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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.

Study Purpose

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

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The study sample (N = 65) was comprised of female patients with breast cancer.
  • Mean age of the sample was 55.4 years.
  • Of patients in the sample, 93% had medium or large breast size.
  • Patients were treated with intensity-modulated radiation therapy (IMRT), receiving 50 Gy in 25 daily fractions with or without a boost of 10–16 Gy. 
  • Fifteen percent of the study sample were African American and 15% were Hispanic.

 

Setting

The study took place at MD Anderson Cancer Center in Houston, TX.

Phase of Care and Clinical Applications

Patients were undergoing active anti-tumor treatment.

Study Design

The study used a single-blind controlled trial design.

Measurement Instruments/Methods

The National Cancer Institute Common Toxicity Criteria (version 3) for skin toxicity grading was used.

Results

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.

Conclusions

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.

Limitations

  • The sample size was small, with less than 100 participants.
  • Findings are not generalizable to other patient groups based on radiation therapy dosage and site.
  • No information regarding patient adherence to the protocol is provided. 
  • Procedures state that the attending physician had discretion to order additional treatments; however, no information is provided as to whether this occurred or not. 
  • The study was ended early.

Nursing Implications

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.

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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. 

Study Purpose

To evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of dyspnea on exertion in patients with advanced cancer

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • N = 13
  • MEAN AGE = 65.2 years
  • MALES: 84.6% (n = 11), FEMALES: 15.4% (n = 2)
  • KEY DISEASE CHARACTERISTICS: Average time after diagnosis was 1.88 years; locations of primary tumors were lung (n = 10; 76.9%), kidney (n = 1; 7.7%), breast (n = 1; 7.7%), and stomach (n = 1; 7.7%)
  • OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria included moderate dyspnea defined as dyspnea caused by basic activities of daily living in the past 24 hours with an intensity of at least 3 on a scale from 0–10; Karnofsky index score > 50; hemoglobin levels within the past month exceeding 10 mg/dl; and SaO2 >90%. Exclusion criteria included patients with advanced chronic obstructive pulmonary disease. 

Setting

  • SITE: Not stated/unknown  
  • LOCATION: Not specified

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

Randomized, double-blinded, crossover, placebo-controlled clinical trial

Measurement Instruments/Methods

  • Edmonton System Assessment System (ESAS), a numeric rating scale to determine changes and severity of breathlessness.
  • Dyspnea intensity scale, a numeric scale from 0–10 (0 = no dyspnea and 10 = maximum severity)
  • Karnofsky Performance Status (KPS)

Results

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%.

Conclusions

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.

Limitations

  • Small sample (< 30)
  • Measurement/methods not well described
  • Findings not generalizable
  • Other limitations/explanation: Study was costly because of the cost of developing a placebo with the characteristics of OTFC. Only a select number of laboratories agreed to manufacture the placebo, increasing the cost of the clinical trial. The study had a single point in time evaluation.

Nursing Implications

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.

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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.

Purpose

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

Search Strategy

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

Literature Evaluated

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.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 4
  • SAMPLE RANGE ACROSS STUDIES = 465–602
  • TOTAL PATIENTS INCLUDED IN REVIEW: 2,267 patients (Although elsewhere in the article, the authors note 2,165 patients.)
  • KEY SAMPLE CHARACTERISTICS: Multi-center, two-arm, parallel, prospective, randomized controlled trials. Three of the four studies included patients who received allogeneic stem cell transplantation. The fourth study included patients experiencing prolonged neutropenia following induction chemotherapy for acute myelogenous leukemia or myelodysplastic syndrome.

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Results

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, I= 0%, p = 0.0001; four trials, 2,267 patients) and also significantly reduced invasive aspergillosis (OR = 0.28, 95% CI 0.17–0.48, I= 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, I= 52%, p = 0.02; two trials, 1,202 patients), but voriconazole did not (OR = 0.56, 95% CI 0.30–1.04, I= 0%, p = 0.06; two trials, 1,065 patients). Second-generation azoles significantly reduced IFIs (OR = 0.47, 95% CI 0.31–0.71, I= 0%, p = 0.0003; three trials, 1,744 patients) and invasive aspergillosis (OR = 0.31, 95% CI 0.13–0.52, I= 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, I= 35%, p = 0.02; two trials, 827 patients) and cases of invasive aspergillosis (OR = 0.11, 95% CI 0.03–0.40, I= 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, I= 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, I= 0%, p = 0.06; three trials, 1,802 patients).

Conclusions

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.

Limitations

  • Small number of studies (four)
  • Variation between studies regarding duration of administration of antifungal agents
  • No subgroup analysis of specific study populations
  • The risk of heterogeneity is moderate to low, as significant heterogeneity appeared in only a portion of subgroup analyses.

Nursing Implications

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.

Print

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. 

Study Purpose

To study the effectiveness of back massage on anxiety, stress markers, and sleep quality in the caregivers of patients with cancer

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • N = 44
  • MEAN AGE = 42.31 years (range = 24–60 years)
  • MALES: 36.4%, FEMALES: 63.6%
  • KEY DISEASE CHARACTERISTICS: Not stated
  • OTHER KEY SAMPLE CHARACTERISTICS: Caregivers had secondary school education or less. About 50% were spouses, and the rest were parents of the patient. 

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Turkey

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • State-Trait Anxiety Inventory (STAI)
  • Cortisol levels
  • Blood pressure and heart rate
  • Pittsburgh Sleep Quality Index (PSQI)

Results

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.

Conclusions

Daily back massages for caregivers reduced anxiety and improved sleep quality.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: Cortisol levels were within reference levels, so it was not clear how meaningful these changes were. Many patients in the control group had low baseline anxiety levels, and there could have been floor effects in this measure. Measurements were taken immediately after the massage was given, so the duration of effect was not clear.

Nursing Implications

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.

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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.

Study Purpose

To examine the effects of preoperative instruction on anxiety levels after gynecology oncology surgery

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • N = 120    
  • AGE = Median and range were not provided. 50% were older than age 49 years.
  • MALES: 0%; FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Ovarian, endometrial and cervical cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: 61% had no previous surgical experience.

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient    
  • LOCATION: Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Nonrandomized two-group comparative quasiexperimental design

Measurement Instruments/Methods

  • State-Trait Anxiety Inventory (STAI)

Results

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.

Conclusions

No firm conclusions regarding the effects of the preoperative teaching were given, and conclusions on postoperative anxiety cannot be drawn.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Measurement results as reported are unclear. It is surprising that the difference in anxiety scores was greater between groups at baseline but was not statistically significant. However, smaller differences postoperatively were significant. No subgroup analysis was done based on extent of surgery or stage of disease, which could be expected to influence anxiety.

Nursing Implications

Study limitations preclude the ability to draw any firm conclusions from this research.

Print

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.

Study Purpose

Analyze the effectiveness of two noninvasive mechanical and electrical therapies on salivary flow and severity of oral mucositis in patients undergoing allogeneic HCT.

Intervention Characteristics/Basic Study Process

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.
 

Sample Characteristics

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.
 

Setting

SITE: Single site

SETTING TYPE: Inpatient

LOCATION: Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

 Single, blind, randomized controlled trial

Measurement Instruments/Methods

  • Salivary collection and analysis and calculation of salivary flow rates over time
  • WHO oral mucositis scale
  • Salivary cytokine levels
     

Results

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.

Conclusions

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.

Limitations

  • Small sample (<100)
  • Unintended interventions or applicable interventions not described that would influence results*
  • Selective outcomes reporting*
  • Measurement/methods were not well described.

Nursing Implications

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.

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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.

Study Purpose

To evaluate the efficacy of ginger powder in reducing chemotherapy-induced nausea and vomiting (CINV) in children and young adults

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The sample consisted of 32 patients who were studied over a total of 60 chemotherapy cycles.
  • Patient ages ranged from 8–21 years old.
  • Data was reported by chemotherapy cycle, not known in patient sample.
  • All patients had been newly diagnosed with bone sarcoma.

Phase of Care and Clinical Applications

All participants were pediatric patients in active treatment.

Study Design

This was a randomized, double-blind, placebo-controlled trial.

Measurement Instruments/Methods

  • The Edmonton Symptom Assessment Scale (ESAS) and National Cancer Institute guidelines for grading of nausea and vomiting were used to measure symptoms.
  • Patients or guardians were instructed to complete daily diaries recording of emesis episodes and questions related to grading of nausea and vomiting.

Results

  • Incidence of acute nausea in both study groups was 100%. In the control group, acute moderate-to-severe nausea was 93.3% compared to 55.6% in those receiving ginger (p < 0.003).
  • Complete absence of vomiting was reported in 3.3% of controls, compared to 14.81% in the experimental group.
  • Moderate to severe delayed nausea was seen in 73.3% of control cycles compared to 25% in the experimental group (p < 0.001).
  • Moderate to severe delayed-phase vomiting was seen in 46.7% of controls and 14.8% of those who received ginger (p = 0.022).
  • No adverse effects were seen with ginger or the placebo.

Conclusions

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.

Limitations

  • The sample was small with less than 100 participants.
  • Patients may have received either ginger or placebo during different chemotherapy cycles; however, the study design was not done as an actual crossover design. This is a substantial design flaw in this study.
  • Results showed that there was a complete absence of vomiting in the control cycles for the acute phase; however the authors did not discuss or explain this observation, since all other observations suggested reduction in CINV with ginger. 
  • No discussion of compliance with diary documentation of nausea grading was provided.
  • Analysis of subgroups according to the cycle of chemotherapy was not possible, and anticipatory CINV was not measured.
  • Gender distribution between control and experimental groups was significantly different with more males in the experimental group. Known gender differences occur in adults in response to antiemetic therapies. It is not clear if this is also the case in pediatric patients.

Nursing Implications

Ginger may be helpful in mitigation of CINV symptoms for younger patients; however, effectiveness remains unclear.

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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.

Purpose

Systematic review: Homeopathy for anxiety and anxiety disorders

Search Strategy

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.

Literature Evaluated

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.

Sample Characteristics

The sample sizes of the three case studies were 50, 100, and 45.

Results

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.

Conclusions

The reviewers felt it was difficult to assess the extent to which any response could be attributed to homeopathy.

Limitations

  • The RCTs measured different types of anxiety and reported contradictory results, were underpowered, or lacked methodology details.
  • The three studies involving patients with cancer were not controlled or randomized, and they utilized consecutive patients.
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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.

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The study initially involved 180 patients from 34 institutions. The final study reported on 168 evaluable patients.
  • Group one consisted of 48 patients, group two consisted of 50 patients, and group three consisted of 53 patients.
  • Subjects had received radiation therapy to the abdomen or pelvis and experienced grade 1–3 treatment-related proctitis, diarrhea, and melena at least four weeks after completion of therapy. No concurrent chemotherapy was included.

Measurement Instruments/Methods

  • National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE)  was used to measure proctitis, diarrhea, and melena. 
  • A complete response was defined as the absence of symptoms and cessation of symptom medications.
  • A partial response was defined as a reduction in severity grade.
  • Quality of life endpoints were evaluated via the following tools.
    • Functional Alterations Due to Changes in Elimination (FACE) questionnaire
    • Functional Assessment of Cancer Therapy (FACT) questionnaire
    • Medical Outcomes Survey (SF-12®)
    • Spitzer Quality of Life Index (SQLI)

Results

No significant differences were found among the three arms of the study.

Limitations

  • A previous pilot study had more promising results not found in this study. Further dosing trials or possible rectal administration are recommended.
  • A proportion of patients (20%–25%) reported deterioration in the first three months of the study.
Print

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.

Study Purpose

To assess the efficacy of different intermittent pneumatic compression (IPC) protocols on edema volume reduction in women with postmastectomy lymphedema

Intervention Characteristics/Basic Study Process

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.

Sample Characteristics

  • The study sample was comprised of female patients with breast cancer-related upper-extremity lymphedema who were post-treatment.
  • Mean age ranged from 39–80 years.

Setting

The study took place at Wroclaw Medical University, in Wroclaw, Poland.

Study Design

The study used a randomized trial design.

Measurement Instruments/Methods

  • Arm volume measurements were performed by water displacement.
  • Distance between the tip of the third finger and bottom of axillary fossa was determined for each extremity; each subsequent measurement was repeated to this distance and mean value was recorded.
  • Degree of lymphedema was represented by a difference in volume between the swollen upper extremity and the health upper extremity and was expressed in percent.

Results

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.

Conclusions

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.

Limitations

  • The sample size was small, with less than 100 participants.
  • The description of the study population is limited (i.e., length of time post-treatment or extent of surgical intervention).

Nursing Implications

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.

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