Travier, N., Velthuis, M.J., Steins Bisschop, C.N., van den Buijs, B., Monninkhof, E.M., Backx, F., . . . May, A.M. (2015). Effects of an 18-week exercise programme started early during breast cancer treatment: A randomised controlled trial. BMC Medicine, 13, 121.
To examine the effects of an 18-week exercise program on preventing an increase in fatigue. The intervention is offered early after diagnosis and incorporated into the daily clinical practice setting.
An 18-week exercise program (two 60 minute aerobic and strength exercise session per week and including cognitive behavioral principles) supervised by a physical therapist. The control arm of usual care maintained their usual physical activity pattern for 18 weeks and then could participate in an exercise program.
Effects were based on an intention-to-treat analysis using within-group and between-group differences. On the MFI, the only between-group difference seen was a lower increase in physical fatigue at 18 weeks in the intervention group. Although there were decreases in general and mental fatigue in the intervention group at 18 weeks, there was no significant between-group differences. There was no between-group difference on the FQL. The EORTC and Hospital Anxiety/Depression Scale showed decreased QOL, decreased anxiety, and increased depression in both groups at 18 weeks with no between-group difference and improvement in both groups at 36 weeks with decreased improvement in the intervention group. Aerobic capacity and muscle strength were improved in the intervention group at 18 weeks but not at 36 weeks.
An exercise program offered early in the treatment phase of breast cancer appears to positively impact physical fatigue, aerobic capacity, and muscle strength.
There is an opportunity to continue to study the effect of exercise on fatigue in all patients with cancer. It may be challenging to implement a structured exercise program in clinical practice.
Tramsen, L., Salzmann-Manrique, E., Bochennek, K., Klingebiel, T., Reinhardt, D., Creutzig, U., . . . Lehrnbecher, T. (2016). Lack of effectiveness of neutropenic diet and social restrictions as anti-infective measures in children with acute myeloid leukemia: An analysis of the AML-BFM 2004 trial. Journal of Clinical Oncology, 34, 2776–2783.
To evaluate the impact of dietary and social restrictions on infections among children participating in a clinical trial
Data on infectious complications were abstracted from medical records at the institutions where the patients were treated. At the same time, an international survey was conducted regarding practices in restricting social contacts, pets at home, and food diets. Analysis was conducted by linking institutional survey results with associated patient infection–related outcome data.
Infection was defined as clinical signs and symptoms associated with the institution of antibiotics, an isolated pathogen, or an identified infection site though a physical exam or imaging study.
A wide variety of restrictions existed. Over 90% were restricted from attending kindergarten or school, and more than 80% were restricted from eating raw seafood or meat. Higher restriction of social contacts was associated with an increased incidence of bactermia (incidence rate ratio [IRR] = 1.21, p = 0.003). Higher restriction of pets at home was associated with a decreased incidence of pneumonia (IRR = 0.86, p = 0.05). No relationship was observed between food restriction and infections. When adjusted for age, risk stratification, and antibiotic prophylaxis, none of the restrictions used were associated with infections. Patients who were overweight (p = 0.002) or underweight (p = 0.028) had higher risks of infection.
The restriction of social contact, pets at home, and the use of dietary restrictions were not significantly associated with the decreased incidence of infections.
The findings suggest that strict neutropenic diets; restrictions of social contact, such as school attendance; and restriction of pets at home do not reduce infections in pediatric patients with neutropenia. These policies need to be questioned and evaluated further for their effects on overall clinical and quality-of-life outcomes.
Toth, C. (2010). Substitution of gabapentin therapy with pregabalin therapy in neuropathic pain due to peripheral neuropathy. Pain Medicine, 11, 456–465.
The goal of the study was to determine utility of substitution of pregabalin for gabapentin therapy in relief of neuropathic pain.
All patients starting on gabapentin and all patients already using gabapentin as monotherapy were offered the choice of replacing their gabapentin with pregabalin. Comparison was made between the groups switched to pregabalin and a cohort group of patients with peripheral neuropathy and pain receiving only gabapentin without a switch to pregabalin.
The study was conducted at a single site in Canada.
Cohort study
Both gabapentin responder and nonresponders groups had additional pain relief of about 25% following substitution of pregabalin after 6 and 12 months. The percentage of improvement on the EQ-5D VAS was significant (p < 0.025).
Findings show that pregabalin may provide pain relief in this patient population.
The findings support that notion that both pregabalin and gabapentin may provide pain relief in some patients with peripheral neuropathy. The majority of cases were patients with diabetes. Application to patients with cancer is unclear.
Toth, M., Marcantonio, E.R., Davis, R.B., Walton, T., Kahn, J.R., & Phillips, R.S. (2013). Massage therapy for patients with metastatic cancer: A pilot randomized controlled trial. Journal of Alternative and Complementary Medicine, 19, 650–656.
To determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer
The study shows that therapeutic massage at home is a feasible intervention. However, its effects on anxiety or pain were not conclusive. The small and uneven sample sizes across groups are a major weakness of the study. Although two measures were used for anxiety, the authors did not state which measures were used for the main analysis. Validity of measurements (i.e., alertness, and quality-of-life measure) is also problematic.
The role of nurses for this intervention is not clear. The massage therapy given in the present study was a professional intervention.
Toseland, R.W., Blanchard, C.G., & McCallion, P. (1995). A problem solving intervention for caregivers of cancer patients. Social Science and Medicine, 40, 517–528.
An experienced oncology social worker with a master’s degree in social work led six individual, one-hour counseling sessions. All participants attended at least four sessions. The sessions included three components: support, problem solving, and coping skills.
Regional medical oncology center
The study was a properly designed randomized controlled trial: intervention (n = 38) versus standard available care (n = 40).
For caregivers who reported high levels of burden, the intervention led to a significant improvement in their ability to cope with pressing problems. No main effects of the intervention were found on any outcome variable. For caregivers who reported low marital satisfaction, the intervention led to improvement in physical, role, and social functioning.
Torta, R., Siri, I., & Caldera, P. (2008). Sertraline effectiveness and safety in depressed oncological patients. Supportive Care in Cancer, 16, 83–91.
To examine the effectiveness and safety of the antidepressant sertraline (selective serotonin reuptake inhibitor) in treating somatic and emotional symptoms of depression in patients with cancer
To evaluate the effect of sertraline treatment on quality of life (QOL)
The intervention was a 12-week trial with a flexible dose regimen of sertraline. Patients started at a dosage of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), week 4 (T1), and week 12 (T2).
Patients were undergoing the active treatment phase of care.
An open-label, noncomparative, prospective pilot study design was used.
Mean daily dose of sertraline was 57.50 (+_18.74) mg at T1 and 57.41 (+_18.10) mg at T2. Both mean depression scores, analyzed by HADS and MADRS scales, and HADS anxiety scores significantly decreased during the 12 weeks of study (all p values < 0.05). Mean Mini-MAC scores showed that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0 (p < 0.05). QOL improved over time (p < 0.05). CGI was improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. Six patients reported varying degrees of side effects (nausea, agitation, insomnia, and dizziness).
Sertraline may be effective for the treatment of depressed outpatients with cancer. However, stronger evidence is needed.
Nurses can inform patients of a possible option to decrease depressive symptoms during chemotherapy.
Torta, R., Siri, I., & Caldera, P. (2008). Sertraline effectiveness and safety in depressed oncological patients. Supportive Care in Cancer, 16, 83–91.
To examine the effectiveness and safety of sertraline on somatic and emotional symptoms of depression and on the quality of life of cancer patients
The intervention was a 12-week trial with a flexible-dose regimen of sertraline (a selective serotonin reuptake inhibitor). Patients started the regimen with a dose of 25 mg/day, with a possible increase to 100 mg/day. The treatment response was assessed at baseline (T0), at week 4 (T1), and at week 12 (T2).
Single site (outpatient)
Active treatment
Open-label noncomparative prospective pilot study
Mean daily dose of sertraline was 57.50 (±18.74) mg at T1 and 57.41 (±18.10) mg at T2. Both mean depression scores, HADS and MADRS, and HADS anxiety scores significantly decreased during the 12 weeks of the study (all p's < 0.05). Mean mini-MAC scores show that hopelessness and anxious preoccupation decreased significantly at T2, compared with scores at T0 (p < 0.05). Quality of life improved over time (p < 0.05). CGI improved over the treatment period; however, no statistical tests were involved. No severe adverse effects were observed. 6 patients reported varying degrees of side effects (e.g., nausea, agitation, insomnia, dizziness).
Sertraline may be effective; a more definitive conclusion requires stronger evidence.
Nurses can tell patients that sertraline may be an option in the treatment of symptoms of depression during chemotherapy.
Torta, R., Siri, I., & Caldera, P. (2008). Sertraline effectiveness and safety in depressed oncological patients. Supportive Care in Cancer, 16, 83–91.
Sertraline was started at a dosage of 25 mg/day in a single daily dose, with a possible dosage increase based on individual response and tolerability until 100 mg/day. A minimum dosage of 50 mg/day had to be reached. Patient outcomes were assessed at baseline (T0), week 4 (T1), and week 12 (T2).
Psychooncology Unit, St. Giovanni Battista Hospital, University of Turin, Italy
Patients were undergoing the active treatment phase of care.
The study used a pilot, open-label, noncomparative, prospective design.
Montgomery-Åsberg Depression Rating Scale (MADRS)
For lassitude (fatigue), a subitem on the MADRS, there was a significant difference between baseline and week 12. Between baseline and week 4, an improvement was evident but not significant. Fatigue was not a major outcome.
Torta, R., Leombruni, P., Borio, R., & Castelli, L. (2011). Duloxetine for the treatment of mood disorder in cancer patients: A 12-week case-control clinical trial. Human Psychopharmacology, 26, 291–299.
To investigate the efficacy and tolerability of duloxetine in patients with cancer with mood disorder
Consecutive patients with diagnosed mood disorder started a regimen of duloxetine. They received an initial dose of 30 mg/day for one week, then 60 mg daily. If response was poor after one month, the dose was increased to 120 mg. Benzodiazepines were allowed as needed during the first two weeks. Study assessments were done at baseline, week 4, and week 12. Analysis compared results pertaining to those who had cancer and to those who did not.
Prospective observational design
Overall, 20% of patients dropped out of the study. Of the patients with cancer, 15% dropped out due to agitation, insomnia, or tachycardia. Analysis showed similar response over time of those with and without cancer diagnoses. Depression and anxiety by all measures declined at all follow-up times (p < 0.001).
Duloxetine was effective in reducing anxiety and depression in patients with and without cancer. The majority of patients tolerated the medication well.
Findings suggest that antidepressant use by patients with cancer who also have clinically relevant mood disorders can improve symptoms of anxiety and depression. Note: Most antidepressant studies that show a positive impact involve use by patients who have clinically relevant mood disorders at baseline.
Torres Lacomba, M., Yuste Sanchez, M.J., Zapico Goni, A., Prieto Merino, D., Mayoral del Moral, O., Cerezo Tellez, E., & Minayo Mogollon, E. (2010). Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: Randomised, single blinded, clinical trial. BMJ (Clinical Research Ed.), 340, b5396.
To determine effectiveness of an early physiotherapy program in reducing the risk of secondary lymphedema in women after surgery for breast cancer
Early therapy included manual lymph drainage, stretching exercises for key muscle groups, progressive active and assisted shoulder exercises, proprioceptive facilitation exercises without resistance along with education consisting of instruction with printed materials. All patients were followed up 4 weeks after surgery and at 3, 6 and 12 months. Follow-up time points were somewhat flexible by design; however, actual differences in follow-up are not described. If secondary lymphedema occurred, complex decongestive therapy was carried out.
The study took place in an outpatient setting in Spain.
The study used a randomized, single-blinded, controlled trial design.
Incidence of secondary lymphedema was 25% in the control group compared to 7% in the intervention group (p = 0.01). In both groups the volume of the affected arm increased over time. In the control group, the volume was an average of 5.1% greater in the affected arm compared to 1.6% greater in the intervention group (p = 0.0065). Survival analysis showed that secondary lymphedema developed more rapidly in the control group and the protective effect of early physiotherapy remained for a longer time.
Early physiotherapy can be an effective intervention for prevention or mitigation of secondary lymphedema after surgery for breast cancer within one year after surgery.
Early physiotherapy and related exercises are helpful in preventing or mitigating lymphedema in the short term for patients who have had surgery for breast cancer involving axillary lymph node dissection. Ongoing research in this area is needed to determine effective strategies in the longer term for this chronic problem.