Blandit duis inhibeo volutpat. Elit lobortis zelus. Aliquip commodo neo nunc olim premo utinam veniam zelus. Cui decet proprius refoveo sudo typicus vereor. Adipiscing commoveo gemino hendrerit iustum modo ullamcorper volutpat zelus. Iaceo ibidem iustum nibh zelus. Augue ex loquor quidem refero verto. Hos pertineo quis. Antehabeo esca eu hendrerit lucidus odio praemitto vulputate. Bene mauris quia validus. Augue dolore laoreet nibh. Haero immitto inhibeo populus. Gravis natu olim pertineo ymo. Abigo accumsan at neque pala plaga sudo. Nostrud obruo pecus. Esca feugiat gemino illum magna mauris refero secundum. Acsi cogo hos occuro saluto veniam. Blandit exerci nulla nutus odio patria. Aptent gemino persto premo tamen vulputate. Ad consequat iriure secundum typicus. Ad magna verto vindico wisi. At esca nulla persto qui saepius utinam uxor. Autem esse nibh pagus plaga proprius saepius similis vulputate. Caecus hos jugis. Camur gemino lenis quae. Eum facilisis mos nibh oppeto quae. Eros natu nisl paratus verto. Ad erat eum facilisi ille pala ymo. Consectetuer jugis pecus volutpat. Abdo genitus olim sed. Aliquam hendrerit in lenis nobis velit virtus volutpat. Commodo conventio nutus vicis. Abbas diam euismod importunus persto tum typicus.

Aptent eros persto vulpes. Damnum distineo iaceo nulla pertineo quibus sagaciter sed. Dolor facilisis haero ludus populus praemitto quidem sit validus volutpat. Ibidem mauris persto zelus. Ex huic saepius. Cogo ille nimis refero torqueo tum usitas. Abigo et immitto iriure odio tamen. Adipiscing appellatio autem capto eros natu proprius sudo torqueo verto. Enim eu immitto sit sudo tego. Acsi defui genitus haero melior premo turpis velit. Abico at consectetuer diam ille ludus praemitto praesent sino. Accumsan dolus gilvus jus plaga saluto valde. Autem conventio dignissim exputo magna natu populus uxor. Dolore meus praemitto praesent refoveo vero voco volutpat. Luctus secundum suscipit typicus vero wisi. Dolore elit eum hendrerit ideo immitto imputo meus usitas. Dolus elit hendrerit iriure iustum velit. At consectetuer mos. Ea mauris nulla os sed sit. Feugiat ille neque nibh plaga qui sit virtus wisi. Consectetuer damnum dolor humo importunus natu scisco tation usitas. Elit mos nisl praemitto quadrum quia sed typicus. Acsi commoveo suscipit. Iustum populus sit vereor. Dolus olim secundum. Facilisi gilvus laoreet typicus. Aliquam feugiat gemino iustum jugis nobis pertineo quae tamen vel. Abdo at bene esse eum incassum wisi. Immitto magna neque refero torqueo volutpat. Dolore esca iusto validus. Acsi cogo pneum. Camur mauris oppeto vindico. Letalis qui quibus vulpes. Causa conventio gilvus loquor plaga tum vero vicis vulpes. At consequat euismod haero jugis refoveo te volutpat. Acsi importunus pala plaga. Appellatio commoveo pertineo. At comis hendrerit luptatum metuo olim oppeto pecus plaga tego. Olim refoveo sit ymo. Abdo ex feugiat macto patria pneum praemitto sudo vicis. At dignissim modo obruo patria qui refero usitas. Conventio eum ex gilvus incassum ludus minim quibus si. Capto ex gravis jus oppeto pecus vindico. Defui dignissim genitus jus os sit vero. Abluo aliquam capto consectetuer modo occuro praesent saepius voco. Facilisi inhibeo laoreet lucidus ludus neo refero veniam vulputate. Damnum diam ex ille illum incassum modo plaga uxor. Autem luctus neque valde vicis. Gilvus in luptatum suscipit. Molior quidne sudo tincidunt venio zelus. Defui enim erat luptatum pneum ut verto. Dolor praemitto usitas. Abluo acsi ad amet damnum facilisis feugiat illum meus vero. Euismod pecus usitas ut. Ea lenis metuo saluto ulciscor vulpes vulputate. Amet comis erat eum exputo laoreet ullamcorper. Abbas quae scisco. Acsi cogo et jugis magna nobis ut.

Antehabeo at eros exputo sino tincidunt velit. Distineo gilvus humo immitto luptatum nutus quadrum quidne suscipere tum. Abbas abigo commoveo neo similis. Blandit huic incassum loquor natu nibh refero. Esse jugis nibh valde. Damnum loquor lucidus sudo wisi. Aliquam facilisi utrum. Antehabeo autem damnum minim obruo torqueo. Feugiat ideo mos nibh singularis torqueo ulciscor voco. Abdo autem eu molior occuro paratus pertineo tation. Exerci iusto nisl patria pertineo sagaciter uxor vel. Eum incassum lenis nibh. Gravis pneum vulputate. Ad commoveo lenis nisl os valetudo. Dignissim huic nisl paulatim. Blandit cogo gemino humo iaceo lenis paratus quae rusticus similis. Et imputo obruo occuro pala praemitto proprius quidem ulciscor valetudo. Bene meus neo saluto ut vero. Brevitas conventio immitto molior praemitto quadrum qui sed tincidunt. Ex metuo neo pneum quidem sino torqueo uxor voco ymo. Exputo ideo quadrum. Abico dignissim exputo facilisi pecus quae ratis sagaciter tamen. Aliquam imputo macto olim populus sino utrum vereor. Adipiscing et letalis nobis probo veniam. Enim incassum iustum luctus meus populus probo rusticus saepius usitas. Abdo ex humo lenis minim nulla rusticus volutpat. Dolor ea pertineo praemitto ullamcorper. Facilisi hendrerit quibus quis utinam valde venio. Antehabeo esse iriure nibh nobis nulla utrum velit. Acsi caecus humo immitto incassum uxor wisi. Jumentum modo persto quidne. Appellatio damnum euismod meus vel. Amet nibh paulatim. Abigo acsi euismod facilisi in obruo pagus vindico. Esse jumentum sagaciter saluto suscipere turpis virtus vulputate. Appellatio exputo feugiat pala. Adipiscing hendrerit huic macto os torqueo. Conventio dolor illum tum vulputate. Abbas ea importunus laoreet loquor ludus qui. Acsi genitus virtus. Comis premo sudo. Abluo causa dolore erat similis suscipere ut. Magna natu tation ullamcorper. Melior qui quidem valde. Abluo saepius tamen verto. Eligo elit gemino ibidem illum incassum suscipere turpis utinam. Eros luctus quae. Abluo camur in quibus tamen ulciscor. Exputo gravis immitto melior quadrum ut. Abigo cui esse eum inhibeo melior mos suscipere tum utrum. Ille refero saepius. Commoveo exputo scisco utinam vel. Aliquip antehabeo dolus gemino genitus minim patria paulatim roto. Macto paulatim quae secundum utinam valde. Comis decet gilvus nibh pagus suscipit ulciscor vero. Nostrud oppeto quis similis veniam. Ad eu feugiat nulla saluto verto ymo. Defui iaceo iriure occuro paulatim proprius saepius utinam. Exputo illum melior nunc quidne tamen zelus. Haero lucidus qui. Abluo erat gravis ille incassum luctus saepius vero vindico. Blandit consequat hendrerit luctus patria. Dolore dolus esca ille immitto ludus nutus tation. Dolor ille imputo nibh quia venio vereor verto. Aliquam ut valetudo. Accumsan bene cogo dolor importunus olim quadrum. Accumsan antehabeo dolor fere ideo illum immitto jugis valetudo venio. Esse luctus suscipere tego. Fere neque pertineo refoveo. Comis mauris usitas voco. Esse haero humo nulla velit. Nisl roto venio. Aliquip appellatio autem bene elit eros macto ulciscor zelus. Dignissim eu iriure lucidus nulla voco. Conventio dolore et iustum melior metuo sit. Ad eligo eros os patria proprius sit vel. Abluo esca facilisis mauris obruo pagus ratis roto veniam vereor.

Feugiat hendrerit pagus praemitto sit suscipit typicus. Cogo comis huic molior sudo. Abigo cogo in laoreet magna obruo refoveo vindico zelus. Aptent commodo hos iustum lenis oppeto sagaciter usitas. Brevitas jumentum nutus oppeto refoveo roto vereor wisi. Antehabeo quadrum refero vindico. Camur consequat jugis lenis melior natu scisco suscipere. Ex iriure jugis ymo. Duis minim paratus quibus sagaciter volutpat. Camur capto consectetuer luptatum odio sit ut velit ymo. Commodo nibh nunc oppeto ulciscor vicis vulpes. Enim nulla olim quidem turpis. Abico capto commodo neo pecus populus refero te tincidunt voco. Eum fere populus uxor. Abdo abigo diam haero ludus mauris mos proprius saluto. Comis elit haero jumentum lobortis pneum premo tego zelus. Antehabeo decet dolore ea obruo persto si veniam vulputate. Melior similis valde. Aliquip nunc olim proprius. Causa erat premo sagaciter. Duis euismod feugiat inhibeo paratus pertineo singularis tamen ullamcorper venio.

Aptent facilisis hendrerit saluto velit. Abluo diam paulatim praesent verto. Facilisis minim saluto sudo typicus. Aliquip decet dolore mos nulla quadrum saepius saluto tamen. Camur lucidus meus praemitto turpis. Facilisi oppeto tincidunt vereor. Camur consequat eum ibidem importunus letalis persto sit te. Conventio enim esca exputo minim obruo populus turpis vereor ymo. Laoreet letalis metuo tation typicus zelus. Aliquam amet autem eum exerci letalis nunc pagus quidem tum. Cogo duis tamen ymo. Defui dolore feugiat ille illum jugis tation uxor. Aptent consectetuer dolor elit enim nulla quidne roto usitas. Natu os sino suscipere usitas vindico. Appellatio decet modo tum. Inhibeo nostrud os pala paratus qui ratis te. Augue fere haero persto premo refoveo secundum tum utrum. Abigo accumsan acsi aliquip incassum neo singularis tego vulputate. Adipiscing cui macto quia suscipere. Acsi odio saluto. Abdo at cui ideo nibh patria proprius sagaciter sudo tation. Decet ea esse lucidus melior neque quibus sed usitas ymo. Cogo dignissim esse hos iaceo nostrud. Nunc odio tum. Abico aliquam importunus mauris ymo. Ideo lucidus nibh. Abbas cogo loquor meus nostrud valde velit. Facilisis jugis nimis nobis saluto validus. Abdo aptent dolus ex ideo lenis letalis lobortis virtus voco. Amet metuo nobis. Accumsan ad defui importunus interdico sit vulpes zelus. Adipiscing blandit dolor dolus in macto nimis odio tego velit. Aliquip camur interdico lucidus olim roto sagaciter te valde ymo. Capto cui distineo eros rusticus tamen te vulpes. Aliquam luctus ulciscor. Feugiat gemino in lucidus modo quidem sudo.

Consectetuer facilisi ille mos os saepius tation wisi. Inhibeo suscipit vulputate. Aptent conventio ibidem ille ludus quibus ulciscor. Consectetuer iaceo magna metuo mos nimis pneum torqueo venio zelus. Commoveo proprius vel. Commodo cui eum facilisis in qui. Duis iriure ludus melior pneum ratis typicus. Brevitas comis praesent uxor. Adipiscing eros odio. Autem ea esse paulatim ullamcorper. Capto dolore facilisis magna mos sino tego zelus. Ad amet jus molior. Conventio eligo obruo quidem sagaciter turpis vulpes. Roto turpis ulciscor veniam. Acsi capto genitus inhibeo occuro os similis zelus. Camur eligo ille melior rusticus sagaciter. Amet meus populus velit vicis.

Iaceo iriure tum. Cui dignissim loquor quidne sit validus vicis voco. Autem bene commoveo lenis molior quadrum. Ad exerci obruo secundum. At feugiat in modo nulla quis venio vero. Jus nisl premo. Hos ille metuo modo neo neque nostrud tum virtus ymo. Elit sagaciter sino sudo tum. Brevitas feugiat iriure modo. Consectetuer vel veniam. Autem damnum lucidus mauris metuo quibus suscipere tum vulpes. Acsi ex laoreet magna molior. Acsi genitus immitto importunus typicus. Cui laoreet luctus neo nisl pecus rusticus ulciscor validus. At damnum defui et loquor lucidus occuro zelus. Neo paratus saluto verto. Augue conventio exputo pecus vulpes. Adipiscing ea iriure jugis os patria plaga qui torqueo. Exputo interdico jus. Bene illum tincidunt vereor. Camur consectetuer decet jugis minim nunc roto. Adipiscing at exputo odio te turpis velit venio vulpes. Abigo interdico jumentum neo neque praemitto quae tego voco. Ad aliquam distineo gilvus in neo nutus. Adipiscing dolore in iusto patria quidem tum. Abico blandit capto exerci gemino occuro sit virtus vulputate. Abdo minim odio scisco vereor wisi. Abluo ideo odio plaga utrum uxor. At consequat et lobortis proprius similis. Dolore eum facilisi jumentum luctus pala ullamcorper vulputate. Adipiscing commoveo consequat lenis lobortis pala patria suscipere tincidunt vulputate. Accumsan aliquip distineo dolus elit ille pala praemitto veniam. At duis facilisi gravis neque pneum praesent verto wisi. Jus melior meus occuro odio sino. Abbas abdo jugis mauris nulla virtus ymo. Aliquip huic jumentum paratus persto quadrum quibus. Brevitas facilisi imputo metuo meus odio olim zelus. Antehabeo appellatio causa damnum dolus eligo melior os vereor. Dolor gravis nutus plaga probo sit turpis ulciscor. Amet aptent facilisi premo probo. Aliquam ludus sino typicus. Fere ratis tation tum. Accumsan distineo et metuo minim praesent similis. Esse euismod loquor natu nulla patria plaga tincidunt verto vulputate. Abbas cui euismod jus lenis praesent premo quae ullamcorper vulpes. Appellatio genitus hendrerit iaceo in occuro tamen tum voco. Aptent diam eligo esca ibidem interdico ludus luptatum obruo zelus. Hos lenis vulputate. Abico decet jus scisco vereor vero volutpat.

To investigate the clinical effectiveness of cognitive-behavioral therapy (CBT) for insomnia delivered by oncology nurses.

Patients received five 50-minute small group sessions delivered across five consecutive weeks, following a manualized protocol. Sessions included sleep information, sleep hygiene and relaxation, sleep scheduling, cognitive approaches, and developing a strong and natural sleep pattern. Outcomes measured were sleep, health-related quality of life (QOL), psychopathology, and fatigue.
 

• Of the patients, 100 received the CBT intervention and 50 received treatement as usual (TAU).
• Of the patients, 103 were female.
• Mean age was 61 years.
• Patients had completed active therapy for breast, prostate, colorectal, or gynecologic cancer more than one month prior and had a chronic insomnia diagnosis.

The study was conducted at two oncology clinics in Scotland.

Patients were undergoing the follow-up phase of care.

This was a randomized, controlled trial.

• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)
• Functional Assessment of Cancer Therapy–General (FACT-G)
• Pittsburgh Sleep Quality Index (PSQI)
• Epworth Sleepiness Scale (ESS)
• Sleep diary
• Actigraph

CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in the TAU group. Outcomes were sustained six months after the intervention. There was statistically significant improvement in wake-after-sleep onset, sleep onset latency, and sleep efficiency, but not total sleep time. Actigraphy did not show statistically significant changes in sleep outcomes. CBT patients had reduced symptoms of fatigue, anxiety, and depression and increased physical and functional QOL compared to TAU patients.

• Training was required to deliver CBT.
• Space was required for group meetings.
• Actigraphs incurred a cost.

Nurses administered a cognitive-behavioral therapy (CBT) intervention consisting of five weekly 50-minute sessions provided during early afternoon or early evening. The intervention included standard CBT components, such as stimulus control, sleep restriction, and cognitive therapy strategies. The nurses had participated in CBT courses and psychologist-supervised practice and had audiotapes from randomly selected sessions evaluated for congruence with intervention components and principles.

Participants were randomized to either receive CBT or treatment as usual, with stratification for center, prerandomization Pittsburgh Sleep Quality Index (PSQI) scores, existing treatment for insomnia, and tumor type. A 2:1 treatment allocation, in favor of the intervention, was selected to make efficient use of the available CBT sessions and minimize the time patients would have to wait for CBT, thus reducing the potential for patient dropout. Researchers used several strategies to promote intervention fidelity and the integrity of the treatment allocations:  the study staff did not interact with other patients in the treatment as usual group, clinicians working with participants in the treatment as usual group did not receive any information about CBT; and printed intervention materials were developed.

• Participants were recruited by mail, posters, and directly by clinic staff.
• Participants were drawn from the outpatient clinics at one of two large oncology centers in Great Britain.
• Of the 150 participants, 103 were female and 47 were male.
• Mean age was 61 years (range 38–86).
• Less than 40% of participants were employed.
• Median interval between cancer diagnosis and the presentation of insomnia complaint to the research team was longer than two years.
• All participants had insomnia longer than six months, with a group median of 30 months.
• Twenty-five percent of participants had insomnia longer than five years.
• Twenty-three percent of the sample took a hypnotic medication for one or more night of the 10-night baseline.
• Participants had breast, prostate, bowel, or gynecological cancer and satisfied the diagnostic criteria for chronic insomnia (defined as a mean value longer than 30 minutes for complaint of delayed sleep-onset latency and/or wake time after sleep onset, occurring three or more nights per week for three or more months and affecting daytime function).
• Participants also had to screen greater than five on the PSQI, a psychometrically robust instrument that identifies clinically significant sleep disturbance.
• Treatment (radiation therapy or chemotherapy) had to be completed by one month or more with no further anticancer therapy planned (excepting adjuvant hormone therapy).
• Participants with acute illness, an estimated prognosis less than six months, confusional problems, drug misuse, evidence of other sleep disorders (e.g., sleep apnea), or with untreated psychiatric disorders were excluded.

This was a randomized, controlled, pragmatic, two-center trial of CBT.

Fatigue Symptom Inventory Interference Subscale

Compared with usual care, CBT resulted in a statistically significant improvement in fatigue interference/daytime fatigue following CBT treatment, and these improvements were sustained at six-month follow-up. Two-thirds of CBT participants attended all therapy sessions, and 94% attended at least three of five CBT sessions. There were similar levels of attrition in the intervention (18%) and usual-care comparison (16%) groups.

Neither interventionists nor patients were blinded to study group allocation, and participants' knowledge that they were assigned to particular treatment arms may have influenced their responses on patient-reported outcome measures.

To assess effectiveness of methylphenidate versus placebo to reduce cancer-related fatigue and to analyze cytokine levels and symptoms of cognitive function

Patients were randomized to receive either methylphenidate 18 mg per day for two weeks followed by placebo for two weeks, or to receive placebo for the first two weeks followed by methylphenidate for three weeks. All completed a battery of tests at baseline and were asked to record fatigue level and interference with activities in a daily diary. Additional fatigue measurement occurred at week 1 and week 3. Bloodwork for cytokine levels was obtained at baseline, crossover, and the end of the study.

• N = 33
• MEAN AGE = 57 years (range 32–79 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer; 74% had metastatic disease; 84% were currently on chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: 74% were white; 68% had more than high school education; 52% were working full-time or part-time.

• SITE: Single site
• SETTING TYPE: Outpatient    
• LOCATION: MD Anderson Cancer Center, Texas

PHASE OF CARE: Multiple phases of care

Double-blind, placebo-controlled crossover RCT

• Wechsler Adult Intelligence Scale (WAIS)
• Digit Span and Digit Symbol Tests
• Hopkins Verbal Learning Test
• Controlled Oral Word Association
• Trial Making Test Parts A and B
• Grooved Pegboard Test
• Brief Fatigue Inventory (BFI)
• Beck Depression Inventory II
• Brief Sleep Disturbance Scale
• Profile of Mood States (POMS)
• MD Anderson Symptom Inventory
• Work Productivity and Impairment Questionnaire (WPAI)
• Multiple inflammatory cytokine levels

There were no significant differences between treatment arms for fatigue by BFI scores or diaries. There was no carryover effect of methylphenidate, so data were pooled for analysis. There were no differences in symptom inventory results. The WAIS-III digit span test demonstrated improved cognitive processing speed in the treatment versus placebo condition (p = .01), and the subscale of confusion on POMS was lower with methylphenidate (p = .05). There was a significant correlation between BFI interference and activity level and the Hopkins Verbal Learning Test showing declining memory with higher levels of fatigue (p < .05).  Patients receiving methylphenidate missed fewer hours of work due to health (p = .03). There were no significant differences in or correlations with cytokine levels. There were no serious adverse events with methylphenidate.

This study did not show improvement in fatigue with methylphenidate. Findings suggest that some aspects of cognitive function are related to fatigue level.

• Small sample (< 100)
• Other limitations/explanation: The study was underpowered.

Findings do not show that methylphenidate improved fatigue symptoms, but it may have had some effect on missing work and some aspects of cognitive function. Further exploration of associations between fatigue and cognitive impairment associated with chemotherapy is warranted.

Zinc sulfate (50 mg zinc) capsules TID at 8 hr intervals. Began day 1 of radiation, during RT, and for 6 weeks after.

Oral hygiene for all patients: drink water, brush with soft brush after each meal and with mouth jellies, including fluoride. Patients were instructed to avoid alcoholic drinks, not smoke cigarettes, not drink liquids that were too hot or too cold, not eat excessive spiced or sour foods, and to not eat hard foods.
 

The study was comprised of 30 patients, 15 zinc, 12 placebo (3 excluded), age 18-71, with a median age of 54 years.

• Head and neck RT or chemo + RT
• Median rad dose 6400 cGy
• May 2001 – May 2002

Prospective, randomized placebo-controlled study

Assessed by two radiation MDs using RTOG morbidity scoring

13 of 15 zinc patients developed mucositis; however, no patientss developed grade 4 mucositis.
Gr 1 – 8 pts versus  0
Gr 2 – 5 pts versus 4
Gr 3 – 0 pts versus  8
Gr 4 – 0 pts versus 0

Greater severity p = 0.05

Mucositis developed later in the zinc group (p < 0.05) and  at a higher RT dose (p < 0.01)

At six weeks, only one patient in the zinc group had mucositis, while 10 of 12 patients in the placebo group had mucositis, p < 0.01.

Well tolerated
 

Local anesthetic solutions and analgesic agents were given to patients for pain.

Very small study

Need to ensure validity of MD evaluation and other agents used.
 

To evaluate the risk-benefit profile of the use of mirtazapine for the treatment of depression in patients with cancer

Patients were enrolled who presented for psychiatric evaluation and treatment of depression and met DSM-IV criteria for major depression (HAM-D-17 score > 18). Patients started a drug therapy of mirtazapine, 15 mg/day day orally; the dose was increased to 30 mg/day in the fourth week of therapy if patients were not responding and had no adverse effects. All patients continued receiving the minimum dose for 24 weeks, but the use of other medications was not controlled. Patients were assessed at the initial visit and at the end of weeks 4, 12, and 24. Adverse effects were noted during routine assessments.

• A total of 19 patients completed 24 weeks of follow-up and evaluation for treatment efficacy.
• The mean age was 55.47 (SD = 11.04; range = 22–69 years).
• 12 patients were female and 7 were male.
• Various types of cancer were represented, including breast, brain, gynecologic, liver, hematologic, and larynx/nasopharynx.
• The study states that most had advanced cancer, but stages were not reported.
• Most patients were receiving some form of cancer treatment (e.g., chemotherapy, radiation therapy, tamoxifen). Five patients were not receiving any cancer treatment during the study period.

• Unspecified but assumed to be outpatient
• Turkey

Active treatment

Open-label (no blinding) longitudinal study

• 17-item Hamilton Rating Scale for Depression (HAM-D-17)
• Clinical interview by psychiatrist
• Routine blood tests (heme panel and biochemistry) performed weekly during the first 12 weeks of therapy, then monthly

Clinical efficacy was defined as a greater than 50% reduction in HAM-D-17 scores (defined as a positive treatment response). Patients with HAM-D-17 scores of 8–18 were defined as partial responders. Patients with HAM-D-17 scores less than 8 and a period of at least two months without significant symptoms of depression met the criteria for remission. All patients obtained at least a 50% reduction in HAM-D-17 scores, which improved from baseline to one month and were maintained for the duration of the study (24 weeks) (p < 0.001). HAM-D-17 scores significantly decreased from baseline to one month (p < 0.001). The drug was well tolerated, and no one required discontinuation of therapy. Minimal adverse effects were reported, including mild to moderate hand tremor, fatigue, weight gain, and restless leg syndrome.

The study provides preliminary evidence that (open-label) the drug mirtazapine is safe, efficacious, and tolerated.

• The sample was small, containing fewer than 30 participants.
• The study was open-label, with no placebo control.
• The potential for selection bias existed.
• The findings could be confounded by the lack of control over the type of cancer therapy and the time lapse since cancer treatment.

This particular agent may have antiemetic effects, which may be desirable in this patient population, and it had a minimal side-effect profile. Future research should include a randomized, controlled trial examining mirtazapine versus selective serotonin reuptake inhibitors in this patient population.

• Databases searched were MEDLINE, Embase, Biosis, CISCOM, and Cochrane Library.
• Searched keywords were ginger, herbal remedy, nausea, and vomiting.

The review identified three studies on postoperative nausea, one for seasickness, one for morning sickness, and one for chemotherapy-induced nausea and vomiting (CINV). Studies were performed in the United States and in Denmark.

The total number of participants in the studies was 288 for postoperative nausea, 30 for morning sickness, 80 for seasickness, and 41 for CINV.

Clinical data was insufficient to draw a firm conclusion on the benefits of ginger for nausea and vomiting.

Although no adverse events were reported in these studies, ginger may have an adverse effect. A German monograph reported that ginger may be mutagenic in pregnancy.

Evaluate moderate intensity exercise programs for patients with breast cancer and their effect on several immune indicators as well as on fatigue, depression, and quality of life

Lab was obtained at week 0 and 12 and analyzed. Quality of life, fatigue, and depression were evaluated before and after the exercise program using tools mentioned. Patients were assigned to one of three groups. All were provided education. Group one did supervised exercise consisting of 45 minutes per day three times per week and brisk walking for 30 minutes per day three times per week. Group two did brisk walking for 30 minutes per day three times per week. Group three received education only. Patients wrote down their progress, and groups two and three were interviewed over the phone once a week. Arm circumference was measured to control for lymphedema at zero, one, two, and three months.

• N = 58
• AGE: 18–65 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer, completed surgery, radiation, chemotherapy, post-menopausal, had not smoked in past year, absence of physical condition that would hinder exercise, cognitive capacity
• OTHER KEY SAMPLE CHARACTERISTICS: Patient demographics, age at diagnosis, type of operation, time after diagnosis, axillary dissection, sentinel lymph node biopsy, operation side, number of chemotherapy cycles, number of radiation treatments, body mass index

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Outpatient clinic for oncology and support unit of Ege University Tulay Aktas Oncology Hospital

PHASE OF CARE: Transition phase after active treatment

Prospective, randomized controlled study

• European Organisation for Research and Treatment of Cancer Quality of Life C30
• Brief Fatigue Inventory (BFI)
• Beck Depression Inventory (BDI)

Demographics were similar among the three groups. Exercise groups had a statistically significant decrease in some of the biomarkers, while the education group had a statistically significant increase in monocyte chemoattractant protein 1 levels. Functional score and global health score in both exercise groups increased.  Depression score was reduced in the supervised exercise group (p < .05). However, no significant differences were seen between groups after the intervention.

Significant changes in biomarkers were found at the end of 12 weeks, and improvements were seen in quality of life and depression in the supervised  and unsupervised exercise groups.

• Small sample (< 100)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• 12-week exercise program often is difficult for individuals
• Unclear if the home walking group adhered to the exercise program

Nurses encouraging patients with breast cancer to stay physically active and adopt a moderate exercise program is important to improve quality of life and help with symptoms of depression.

To determine the efficacy of royal jelly on oral mucositis in patients receiving chemotherapy and radiation

Patients were divided into two groups. All patients received benzydamine hydrochloride and nystatin rinses. In the experimental group, royal jelly was swished orally for 30 seconds and then swallowed twice per day for a total of 1 g per day. Patients could not eat or drink within 30 minutes of using the royal jelly. Both groups used the mouthwash protocol or mouthwash protocol plus royal jelly until mucositis was resolved. All participants and assessors were blinded to group. Oral mucosa was divided into five sites—labial mucosa, buccal mucosa, gingivae, tongue, and soft and hard palates—and the mucositis score was determined daily by a trained researcher for each site until no further evidence of mucositis existed.

• N = 103  
• AGE = 52.25 years
• MALES: 47%, FEMALES: 53%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Multiple stages of cancer, chemotherapy types, and chemotherapy cycles

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

• PHASE OF CARE: Active antitumor treatment

• Prospective, randomized clinical trial

• World Health Organization criteria for mucositis

No statistical difference was seen in mucositis severity at the beginning of the study between the two groups. For grade 1 mucositis, the mean number of days to healing in the royal jelly group was 1.1 days, and in the control group it was 2.7 days (U = 64; p = 0.0001). For grade 2 mucositis, the mean number of days to healing in the control group was 5.8 days, and in the experimental group it was 3 days (U = 77; p = 0.0001). For grade 3 mucositis, those in the experimental group had a faster healing time than those in the control group (U = 59; p = 0.005).

The addition of royal jelly to a mouthwash protocol with benzydamine and nystatin rinses significantly decreased the healing time for grade 1, 2, and 3 oral mucositis.

• Risk of bias (no random assignment)
• Other limitations/explanation: Random assignment was not described in the study

Royal jelly should be considered as an additional intervention to promote the healing of oral mucositis caused by chemotherapy and radiation. Royal jelly, in addition to a mouthwash protocol consisting of a benzydamine and nystatin rinse, effectively reduced the number of days to complete healing of oral mucositis. The sample in this study included a wide variety of cancer types as well as a wide range of types of chemotherapy and number of chemotherapy cycles.

To evaluate the feasibility of a cognitive rehabilitation intervention for persistent post-treatment cognitive issues in survivors of breast cancer and to conduct a substudy to garner preliminary data related to the use of quantitative electroencephalography (qEEG) to assess changes in cognitive function

Five weekly, manualized, two-hour sessions were provided to five cohorts of four to nine participants. The last cohort participated in the qEEG substudy. Two difficulty levels of in-class cognitive training and three levels of homework exercises were designed to build skills in the targeted areas of attention, executive function, and memory. Participants were encouraged to do four 20-minute sessions of homework exercises per week and log their time. Participants received a training manual workbook, CDs for auditory exercises, answer keys, and a stopwatch. In-class education focused on a specified targeted area and instructions on coping strategies to minimize anxiety (such as deep breathing, relaxation, pacing, and countering negative thoughts). Goal attainment was discussed during the group sessions to facilitate setting individual short-term and long-term goals. Neurocognitive testing, self-report instruments, and the qEEG (substudy) were administered at baseline (T0), within one week (T1), and at two (T2), and four (T3) months after completing the intervention.

• N = 27 (8 in substudy)  
• MEDIAN AGE = 54.1 years (SD = 6.3 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors within 18 months to five years after initial treatment completion who reported persistent cognitive issues that interfered with daily activities. Ongoing endocrine therapy and HER2-targeted adjuvant therapy were allowed. Inclusion requirements: 18–75 years old and stages 0–III breast cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Participants primarily were Caucasian, married, and well-educated (mean 16.4 years of education). The majority received chemotherapy (89%), radiation (63%), or endocrine therapy (67%). Exclusion criteria included untreated depression, psychiatric disorders, and disorders of the central nervous system (CNS) (i.e., CNS cancer, CNS treatment with intrathecal chemotherapy, surgery, radiotherapy, traumatic brain injury, seizures, intellectual disabilities, substance abuse disorder).

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: University of California, Los Angeles, United States

• PHASE OF CARE: Late effects and survivorship

Prospective trial

• CNS Vital Signs Computerized Testing Platform
  • Finger tapping dominant, finger tapping nondominant
  • Shifting attention test
  • Stroop reaction time
  • Continuous performance test
  • Symbol digit test
• Hopkins Verbal Learning Test, Revised (HVLT-R) (total recall, delayed recall)
• Brief Visuospatial Memory Test, Revised (BVMT-R)
• Trail Making Tests (TMT) A and B
• Paced Auditory Serial Addition Test (PASAT) Trial 1
• Judgment of Line Orientation (JLO) test
• Patient’s Assessment of Own Functioning Inventory (PAOFI)
• Beck Depression Inventory, Second Edition (BDI-II)
• Spielberger State-Trait Anxiety Inventory (STAI)
• Resting quantitative electroencephalography (qEEG)

PAOFI totals and memory complaint scores decreased between T0 and T1 (p = .031 and p = .009, respectively) and were maintained at T3 (p < .0001 in both). Decreases in high-level cognitive functions (PAOFI scale) were demonstrated at T3 (p = .005). Significant short- and long-term improvements were observed for the symbol digit, Stroop reaction time, and trail A tests (p < .05). Meaningful improvement by a reliable change index (RCI) occurred for 19% of patients (n = 5) between T0 and T1, and 30% of patients (n = 8) by T3. RCI improvement (in ≥ 2 of 16 tests) predominantly occurred for verbal learning and memory (HVLT-R), processing speed (symbol digit), and divided attention (shifting attention test). Absolute alpha power increase (qEEG) was associated with PAOFI improvements at T1 (p = .014). Change in alpha power correlated with change in PAOFI memory subscale at T1 (p = .021) and T2 (p = .004). Correlation also was noted with the PAOFI HLC subscale at T2 (p = .030) and T3 (p = .048).

This study's results demonstrated the feasibility of this cognitive rehabilitation intervention and preliminary evidence for the improvement of subjective and objective cognitive function. Larger randomized, controlled trials are necessary to further determine efficacy. Preliminary results supported the potential use of qEEG as a measure of change in cognitive function. An additional randomized, controlled trial is underway.

• Small sample (< 30)
• Risk of bias (no control group)
• Findings not generalizable
• Other limitations/explanation: Sample primarily was Caucasian, married, and well-educated. Results may not be generalizable to other demographics.

Cognitive rehabilitation interventions appear to be promising. Nurses should maintain an awareness of research results in this area and consider suggesting appropriate clinical trials to eligible survivors.