Female participants were were admitted for cyclophosphamide (6,000 mg/m²), thiotepa (500 mg/m²) and carboplatin (800 mg/m²) over 96 hours seven and four days prior to stem cell transplantation. Mesna (7,400 mg/m²; 1,500 mg/m² per day) was administered by continuous infusion over 120 hours. After December 1998, women enrolled in the study received glutamine (10 g orally three times daily) for four days starting 24 hours after the completion of paclitaxel. Data were collected at baseline and two weeks after completion of chemotherapy. In addition, paired pre- and post-paclitaxel evaluations were performed on all women.

• The study had a sample size of 45 women with advanced breast cancer, 12 who received glutamine 10 g orally three times daily for four days starting 24 hours after the completion of paclitaxel, and 33 women placed in the historical comparison group.
• Women were eligible to participate they were to receive high-dose chemotherapy (paclitaxel 825 mg/m² via continuous infusion over 24 hours four days before transplantation and melphalan 90 mg/m² per day for two consecutive days after recovery) with stem cell support.
• Women with stage IV breast cancer also were eligible if their disease had responded (partial or complete response) to conventional dose chemotherapy.
• Those with central nervous system metastases, prior progression while on a taxane, compromised organ function, or baseline neuropathy from chemotherapy that was disabling were excluded.

• A detailed neurologic history and neuropathy assessment instrument was used.
• Questions assessing symptoms were asked separately for fingers and toes and were graded as mild, moderate, or severe as well as their interference with functioning.
• Evaluation of reflexes, vibration sense, pin prick, and proprioception were performed on upper and lower extremities.
• Cerebellar function, gait, and motor weakness also were evaluated.
• Nerve conduction studies were performed in four nerves, with motor responses recorded.
• Serial sensory nerve conduction studies were performed on three nerves.

Women who received glutamine had fewer symptoms, with 8% of women who received glutamine reporting dysesthesias in the fingers and toes, as compared to 40% of the women who did not receive glutamine. In addition, the frequency of moderate to severe numbness was observed less often in the glutamine-treated group than in the non-glutamine group for both fingers and toes. Moderate to severe parasthesias also were observed less frequently in those who received glutamine.

• A non-randomized design.
• Unbalanced treatment and comparison groups.
• The grading of myalgias was not collected prospectively.
• Retrospective chart reviews were performed.
• Neurologic examinations can vary in their findings, even when performed by one examiner.

To compare effects of an integrated yoga intervention with those of a brief supportive intervention on salivary cortisol levels and mood in patients with early breast cancer undergoing adjuvant radiotherapy

Patients were randomly assigned to a six-week yoga intervention or a control group. The yoga intervention included a set of asanas (postures), breathing exercises, meditation, and yogic relaxation techniques with imagery. Individual hour-long sessions were to be attended at least three times per week for six weeks during radiation treatments. These were administered by a trained yoga therapist. The control intervention was brief supportive therapy with education that was routinely offered to all patients. Control patients and caretakers underwent counseling sessions for 15 minutes every 10 days with a social worker as well. Study data were collected at baseline and at the end of the study period. Patients were asked to provide saliva samples three times per day for three consecutive days before and after radiotherapy. Specific procedures for saliva collection, storage, and immunoassay were followed.

• The study reported on a sample of 75 female patients.
• Mean patient age was 46 years (SD = 9.13 years) in the yoga group and 48.5 years (SD = 10.2 years) in the control group.
• All patients had breast cancer, with 73.9% having stage III disease and all having undergone mastectomy.
• Most patients (77.3%) also received three cycles of adjuvant chemotherapy, 97.8% were married, and 54.5% were premenopausal.

• Single site
• Outpatient setting
• India

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• Hospital Anxiety and Depression Scale (HADS)
• Perceived Stress Scale
• Mean cortisol levels and diurnal cortisol response

There were no significant effects of the yoga intervention on cortisol results overall; however, the mean pooled diurnal cortisol and 6 am cortisol levels were lower in the yoga group (p < 0.05). There were significant declines in anxiety levels in both groups. ANCOVA showed a significant decrease in reported anxiety in the yoga group compared to controls (p < 0.001). Depression declined in both groups over time. ANCOVA showed a significant decrease in reported depression in the yoga group compared to controls (p = 0.002). There was a significant decrease in perceived stress in the yoga group (p < 0.001), but not in the control group. Effect sizes seen were 0.31 for anxiety and depression scores and 0.36 for perceived stress.

Results suggest decreases in anxiety, depression, perceived stress, and 6 am and pooled mean cortisol levels with the yoga intervention used here.

• The study had a small sample size, with less than 100 participants.
• It is not clear that the control condition provided the same amount of attention to patients as that provided with the yoga intervention.
• There was no blinding, with associated risk of bias.
• Demographics show that the vast majority of patients were married, which may not be typical of other patient populations. Potential partner/family supports may have contributed to results seen.
• Cultural aspects may have impacted results seen.
• No information regarding the extent of mastectomy was provided, and there is no subgroup analysis based on surgery type, between those who did and did not have chemotherapy as well, or in association with other patient symptoms that contribute to symptoms measured here.

Findings show that anxiety and depressive symptoms decline over time among patients in active treatment with adjuvant radiation therapy in women with breast cancer. Participation in stress reduction interventions, such as yoga, may augment this decline. Changes in cortisol findings seen here with yoga suggest that effects may be attributed to stress reduction, rather than attention, social support, and education alone. Further research in this area is warranted to determine efficacy of yoga in other patient groups, and association with other patient symptoms and problems associated with anxiety and depression.

To evaluate the efficacy and safety of palifermin given as a single dose before each cycle in patients receiving doxorubicin-based multicycle chemotherapy

Patients were randomly assigned in a 2:1 ratio to receive palifermin or placebo.

• The study reported on 48 patients with an age range of 15–65 years.
• The sample was 53% male and 47% female.
• All patients had sarcoma with Karnofsky performance status greater than or equal to 80% and adequate bone marrow, renal, and hepatic function.

This study was conducted at a single-site at the University of Texas M.D. Anderson Cancer Center.

Patients were undergoing the active treatment phase of care.

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

• The World Health Organization (WHO) oral toxicity scale was used.
• Common Terminology Criteria for Adverse Events were used.
• A patient-reported outcome questionnaire was used; no data was provided about the reliability or validity of this instrument.
• A daily record symptom record diary was used; no data was provided about the reliability or validity of this instrument but it was referenced.
• Optical imaging studies and oral punch biopsies were performed prior to and 48–72 hours after the first dose of study drug to evaluate biologic effects of treatment on mucosa.

Palifermin significantly reduced the incidence of moderate to severe (grade 2 or higher) mucositis (44% versus 88%; p <0.001) and severe mucositis (13% versus 51%; p < 0.002).

A single dose of palifermin before each cycle reduced the incidence and severity of mucositis. It also demonstrated effectiveness as secondary prophylaxis in a few patients with severe mucositis.

• The sample size was small with fewer than 100 patients.
• A perceived unblinding of the treatment may have occurred because of notable differences between the biologic effects of palifermin and placebo.
• The study only looked at treatment of one disease.
• The follow-up period was short.

Mucositis and the pain it causes can significantly impact patients with cancer during treatment. Further research is needed to establish the alleviation of pain and the improved ability to drink, eat, and talk. If the mucosal lining is maintained, it would be important to establish if there are fewer infections, use of total parenteral nutrition (TPN) to maintain nutrition, and use of opiod patient-controlled analgesia (PCA) for pain control.

To compare the efficacy and safety of subcutaneous denosumab versus IV zoledronic acid for the treatment of established bone metastases

Patients were allocated to one of two treatment arms using a computer-generated randomization schedule with a permuted block size of 4. Randomization was stratified by tumor type, previous skeletal-related event (SRE), and systemic anti-cancer therapy. Daily calcium and vitamin D supplements were strongly recommended. Patients received either subcutaneous denosumab (120 mg) every four weeks or IV zoledronic acid (4 mg, dose adjusted for renal function) every four weeks for the treatment of established bone metastases.

• N = 1,776
• AGE = 18 years or older
• MALES: 64%, FEMALES: 36%
• KEY DISEASE CHARACTERISTICS: Eligible patients were diagnosed with solid tumors (except breast or prostate) or multiple myeloma with radiographic evidence of one or more bone metastases or bone disease.
• OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group score of 0, 1, or 2; adequate organ function; and a life expectancy of six months or longer

• SITE: Multi-site, international    
• SETTING TYPE: Outpatient    
• LOCATION: Multi-country

• PHASE OF CARE: Palliative
• APPLICATIONS: Palliative care

• International, randomized, double-blind, double-dummy phase 3 trial

• Radiographic evaluation every 12 weeks and as needed
• Brief Pain Inventory (BPI)-Short Form
• Health-related quality of life measured by the Functional Assessment of Cancer Therapy-Generated instrument (FACT-G)

Denosumab delayed time to first SRE or hypercalcemia of malignancy (19 months for denosumab versus 14.4 months for zoledronic acid) and reduced the risk of radiation to bone by 22%. Denosumab reduced the risk of a two-point increase (i.e., worsening) for the BPI worst pain rating by 15% relative to denosumab. Some evidence showed delay in the time to increased pain interference (6.5 months for denosumab versus 5.8 months for zoledronic acid). Both treatments were associated with the maintenance of health-related quality of life. For patients with an analgesic score of 2 or less (no or weak opioid use), fewer patients in the denosumab group than in the zoledronic acid group shifted to strong opioid analgesic use. On average, there was a 27% relative increase in the proportion of zoledronic acid-treated patients who initiated strong opioid analgesics compared with the denosumab-treated group.

The use of denosumab was associated with better prevention of SREs secondary to solid tumors or multiple myeloma compared to zoledronic acid. Denosumab also delayed pain progression and worsening of pain interference.

Skeletal pain is one of the most difficult to treat components of metastatic bone disease. In this study, differences were noted in pain, pain interference, and analgesic use between the treatment groups. Denosumab significantly delayed the worsening of pain and pain interference, as measured by the BPI.

To investigate efficacy and contribution of an intermittent pneumatic compression pump in lymphedema management and evaluation of measurement method correlation

Patients were randomized into two groups by consecutive alternating allocation by time of admittance. Group 1 received complete decongestive therapy (CDT) treatment (skin care, manual lymphatic drainage, compression bandage, compression garments, and exercise). Group 2 received CDT in combination with the intermittent pneumatic compression pump after manual drainage for 45 minutes at 40mmHg. Both groups were treated five times per week for three weeks for a total of 15 sessions. Measurements were obtained initially, post-therapy in week three, and one month postcompletion.

• N = 31 (final sample); 15 in Group 1 and 17 in Group 2
• MEAN  AGE = 56 years (Group 1), 55 years (Group 2)
• AGE RANGE = 37–75 years (Group 1), 42–75 years (Group 2) 
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with unilateral upper extremity lymphedema postmastectomy, no history of physical therapy prior to trial, and more than 2 cm circumference difference or more than 10% difference in arm volume between unaffected and affected arm
• OTHER KEY SAMPLE CHARACTERISTICS: Patients with bilateral lymphedema, metastases, continuing radiation therapy, cellulites, thrombosis, elephantiasis, infection, carcinomatosa, congestive heart disease, and those currently using medication that affects body fluids or electrolye balance were excluded.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: Physical Medicine and Rehabilitation Department, Atatürk University Faculty of Medicine

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care, palliative care

• Randomized, controlled trial

• Affected and unaffected upper limbs were measured with tape at four sites: metacarpophalangeal joint, wrists, and 10 cm below and above the lateral epicondyles.
• Dermal thickness was measured with ultrasonography at the affected and unaffected limbs.
• Circumferences, dermal thickness, and the volume of affected and unaffected limbs were calculated, and the difference between them was recorded as delta.
• Pain was measured by a visual analog scale of 0–10.
• All measurements were taken by the same physician who was blind to the treatment groups.

Significant correlation (p = 0.001) between dermal thickness with ultrasound and circumference of forearm measurement and water immersion measure method on forearm. Pre- and post-treatment measurements with both groups were significantly reduced, but no statistically significant difference between groups after therapy and one month later were noted.

CDT remains the standard treatment for lymphedema. The addition of the pneumatic pump to CDT yielded no significant improvement in lymphedema. Limitations included small sample size and no long-term follow-up. More prospective randomized studies are needed to evaluate potential efficacy of pneumatic pump and to correlate ultrasound measurement of dermal thickness with water immersion method on forearms.

• Small sample (< 30)
• Measurement/methods not well described

Nurses should continue to focus on education for prevention and early intervention for lymphedema.

The objective was to identify articles that evaluate the efficacy of oxygen therapy and medical air for the improvement of dyspnea in patients with cancer.

Databases searched were MEDLINE and EMBASE (1966-December 2006).

Search keywords were MeSH terms including dyspnea (dyspnoea) , oxygen, and palliative care and text words including oxygen, dyspnea, breathlessness, oxygen, and inhalation therapy.

Randomized controlled trials comparing oxygen and medical air in patients with cancer suffering from refractory dyspnea who do not qualify for home oxygen therapy were included.

Studies were excluded if

• Study subjects had a mean PaO₂ less than 55 mmHg or more than 50% of subjects had oxygen saturation less than 88% by pulse oximetry
• Study subjects were already receiving home oxygen therapy
• Study intervention was not oxygen versus placebo
• Method of oxygen delivery was something other than nasal cannula, mouthpiece, or mask
• No dyspnea outcomes were reported.

Studies also were excluded for \"other\" reason (e.g., study articles were not editorial or review article).

A total of 203 citations was reviewed with 54 full-text articles examined. None of the selected studies had evidence of calculations to claim adequate power to answer the questions defined. All five studies included in the analysis were blinded, randomized, controlled crossover trials. Each study was assigned a Jadad score in quality evaluation. External validity was assessed for subject description, detailed intervention description, and adequately reported dyspnea outcomes. Dyspnea ratings as assessed by the Modified Borg’s 0-10 numerical rating scale (NRS), 100 mm visual analog scale (VAS), or 300 mm VAS were converted to standardized mean differences (SMDs). When data pertaining to paired analyses were missing in two periods of crossover trials, standard errors were interpreted. P-values were used to estimate correlations between repeated outcomes when available and when unavailable, the lowest estimate from other studies was used. Meta-analysis was performed only on studies from which means and variances from for dyspnea measurements could be determined from published reports, and effect sizes were reported as SMD with 95% confidence intervals. Statistical significance was determined by a P < 0.05. If additional data were needed, authors were contacted.

Four studies focused on comparing oxygen versus medical air for dyspnea relief, while the fifth compared Heliox28 (an agent that contains 72% helium and 28% oxygen) with oxygen and medical air. In three studies, oxygen was delivered by nasal cannula, and in the other two by face mask. Doses of oxygen ranged from 3-5 L/min. Oxygen was administered at rest in three studies and during a six-minute walk test (6MWT) in two studies.

One hundred thirty-four were included in meta-analysis (148 were analyzed). Studies had a median of 33 participants, with a mean of 29.6 and range of 14-51. The median participant age was 65 years; 39% were female, and no data related to race or ethnicity were available. Subjects presented with the following malignancies: lung cancer (65%) or unspecified cancer with metastasis to lung (15%), breast cancer (5%), colon (3%), and other (i.e., lymphoma, melanoma, sarcoma, carcinoid, skin, bladder, and head and neck) (7%). Baseline oxygen saturation for four of the five was reported. Baseline dyspnea at rest, as provided by three of the studies, was 0 (modified Borg), 5 mm (NRS), and 59 mm by 100 mm (VAS).

Oxygen therapy was shown ineffective in the relief of dyspnea in mildly or non-hypoxemic patients with cancer (SMD = -0.09, 95% CI -0.22 to 0.04; P = 0.16). Sensitivity analysis on the three included studies for which patient data were available was stable. Conflicting results were reported in the two studies that compared the effect of oxygen therapy on exercise tolerance (via 6MWT), where one study (Ahmedzai et al., 2004) indicated a statistically significant increase in distance with oxygen (174.6 m; SD = 11.2) use over medical air (128.8 m; P < 0.01, SD = 10.3), while the other (Bruera et al., 2003) did not indicate a difference between use of oxygen (331.6 m; SD = 54.9) and medical air (330.7 m; SD = 57.9). Of the four out of five studies that provided data on still-blinded patient preference for oxygen versus medical air, two studies reported a statistically significant still-blinded patient preference for oxygen over medical air. Four out of five studies had poor quality of reporting and inadequate discussion of randomization and blinding methodology.

Oxygen therapy did not appear to relieve the overall sensation of dyspnea in patients with cancer who do not qualify for long-term home oxygen therapy.

Study limitations include small patient sample size (n = 148), and 65% of patients were diagnosed with lung cancer (which limits the generalizability of data from populations with a wider range of malignancies with other factors contributing to dyspnea).

Further research and evaluation still is indicated. Despite conflicting findings among studies related to patient preference and oxygen effect on endurance and the overall lack of support for oxygen therapy in palliation of refractory dyspnea in patients with cancer, the subjective/psychological nature of dyspnea indicates that oxygen therapy may provide a comforting sense of dyspneic relief in some populations if served as a supplement to other, more effective interventions.

The objective was to summarize and evaluate evidence for the use of oxygen for the relief of dyspnea, with particular focus on situations in which oxygen is not already funded via long-term oxygen treatment guidelines.

• This article was an expert review of selected recent articles regarding use of oxygen for management of breathlessness.
• The authors did not describe a clear study design.
• Suggested support of oxygen was based upon a single 2005 article.
• A total of four studies were reviewed initally; four studies were included in the report.
• The method of study evaluation was not defined.
• The total sample size was not applicable.
• The sample range across studies was not applicable.
• Sample characteristics were not applicable.
• Databases searched were not defined.
• Search keywords were chronic obstructive pulmonary disease, dyspnea, malignancy, oxygen, and palliative care.
• Recent/new data from one randomized controlled trial and three systematic reviews regarding use of oxygen for management of breathlessness were included.
• Exclusion criteria were not defined.

The literature reviewed in this manuscript was dated 1980-2008. Early articles were used to support conclusions in the four articles dated 2007 (3) and 2008 (1).

Based on their evaluation of a single systematic review and meta-analysis, no conclusive benefit of oxygen therapy was determined among the cancer population. The authors recommend the N of one methodology, where oxygen or air should be used on an individual basis for breathlessness at rest or with exercise. They advocate this oxygen trial start with short-burst oxygen and continued use for specific patients who report reduction in breathlessness, regardless of level of hypoxia. They term this palliative oxygen rather than treatment of hypoxia.

To determine the efficacy and tolerability of Lactobacillus rhamnosus (marketed as Antibiophilus) in treating radiation-induced diarrhea

Patients in the treatment group were instructed to use Antibiophilus sachets containing 1.5 grams of Lactobacillus rhamnosus. Patients in the control group used identically appearing placebo sachets containing 700 mg corn starch, 797 mg microcrystalline cellulose, 1.37 mg iron oxide, 1.13 mg orange coloring agent, and 1 mg caramel aroma. Both groups used the sachets three times per day and were asked to document the date and time of any rescue medication.

Patients were between 19–75 years old and had developed diarrhea within 4 weeks of receiving radiation therapy to the abdomen. The experimental group contained 102 patients, and the control group contained 103 patients.

This was a randomized, double-blind, parallel group study.

• The primary endpoint to assess efficacy was the time to and frequency of rescue medication for diarrhea. 
• Secondary endpoints were the number of bowel movements and diarrhea grading (0 for no diarrhea, 1 for mild, 2 for moderate, and 3 for severe).

• A greater percentage of patients in the control group (48%) required rescue medication compared to the experimental group (35%), but the difference was not statistically significant (p = 0.064).
• The control group experienced a greater average number of bowel movements per day (3.2) compared to the experimental group (2.4), but the difference was not statistically significant (p < 0.10).
• Diarrhea was graded at a higher severity for the control group (1) compared to the experimental group (0.7), but the difference was not statistically significant.
• Although the results suggested a superior efficacy for diarrhea treatment in the experimental group, the results failed to show a statistically significant difference for any of the measured variables. Despite this lack of statistically significant differences, the authors concluded that antibiophilus therapy yielded a favorable benefit-to-risk ratio.

• The study population was limited to patients who were already experiencing diarrhea. The study did not provide any data regarding prevention of diarrhea.
• The endpoints were based on patients' subjective reports.

This study involved a large sample. Although the results suggested a superior efficacy for diarrhea treatment in the experimental group, the results failed to show a statistically significant difference for any of the measured variables. 

To investigate the effects of yoga on patients with breast cancer to help them cope with the treatment process and reduce social isolation

Patients were given eight sessions of classical yoga twice a week in a physical therapy department. Each session lasted one hour, including warm up and breathing exercises, asanas, relaxation, and medication. Study data were collected before and after treatment. All sessions were taught by one yoga physiotherapist, and all assessments were done by another yoga teacher.

• The study reported on a sample of 20 female patients.
• Mean patient age was 41.6 years (SD = 6.17 years).
• All patients had breast cancer and had received chemotherapy. At least six months had passed since completion of chemotherapy.

• Single site
• Outpatient setting
• Turkey

Patients were undergoing the transition phase of care after initial treatment.

A prospective trial with a pre/post-test design was used.

• State-Trait Anxiety Inventory
• Visual analog scale for satisfaction
• Nottingham Health Profile (NHP): for quality-of-life measure

State and trait anxiety significantly declined from baseline after the yoga intervention (p = 0.001). All NHP parameters improved after the yoga sessions, including energy level, pain, sleep, emotional level, social adaptation, and physical skills.

Participation in yoga sessions was associated with reduced anxiety and improved quality-of-life scores after initial cancer treatment in these patients with breast cancer.

• The study had a small sample size, with less than 30 participants.
• No demographic information to describe the sample other than age was provided, so relevant sample characteristics are not known.
• It is not clear if yoga sessions were done in groups or individually.
• There was no comparison or control group, and it has been shown that anxiety and other symptoms tend to decline over time, so it is not known if changes seen here were due to time or the intervention as well.
• The measure used for quality of life is somewhat questionable, as the instrument is not generally used to measure quality of life, and application in cancer survivors was not discussed.

Findings suggest that yoga may be helpful for patients with cancer to reduce stress and improve overall fitness and ability to relax.

To evaluate the preventive effect of topical corticosteroids on radiodermatitis

Patients were randomized to use betamethasone or  a moisturizer (Essex) as a control. Patients in the steroid group applied the betamethasone once daily and the moisturizer once daily. Those in the control group applied the moisturizer twice daily. Creams were applied to the irradiated area four hours before or directly after radiation therapy and again in the evening. Creams were applied every day during radiation therapy and for two weeks after the completion of radiation therapy. Symptoms were reported weekly by patients. Radiation Therapy Oncology Group (RTOG) assessment was conducted at the end of radiation treatment.

• N = 202   
• MEDIAN AGE = 63 years
• FEMALES: 100%
• CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer. Sixty-seven percent also received chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Two percent in each group were smokers.

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

PHASE OF CARE: Active antitumor treatment

Double-blind, randomized, controlled trial with active control

• Visual analog scale (VAS) for symptoms of burning and itching
• RTOG grading

For all patients receiving either conventional or hypofractional radiation therapy, those in the corticosteroid group had a significantly lower incidence of radiodermatitis above grade 1 (p < 0.0001). Symptoms of burning and itching were also less prevalent in patients receiving the steroid at the end of treatment and one week later. There were no differences in outcomes based upon skin type. Compliance with the intervention was greater than 95%.

A potent topical steroid was effective in reducing radiodermatitis severity and symptoms among women treated with radiation therapy for breast cancer.

A topical steroid was effective in reducing radiodermatitis. Long-term effects of extended use of strong topical steroids are unknown. Nurses can suggest topical steroid use to reduce symptoms and severity of radiodermatitis.