Jantunen, E., Kuittinen, T., & Nousiainen, T. (2002). A pilot study on feasibility and efficacy of amifostine preceding high-dose melphalan with autologous stem cell support in myeloma patients. Leukemia and Lymphoma, 43, 1961–1965.
The study was conducted between November 1998 and February 2000.
This was a pilot, feasibility study.
The National Cancer Institute (NCI) Common Toxicity Criteria for Oral Mucositis was used to assess oral mucositis daily.
Most of the patients (9 out of 10) received the full dose of amifostine. One patient received only 780 mg/m2 because of recurrent hypotension. Significant nausea, as well as hypotension and vomiting, occurred.
Amifostine did not show a benefit for gastrointestinal toxicity or mucositis of more than grade 2.
Jang, G., Song, H.H., Park, K.U., Kim, H.S., Choi, D.R., Kwon, J.H., . . . Zang, D.Y. (2013). A phase II study to evaluate the efficacy of ramosetron, aprepitant, and dexamethasone in preventing cisplatin-induced nausea and vomiting in chemotherapy-naive cancer patients. Cancer Research and Treatment, 45(3), 172–177.
To evaluate the efficacy of ramosetron, aprepitant, and dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based chemotherapy
On day 1, all patients received intravenous 0.6 mg ramosetron and oral 12 mg dexamethasone 30 minutes before chemotherapy, and they received 125 mg aprepitant orally one hour before chemotherapy. On days 2 and 3, patients received 80 mg aprepitant and 8 mg dexamethasone orally in the morning. On day 4, patients only received 8 mg dexamethasone. Patients could take rescue antiemetic medications at any time for vomiting or severe nausea. Antiemetic rescue medications were determined by treating physicians.
Prospective, open-label study
Complete response (CR) was achieved by 94.9% of patients in the acute phase, 92.3% in the delayed phase, and 92.3% in the overall phase. Absolute CR was achieved by 74.4% in the acute phase, 51.3% in the delayed phase, and 46.2% in the overall phase. The median nausea score during the acute phase was 0 (interquartile range [IQR] 0–1), 0 in the delayed phase (IQR 0–4), and 2 during the overall phase (IQR 0–4). On the VAS, mild nausea was observed in 10% of patients in the acute phase and 13% of patients in the delayed phase. Moderate to severe nausea was observed in 15% of patients in the acute phase and 36% of patients in the delayed phase.
The combination of ramosetron, aprepitant, and dexamethasone is an effective CINV regimen. The overwhelming majority of patients in this study achieved a complete response and experienced no nausea or vomiting in both the acute and delayed phase after chemotherapy.
Ramosetron, aprepitant, and dexamethasone is an effective regimen to prevent CINV in patients receiving cisplatin-based therapy. Almost all of the patients were able to achieve a complete response in both the acute and delayed phase after administration of chemotherapy. In this study, the majority of patients were receiving palliative care, therefore this combination of drugs should be considered for palliative care patients.
Janelsins, M.C., Peppone, L.J., Heckler, C.E., Kesler, S.R., Sprod, L.K., Atkins, J., . . . Mustian, K.M. (2015). YOCAS©® Yoga reduces self-reported memory difficulty in cancer survivors in a nationwide randomized clinical trial: Investigating relationships between memory and sleep. Integrative Cancer Therapies, 15, 263–271.
To investigate the effect of a combined hatha and restorative yoga intervention on memory in cancer survivors and to explore relationships between memory and sleep
YOCAS©® (Yoga for Cancer Survivors) is an instructor-guided standardized program that incorporates movement emphasizing restorative poses, breathing exercises, and mindfulness exercises. The intervention was offered twice a week in the late afternoon or evening over 75 minutes for a total of eight sessions. Although all the group trainers were Registered Yoga Alliance Teachers, they were also required to complete a training session, reviewing a detailed YOCAS©® manual to facilitate standardization across sites.
PHASE OF CARE: Late effects and survivorship
Secondary analysis of a randomized, clinical trial
At baseline, the average score on the MDASI indicated only a mild level of perceived memory problems overall. Although both groups continued to report memory problems as being mild, a significant decrease (p < 0.05) was observed in patients who completed the intervention. This difference continued to be significant when controlling for differences in age, gender, educational level, past treatment regimen, current hormonal therapy, baseline memory, and baseline sleep scores. Of note, those who received the intervention also had improved sleep (p < 0.05), which accounted for approximately 26% of the improvement in memory (p = 0.039).
Although yoga appeared to decrease perceived memory problems, this outcome was based on a single item of the MDASI. Further longitudinal studies designed specifically to measure the effect of yoga on cognitive function as measured by both objective and subjective measures are warranted.
Although this study suggested that yoga may improve patients’ perception of memory problems, some of the benefit was because of better sleep.
Jane, S.W., Chen, S.L., Wilkie, D.J., Lin, Y.C., Foreman, S.W., Beaton, R.D., . . . Liao, M.N. (2011). Effects of massage on pain, mood status, relaxation, and sleep in Taiwanese patients with metastatic bone pain: A randomized clinical trial. Pain, 152, 2432–2442.
To compare the efficacy of massage therapy to a social attention condition in Taiwanese patients with cancer with bone metastases
The study was a randomized, controlled clinical trial.
This trial documented therapeutic effects of massage on improving pain intensity, mood status, and muscle relaxation in patients with metastatic bone pain. The study has clinical implications supporting massage therapy and other medical modalities for optimal improvement in patients with cancer with bone metastases.
Massage therapy may play an important role in cancer bone pain, sleep, and, mood.
Jandhyala, R., & Fullarton, J. (2012). Various formulations of oral transmucosal fentanyl for breakthrough cancer pain: An indirect mixed treatment comparison meta-analysis. BMJ Supportive and Palliative Care, 2, 156–162.
PHASE OF CARE: Multiple phases of care (not reported)
APPLICATIONS: Palliative care
No head to head trials between products existed. FBT produced a greater improvement in PID in the first 60 minutes after dosing (66% more probable than ODT and 68% more than OTFC). ODT and OTFC showed similar benefits, and ODT had a slightly higher benefit with a 53% probability of pain relief at 60 minutes. The two agents compared with morphine sulfate immediate-release, FBT and ODT, were compared, and benefits were significant within 15 minutes after dosing.
FBT may be advantageous as a fentanyl product, as it showed an advantage over ODT and OTFC.
Two of the trials compared FBT to a placebo, so more paitents received FBT. Therefore, cell sizes were not similar, resulting in an unequal comparison. Seven transmucosal immediate-release fentanyl (TIRF) studies existed. Only three were used in the comparison. Limited databases were searched.
Some TIRF products may have better efficacy compared to others. This analysis showed that FBT had an advantage. All products were shown to be superior to morphine in achieving pain relief one hour after dosing. Additional head to head comparison studies are needed.
Jandhyala, R., Fullarton, J.R., & Bennett, M.I. (2013). Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: A meta-analysis of comparative trials. Journal of Pain and Symptom Management, 46, 573–580.
STUDY PURPOSE: To evaluate the efficacy of oral fentanyl combinations for breakthrough cancer-related pain
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: PubMed
KEYWORDS: breakthrough cancer pain; incident pain; pain flare; morphine; fentanyl
INCLUSION CRITERIA: RCT
EXCLUSION CRITERIA: Not specified
TOTAL REFERENCES RETRIEVED: Not stated
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not stated
APPLICATIONS: Palliative care
The probability of superior relief of breakthrough pain by differences in pain intensity scores at 15- and 60-minute intervals was calculated for immediate-release morphine and fentanyl preparations, versus placebo and versus each other. There was a 61% probability that morphine would produce a better outcome than placebo. Corresponding results versus placebo for fentanyl buccal tablet (FBT) was 97%, for orally disintegrating tablet (ODT) was 72%, and for transmucosal oral fentanyl (OTF) tablet was 81%. The probability of superiority of fentanyl over morphine during the first 60 minutes was 68% for FBT, 57% for ODT, and 66% for OTF. Pain intensity differences were larger for fentanyl preparations than for morphine when compared to placebo.
Findings suggest that oral fentanyl preparations may provide better relief of breakthrough pain during the first 60 minutes than immediate-release oral morphine.
Findings suggest that oral fentanyl preparations may be more effective for management of breakthrough pain than oral immediate-release morphine. It should be noted however, that the duration of effect with morphine could be longer because of differences in half-life. Onset, intensity, and duration of relief of breakthrough pain with various approaches need to be evaluated to determine the best approach for individual patients.
Jain, S., Pavlik, D., Distefan, J., Bruyere, R. L., Acer, J., Garcia, R., . . . Mills, P. J. (2012). Complementary medicine for fatigue and cortisol variability in breast cancer survivors: a randomized controlled trial. Cancer, 118, 777–787.
To examine, within a blinded, randomized, controlled trial design, whether biofield therapy (hands-on healing) would significantly reduce fatigue in survivors with persistent cancer-related fatigue compared to mock healing and a wait-list control group.
Energy chelation (hands-on-healing with standard hand positions focusing for five to seven minutes over each body part, i.e., feet, hips, knees, bladder, stomach, hands, elbows, shoulders, heart, throat, head, and heart) for one hour, two times each week for four weeks in the intervention group; mock biofield therapy for one hour, two times each week for four weeks; and a wait-list with no specific intervention. All participants submitted saliva samples at four time points. Timing of self-reported measures of quality of life (QOL) and depression were not reported.
The study used a blinded, randomized, controlled design.
Nonspecific factors are important in responses to biofield interventions for fatigue. Belief predicts QOL responses but not fatigue or cortisol variability. Biofield therapies increase cortisol variability independent of belief and other nonspecific factors. A need exists to further examine the effects of specific processes of biofield healing on outcomes for cancer populations.
Use of a hands-on healing intervention takes time and a skill set not traditionally taught in undergraduate or graduate nursing programs. Few clinical nurses have the time or skills to practice hands-on healing as described in the study. The intervention is noninvasive and a potentially effective independent nursing intervention with a minimal side effect profile.
Jain, S., & Mills, P. J. (2010). Biofield therapies: helpful or full of hype? A best evidence synthesis. International Journal of Behavioral Medicine, 17, 1–16.
To determine whether biofield therapies affect positive health outcomes and reduce disease symptoms.
Databases searched were PubMed, CINAHL, PyscINFO, and Allied and Complementary Medicine (AMED).
Search keywords were spiritual healing, subtle energy, energy healing, biofield healing, external qi therapy, emitted chi, emitted qi, qi therapy, Johrei, pranic healing, polarity therapy, Reiki, therapeutic touch, and healing touch. Investigators also manually searched the reference sections of studies and review papers.
Studies were included if they
Studies were excluded if they related to distant healing or intercessory prayer; integrated modalities that were not biofield-based modalities with biofield-based modalities in such a way that the interventions could not be separated; were animal, plant, and/or in vitro studies; were clinical studies with group assignment but without randomization; were purely descriptive studies; or were unpublished dissertations.
Patients were undergoing the active treatment phase of care.
The authors presented results according to type of patient and levels of evidence.
Proximally practiced biofield therapies are promising complementary interventions as means of reducing pain intensity in multiple populations, reducing anxiety in hospitalized populations, and reducing agitated behaviors in patients with dementia. The long-term effects of the therapies on fatigue and autonomic nervous system activity are unclear.
Future research should compare biofield therapies with empirically supported treatments for specific conditions.
Jaing, T.H., Tsay, P.K., Hung, I.J., Yang, C.P., & Hu, W.Y. (2004). Single-dose oral granisetron versus multidose intravenous ondansetron for moderately emetogenic cyclophosphamide-based chemotherapy in pediatric outpatients with acute lymphoblastic leukemia. Pediatric Hematology and Oncology, 21, 227–235.
To compare the efficacy of multidose ondansetron with single-dose granisetron in complete emesis control and time spent in an ambulatory care setting in children with acute lymphoblastic leukemia (ALL) receiving moderately emetogenic cyclophosphamide-based chemotherapy
Eligible patients entered a four-week run-in period during which they were given antiemetic agents according to the randomization scheme before their scheduled IV cyclophosphamide chemotherapy. Regimens were either single-dose granisetron (0.5 mg for patients weighing 25–50 kg or 1 mg for patients over 50 kg) administered orally one hour before chemotherapy or three doses of ondansetron (0.15 mg/kg administered IV one hour before chemotherapy and again four hours after the first dose with an additional oral dose eight hours after the first dose). Parents were asked to keep a log of their child’s emetic episodes during the first 24 hours following chemotherapy. Antiemetic efficacy was assessed by the number of vomiting episodes, the need for rescue medication, and the extent of nausea and appetite loss.
Single-institution, randomized, open-label, two-period crossover investigation
In the granisetron arm, 20 out of 33 patients (60.6%) experienced complete efficacy compared to 15 out of 33 patients (45.5%) in the ondansetron arm, this was not statistically significant (p = 0.227). In both treatment groups, that males were less likely to respond to antiemetic treatment than females. In the granisetron group, 100% (12 out of 12) of females versus 76.2% (16 out of 21) of males experienced complete efficacy. In the ondansetron group, 100% (12 out of 12) of females versus 81% (17 out of 21) of males experienced complete efficacy. These differences did not meet a statistical significance (p = 0.271). The cost analysis demonstrated that granisetron costs about $0.20/kg (20 mcg/kg per patient), and ondansetron costs $20.09 per 8 mg vial or $6.18 per 4 mg tablet. This equates to about $0.99/kg (0.15 mg/kg per patient). The drug cost differential between the two modalities is $0.79/kg, favoring granisetron therapy on the basis of cost.
A single prophylactic oral dose of granisetron (10–20 mcg/kg) given prior to moderately emetogenic chemotherapy was at least as safe and effective as a triple dose of ondansetron given under similar circumstances. It also was more cost effective.
Based on this study, a single dose of oral granisetron (10–20 mcg/kg) is as safe and effective as a triple dose of ondansetron for moderately emetogenic chemotherapy in children with ALL in the acute phase of chemotherapy-induced nausea and vomiting only. There seems to be a gender difference in antiemetic efficacy.
Jahr, S., Schoppe, B., & Reisshauer, A. (2008). Effect of treatment with low-intensity and extremely low-frequency electrostatic fields (Deep Oscillation) on breast tissue and pain in patients with secondary breast lymphoedema. Journal of Rehabilitation Medicine: Official Journal of the UEMS European Board of Physical and Rehabilitation Medicine, 40(8), 645–650.
To evaluate the symptoms and functional limitations of patients with secondary breast lymphedema following surgical treatment and to assess the additional therapeutic benefit of Deep Oscillation when combined with manual lymphatic drainage
Patients were randomized to the treatment group or the control group. The treatment group received 12 sessions of manual lymphatic drainage supplemented by Deep Oscillation, and the control group received manual lymphatic drainage alone.
The study took place at a single site in Berlin, Germany.
The study used a randomized controlled trial design.
Patients had high pain and swelling scores at baseline. Shoulder mobility was impaired in all patients; restriction of cervical spine mobility was common at baseline and declined further in the control group. Deep Oscillation resulted in significant pain reduction in the treatment group. The subjective reported reduction of swelling was confirmed objectively by 3D measurement only in the treatment group.
Additional Deep Oscillation supplementary to manual lymphatic drainage can enhance pain alleviation and swelling reduction.
More attention should be paid to patients with breast lymphedema. Treatment with low-intensity and extremely low-frequency electrostatic fields could be a useful supplementary therapy in the management of patients with breast lymphedema. However, more studies with larger sample sizes are needed to duplicate the findings from this study.