Cassileth, B. R., & Vickers, A. J. (2004). Massage therapy for symptom control: outcome study at a major cancer center. Journal of Pain and Symptom Management, 28, 244–249.
Patients received one of three types of massage therapy and were asked to report their symptoms posttherapy. Massages were provided by 12 licensed massage therapists. Patients were referred by physicians, nurses, or self. Patients received Swedish, light touch, or foot massage according to their preference. On average, sessions lasted 20 minutes for inpatients and 60 minutes for outpatients.
In total, 1,290 patients were included.
Inpatient and outpatient
Patients reported the level of symptom distress (0–10) on a card prior to and following massage therapy. Comparisons were analyzed by analysis of covariance, with the baseline score as the covariate.
The effect of massage on symptom relief was demonstrated as a positive response with respect to depression.
Cassileth, B.R., & Vickers, A.J. (2004). Massage therapy for symptom control: Outcome study at a major cancer center. Journal of Pain and Symptom Management, 28, 244-249.
Patients with cancer received light touch, Swedish, or foot massage. No control group was included.
The study was conducted in Inpatient and outpatient settings.
A visual analog scale (VAS) was used to measure nausea and vomiting, pain, fatigue, stress, anxiety, and depression.
Just more than half (51%) experienced a decrease in nausea.
A risk of bias exists for nontraditional treatment.
Casley-Smith, J.R. & Casley-Smith, J.R. (1996). Lymphedema initiated by aircraft flights. Aviation, Space and Environmental Medicine, 67(1), 52–56.
To describe reported incidence and triggering factors related to development of lymphedema in patients with lymphedema
Questionnaires were sent to 1,020 patients with lymphedema. The names were taken from the Lymphedema Association of Australia. The questionnaire asked about many aspects of their disease. One of the questions was “What triggered your lymphedema?\" Answer choices were infection, insect bite, plane flight, burn, other, or unknown.
Questionnaires were sent to 1,020 patients with lymphedema. A total of 749 responded to the survey, and 531 of these answered the question about what triggered the lymphedema. Responses were as follows: 41 had the condition since birth, 163 had postmastectomy lymphedemas, 136 had primary and 191 had secondary leg lymphedemas. Of those who did not have the condition since birth (n = 490), 27 claimed that it started during an aircraft flight (15 legs and 12 arms). In addition, flying was the identified cause of existing lymphedema to permanently worsen in 23 arms and 44 legs.
Cascinu, S., Catalano, V., Cordella, L., Labiance, R., Giordani, P., Baldelli, A.M., . . . Catalano, G. (2002). Neuroprotective effect of reduced glutathione on oxaliplatin-based chemotherapy in advanced colorectal cancer: A randomized, double-blind, placebo-controlled trial. Journal of Clinical Oncology, 20, 3478–3483.
Fifty-two patients with advanced colorectal cancer who were treated with a bimonthly oxaliplatin-based regimen were randomized to receive glutathione (GSH) (1,500 mg/m² over a 15-minute infusion period before oxaliplatin) or normal saline solution. Chemotherapy regimen was given as follows: oxaliplatin 100 mg/m² on day 1 concurrent with leucovorin 250 mg/m² followed by 5-FU 1,500 mg/m² per day for two consecutive days every two weeks. GSH was administered at a dose of 1,500 mg/m² in 100 ml of normal saline over 15 minutes immediately before each oxaliplatin administration. The placebo-randomized patients received normal saline. Disease response was assessed after four cycles of therapy. Those with responsive or stable disease received four additional cycles of treatment.
The study had a randomized, double-blind, placebo-controlled trial design.
At baseline, no patients suffered from clinical neuropathy in either arm. At the time of second the neurologic exam (four cycles) seven patients had clinical neuropathy in the GSH arm and 11 in the placebo arm. After eight cycles of chemotherapy, nine patients had clinical neuropathy in the GSH arm compared with 15 patients in the placebo arm with an incidence of moderate to severe (grade 2–4) clinical neurotoxicity present in 11 of 19 assessable patients in the placebo arm, as compared to 2 of 21 assessable patients in GSH arm. No grade 3–4 neurotoxicity was present in GSH arm while grade 3–4 neurotoxicity was reported in five patients in placebo arm. Only 18 patients received 12 cycles of chemotherapy, 10 in the GSH arm and 8 in the placebo arm. Grade 2–3 neurotoxicity was observed in three patients in GSH arm and eight patients in the placebo arm.
The study was performed on patients who had received preliminary date on a small number of patients with no true control group.
Cascinu, S., Cordella, L., Del Ferro, E., Fronzoni, M., & Catalana, G. (1995). Neuroprotective effect of reduced glutathione on cisplatin-based chemotherapy in advanced gastric cancer: A randomized double-blind placebo-controlled trial. Journal of Clinical Oncology, 13, 26–32.
Fifty patients with advanced gastric cancer were randomized to receive either 1.5 g/m² GSH in 1 L of normal saline or normal saline 1 L as a placebo infusion given over 15 minutes before cisplatin-based chemotherapy. GSH also was given by intramuscular injection on days 2 and 5. One cycle consisted of nine weekly treatments. Patients who showed responsive or stable disease received an additional six weeks of therapy.
The study had a randomized, placebo-controlled clinical trial design.
Seven patients in the placebo group were unable to complete the study (six with progressive disease and one from grade 3 neurotoxicity). Only one patient in the GSH group was not able to complete the study. At nine weeks, no patients who received GSH had clinical evidence of neuropathy, compared to16 patients (66%) in the placebo-control group. After 15 weeks, 4 of 24 (17%) patients in the GSH arm showed clinical evidence of neurotoxicity compared to 16 (88%) in the placebo-control group. Most common symptoms included distal parasthesias and numbness in legs, decreased sense of vibration, and reduced or absent deep reflexes. No changes in mean latency and sensory amplitude potentials were noted in the group that received GSH but were significantly affected at 9 and 15 weeks in the control group. No patients reported ototoxicity.
Casault, L., Savard, J., Ivers, H., & Savard, M.H. (2015). A randomized-controlled trial of an early minimal cognitive-behavioural therapy for insomnia comorbid with cancer. Behaviour Research and Therapy, 67, 45–54.
To examine the efficacy of an early minimal cognitive behavioral therapy (CBT) intervention for insomnia in patients with cancer
The treatment consisted of self-help CBT provided with written materials and three phone consultations. Participants completed a quiz after each booklet was read and were asked to maintain a daily sleep diary. Control patients did not receive any intervention. The study was conducted over six weeks. Study measures were obtained at baseline, at the end of six weeks, and three and six months later. Participants were paid after each assessment was completed.
Randomized, controlled trial
There were significant effects over time by study group on ISI scores in favor of the CBT intervention at six weeks (p < 0.001), and there were improvements in all sleep variables with effect sizes (d) ranging from 0.46–1.34. Control patients also showed improvements. There were no significant changes from the six-week to six-month time point in either group. Those in the CBT group had a reduction in hypnotic dosage (d = 0.40). There were significant improvements in anxiety scores (p < 0.001) in the CBT group at six weeks. Depression declined significantly in both groups. No significant effect on fatigue was found. A greater proportion of CBT patients achieved a sleep efficiency level greater than or equal to 85% (p = 0.01). More than 97% of patients completed the materials, and 91.2% completed the quiz on average.
The brief CBT intervention used here was effective in improving insomnia and anxiety among patients with cancer.
CBT interventions are effective in treating sleep–wake disturbances and psychological issues. This study demonstrated that the provision of a CBT approach via booklets and quizzes on the CBT for sleep content with follow-up and counseling by phone was an effective way to deliver the intervention. Although this sample size was small, it did approximate the size required from a power analysis. This approach to providing a CBT intervention can be practical and cost-effective. However, significant effects were only seen during the active study period, and effects were not shown to endure long-term.
Carvalho, P.A., Jaguar, G.C., Pellizzon, A.C., Prado, J.D., Lopes, R.N., & Alves, F.A. (2011). Evaluation of low-level laser therapy in the prevention and treatment of radiation-induced mucositis: a double-blind randomized study in head and neck cancer patients. Oral Oncology, 47, 1176–1181.
To determine the efficacy of low‐level laser treatment (LLLT) in the prevention and treatment of radioinduced oral mucositis in patients with oral and oropharynx cancer
Patients were randomized into two groups. Group 1 received 660 nm/15 mW/3.8 J/cm² spot size 4 mm² LLLT, and Group 2 received 660 nm/5 mW/1.3 J/cm² spot size 4 mm² LLLT, both beginning on the first day of radiation. In both groups, LLLT application was done daily for five consecutive days per week starting on the first day of radiation therapy. Prior to the study, all patients underwent oral care, including an oral examination, preventive dental treatment, instructions for oral care during radiation therapy, and prescription mouthwashes and fluoride treatment. Randomized sample selection was based on the eligibility criteria that each patient was diagnosed with cancer of the oral cavity or oropharynx and treated with radiation therapy.
This was a single-site study conducted in an inpatient setting at Hospital A.C. Camargo, Sao Paulo Brazil.
Patients were undergoing the active treatment phase of care.
This was a prospective, randomized, double-blind study.
Group 1 had a delay in presentation with oral mucositis compared to Group 2 (13.5 days to 9.8 days, respectively). Group 2 presented with a higher grade of mucositis as compared to Group 1, and Group 2 reported higher overall pain scores.
This study reported a delay in development of mucositis, a decrease in severity of mucositis, and a decrease in pain scores with the group that received the higher dose of LLLT during treatment for oral or oropharynx cancer.
Further studies are necessary to define dose, application time, and number of sessions needed for laser therapy in prevention and management of oral mucositis.
Carvalho, A.F., Hyphantis, T., Sales, P.M., Soeiro-de-Souza, M.G., Macedo, D.S., Cha, D.S., . . . Pavlidis, N. (2014). Major depressive disorder in breast cancer: A critical systematic review of pharmacological and psychotherapeutic clinical trials. Cancer Treatment Reviews, 40, 349–355.
PHASE OF CARE: Multiple phases of care
Of 677 articles, 22 were selected for a full review. Following consensus, only two were found eligible for key question 1. In one RCT, mianserin had significant antidepressant effects compared to a placebo. In the second RCT, desipramine and paroxetine no were more efficacious than a placebo. Of 1,149 articles, 52 articles were selected for full review for key question 2, but none met the inclusion criteria.
The results of this systematic review highlight the paucity of RCTs evaluating the efficacy and tolerability of antidepressants for the treatment of MDDs in women with breast cancer. No RCTs for psychotherapeutic approaches were identified for this systematic review, emphasizing the lack of data for the treatment of MDDs in patients with breast cancer. Further research is needed on the treatment of MDDs based on clinical experience.
Psychological distress is an unmet need in patients with breast cancer and needs to be researched further.
Carvalho, C.C., Lopes Chaves, E.C., Iunes, D.H., Simão, T.P., Marciano Grasselli, C.S., & Braga, C.G. (2014). Effectiveness of prayer in reducing anxiety in cancer patients. Revista Da Escola De Enfermagem Da USP, 48, 684–690.
To evaluate the effect of prayer on the anxiety of patients with cancer receiving chemotherapy
Participants were interviewed about sociodemographic and clinical characteristics. They were then given the Duke University Religion Index (DUREL) to measure three dimensions of religiosity. Then, they applied the State-Trait Anxiety Inventory (STAI-S and STAI-T). Preintervention data collection included a repeat STAI-S and a saliva and vital sign measurement taken by the same examiner. The prayer intervention was then conducted by the researcher. The intervention consisted of a specific Christian prayer delivered in an audio recording over 11 minutes. Thirty minutes after prayer, the STAI-S and salivary sample and vital signs were repeated. The control group received the same protocol with no prayer intervention.
Quasi-experimental, pre- and postintervention study with a control group
The sample revealed a high level of religiosity. Anxiety state was influenced by nonorganizational religious activity (p = 0.01), and a correlation with age group (p = 0.01) existed. The anxiety profile measure before the intervention displayed moderate levels of anxiety. A comparison of pre- and postintervention means demonstrated modified values for state anxiety, blood pressure, and respiration rate. The STAI-S showed reduced anxiety after prayer at each moment. Values related to anxiety levels and vital signs were reduced after each intervention and for all three repetitions of pre- and postintervention observation (anxiety levels [p < 0.00], respiratory rate [p = 0.04], blood pressure [p = 0.00]).
The authors concluded that prayer is effective in reducing the anxiety of patients receiving chemotherapy. Evaluating anxiety by measuring vital signs is recommended as a simple technique. The nursing application of a standardized prayer protocol in the clinical environment addresses patients' spiritual dimensions and could reduce anxiety.
The spiritual care of patients with cancer is an important dimension of care. Continued research on the effectiveness of prayer for patients who value prayer can be meaningful in reducing anxiety.
Carulli, G., Rocco, M., Panichi, A., Chios, C.F., Ciurli, E., Mannucci, C., . . . Petrini, M. (2013). Treatment of oral mucositis in hematologic patients undergoing autologous or allogeneic transplantation of peripheral blood stem cells: A prospective, randomized study with a mouthwash containing Camelia Sinensis leaf extract. Hematology Reports, 5, 21–25.
To examine the effectiveness of Camelia Sinensis leaf extract to prevent oral mucositis (OM) in patients undergoes autologous and allogeneic stem cell transplant (SCT)
Patients undergoing SCT randomly were assigned to the experimental group or the control group. Patients in the experimental group received 20 ml of Baxidil Onco® four times a day from day -1 to day +30, in addition to standard prophylactic measures. Baxidil Onco is composed of Camelia Sinensis leaf extract and palmitoyl hydrolyzed wheat protein. Patients in the control group received standard prophylactic measures only. As a standard measure, all patients received mouthwashes with 0.9% saline/sodium bicarbonate solution, 0.12% chlorhexidine, and amphotericin B.
Patients with grade 2 or higher OM additionally received oral care with sponges or soft gauzes. All patients also received 400 mg acyclovir twice daily from day -3 to 16 weeks, 400 mg fluconazole once daily, 500 mg ciprofloxacin once daily, and 960 mcg co-trimoxazole twice daily until day of transplant.
PHASE OF CARE: Active antitumor treatment
OM was found in 81.2% of patients in the control group and 50% of patients in the study group (p = 0.022). Incidence rates for patients undergoing allogeneic transplant were 89% in the control group and 64% in the study group. Moderate to severe mucositis was more prevalent in the control group (56.2%) than in the study group (25%) (p = 0.029). No statistically significant results were found in incidence of severe mucositis (p = 0.16). Total requirement of morphine was 1,300 mg for the study group and 2,880 mg in the control group. However, this result was not statistically examined.
Baxidil Onco may be effective in reducing OM in patients undergoing hematopoietic SCT. A caution may apply for patients with wheat allergy. More patients were undergoing allogeneic transplant in the control group than in the study group. Because incidence of mucositis generally is higher in allogeneic hematopoietic SCT, this presents a potential bias. Further study with larger sample sizes is necessary.
Baxidil Onco may help reduce OM for patients undergoing hematopoietic SCT. However, further study with larger sample sizes is necessary for this to be used as a standard of practice.