Pinnix, C., Perkins, G.H., Strom, E.A., Tereffe, W., Woodward, W., Oh, J. L., . . . Yu, T.K. (2011). Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: Single-blind randomized phase III clinical trial. International Journal of Radiation Oncology, Biology, Physics, 83(4), 1089–1094.
To determine effectiveness of an hyaluronic acid-based emulsion to reduce development of greater than or equal to grade 2 radiodermatitis in women receiving adjuvant breast radiation
Women were randomly assigned to use topical hyaluronic acid on the medical or lateral half of the irradiated breast, and a control, petrolatum-based substance to the other half of the breast. Agents were to be applied three times daily beginning one day before the start of radiation therapy and continuing throughout the treatment period. Agents were not applied within four hours prior to radiation treatment. Patients were not to apply other topical products unless otherwise instructed by the physician. All other agents used were to be documented.
The study took place at MD Anderson Cancer Center in Houston, TX.
Patients were undergoing active anti-tumor treatment.
The study used a single-blind controlled trial design.
The National Cancer Institute Common Toxicity Criteria (version 3) for skin toxicity grading was used.
Twelve percent dropped out of the study for a variety of reasons. In weeks 1–5 there were no differences between groups in severity of dermatitis in intent to treat and evaluable patient groups. In week 6 the side of the breast treated with hyaluronic acid was scored worse (p = 0.009). No associations were found between severity of dermatitis and body mass index, breast size, smoking history, diabetes or radiation dose. Forty-nine percent of control areas developed greater than grade 2 dermatitis compared to 61% of evaluable areas using hyaluronic acid emulsion. Overall, 1.4% developed grade 3 radiodermatitis.
Prophylactic application of a hyaluronic acid-based emulsion did not reduce the incidence of greather than or equal to grade 2 radiodermatitis in this group of women receiving adjuvant radiation therapy for breast cancer.
In the study, hyaluronic acid gel was not as effective as a petrolatum based gel for reducing the severity of radiodermatitis. Authors noted that the radiation therapy approach was forward-planned IMRT, which may also have led to significant reduction in severe dermatitis, since the percent of patients with grade 3 dermatitis in the study was lower than reported elsewhere. Other studies that showed hyaluronic acid to be effective were in patients who had higher doses of radiation. It is also not clear if there is a difference in effect of hyaluronic acid for prevention or treatment of radiodermatitis.
Pinna, M.A., Bruera, E., Moralo, M.J., Correas, M.A., & Vargas, R.M. (2015). A randomized crossover clinical trial to evaluate the efficacy of oral transmucosal fentanyl citrate in the treatment of dyspnea on exertion in patients with advanced cancer. The American Journal of Hospice and Palliative Care, 32, 298–304.
To evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of dyspnea on exertion in patients with advanced cancer
Subjects were chosen over the course of one year. The participants were assigned to one of two treatment groups. The study administered a dosage of 200 µg to patients who were not receiving opioid treatment and 400 µg to those using opioids for other cancer-related symptoms. Prior to testing, the patients remained at rest for five minutes. They were then given OTFC, and the 6-Minute Walk Test (6MWT) was carried out. During visit 2, patients who had been receiving the investigational product were given the placebos and vice versa. At least two days passed between visits 1 and 2 to perform the 6MWT. The follow-up of patients covered a maximum period of seven calendar days.
Randomized, double-blinded, crossover, placebo-controlled clinical trial
Patients were classified into three categories according to the differences observed in dyspnea before and after completion of the 6MWT. 1) Better response to the treatment obtained in the first period, 2) same response to both the periods, and 3) better response to the treatment obtained in the second period. No differences between treatments were demonstrated (P = 1). There were no differences between the change in oxygen saturation level before and after the 6MWT (P = 0.7541). The distance walked in the different sequences did not vary independently (P = 0.6550). There were no differences in the relation to the Edmonton Symptom Assessment System before or after the 6MWT (P = 0.1234). No secondary effects associated with the medication were observed. Type 2 error was ruled out with a confidence level exceeding 5%.
The study concluded that it could not demonstrate that OFTC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all the patients. This study had a small sample size of 13 patients. It was observed that OTFC may reduce dyspnea in the first three minutes of initiating the test, but this lacked statistical significance.
Dyspnea is one of the most common and distressing symptoms experienced by patients with advanced cancer. This study demonstrated some benefit of transmucosal fentanyl citrate on dyspnea with exertion in the first three minutes, but this result was not statistically significant. Overall, transmucosal fentanyl did not ffect dyspnea with exertion in these patients. This study was small with only 13 participants, and a placebo effect was observed in all patients.
Ping, B., Zhu, Y., Gao, Y., Yue, C., & Wu, B. (2013). Second- versus first-generation azoles for antifungal prophylaxis in hematology patients: A systematic review and meta-analysis. Annals of Hematology, 92, 831–839.
STUDY PURPOSE: To compare second-generation azoles with first-generation azoles in patients with hematologic malignancies by comparing rates of proven or probable invasive fungal infections (IFIs), invasive aspergillosis, receipt of empirical antifungal therapy, overall mortality, and withdrawal from studies related to development of adverse effects
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: MEDLINE, EMBASE, and Cochrane Registry of Controlled Trials databases; conference proceedings from the American Society of Hematology, American Society of Clinical Oncology, European Hematology Association, and European Group for Blood and Marrow Transplantation from 2002–2012
KEYWORDS: voriconazole or posaconazole and prophylaxis or prevention
INCLUSION CRITERIA: Studies written in English; prospective and randomized controlled trials comparing second-generation and first-generation azole antifungal agents with regards to antifungal prophylaxis in patients with hematologic malignancies who were neutropenic following cytotoxic chemotherapy or hematopoietic stem cell transplantation, or receiving immunosuppressive therapy
EXCLUSION CRITERIA: IV administration of azole antifungal agents, unless the IFI was proven or suspected; prospective studies in which the control arm used a historical cohort; ongoing trials
TOTAL REFERENCES RETRIEVED = 168 reviewed (Of these, 18 were identified as potentially relevant; of these, 14 were screened out.)
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers independently screened the literature for eligibility for inclusion, and two other reviewers independently extracted the data from included studies and assessed for quality parameters.
PHASE OF CARE: Transition phase after active treatment
Prophylaxis using second-generation azole antifungal agents significantly reduced IFIs as compared to first-generation agents (OR = 0.47, 95% CI 0.32–0.69, I2 = 0%, p = 0.0001; four trials, 2,267 patients) and also significantly reduced invasive aspergillosis (OR = 0.28, 95% CI 0.17–0.48, I2 = 28%, p < 0.00001; four trials, 2,267 patients). Additionally, posaconazole significantly reduced the incidence of fungal infection (OR = 0.40, 95% CI 0.19–0.87, I2 = 52%, p = 0.02; two trials, 1,202 patients), but voriconazole did not (OR = 0.56, 95% CI 0.30–1.04, I2 = 0%, p = 0.06; two trials, 1,065 patients). Second-generation azoles significantly reduced IFIs (OR = 0.47, 95% CI 0.31–0.71, I2 = 0%, p = 0.0003; three trials, 1,744 patients) and invasive aspergillosis (OR = 0.31, 95% CI 0.13–0.52, I2 = 44%, p < 0.0001; three trials, 1,744 patients) when compared to fluconazole. When compared to itraconazole, second-generation azoles resulted in significantly fewer IFIs (OR = 0.35, 95% CI 0.14–0.87, I2 = 35%, p = 0.02; two trials, 827 patients) and cases of invasive aspergillosis (OR = 0.11, 95% CI 0.03–0.40, I2 = 0%, p = 0.0008; two trials, 827 patients).
Significantly fewer patients receiving prophylaxis with second-generation azoles required empirical antifungal therapy (OR = 0.62, 95% CI 0.50–0.77, I2 = 0%, p < 0.0001; three trials, 1,667 patients). Despite these findings, no difference was noted in overall mortality in patients receiving antifungal prophylaxis with second-generation or first-generation azoles (OR = 0.81, 95% CI 0.64–1.01, I2 = 0%, p = 0.06; three trials, 1,802 patients).
Patients with hematologic malignancies are at increased risk of IFIs, with invasive aspergillosis being particularly worrisome. Second-generation azoles appear to be superior to first-generation azoles in regards to prevention of IFIs, including invasive aspergillosis, without increased risk of adverse events. Second-generation agents also have better bioavailability and fewer drug-drug interactions than first-generation agents.
This meta-analysis suggests that antifungal prophylaxis with second-generation azoles is more effective than first-generation azoles in prevention of IFIs, and without increase in adverse events. Interestingly, no difference was observed in overall mortality.
Pinar, R., & Afsar, F. (2015). Back massage to decrease state anxiety, cortisol level, blood pressure, heart rate and increase sleep quality in family caregivers of patients with cancer: A randomised controlled trial. Asian Pacific Journal of Cancer Prevention, 16, 8127–8133.
To study the effectiveness of back massage on anxiety, stress markers, and sleep quality in the caregivers of patients with cancer
Caregivers were randomized to treatment and control groups. Caregivers in the treatment group rested for 10 minutes in a silent room then were given a 15-minute back massage each evening. The control group rested quietly in a separate silence room. Study measures were obtained at baseline and on day 7. Blood samples were obtained on day 7 for cortisol levels.
Randomized, controlled trial
Overall, 100% of the intervention group had moderate levels of anxiety at baseline, and those in the control group had low to high anxiety. Anxiety declined in the intervention group (p = 0.000) and remained essentially stable in the control group. Cortisol levels declined in the intervention group (p = 0.01) and were within reference levels. At baseline, 77.3% of caregivers in both groups had PSQI scores of 5 or greater, indicating poor sleep quality. Sleep quality scores declined in the intervention group (p = 0.000) and increased in the control group (p = 0.003) among those with initial scores greater than 5.
Daily back massages for caregivers reduced anxiety and improved sleep quality.
Back massage is a simple technique that nurses can use to help reduce anxiety and stress for the caregivers of patients with cancer. This is a complementary nursing action that can be used to support caregivers.
Pinar, G., Kurt, A., & Gungor, T. (2011). The efficacy of preopoerative instruction in reducing anxiety following gyneoncological surgery: A case control study. World Journal of Surgical Oncology, 9, 38–45.
To examine the effects of preoperative instruction on anxiety levels after gynecology oncology surgery
A random sample of patients scheduled for surgery was selected, and patients were assigned to intervention and control groups. Those in the control group received typical preoperative teaching. The intervention group was informed in detail with written information provided in an interactive situation to patients and caregivers. Instruction included anatomical information, routine preoperative preparation (e.g., removal of dentures, medications for the procedure), and postoperative care (e.g., management of pain, Kegel exercises). Instruction also included information on relaxation and imagery techniques. Study measures were obtained prior to surgery and after surgery immediately prior to hospital discharge.
Authors reported STAI-I results and STAI-II results, but it is not clear what STAI-II refers to. STAI postoperative results declined similarly in both groups. STAI-II postoperative results were higher in both groups and increased more in the intervention group than the control group. The difference between postoperative study groups showed overall lower anxiety scores in the intervention group (p = .004). Baseline anxiety was higher in the control group but not statistically different from the intervention group.
No firm conclusions regarding the effects of the preoperative teaching were given, and conclusions on postoperative anxiety cannot be drawn.
Study limitations preclude the ability to draw any firm conclusions from this research.
Pimenta Amaral, T. M., Campos, C. C., Moreira Dos Santos, T. P., Leles, C. R., Teixeira, A. L., Teixeira, M. M., et al. (2012). Effect of salivary stimulation therapies on salivary flow and chemotherapy-induced mucositis: a preliminary study. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 113(5), 628-637.
Analyze the effectiveness of two noninvasive mechanical and electrical therapies on salivary flow and severity of oral mucositis in patients undergoing allogeneic HCT.
INTERVENTION DESCRIPTION
Patients undergoing myeloablative conditioning for allogeneic HCT were randomized to four groups: (1) control group (no salivary stimulation therapy, (2) salivary stimulation using a mechanical chewing instrument, (3) TENS stimulation, and (4) combination of TENS and mechanical chewing. Saliva samples were obtained twice before HCT and three times after transplantation. Severity of mucositis was evaluated by a single examiner four days per week from day 7 to day 30 post-HCT. Patients assigned to the mechanical chewing used a silicone instrument and were instructed to perform mastication exercises after meals 4 times daily for 10 minutes. TENS stimulation was given 3 times a week for 30 minutes each, with electrodes placed at 3 regions of the face corresponding to parotid, submandibular, and sublingual salivery glands.
The study was comprised of 35 patients with a mean patient age of 33.56 years (SD = 12.46 years).
MALES 33.7%, FEMALES 66.3%
KEY DISEASE CHARACTERISTICS: All received conditioning with cyclophosphamide with or without busulfan for HCT. Cyclosporin in combination with methotrexate or mycophenolate mofetil was used for GVHD prophylaxis. All underwent allogeneic HCT. Underlying diseases were bone marrow aplasia, AML, ALL, Hodgkin’s lymphoma, and mantle cell lymphoma. 75% had malignant diseases.
SITE: Single site
SETTING TYPE: Inpatient
LOCATION: Brazil
PHASE OF CARE: Active antitumor treatment
Single, blind, randomized controlled trial
Resting salivary flow showed a tendency toward decrease in all patients. In all therapy groups combined, salivary flow showed less of a decrease than control patients, but this difference was not significant. At the end of the study, the TENS and TENS plus chewing group showed an increase in salivary flow, while the other two groups showed a decline (p < 0.05). Mucositis occurred in 68.5% of patients. There were no differences in grades of mucositis between groups. There was a tendency of lower salivary flow in patients with mucositis of any grade.There were no significant differences seen in salivary TNF and IL-10 levels in relation to occurrence of mucositis.
Electrical salivary stimulation therapy, alone or combined with mechanical chewing therapy appeared to increase salivary flow when compared to chewing therapy alone or no salivary stimulation therapy; however, there was no significant difference seen in mucositis occurrence or severity based on study group or salivary flow.
Salivary flow decline may contribute to development and severity of oral mucositis. This study shows that electrical stimulation may improve salivary flow. Further research in this are is needed to fully evaluate the effectiveness of salivary stimulation in the management of oral mucositis.
Pillai, A.K., Sharma, K.K., Gupta, Y.K., & Bakhshi, S. (2010). Anti-emetic effect of ginger powder versus placebo as an add-on therapy in children and young adults receiving high emetogenic chemotherapy. Pediatric Blood and Cancer, 56, 234–238.
To evaluate the efficacy of ginger powder in reducing chemotherapy-induced nausea and vomiting (CINV) in children and young adults
Participants were randomly assigned to receive either ginger powder tablets or placebo tablets to be taken daily at night during the first three days of chemotherapy and then three times daily for the next two days after chemotherapy was completed. The total dose of ginger powder was 1,000–2,000 mg per day, based on body weight. Ondansetron and dexamethasone were used as standard antiemetics.
Randomization was done for each cycle of chemotherapy. Data were analyzed according to treatment cycle grouping. Patients received a follow-up telephone call on the seventh and tenth days of chemotherapy to reinforce diary use.
All participants were pediatric patients in active treatment.
This was a randomized, double-blind, placebo-controlled trial.
Ginger powder may have a positive impact in reducing acute and delayed nausea as an adjunct to standard antiemetic treatment in children and young adults, and it was not associated with any adverse effects.
Ginger may be helpful in mitigation of CINV symptoms for younger patients; however, effectiveness remains unclear.
Pilkington, K., Kirkwood, G., Rampes, H., Fisher P., & Richardson, J. (2006). Homeopathy for anxiety and anxiety disorders: A systematic review of the research. Homeopathy, 95, 151–162.
Systematic review: Homeopathy for anxiety and anxiety disorders
A comprehensive search of major biomedical databases including MEDLINE, EMBASE, CINAHL, PsycINFO, and Cochrane Library, as well as specialist complementary and alternative medicine (CAM) databases AMED, CISCOM, and Hom-Inform, was conducted.
Only eight randomized controlled trials (RCTs) were identified. The types of anxiety studied were test anxiety, generalized anxiety disorder, and anxiety related to medical or physical conditions, such as cancer or surgical procedures. Single case reports/studies were the most frequent study type, but others also were found. Three of the uncontrolled case studies were on patients with cancer with anxiety, which were referred to U.K. homeopathic hospital. The interventions were individualized homeopathy. All three used the Hospital Anxiety and Depression Scale as one measure, as well as others.
The sample sizes of the three case studies were 50, 100, and 45.
A comprehensive search demonstrated that there is limited evidence on the benefit of homeopathy in anxiety. The results were contradictory. Some patients’ anxiety improved, while others experienced worsening of symptoms and reappearance of old symptoms.
The reviewers felt it was difficult to assess the extent to which any response could be attributed to homeopathy.
Pilepich, M.V., Paulus, R., St. Clair, W., Barasacchio, R.A., Rostock, R., & Miller, R.C. (2006). Phase III study of pentosanpolysulfate (PPS) in treatment of gastrointestinal tract sequelae of radiotherapy. American Journal of Clinical Oncology, 29(2), 132–137.
Patients were randomized to one of three groups. In group one, patients received 100 mg of pentosanpolysulfate (PPS) three times per day. PPS is a glycosaminoglycan marketed as Elmiron® and SP54. It has been used to treat radiation-induced sequelae of the bladder. In group two, patients received 200 mg PPS three times per day. In group three, patients received placebo three times per day. If no improvement occurred in two months, treatment was discontinued. If symptoms improved or resolved, treatment was continued for an additional four months.
No significant differences were found among the three arms of the study.
Pilch, U., Wozniewski, M., & Szuba, A. (2009). Influence of compression cycle time and number of sleeve chambers on upper extremity lymphedema volume reduction during intermittent pneumatic compression. Lymphology, 42(1), 26–35.
To assess the efficacy of different intermittent pneumatic compression (IPC) protocols on edema volume reduction in women with postmastectomy lymphedema
Study subjects were randomly allocated to four groups with different cycles and sleeves for IPC. All women underwent IPC treatment for five weeks, five times per week for one hour for 25 sessions in total. Arm volume measurements for both arms were performed before and after each session. Group I (n = 17) received one-to-one cycles of compression and interval (90 seconds each), with a single chamber sleeve. Group II (n = 9) received a one-to-one cycle of compression and interval (90 seconds each), with a three-chamber sleeve. Group III (n = 11) received a one-to-one cycle of compression and interval (45 seconds and 15 seconds, respectively), with a single chamber sleeve. Group IV (n = 20) received a one-to-one cycle of compression and interval (45 seconds and 15 seconds, respectively) with a three-chamber sleeve.
The study took place at Wroclaw Medical University, in Wroclaw, Poland.
The study used a randomized trial design.
Significant differences in edema (29%–47%) were observed in all groups post-treatment with the most significant decrease seen in Group IV. The least reduction was observed in Group III, with Groups I and II experiencing similar decreases. Further comparison revealed the 45 second cycles with a three compartmental sleeve proved almost twice as effective as the 45 second cycle with single compartment sleeve.
IPC can be effective in decreasing lymphedema in upper extremities in patients with breast cancer post-treatment. Further studies are needed to validate the finding of enhanced results with a shorter compression cycle and cyclic sequential massage.
IPC devices may be efficacious in treatment of lymphedema. More studies are needed to compare pneumatic compression devices and determination of standard equipment for treatment. Nurses need to build awareness for prevention and early detection and early intervention.