To report the effects of a strength training and walking program in patients with stage IV lung and colorectal cancer.

Patients were given usual care or 1.5 hours of training by a physical therapist on rapid, easy, strength training exercises (REST) and pedometer-based walking using an instruction manual, resistance bands, an exertion rating scale, and a study log. They were then followed bimonthly by telephone for eight weeks.

• The study reported on a final sample of 56 patients.
• Mean patient age was 63.8 years in the intervention group and 65.5 years in the control group.
• The intervention group was 48.5% male and 51.5% female. The control group was 57.6% male and 42.4% female.
• Patients had stage IV lung or colorectal cancer.

• Single site 
• Outpatient setting
• Mayo Clinic

Patients were undergoing the end of life phase of care.

The study was a single-blinded, randomized, controlled trial.

• Activity Measure for Post-Acute Care Computerized Adaptive Testing (AM-PAC CAT)
• AM-PAC Mobility
• Functional Assessment of Cancer Therapy-General (FACT-G)
• FACT-Fatigue (FACT-F) subscale
• Numerical rating scale for pain and sleep quality
• Pedometer step-count logs
• REST logs
• Vital sign collection

Mobility, fatigue, and sleep measures were statistically significant between the intervention and control groups from baseline to week 8 (p = 0.002, p = 0.03, and p = 0.002, respectively), in favor of exercise. Other measures did not show significance. The number of REST sessions and weeks logged with step counts were associated with changes in the mobility score. Survival and withdrawals did not differ significantly between the groups.

A home-based intervention using walking and strength exercises may improve mobility, fatigue, and sleep quality in patients with stage IV colorectal or lung cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no blinding and no appropriate attentional control condition.

The teaching of walking exercises and strength routines may improve functioning in this patient population in terms of mobility, sleep quality, and fatigue. The one-time education session may be appealing to nurses looking for a timely intervention to help improve these symptoms.

To describe the feasibility of delivering a structured physical therapy (PT) program as part of a multidisciplinary intervention to patients undergoing outpatient radiotherapy for advanced cancer.

Patients were randomly assigned to receive the structured intervention or standard care using a stratified approach based on Eastern Cooperative Oncology Group (ECOG) performance status, age, sex, and tumor type. The structured multidisciplinary intervention consisted of eight sessions delivered by a PT and a psychiatrist or a psychologist with facilitation provided by an advanced practice nurse, licensed social worker, or certified hospital chaplain depending on the theme. Cognitive, emotional, social, and spiritual dimensions of the intervention centered on specific topics and coping strategies related to patients' goal setting, challenging negative thoughts, communication, and hope. PT sessions incorporated education and provision of printed material, truncal and upper-limb strengthening exercises, and lower-limb strengthening alternating between standing and seated exercises. These were performed with resistance provided by elastic bands. Aerobic conditioning was not included, although patients were encouraged to engage in regular physical activity. Standard care consisted of regular assessment of treatment toxicities. Patients were not counseled regarding the potential benefits of exercise.

This report focused on the PT and interdisciplinary structured intervention aspects of a previously reported study (Rummans et al. 2006).

• The study was comprised of 103 patients (59%–69% male) receiving radiotherapy for two weeks or longer who received no more than one treatment at the time of study entry.
• Age was 59.4–59.7 years. 
• The highest percentage of patients had gastrointestinal cancer; the sample also included head and neck, lung, brain, and other cancers
• Of the patients, 59%–63% were also receiving chemotherapy, 78%–89% were married, 32% were fully active performance status, and 55% were currently employed.
• Patients were included if they had an ECOG performance status of three or greater and had recurrent disease following a six-month disease-free survival.
• Radiation doses ranged from 3000 to 7200 cGy.

• Single site
• Mayo Clinic

The study was a single-blind, randomized, controlled trial.

• Spitzer Uniscale used for quality of life (QOL) measurement
• Linear analog scales (0–10) for self-assessment of physical well-being and fatigue. These scores were subsequently converted to a 100-point scale.
• Profile of Mood States (POMS) Short Form Vigor and Fatigue subscales
• 30-minute walk

• Six patients were not eligible for analysis due to missing more than four PT sessions.
• Attendance rates for the entire cohort were 89.3%.
• Mean scores after approximately one week of the intervention differed significantly between the intervention and control groups only in overall physical well-being (p = 0.02).
• Changes from baseline were not different between the two groups in any measure at weeks 8 and 27.
• Approximately half of the intervention group declined functionally despite participation in the structured program.

The structured intervention appeared to provide short-term improvement in overall perception of well-being; however, this effect was not sustained over the duration of the trial.

• No commonly used fatigue measures were reported.
• The authors reported improvement in fatigue; however, the measure was actually patient perception of overall well-being.
• There was no attentional control group for comparison.
• The 50% decline in function for patients in the intervention group points to the need to determine which patients might benefit the most from such an intervention and what type of exercise or combined intervention is most effective.
• The study assessed subjective physical well-being rather than objective performance or the specific phenomenon of fatigue.

To examine progressive muscle relaxation training (PMRT) in reducing anxiety and improving quality of life in patients with colorectal cancer after stoma surgery

PMRT was provided for 20 minutes along with deep breathing (10 major muscle groups were used, but not valsalva response). Participants received two teaching sessions and practiced at home for 10 weeks. Measurements were taken during hospitalization and 5 and 10 weeks after surgery and intervention.

The study reported on a sample of 59 participants.

The sample was recruited from the department of surgery of two public hospitals in Hong Kong.

A longitudinal randomized controlled trial design was used.

• State-Trait Anxiety Inventory (Chinese version)
• Quality of Life Index for Colostomy Patients (Chinese translation)
• World Health Organization Quality of Life measure–abbreviated (Hong Kong Chinese version)
• Medical/social/demographic data, including frequency of home practice of PMRT

R-ANOVA indicated there was a significant difference in state-anxiety over the 10 weeks between the two groups (p < 0.01), with the experimental group reporting a significantly lower state-anxiety level than the control group. Also, scores significantly decreased over time (10 weeks) in both groups (p < 0.001), indicating a 43% decrease.

• No baseline assessment was performed preoperatively.
• PMRT is time-consuming and labor intensive.

To determine the effectiveness and safety of viral vaccines in patients with hematologic malignancies. The primary outcome was the incidence of infection. Secondary outcomes were mortality, incidence of complications, severe viral infection, hospitalization, immune response, and adverse effects.

Databases searched were the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and CINAHL (June 2010). In addition, reference lists of relevant articles, abstracts from scientific meetings, and contacted vaccine manufacturers were used.

Randomized, controlled trials (RCTs) evaluating viral vaccines in patients with hematologic malignancies were included. No exclusion criteria were stated.

A total of 565 references were retrieved.

Relative risk (RR) was used for binary data, and mean difference (MD) was used for continuous data. The fixed-effect model was used in meta-analyses. Two authors (first and second authors) independently reviewed titles and abstracts of references retrieved from the searches and selected all potentially relevant studies. Copies of these articles were obtained and reviewed independently by the same authors against predefined inclusion criteria. The authors were not blinded to the names of the trial authors, institutions, or journal of publication. All disagreements about the selection of studies were resolved by consensus.

Interventions evaluated included heat-inactivated varicella-zoster virus (VZV) vaccine (two trials), influenza vaccines (five trials), and inactivated poliovirus vaccine (IPV) (one trial).

• The final study sample included eight RCTs.
• Three hundred five patients were in intervention groups and 288 were in control groups.  
• Sample sizes across studies ranged from 25 to 182.
• Patients of all ages with hematologic malignancies, including acute and chronic leukemias, lymphomas (Hodgkin and non-Hodgkin), and myelomas, were included. Trials evaluating all forms of viral vaccines, including influenza, varicella, hepatitis A, hepatitis B, measles, mumps, rubella, and poliomyelitis, were included in the review. The control interventions could be placebo vaccine, no vaccine, an alternative form of vaccine, or alternative dosing regimens or schedules.

Patients were undergoing the active treatment phase of care.

The VZV vaccine might reduce herpes zoster compared with no vaccine (relative risk [RR] = 0.54; 95% confidence interval [CI] [0.3, 1.0]; p = 0.05). Vaccination also demonstrated efficacy in immune response but frequently caused local adverse effects. One trial reported a severity score of zoster that favored vaccination (MD = 2.6; 95% CI [0.94, 4.26]; p = 0.002). Two RCTs compared inactivated influenza vaccine with no vaccine and reported a lower risk of lower respiratory infections (RR = 0.39; 95% CI [0.19, 0.78]; p = 0.008) and hospitalization (RR = 0.17; 95% CI [0.09, 0.31]; p < 0.00001) in vaccine recipients. However, vaccine recipients more frequently experienced irritability and local adverse effects. There was no significant difference in seroconversion between one and two doses of influenza vaccine (one trial), or between recombinant and standard influenza vaccine (one trial), or influenza vaccine given with or without reinduction chemotherapy (one trial). The IPV trial comparing vaccination starting at 6 versus 18 months after stem cell transplantation (SCT) found no significant difference in seroconversion.

Inactivated VZV vaccine might reduce zoster severity in adult SCT recipients. Inactivated influenza vaccine might reduce respiratory infections and hospitalization in adults with multiple myeloma or children with leukemia or lymphoma. Local adverse effects occur frequently.

The quality of evidence is low.

Further high-quality RCTs are needed.

Test the effects of a group cognitive rehabilitation program on memory and attention in cancer survivors

Patients randomly were assigned to the treatment or a wait-list control group. The intervention consisted of hourly trainings that incorporated didactic teaching methods, focusing primarily on memory aids and skills, as well as mindfulness meditation. A portion of each session was dedicated to reviewing and practicing skills.  The intervention was offered weekly over seven consecutive weeks, delivered in a group format. Homework was assigned to the participants with the expectation that they practice the intervention independently at home. Objective measures were evaluated twice at baseline (in an attempt to eliminate potential practice effects) and one month after completion of the intervention. Subjective measures were evaluated at baseline and one month after completion of the intervention. Control group participants underwent subsequent testing seven to eight weeks after their initial evaluation.

• N = 28    
• MEAN AGE: 58.9 years (SD = 2.4 years)
• MALES: 7%, FEMALES: 93%
• KEY DISEASE CHARACTERISTICS: All subjects had completed cancer therapy at least six months ago and had concerns about their cognitive functioning.

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: Fred Hutchison Cancer Research Center, Seattle, WA

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Late effects and survivorship

Randomized clinical trial

• Functional Assessment of Cancer Therapy-Cognition (FACT-Cog)
• Rey Auditory Verbal Learning Test
• Stroop Color and Word Test
• Wechsler Adult Intelligence Scale (WAIS)-Digit Symbol Subtest
• WAIS-Digit Span Subtest
• Patient Health Questionnaire-9 (PHQ-9)
• Beck Anxiety Inventory (BAI)
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)

Patients who received the cognitive rehabilitation intervention had improvements in perceived cognitive function (p < 0.01), perceived cognitive abilities (p < 0.01), and cognitive quality of life (p < 0.01) as measured by the FACT-Cog and in one measure of attention, digit span backward (p < 0.01). In contrast, differences were not found between the treatment and control groups in other objective measures of cognition. No significant differences between groups over time were found for anxiety, depression, or fatigue.

Findings from this study suggest that cognitive rehabilitation may improve attention and perceived cognitive functioning, but not memory, in patients with cancer. The fact that significant differences were not found in anxiety, depression, or fatigue suggests that they were not related to the any improved cognitive functioning.

• Small sample (< 30)
• Risk of bias (no appropriate attentional control condition)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Feasibility may be an issue. In addition, the results may be influenced by subject withdrawal prior to the completion of the intervention as well as variability in the number of sessions attended (may indicate that the “treatment” is too burdensome).

Although this study found improvements in perceived cognitive function and one objective measure of attention, it was underpowered and patient compliance was inconsistent. Further research with larger sample sizes is warranted to determine effectiveness. In addition, longer follow-up is required to determine the sustainability of any improvements in cognitive functioning.

To evaluate the efficacy of class IV laser therapy in pediatric patients affected by severe oral mucositis (OM)

Laser treatments were performed twice daily for four consecutive days, all over the oral cavity in ulcerated and erythematous areas. Treatment was started on average 7.5 days after the end of chemotherapy.

• N = 18     
• AGE: 10–17 years 
• MEDIAN AGE: 13 years
• MALES: 12 (67%); FEMALES: 6 (33%)
• KEY DISEASE CHARACTERISTICS: 10 patients (55.4%) were affected by acute lymphoblastic leukaemia, 4 patients (22.2%) by non-Hodgkin lymphoma, 1 patient (5.6%) by Ewing’s sarcoma, 1 patient (5.6%) by acute myeloid leukaemia, one patient (5.6%) by aplastic anaemia, and one patient (5.6%) by osteosarcoma. All patients underwent chemotherapy with various drugs depending on their neoplasia, whereas six patients also had been subdued to hematopoietic stem cell transplantation prior to total body irradiation.

• SITE: Single site 
• SETTING TYPE: Inpatient  
• LOCATION: Pediatric Hemato-Oncology Department at the Institute for Maternal and Child Health—IRCCS Burlo Garofolo, Italy

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

• Single-blind, quasi-experimental

• World Health Organization (WHO) Oral Mucositis Grading Objective Scale
• Visual analog scale to assess pain  
• A validated questionnaire 
• Photographs of lesions were taken during each session.
• Patients were re-evaluated 11 days after the first day of laser therapy.

The use of class IV laser therapy (high-power laser therapy [HPLT]) was effective and induced better healing, reduced inflammation, and limited thermal damage along with maintained tissue integrity as compared to traditional low-power laser therapy (LPLT). All patients experienced a statistically significant decrease in pain sensation the day after the first laser application, with lesions healing by day 11.

The innovative protocol used, HPLT, employs high power and high wavelength as compared to traditional protocols and was effective, safe, and non-invasive for the treatment of OM. It accelerates healing time and causes reduction of pain and inflammation of OM. The efficacy of LPLT in pediatric patients with cancer has been established. Thus, laser light therapy has proved to be successful in the prevention and treatment of chemotherapy-induced OM. In the present study, all patients perceived a great improvement in all lesions and functional capacity.

• Small sample (< 30)
• Risk of bias (no random assignment)
• Findings not generalizable
• Subject withdrawals ≥ 10%

A gap indicates a lack of knowledge regarding dosing levels of laser therapy (low versus high, adult versus pediatric), so additional research is needed. More double-blind, randomized, controlled studies are needed, as well as laser protocols.

• FINAL NUMBER STUDIES INCLUDED = 22 in qualitative synthesis (six studies of CINV) and five in meta-analysis
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,459
• SAMPLE RANGE ACROSS STUDIES: 51–480 patients
• KEY SAMPLE CHARACTERISTICS: Various cancer types

PHASE OF CARE: Active antitumor treatment (for CINV trials)

All studies favored pharmacopuncture over the control group, but outcome measures varied. Five out of six studies reported response rates as an outcome measure. Two studies calculated response rate using emesis episodes. One study (26) used two outcome measures, the total number of emesis episodes in 21 days and the proportion of emesis-free days in the same period.

The level of evidence was not strong enough to draw any conclusions. There was a careful suggestion that pharmacopuncture may help alleviate cancer-related pain, CINV, and other symptoms such as ileus, hiccups, fever, quality of life, and gastrointestinal disturbances.

The findings of this meta-analysis should be interpreted with consideration of its limitations. Additional rigorously designed and conducted studies are required.

The primary aim of this study was to evaluate the effect of triclosan-coated sutures on cervical surgical wound infection rates. A secondary aim was to analyze the risk factors for wound infections in patients undergoing surgery for head and neck cancer.
 

The study sample was comprised of patients who were admitted to the Tri-Service General Hospital, National Defense Medical Center, in Taipei, Taiwan, from January 2007 to December 2009. The patients were admitted for tumor ablation after a diagnosis of head and neck cancer and they received reconstructive surgery after wide excision of the tumor. The patients also had an exploration of the cervical area for radical neck lymph node disection or vascular examination for microsurgical anastomoses.

Patients were randomized into the triclosan group or a control group by a flip of a coin.

All surgical procedures were the same. All patients received IV prophylactic antibiotics (1 g cephazolin every eight hours for three days and 80 mg of gentamycin every 12 hours for three days). Dressings were changed daily for wound care and evaluation. The closed suction neck drain was removed when there was less than 10 ml per day of drainage. Infections were inspected for and defined as local erythematous change in the sutured wound with purulent discharge, cervical wound dehiscence, or neck skin necrosis. Surgical wound and intra-oral flap sutures were removed two weeks post-surgery and evaluated for delayed healing defined as intra-oral wound dehiscence and surgical complications, such as flap necrosis, intra-oral flap dehiscence, oral-cervical fistula, and neck wound infection.

The total sample was 241 participants.

Mean age in the triclosan group was 53.6 years (SD = 9.8); the mean age in the control group was 51.1 years (SD = 11.3).

Males made up 93.4% of the sample; females made up 6.6%.

138 patients were stage T1 or T2 (58 in the triclosan group; 80 in the control group) and 103 were stage T3 or T4 (54 in the triclosan group; 49 in the control group)

67 patients had prior head and neck reconstruction (29 in the triclosan group; 38 in the control group), 91 had preoperative radiotherapy (46 in the triclosan group; 45 in the control group), 55 had diabetes (30 in the triclosan group; 25 in the control group), 219 underwent free flap transfer (102 in the triclosan group; 117 in the control group), flap sizes in the triclosan group were an average of 81 cm² (+ 57.9) and 72.7 cm² (+ 56.4) in the control group, and the length of stay for participants in the triclosan group was 35.3 days (+ 14.3) and 35.9 days (+ 21) in the control group.
 

A single-site inpatient setting in Taipei, Taiwan
 

Active treatment

Randomized, controlled trial

Thirty-six patients incurred infections, 17 in the triclosan group and 19 in the control group (p = 1.0). Risk factors for postoperative cervical wound infection included stages T3 and T4 (OR = 3.09, 95% CI [1.39, 6.87], p = 0.006); diabetes (OR = 2.01, 95% CI [0.88, 4.58], p = 0.098); delayed healing of intra-oral wound (OR = 5.82, 95% CI [2.66, 12.77], p < 0.001). Patients with infections had a statistically significantly longer length of stay (56.4 + 27.2 days) compared to no infection (32 + 13 days).

There was no statistically significant difference in infection rates between patients who received triclosan-coated sutures and controls. Advanced tumor stage, delayed intra-oral flap healing, and oral cavity contamination by normal flora were risk factors for infection.

Keeping the surgical site clean and clear from contamination is essential for infection prevention of surgical sites in patients with head and neck tumors. Study findings did not show a benefit with use of triclosan coated sutures in the surgical procedure.

To examine the effects of konjac glucomannan (KGM) supplementation on bowel habits and colonic environment in adults with constipation, and to examine the method by which KGM modulates bowel habits.

Patients who self-reported having constipation for more than six months were recruited from an outpatient clinic. The study comprised a three-week placebo (gelatin capsules containing corn starch) period, a one-week adaptation period in which KGM was gradually increased from 1.5 to 3 g per day, and a three-week KGM period (1.5 g KGM per meal or 4.5 g per day). Capsules were taken with 150 ml of water. Patients followed a typical low-fiber Chinese diet and were instructed to maintain their usual physical activity, lifestyle, and sleeping habits. Capsule consumption (compliance) was verified daily.

• The study reported on a sample of seven women.
• Mean patient age was 45.9 years (SD = 2.7).
• Patients self-reported having constipation (less than one bowel movement per day or straining with bowel movements).
• None of the patients used laxatives or enemas.

Taiwan

This was a single-blind, placebo-controlled, crossover study.

• Patients recorded the following on a daily basis: ease of bowel movements, symptoms (e.g., feeling of incomplete evacuation, abdominal cramping, borborygmi, bloating, flatulence), and stool consistency.
• Participants collected their stools on days 15 through 21 during the placebo- and KGM-periods to determine fecal weight, composition, microflora, pH, and short-chain fatty acid content.

• Frequency of defecation and feelings of relief after bowel movements significantly improved (p < 0.05) by the second and third weeks of KGM.
• Ease of passage of bowel movements and reduction in the severity of borborygmi significantly improved (p < 0.05) by the third week of KGM.
• Flatulence significantly increased (p < 0.05).
• KGM did not significantly decrease abdominal cramping or bloating or significantly soften feces.
• KGM significantly increased proportions (percentage of total bacteria) of bifidobacteria and lactobacilli, and decreased the relative proportion of clostridia, compared with placebo (p < 0.05).

Adding KGM (4.5 g per day) to a low-fiber diet may increase frequency of bowel movements and improve colonic ecology.

• The sample size was extremely small.
• Participants were all women and volunteers.
• Patients with cancer were not included. 
• The design was only single blinded.

KGM (4.5 g per day) may increase frequency of bowel movements in adults with mild constipation (participants did not use laxatives or enemas). The ecology of the colon may improve with KGM supplementation because the proportion of fecal clostridia and fecal pH decreased. Additional studies are warranted that include an oncology population and a larger sample size.

To evaluate the impact of melatonin on survivors of breast cancer with data analysis of secondary quality-of-life outcomes (sleep, mood, hot flashes)

Participants were randomized using 1:1 randomization format and received four months of 3 mg melatonin or placebo nightly at 9 pm.

• N = 85
• MEAN AGE: 59 years
• RANGE: 38-81 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Stage I-III primary nonmetastatic breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, completed with active treatment (surgery, radiation, chemotherapy, and hormonal therapy) 60 days prior to enrollment.
• OTHER KEY SAMPLE CHARACTERISTICS: There was no history of other cancers except nonmelanoma skin cancer; no night-shift work; no active seizures with medication; and no beta-blocker, warfarin, hormonal therapy, black cohosh, flaxseed, soy, or sleep-aid use. There was also no melatonin use 30 days prior to enrollment.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Dana-Farber/Harvard Cancer Center, Boston, MA

PHASE OF CARE: Transition phase after active treatment

• Secondary analysis of the effect of melatonin on sleep, mood, and hot flashes
• Original study was a double-blind, placebo-controlled, randomized trial

• Subjective measures included Pittsburgh Sleep Quality Index (PSQI) (19-item scale)
• Center for Epidemiologic Studies Depression (CES-D) (20-item scale)
• North Center Cancer Treatment Group hot flash diary (frequency and intensity of hot flashes over seven days, and severity [1 = mild to 4 = very severe]).
• Diary data summed but number of and severity of hot flashes per day, calculation of hot flash score using frequency and severity

No baseline differences in characteristics were noted between groups (n = 48 melatonin; n = 46 placebo). Sleep outcomes included significant improvement in sleep quality, daytime dysfunction, and PSQI total scores in treatment versus placebo. Overall change of sleep over time using all time points, which was adjusted for multiple comparisons, showed overall high PSQI global scores in placebo group (1.67) (95% CI [0.67, 2.66]), indicating worse sleep quality. CES-D scores did not change over time. Hot flash frequency decreased over time for both treatment groups. Only grade 1-2 toxicities were reported.

The use of oral 3 mg of melatonin showed minimal side effects with possible impact on the improvement of subjective sleep quality. There was no exclusion for prior sleep disorders, limiting understanding of MOA of melatonin and preexisting sleep disorders. Sleep was a secondary outcome of this study and needs larger RCT trials to verify results.

• Small sample (less than 100)
• Details of randomization process are missing.
• Melatonin dose is often started low and increased as needed; yet the rationale for a stable 3 mg dose of melatonin in this study is unclear
• Underpowered for evaluation of effect on hot flashes

Oral 3 mg melatonin is potentially a safe and effective treatment for sleep disturbances in survivors of breast cancer with baseline poor sleep quality. However, additional larger scale-studies in which sleep is the primary variable outcome are needed using objective and subjective measures of sleep.