogeneity among the studies reviewed limited the scope of the statistical analysis, so a narrative synthesis and meta-analysis were conducted. Heterogeneity may also limit the generalizability of the overall study results.
This review indicated that low-intensity exercise was recommended to protect the arm from adverse events. However, supervision and compression garments were featured in the reviewed studies, and their impact and effectiveness need to be confirmed. In addition, no evidence was available to suggest that high-intensity weight training was harmful to the arm. Research efforts need to be made in this area.
Paramanandam, V.S., & Dunn, V. (2014). Exercise for the management of cancer-related fatigue in lung cancer: A systematic review. European Journal of Cancer Care, 24, 4–14.
Three of the 10 studies showed a significant reduction in fatigue with exercise, one using aerobic exercise, one using chest physiotherapy, and one using pulmonary rehab. The other studies showed improvement but did not reach statistical significance. All studies were level 4 or 5 evidence (low). Studies with significant results, however, were not similar in their exercise intervention. Exercise was safe and feasible for adults with lung cancer. All studies provided exercise under supervision, and most included aerobic and interval training
\"This current review shows that exercise is beneficial and safe in lung cancer-related fatigue; however, the studies are small and, without any control groups, are lacking clinically significant effects. Thus, exercises could be used in the management of cancer-related fatigue in lung cancer in view of the available evidence in other cancer cohorts with due caution. There is an urgent need of further research with adequate sample size, preferably randomized controlled trials, to evaluate the effect of exercise in this cancer cohort” (p. 10).
In light of studies on the effects of exercise in other diseases, exercise can be considered for the management of fatigue in patients with lung cancer with attention to performance status. Patients perhaps should undergo individual testing and exercise prescription. Additional research is needed.
Papas, A.S., Clark, R.E., Martuscelli, G., O’Loughlin, K.T., Johansen, E., & Miller, K.B. (2003). A prospective, randomized trial for the prevention of mucositis in patients undergoing hematopoietic stem cell transplantation. Bone Marrow Transplantation, 31, 705–712.
Patients rinsed with 30 ml of calcium phosphate at least four times per day. Patients also received four topical treatments of 1% fluoride as neutral 2% sodium fluoride gel administered by tray at the screening visit and completed prior to hospitalization.
Patients in the control group received an aqueous 0.01% sodium fluoride rinse. Prior to transplantation, the control group received four topical treatments with a placebo gel administered with the same technique as the experimental group. During transplantation, patients used the sodium fluoride rinse at least four times daily, 30 ml each time.
Patients who developed severe mucositis were instructed to rinse up to 10 times per day with their solution.
All patients received acyclovir and antifungal prophylaxis per protocol.
This was a randomized, controlled trial.
The National Institute of Dental and Craniofacial Research scale was used.
The following were measured and recorded.
Papadeas, E., Naxakis, S., Riga, M., & Kalofonos. C. (2007). Prevention of 5-fluorouracil-related stomatitis by oral cryotherapy: A randomized controlled study. European Journal of Oncology Nursing, 11, 60–65.
Pandya, K.J., Morrow, G.R., Roscoe, J.A., Zhao, H., Hickok, J.T., Pajon, E., … Flynn, P.J. (2005). Gabapentin for hot flashes in 420 women with breast cancer: A randomised double-blind placebo-controlled trial. Lancet, 366, 818–824.
Assess efficacy of gabapentin in controlling hot flashes in women with breast cancer
Patients were randomized to placebo, gabapentin 300 mg/day, or gabapentin 300 mg three times a day for eight weeks.
University community clinic oncology program
Randomized, double-blind, placebo-controlled multi-institutional trial.
Decreases in hot flash severity scores between baseline and weeks 4 and 8, respectively were: 21% and 15% in the placebo group; 33% and 31% in the group assigned gabapentin 300 mg; and 49% and 46% in the group assigned gabapentin 900 mg. The differences between the groups were significant (p = 0.0001 at four weeks and p = 0.007 at eight weeks by analysis of covariance for overall treatment effect).
Gabapentin was effective in control of hot flashes at a dose of 900 mg/day but not at a dose of 300 mg/day.
Pandya, K.J., Raubertas, R.F., Flynn, P.J., Hynes, H.E., Rosenbluth, R.J., Kirshner, J.J., … Morrow, G.R. (2000). Oral clonidine in postmenopausal patients with breast cancer experiencing tamoxifen-induced hot flashes: A University of Rochester Cancer Center community clinical oncology program study. Annals of Internal Medicine, 132, 788–793.
The study evaluated oral clonidine in postmenopausal patients with breast cancer experiencing tamoxifen-induced hot flashes.
Participants received oral clonidine hydrochloride 0.1 mg daily or placebo at bedtime for eight weeks.
The study enrolled 198 postmenopausal women (mean age 71 years) with breast cancer taking tamoxifen and stratified by time since menopause (less than three years, more than three years), duration of tamoxifen use (less than one year; longer than one year), and baseline frequency of hot flashes (less than 10 per day, more than 10 per/day). One hundred forty-nine (149) completed the study. Of the participants, 99 received clonidine and 99 received the placebo.
A community oncology clinic conducted the study.
The study was a randomized, double blind, placebo-controlled trial.
Measures included:
One hundred forty-nine (149) of 198 completed 12 weeks of follow-up (73 in clonidine group and 76 in placebo group.) Oral clonidine was shown to be effective. The mean decrease in hot flash frequency was greater in the clonidine group after week 4 (37% to 20%) and week 8 (38% to 24%). The clonidine group had more difficulty with sleep (41%–21%). A significant difference was seen in the mean change in QOL scale (p = 0.02) at 8 weeks.
Limitations included: