Researchers employed a pilot study to investigate the safety and effectiveness of a stellate-ganglion block to ameliorate hot flashes in women with breast cancer .

Anesthetic was injected  at the anterolateral aspect of the C6 vertebra on the right side under fluoroscopy.

The study treated 13 breast cancer survivors who were experiencing severe hot flashes, night awakenings.

Participants recorded hot flashes in a daily diary by use of the Hot-Flash Score. Scores were recorded 1 week before the procedure and then weekly after the procedure for 12 weeks.

The total number of hot flashes decreased from 79.4 mean episodes to 49.9 in the first two weeks, and continued to decrease during the follow-up period to 8.1 per week. Night awakenings decreased from 19.5 mean episodes per week to 7.3 during treatment then to 1.4 per week during follow up. Very severe hot flash episodes decreased to near zero at follow up.

No adverse events resulting from the stellate-ganglion block were reported, although patients had temporary Horner’s syndrome indicating the effectiveness of the block.

This was a limited pilot study with a very small sample size.

To provide access to methylnaltrexone for patients who participated in a prior study of the agent, and to continue to evaluate the safety and efficacy of methylnaltrexone in patients with opioid-induced constipation.

This open-label drug extension study recruited participants from both the control and active treatment groups of a prior methylnaltrexone study. All patients were at the end of life, were not pregnant, and were using birth control. Patient received methylnaltrexone 0.15 mg/kg subcutaneously as needed once per day. The dose was increased to 0.3 mg/kg if the agent was not effective in four hours.  The dose was reduced to 0.075 mg/kg if the patient had adverse events. 

• The study reported on a sample of 89 participants (39% male and 61% female).
• Mean age was older than 65 years (range 66.9–68.9).
• Most participants (55.9%) were diagnosed with cancer.

• Multi-site
• Inpatient and outpatient
• United States
   

• Patients were undergoing the end-of-life phase of care.
• The study has clinical applicability for end-of-life and palliative care.

This was a nonrandomized, single-arm, drug continuation study.

• Rescue-free laxation time period    
• Efficacy endpoints identified by the research team
• Modified Himmelsbach Scale
• Global Clinical Impression of Change
   

All patients (control group and active treatment group, as defined in the prior study) received a minimum of one drug dose. Patient laxation effect was similar between the active treatment (45.3%) and control (48.3%) groups. Most patients had an effect in less than one hour. Side effects included abdominal pain, nausea, and vomiting. Serious adverse events considered drug related were muscle spasms, abdominal pain, and pain exacerbation. The effect on patient pain levels was minimal. Opioid withdrawal symptoms ranged from none to mild.  

Patients obtained benefit from methylnaltrexone for up to three months, and the agent was well tolerated.

•  The sample size was small (less than 100).
•  The study had no true control group, as control patients also received methylnaltrexone in this extension study.
   

Patients at the end of life who have an ongoing need for methylnaltrexone may continue to receive an effect from the drug for up to three months when it is used as needed.

To compare the efficacy of EMLA cream to EMLA plus hypnosis in the relief of venipuncture-induced pain and anxiety; to determine whether the intervention has a beneficial effect on parents’ anxiety levels during their child’s venipuncture

Patients arriving at the unit had 2.5 g EMLA cream 5% applied over a prominent vein. Those who agreed to the study were randomized to one of three groups: EMLA alone, EMLA plus hypnosis, or EMLA plus attention. Hypnosis included a 15-minute session with a therapist in a private room. The therapist provided analgesic suggestions and led the patient in relaxation. The attention group received a 15-minute session with the therapist and engaged in conversation unrelated to the procedure. Investigators collected measures of pain and anxiety immediately after the intervention and during two follow-up venipunctures. EMLA was removed after 60 minutes.

• The sample was composed of 45 participants.
• Mean patient age was 8.4 years (SD = 2.21 years). The age range was 6–14 years.
• The sample consisted of 25 females and 20 males.
• All patients were pediatric patients with cancer.

• Single site
• Outpatient
• Children’s hospital in Greece

Randomized blinded, controlled trial

• Visual analog scale (VAS), 0–100 mm, to measure pain intensity
• VAS, 0–100 mm, to measure the intensity of anxiety of children and parents
• Procedure behavioral checklist, to document presence and intensity of 10 behaviors indicative of pain and anxiety (inter-rater reliability = 0.85), conducted on 22 procedures

• The EMLA plus hypnosis group experienced less anticipatory anxiety, procedure-related pain, anxiety, behavioral distress, and parental anxiety than did the other two groups (p < 0.001).
• The benefits that the EMLA plus hypnosis group enjoyed continued through the two consecutive venipunctures: significant change in mean self-reported pain over time (p < 0.001) and anxiety over time (p = 0.007).

The study showed that hypnosis, used in conjunction with the local anesthetic EMLA, helped to decrease procedure-related pain anxiety, and distress in pediatric cancer patients. In addition, the intervention helped to decrease parental anxiety.

• The study had a small sample, with fewer than 100 patients.
• The study had a risk of bias due to lack of blinding.
• The intervention must be implemented by a trained therapist. This fact could decrease the feasibility of the intervention.

Oncology nurses in the pediatric setting may want to advocate for the use of hypnosis, along with local anesthetic, to decrease the pain and anxiety of venipuncture.

The purpose of this study was to determine the effect of zinc supplementation on radiation-induced mucositis in patients with nasopharyngeal carcinoma (NPC) and those with oral cancers (OC).
 

Patients were randomly assigned to experimental or control groups. The experimental group received 75 mg zine 4 times/day for three months during radiation therapy. Control group patients received soy bean capsules.  Patients were evaluated if mucositis was detected, weekly. Patients were followed at 3 and 12 months post-radiation therapy completion. Side effects were evaluated by a blinded physician observer.

The study was comprised of 83 patients, age >18 years of age.

MALES 85.5%, FEMALES 14.5%

KEY DISEASE CHARACTERISTICS: 40 were patients with nasopharyngeal cancers (NPC) and 43 were patients with oral cavity cancers (OC).

OTHER KEY SAMPLE CHARACTERISTICS: zinc supplementation
 

SITE: Single site

PHASE OF CARE: Active treatment

Randomized double blind study

Serum zinc, cell count, blood urea nitrogen (BUN), creatinine, glutamic oxalacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), transferrin, and body weight were checked one week prior to radiotherapy and were repeated biweekly until radiotherapy was completed. The serum zinc level was checked using the atomic absorption method.
 

The study found that there is a discrepancy in the effects of zinc supplementation in preventing mucositis between patients with NPC and those with OC, as there were significant effects of zinc supplementation in improving mucositis in patients with OC. Grade 2-3 mucositis occurred earlier in patients receiving placebo.
 

Further studies need to be done to investigate the effect of zinc supplementation in preventing the severity of mucositis in relation to the different radiation fields between those associated with patients diagnosed with oral cancer and nasopharyngeal cancer. This study was focused on subgroup analysis of a previous report.

 Small sample <100

Zinc supplementation may be of benefit in the prevention of oral mucositis. It appears that efficacy may differ according to the specific type and location of the tumor.

To complete a systematic review to evaluate the effect of patient education on the pain intensity, pain interference, and quality of life of patients with cancer 

• Databases searched were MEDLINE, CINAHL, PubMed, EMBASE, PsycINFO, and Database of Abstracts of Reviews of Effects (DARE).
• Search keywords were cancer, malignancy, neoplasm, tumor, nursing, pain, pain management, educational intervention, coaching, training, barriers, mood, well-being, wellness, anxiety, functional ability, patient teaching, patient education, quality of life, and systematic review.
• Studies were included if they
  • Were randomized controlled trials of pain education for cancer patients
  • Were published in English
  • Involved adults with cancer-related pain and educational intervention in the form of information, instructions, or advice via written or auditory means by a healthcare provider to a patient with cancer
  • Included quality-of-life measures based on functional status, perceived pain control, well-being, anxiety, satisfaction with pain treatment, pain interference, physical functioning, and pain intensity and interference
• Studies were excluded if they involved only caregivers or family members or if they used measures of quality of life or pain as the only outcome measures.
   

The search retrieved 68 references. Authors considered 23 references. Authors evaluated studies on the basis of methodological quality assessment; two independent reviewers assessed all studies by using the Jadad scoring system. In the event of a discrepancy, a third reviewer evaluated the study. Data were obtained by means of the PICO (participants, interventions, comparison, and outcomes) approach. The study employed six different instruments to measure quality of life across four studies; two instruments were used to evaluate pain (three studies used the Brief Pain Inventory).

• The final number of studies analyzed was four.
• The sample size, across studies, was 647 patients. The sample range was 97–189 patients.
• Patients were American or Australian, 55–62 years old, and recruited from outpatient clinics. The sample included various types of pain and cancer diagnoses.

Clinical applications: late effects and survivorship, palliative care

Pain scores decreased as a result of the educational interventions in each study, but effects of education on quality of life were not statistically significant.

A limited number of studies evaluating effects of education on cancer pain and quality of life are available. Based on available studies, education about pain has little effect on quality of life in the specified patient population.

• The studies used different tools to evaluate quality of life
• Whether authors assessed methodological quality is unclear.

• FINAL NUMBER STUDIES INCLUDED = 11
• TOTAL PATIENTS INCLUDED IN REVIEW = 731
• SAMPLE RANGE ACROSS STUDIES: 13–302 patients
• KEY SAMPLE CHARACTERISTICS: Age range was 20–81 years; average age was 52–59 years; variety of diagnoses but mainly breast cancer

PHASE OF CARE: All phases

Seven out of eight acupuncture studies showed improvement in CRF, but only four reached statistic significance. All four acupressure studies showed significant improvement. The four studies that showed improvement during initial treatment determined that results could be maintained for as many as 12 weeks. However, the maintenance study did not determine any extra benefit. Three studies reported no side effects. In other studies, adverse events were identified as minor and transient. Four studies used acupressure. These showed positive results. However, three studies were underpowered, and the comparability of study groups was questionable.

Acupuncture and acupressure may be helpful in reducing fatigue. However, because of multiple methodologic flaws in studies reviewed, no firm conclusions can be made regarding the effectiveness of these interventions.

• Heterogeneity of the samples, sizes, types of cancer, treatments administered, length, dose, and intensity of treatment
• Studies had multiple flaws

Acupuncture and acupressure appear to be safe and may be effective. Therefore, this intervention may be suggested for patients with CRF. Additional research is needed to confirm their effectiveness.

To determine if water exercise was more effective than land exercise and the current standard of care to reduce limb volume, body mass index (BMI), and perceptions of swelling in female cancer survivors with secondary lymphedema

• N = 88   
• AGE = 58–63 years (SD = 11)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors with secondary arm lymphedema (n = 69), of which 99% underwent surgical nodal dissections during breast cancer surgery (sentinel lymph node biopsy [46%]) and 93% underwent external beam radiation; gynecologic cancer survivors with secondary leg lymphedema (n = 14), of which 60% underwent lymph node dissection with surgery and 100% underwent external beam radiation
• OTHER KEY SAMPLE CHARACTERISTICS: Self-reported level of physical activity (walking, jogging, strength training, bicycling) and height and weight for calculation of BMI were provided by all participants prior to intervention. Participants reported comorbidities (specifically hypertension, cardiovascular), frequency of MLD prior to intervention, and self-report of relevant medications (diuretics, anti-hypertensives, anticoagulates)

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Two hospitals and one primary healthcare unit in the middle, east, and north of Sweden

• PHASE OF CARE: Late effects and survivorship

• Non-randomized, controlled, clinical intervention study conducted at three different sites comparing water exercise, land exercise, and standard of care

• Limb volume = water displacement or circumference with tape measurement
• Range of motion = goniometry
• Disability of Arm, Shoulder, and Hand (DASH) questionnaire
• Hip Osteoarthritis Outcome Score (HOOS) questionnaire
• Demographic, clinical, and health data = study-specific questionnaire 
• General well-being = visual digital scale ranged from 1–7
• Body-image = seven questions from validated body awareness verbal Likert-type scale 
• Study-specific lymphedema questionnaire (108 questions)
• Self-report of height and weight were used for the calculation of BMI.

Physical exercise does not worsen lymphedema and, based on the results from this study, female cancer survivors with secondary arm lymphedema experience decreased volume, BMI, and self-reported frequency of swelling after water exercise compared to land exercise. Conclusions about the value of land or water exercise as an intervention for female cancer survivors with secondary leg lymphedema cannot be drawn from this study because of the small number of subjects in that group.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable 
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Water exercises were performed in colder water (less than 29°C); warmer water often increases mobility, and physiotherapy for lymphedema is performed in warmer water (33–34°C).
• The study included only one follow-up at end of intervention. 
• Limb volume was measured either with circumference or water displacement based on the facility/intervention group. 
• The number of leg lymphedema survivors was too small to draw conclusions.
• Unclear if HOOS was previously used in same type of study
• Assignment to intervention group was based on city.
• Women were asked if they wanted to participate (self-selection bias).
• Pre-study criteria for compliance rate/participation of at least seven times served as a confounding factor.
• BMI was based on self-report of height and weight.
• The number of dropped participants in the text does not mention the standard group of four participants who were lost to follow-up.
• Almost full adherence to wearing compression
• Unclear when post-intervention measures were taken
• Unclear on the use of compression and if some used compression who normally did not
• The resultant reduction in limb volume may be related to the introduction of a compression garment rather than the exercise program.

Water exercise can be beneficial to female cancer survivors with secondary arm lymphedema. Further interdisciplinary research is needed to design studies that will lead to the development of guidelines/protocols specific to exercise for cancer survivors with secondary arm and leg lymphedema.

To examine the effect of a support intervention on immune function and levels of depression, anxiety, and fatigue in patients with breast cancer after completion of surgery and adjuvant treatment

A total of 41 women were chosen from an ongoing prospective randomized study. The first patients in each stratum of treatment were chosen for current study. Twenty-one women received adjuvant combined radio-chemotherapy (CT-RT), and 20 women received radiotherapy (RT). Eleven CT-RT patients and 10 RT patients were randomized to the support group, while 10 CT-RT and 10 RT patients served as controls. The support intervention consisted of educational lectures about cancer etiology, risk factors, treatment, psychological and physical effects, and coping. Exercise, relaxation training, qigong, and art therapy were also included. The intervention was provided for one week and then for another four days two months later. Study measures were obtained at baseline, 2 months, 6 months, and 12 months.

• The study reported on a sample of 41 patients with breast cancer (100% female).
• Patient age range was 56–69 years.
• Most patients were receiving chemotherapy and radiation therapy.

• Single site
• Outpatient setting
• Vasteras Hospital, Sweden

Patients were in the transition phase after initial treatment.

A randomized controlled trial design was used.

• Hospital Anxiety and Depression Scale    
• Norwegian Fatigue Questionnaire
• Immune Analysis

There was no significant immune effect from the support intervention. More patients in the support group had higher anxiety scores at the start of the intervention compared to the nonsupport group. The mean value anxiety score in the support group was also higher compared to the nonsupport group and improved significantly over time. Low levels of depression were reported in both groups, with no significant difference in depression scores. There was no significant difference in fatigue, but fatigue significantly improved over time in all patients. There were no significant differences in study measures between groups.

The support intervention had no effect on depression or immune parameters. There was no difference in improvement of anxiety and fatigue over time associated with the intervention.

• The study had a small sample, with less than 100 participants.
• The sample had low depression scores at baseline.
• It is not clear how the intervention was provided, whether individually, in groups, in the home, or in some other setting. 
• The study had no blinding.

Findings do not support effectiveness of the intervention tested here. Results show that depression, anxiety, and fatigue improved significantly over time.

To examine the effect of a support intervention on immune function and levels of depression, anxiety, and fatigue in breast cancer patients after completion of surgery and adjuvant treatment  

Authors chose 41 women from an ongoing prospective randomized study. The first patients in each stratum of treatment were chosen for the current study. Of the 41 women, 21 received adjuvant combined radiochemotherapy (CT-RT) and 20 women received radiotherapy (RT). Eleven women (CT-RT) were randomized to the support group, and 10 women (RT) were randomized to the support group. Ten CT-RT and 10 RT patients served as controls. The support intervention consisted of educational lectures about cancer etiology risk factors, treatment, psychological and physical effects, and coping. Exercise, relaxation training, qigong, and art therapy were also included. The intervention was provided for one week and, two months later, for another four days. Study measures were obtained at baseline, 2 months, 6 months, and 12 months.

• The sample was composed of 41 participants.
• The range of mean patient age was 56–69 years.
• Males: 0 %; females: 100%.
• Participants were patients with breast cancer.
• Most patients were receiving chemotherapy and radiation therapy.
   

• Single site
• Outpatient
• Vasteras Hospital, Sweden
   

Phase of care: transition phase after initial treatment

Randomized controlled trial

• Hospital Anxiety and Depression Scale    
• Norwegian Fatigue Questionnaire
• Immune analysis
   

• Results revealed no significant immune effect from support intervention.
• More patients in the support group had higher anxiety scores at the start of the intervention than did patients in the nonsupport group.
• The mean value of anxiety in the support group was higher than that in the nonsupport group, and the value improved significantly over time.
• Patients in both groups had low levels of depression, with no significant difference in depression scores.
• Patients in both groups had no significant difference in fatigue. The measure of fatigue decreased over time for all patients.
• No significant differences in study measures existed between groups.
   

The support intervention had no effect on depression or immune parameters. The intervention did not appear to cause any difference in improvement of anxiety and fatigue over time.

• The  study had a small sample size, with fewer than 100 participants.
• Participants had low depression scores at baseline.
• Authors did not specify how the intervention was provided—individually, in groups, in the home, or in some other setting. 
• The study had a risk of bias due to no blinding.

Findings do not support effectiveness of the intervention tested here. Results show that levels of depression, anxiety, and fatigue reduced significantly over time.

A residential, rehabilitative, psychoeducational intervention was conducted over a six-day period, followed by a four-day follow-up/booster intervention two months after the initial visit. Members of the intervention team included oncologists, social workers, art therapists, massage therapists, and a person trained in qigong and visualization; all had several years of experience and were trained according to the method of Grahn (1993). During the intervention period, patients received information about cancer, risk factors, treatment, psychological effects, and coping mechanisms. Physical exercise, relaxation training, qigong, and art therapy were mixed with educational lectures. Social activities, such as concerts and visits to museums and restaurants, were provided, along with opportunities for peer support. The residential rehabilitation environment was chosen for its beautiful and restful surroundings.

• Patients (n = 59) were primarily women; only two males participated.
• Median age was 53 years (range 29–81).
• Diagnoses included breast cancer (61%), gynecologic cancer (20%), and gastrointestinal malignancy (9%).
• The median time from the end of treatment to intervention was 1.2 years (range 6 months–3 years).

The intervention venue was a residential rehabilitation setting selected specifically to deliver the intervention.

Patients were undergoing the long-term follow-up phase of care.

The study was uncontrolled—fatigue was evaluated immediately after the first six-day intervention, with follow-up at 3, 6, and 12 months postintervention.

Norwegian fatigue questionnaire—an 11-item measure with two factors:  physical fatigue and mental fatigue. The total score is created by totaling the 11 items.

At the conclusion of the intervention, there were statistically significant differences in fatigue reflected on most of the single-item scores on the Norwegian fatigue scale, as well as a statistically significant difference in the scores on the physical and mental fatigue factors. Only the improvement in physical fatigue remained statistically significant at three-month follow-up, and there were no significant improvements in fatigue noted at the 6- and 12-month postintervention time points.

• The study lacked a control group.
• The sample size was not justified by power analysis; it is unknown whether the study was powered to detect an effect.
• No information was provided relative to the psychometric properties of the fatigue measure.
• No explanation of the gender bias in study participation and recruitment was offered.
• Generalization of the study results is limited by the primarily female sample and the overrepresentation among patients of breast and gynecologic malignancies.
• Costs of residential group treatment were unexplored.

The program requires the involvement of several skilled professionals.