The study tested whether magnesium would diminish bothersome hot flashes in breast cancer patients

Patients were assessed at baseline for all variables. They recieved magnesium 400 mg daily for 2 weeks. If symptom relief on hot flashes was seen, they stayed with same dose for 2 weeks more. If not, they increased  to 400 mg twice daily for 2 weeks.

Twenty-nine women with a mean age of 53.5 years were enrolled.  All were breast cancer patients with ECOG Performance status 0-1 & 2.  Patients were excluded if they:

• Had decreased renal function or hypersensitivity to magnesium 
• Were pregnant or nursing
• Were receiving antineoplastic chemotherapy or other investigational drugs within 4 weeks prior to study 
• Had an addition or change of androgens, estrogens, progestins, gabapentin, or antidepressants within 4 weeks prior to study entry; or any change in dose of tamoxifen, raloxifene, or aromatase inhibitors within 4 weeks.

Excluded Renal 
 

• SITE: Single site   
• SETTING TYPE: Not specified   
• LOCATION:  Massey Cancer Center - Virginia, USA
   

• PHASE OF CARE: Transition phase after initial treatment
• APPLICATIONS: Late effects & survivorship; End of life and palliative care
   

This was an observational study.

Instruments and assessments included.

• The Symptom Assessment Scale for overall quality of life
• Linear analog scale Quality of Life questionaires
• CTEP toxicities scale to asses toxicity
• Hot flashes diary- 5 weeks
• Self Assessment Scale  (21 questions) Dr Charles Loprinzi
• ECOG Performance Status
   

Hot flash frequency and score were reduced with magnesium.  The average weekly hot flash score decreased by 50.4% from 109.8 (SE, 40.9) to 47.8 (SE, 13.8), p value 0.02. Magnesium does not have effect on overall quality of life. Fatigue and distress due to hot flashes showed modest benefit. Minor side-effects included migraine, headache, and nausea.                          

The findings suggest that oral magnesium supplementation is effective in reducing the severity and frequency of hot flashes in women after treatment for breast cancer

This study used a small sample <30. The study design was not controlled or randomized. There was possible variance in grading side-effects or toxicity. Magnesium should be tested in a larger population

Magnesium may safely decrease hot flashes, with few side effects and low cost.  Further research in use of magnesium supplements is warranted.

To investigate the effectiveness and tolerability of open-label treatment with escitalopram in patients with breast cancer who have major depressive disorder

Patients received escitalopram at 5 mg/day in week 1. After week 1, the dose was adjusted to 5–20 mg/day. Patients were evaluated at baseline, 1, 2, 4, 8, and 12 weeks.

• A total of 79 patients participated in the study. 
• Patients' mean age was 49.1 years.   
• The sample was 100% female.
• All patients had a breast cancer diagnosis.
• Patients met the criteria for a current major depressive episode and scored 16 or higher on the Hospital Anxiety and Depression Scale.
   

Outpatient settings in the Republic of Korea
 

Transition phase after initial treatment

Prospective study

• Hamilton Depression Rating Scale (HAMD) 
• Functional Assessment of Cancer Therapy Breast (FACT-B)
• MD Anderson Symptoms Inventory
• Clinical Global Impression-Severity (CGI-S)
• Distress Thermometer (DT)
   

62 patients were included in the efficacy analysis, and only 45.6% completed the full 12-week study. Dropouts occurred because of lack of efficacy, no symptom improvement, side effects, and unspecified reasons. 34% of the sample dropped out due to lack of effectiveness or no change in symptoms.

Significant decreases were seen at week 1 and forward in HAMD (p < 0.001), DT (p < 0.001), and CGI-S (p < 0.003). FACT-B scores improved after week 2 (p = 0.011). No differences were observed in baseline scores between responders and nonresponders.

No serious adverse events were reported. The most common side effects were dry mouth, drowsiness, constipation, and increased sweating. Sleep disturbance, shortness of breath, and sadness were improved, but pain, fatigue, and anorexia did not improve.

Escitalopram reduced depression in some patients with breast cancer who had major depressive disorder.

• The sample size was small, fewer than 100 participants.
• No control group was used, and the study had an open-label design. 
• The drop-out rate was more than 30% because of lack of effect. 
• The study was, as the authors said, \"underpowered.\"
   

Escitalopram may be an effective treatment for symptoms of depression in some patients with breast cancer; however, about a third of patients in the study did not experience an effect. Nurses should be aware of side effects that may worsen existing symptoms.

To assess the effects of foot bathing and foot massage for chemotherapy-induced peripheral neuropathy

Patients receiving taxane- or platinum-based chemotherapy were alternately assigned to receive foot baths or foot massage. Both interventions were performed for 30 minutes three times every other day during the patients' hospital stay and five additional times in the home. When at home, phone calls were made to encourage compliance with the intervention. Primary caregivers were instructed in procedures. Study assessments were conducted after the first and eighth treatments. A water temperature of 40 degrees centigrade was used for foot baths.

• N = 48   
• MEAN AGE = 58.94 years
• MALES: 58.33%, FEMALES: 41.67%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Stomach or colorectal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: One-fourth were receiving gabapentin, and one-third were using opioids, for pain.

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Republic of Korea

PHASE OF CARE: Active antitumor treatment

Two-group, prospective trial

• Forehead and foot skin temperatures
• Common Terminology Criteria for Adverse Events (CTCAE) toxicity scale for sensory items only
• Functional Assessment for Cancer Therapy Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NT) for quality of life

Foot skin temperature increased about 2 degrees in patients receiving the foot baths and increased less than 1 degree in those receiving foot massage (p = 0.001). There was no significant difference between the groups in grade of sensory neurotoxicity. Those receiving the foot bath reported improved emotional and functional well-being (p < 0.02).

Neither foot baths nor foot massage resulted in improvement in sensory neurotoxicity scores. Those receiving foot baths had increased skin temperature immediately after the intervention and reported improved well-being.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Chemotherapy-induced peripheral neuropathy measurement not very sensitive
• No information as to whether any medications for neuropathic symptoms changed over the course of the study

Foot baths and foot massage did not demonstrate results in improvement in sensory symptoms in this study. Patients may experience an improved sense of well-being with foot baths.

To evaluate the effects of a stellate ganglion block (SGB) and steroids on breast cancer-related lymphedema

Patients were randomly assigned to one of three groups using different substances injected for SGB, (1) bupivacaine alone, (2) bupivacaine and triamcinolone, or (3) triamcinolone alone. Patients were given three consecutive blocks every two weeks. Outcome measurements were obtained at two, four, and eight weeks.

• N = 32  
• MEAN AGE = 54.7 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer, and all but one received surgery with lymph node dissection

• SITE: Single site  
• SETTING TYPE: Outpatient    
• LOCATION: South Korea

• PHASE OF CARE: Transition phase after active treatment

Double-blinded, randomized, controlled study

• Forearm and upper arm circumference measurement
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30)

Forearm circumference was significantly decreased in all groups one month after three treatments. Upper arm measures showed significant reductions at different time points across the three groups, but all showed a statistically significant reduction over time (p < 0.017). Those who received SGB with triamcinolone had a slightly larger reduction in upper arm circumference. There were no differences between groups in quality of life measures.

SGBs may be a viable alternative treatment for breast cancer-related arm lymphedema. The use of a corticosteroid for the block might produce the most effective results.

• Small sample (< 100)

SGBs may be an effective alternative treatment for breast cancer-related lymphedema. Additional research is needed to confirm these findings.

To demonstrate that DA-3031 is not inferior to daily filgrastim to manage neutropenia

Patients were randomly assigned to receive daily filgrastim or DA-3031. Daily filgrastim at 100mcg/m² began 24 hours after chemotherapy was started and continued until absolute neutrophil count was at least 5 x 10⁹, or for 10 days. Those in the experimental group received 6 mg DA-3031 by subcutaneous injection on day 2 of each chemotherapy cycle. Patients received TAC chemotherapy every three weeks up to six cycles. The noninferiority margin set was two days for the duration of grade 4 neutropenia.

• N = 74 for ITT analysis, 63 completed the protocol
• MEAN AGE = 6.44
• AGE RANGE = 30–67 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving TAC chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: Previous colony-stimulating factor exposure, prior hematopoietic cell transplantation, and prior treatment with antibiotics within 72 hours of starting chemotherapy were exclusions.

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Korea

PHASE OF CARE: Active antitumor treatment

Open-label, noninferiority, randomized, controlled trial

• Common Terminology Criteria for Adverse Events, version 4
• Time to absolute neutrophil count recovery to at least 2 x 10⁹/L

Mean duration of grade 4 neutropenia was 2.08 (SD = 0.85) days for the filgrastim group and 2.28 (SD = 1.14) days for the DA-3031 group. The difference between groups was 0.2 (SD = 1) days, supporting noninferiority of DA-3031. There were no significant differences between groups in absolute neutrophil coutn recovery time, incidence of febrile neutropenia, hospitalization, or requirement for intravenous antibiotics. There was no significant difference between groups in musculoskeletal symptoms associated with colony-stimulating factor administration. The findings were similar across all chemotherapy cycles. ITT and per protocol analysis were similar.

DA-3031, a once-per-cycle colony-stimulating factor, was not inferior to daily filgrastim.

• Small sample (< 100)
• Risk of bias (no blinding)
• ITT analysis had a 90% power.

DA-3031, a pegylated colony-stimulating factor was comparable to daily pegfilgrastim for neutropenia-related outcomes among women receiving TAC therapy. A once-per-cycle colony-stimulating factor can be more practical for patients because it does not require daily injections. Comparative costs of these two approaches was not discussed and may need to be considered in the selection of an approach.

To evaluate the safety and efficacy of once-per-cycle DA-3031 in patients receiving chemotherapy for breast cancer

Patients were randomized to daily injections of filgrastim 100 mcg/m² beginning 24 hours after chemotherapy until absolute neutrophil count (ANC) was 5x10⁹ after nadir or up to 10 days, or to one of two doses of pegfilgrastim (3.6 mg or 6 mg). The primary endpoint was duration of grade 4 neutropenia.

• N = 61
• MEAN AGE = 44.9 years
• AGE RANGE = 29–67 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer and were receiving chemotherapy consisting of doxorubicin, cyclophosphamide, and docetaxel. Chemotherapy was given every three weeks for up to six cycles.

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

• Randomized, open-label, phase II

• National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.01)

No significant differences were seen among groups in ANC nadirs or time to recovery. Overall incidence of febrile neutropenia was 9.8%, with no significant differences between groups. The most common adverse event was musculoskeletal pain, with no significant differences between groups, although pain was slightly higher in the 6 mg pegfilgrastim group.

Single-dose pegfilgrastim had similar efficacy and side effects to daily filgrastim.

• Small sample (less than 100)
• Risk of bias (no blinding)

Daily dosing of filgrastim had essentially the same efficacy and side effects as once-per-cycle pegfilgrastim. Severity of musculoskeletal pain appeared to be slightly higher with the higher dose of pegfilgrastim. Reducing the need for daily injections may be an important consideration for some patients and has been shown to have essentially the same effects. Higher doses may be associated with increased musculoskeletal pain. Although not statistically significant, this can be an important consideration to promote patient quality of care.

Primary Aim:  To evaluate the effectiveness of author-defined intensive use (three times daily [TID] use starting two or three weeks before radiotherapy [RT] and continuing this frequency throughout RT) application of a lotion preparation made of 3% urea, polidocanol, and hyaluronic acid for preventing the appearance of acute radiodermatitis and controlling its severity in patients actively undergoing RT for breast cancer.

Secondary Aim:  To study effectiveness, the authors compared the incidence and grade of toxicity with 174 patients with breast cancer treated in the same clinic the previous year. These patients used skin-support measures at the beginning of RT or when radiodermatitis occurred.

Ureadin cream was used TID for two to three weeks prior to the start of external beam RT (EBRT) and continued for the entire treatment period. This use was considered intensive compared to other studies and the standard use schedule of twice daily (BID) cream application at the start of RT or 10 days before starting RT.

• The sample was comprised of 98 women with breast cancer.
• Mean age was 59 years (range 57–61).
• Patients were treated with conservative surgery and scheduled to start EBRT with a 10-week follow-up period. 
• The RT field included the entire mammary gland; maximum dose was 50 Gy in 25 fractions of 2 Gy each day, followed by an electron boost to the surgical bed to a total dose 60 to 70 Gy.
• One patient had RT to the internal mammary lymph nodes.
• RT was interrupted in two patients; one was due to grade 3 radiodermatitis (14-day interruption) and one required vertebroplasty (40-day interruption).

• Single site  
• Outpatient
• Radiation Oncology Department, Hospital General de Catlunya, Spain

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

This was a prospective, observational study performed over 14 months.

• Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) acute toxicity scale:  weekly evaluation
• Visual analog scale (VAS) for patients to rate pain, itching, redness, desquamation, and effect on quality of life (QOL)
• Numeric scale (0–3) for patients and physicians to rate effectiveness, tolerability, and cosmetic properties of the lotion (0 = poor; 1 = moderate; 2 = good; 3 = excellent). Also, patients were asked to give an overall score out of 10.

The overall rate of radiodermatitis was 72.4%, with 51% of patients being toxicity grade 1; 20% grade 2, and 1% grade 3. The first case of skin toxicity appeared in third week of treatment; in >87% of patients, radiodermatitis appeared between weeks 5 and 7. The severity of radiodermatitis with the intensive use of the lotion was significantly lower (72.4% vs. 84.5%; p < 0.05). The grade of toxicity was significantly lower in intensive-use patients (p < 0.001), and grade 2 toxicity or higher was significantly lower (21.4% vs. 50%; p < 0.01). Severity of clinical symptoms of pain, itching, redness, desquamation, and impact on QOL was reported as negligible by patients.

For patients with breast cancer who undergo conservative surgery and will receive RT to a dose of 60 to 70 Gy, use of Ureadin on an intensive basis (TID beginning two to three weeks prior to the start of RT) compared to BID use is considered effective at reducing the incidence and grade of skin toxicity during RT and is well tolerated by patients.

•  The study had a small sample size, with less than 100 patients.
•  The study lacked an appropriate control group.

1. Intensive use of skin care preparation two to three weeks prior to starting RT seems effective at reducing the incidence of skin toxicity and probably increases better tolerance to RT for patients with breast cancer.
2. The ingredients in this lotion (urea, hyaluronic acid, and polidocanol) seem effective in keeping irradiated skin hydrated and lessening reports of pain, redness, and itching experienced by patients undergoing EBRT to the breast.
3. It is possible that these findings could be useful for other cancer diagnoses for patients undergoing EBRT.
4. The cost burden to patients would need to be studied; if patients are starting a prophylactic skin care regimen two to three weeks before RT, during the six to seven weeks of RT, and for one to two weeks after RT, is it cost-effective to prescribe this regimen routinely? (Online search of amazon.com showed Ureadin-Iralfaris-lotion supplied as 250 mL for $30.95).
5. Depending on the type of cancer, date of simulation, and start date for RT, it may not be feasible to start this skin care regimen two to three weeks prior to start of RT.
6. It would be interesting to compare the effectiveness of Ureadin to US commercial preparations containing hyaluronic acid (i.e., XClair, Miaderm, or Biafine).

• FINAL NUMBER STUDIES INCLUDED = 11 
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,091 
• KEY SAMPLE CHARACTERISTICS: Women who received either modified radical mastectomies or breast conservation surgery along with different axillary node management

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Elder care

Weight training exercise with low to moderate intensity (no trials used high-intensity weight training) and relatively slow progression significantly improved upper limb strength (SMD = 0.93, 95% CI 0.73–1.12) and lower limb strength (SMD = 0.75, 95% CI 0.47–1.04) without increasing arm volume or the incidence of breast cancer-related lymphedema. No significant effects were noted for body mass index (SMD = -0.10, 95% -0.31–0.11). Some aspects of quality of life may have improved with weight training. Participants in all trials used pressure garments and received supervision.

Weight training appeared to be safe and beneficial in improving limb strength and the physical components of quality of life in women with or at risk of lymphedema. Pressure garments, supervision, and limiting the intensity of the weight training may be important, but this could not be confirmed with this review.

A potential selection bias of the studies reviewed may exist because no blinding methods were employed among authors and affiliations. Heterogeneity among the studies reviewed limited the scope of the statistical analysis, so a narrative synthesis and meta-analysis were conducted. Heterogeneity may also limit the generalizability of the overall study results.

This review indicated that low-intensity exercise was recommended to protect the arm from adverse events. However, supervision and compression garments were featured in the reviewed studies, and their impact and effectiveness need to be confirmed. In addition, no evidence was available to suggest that high-intensity weight training was harmful to the arm. Research efforts need to be made in this area.

• FINAL NUMBER STUDIES INCLUDED = 10
• TOTAL PATIENTS INCLUDED IN REVIEW = 192
• SAMPLE RANGE ACROSS STUDIES = 1–45 patients
• KEY SAMPLE CHARACTERISTICS: Adults with lung cancer

• PHASE OF CARE: All phases
• APPLICATIONS: Elder care, palliative care

Three of the 10 studies showed a significant reduction in fatigue with exercise, one using aerobic exercise, one using chest physiotherapy, and one using pulmonary rehab. The other studies showed improvement but did not reach statistical significance. All studies were level 4 or 5 evidence (low). Studies with significant results, however, were not similar in their exercise intervention. Exercise was safe and feasible for adults with lung cancer. All studies provided exercise under supervision, and most included aerobic and interval training

\"This current review shows that exercise is beneficial and safe in lung cancer-related fatigue; however, the studies are small and, without any control groups, are lacking clinically significant effects. Thus, exercises could be used in the management of cancer-related fatigue in lung cancer in view of the available evidence in other cancer cohorts with due caution. There is an urgent need of further research with adequate sample size, preferably randomized controlled trials, to evaluate the effect of exercise in this cancer cohort” (p. 10).

• Small number of studies
• Small sample sizes
• Most studies without randomization or control groups
• Studies retrieved and reviewed by one student and advisor

In light of studies on the effects of exercise in other diseases, exercise can be considered for the management of fatigue in patients with lung cancer with attention to performance status. Patients perhaps should undergo individual testing and exercise prescription. Additional research is needed.

Patients rinsed with 30 ml of calcium phosphate at least four times per day. Patients also received four topical treatments of 1% fluoride as neutral 2% sodium fluoride gel administered by tray at the screening visit and completed prior to hospitalization.

Patients in the control group received an aqueous 0.01% sodium fluoride rinse. Prior to transplantation, the control group received four topical treatments with a placebo gel administered with the same technique as the experimental group. During transplantation, patients used the sodium fluoride rinse at least four times daily, 30 ml each time.

Patients who developed severe mucositis were instructed to rinse up to 10 times per day with their solution.

All patients received acyclovir and antifungal prophylaxis per protocol.

• The study reported on 95 patients undergoing hematopoietic stem cell transplantation (HSCT).
• Patients receiving autologous HSCT had peripheral stem cells and granulocyte colony-stimulating factor (G-CSF).
• Patients receiving allogenic HSCT had bone marrow cells and methotrexate (MTX).
• The experimental group had 50 patients, and the control group had 47 patients.

This was a randomized, controlled trial.

The National Institute of Dental and Craniofacial Research scale was used.

The following were measured and recorded.

• Days to absolute neutorphile count (ANC) greater than 200 mm³
• Days to ANC greater than 500 mm³
• Days of mucositis
• Peak mucositis level
• Peak pain level
• Days of pain
• Milligrams of self-administered morphine
• Days of morphine
• Average length of stay (ALOS)

• Duration of mucositis was 7.2 days in the control group and 3.72 days in the caphosol group (p = 0.00096).
• The control group had a smaller percentage of patients experiencing no mucositis (19% versus 40%).
• Peak mucositis was significantly higher for the control group (p = 0.004).
• The experimental group experienced fewer days of pain, milligrams of morphine, and days of morphine.

• The study had an adequate sample size according to power analysis.
• Frequency, duration, and severity of oral inflammatory processes were significantly lower in the experimental group.

• Use of fluoride may have decreased infection.
• No comparison was provided between allogeneic and autologous transplantations and the presence of mucositis.