Monk, J.P., Phillips, G., Waite, R., Kuhn, J., Schaaf, L.J., Otterson, G.A., . . . Villalona-Calero, M.A. (2006). Assessment of tumor necrosis factor alpha blockade as an intervention to improve tolerability of dose-intensive chemotherapy in cancer patients. Journal of Clinical Oncology, 24, 1852–1859.
N = 28
MEDIAN AGE = 56 years
AGE RANGE = 25–83 years
MALES = 17
KEY DISEASE CHARACTERISTICS: Most had received previous chemotherapy and/or radiotherapy and had multiple disease sites. The most common disease site was non-small-cell lung.
EXCLUSION CRITERIA: Patients were excluded if they were scheduled for major surgery, radiotherapy, or chemotherapy within 28 days of study entry or had brain metastases, serious infections, or psychiatric disorders that would interfere with consent or follow-up; pre-existing moderate-to-severe peripheral neuropathy; or cardiac disease. Pregnant or lactating women also were excluded.
Patients randomly were selected to receive etanercept/docetaxel. Less fatigue was self-reported in comparison to patients who received docetaxel only (p < 0.001). The FSI Interference score of Cohort A was significantly greater than the score of Cohort B (p < 0.001). Patients receiving additional cycles for treatment (Cohorts B,C, and D) did not experience worsening fatigue.
Momm, F., Weibenberger, C., Bartelt, S., & Henke M. (2003). Moist skin care can diminish acute radiation-induced skin toxicity. Strahlentherapie und Onkologie, 179, 708–712.
To investigate whether moist skin care with 3% urea lotion will reduce acute radiation (RT) skin toxicity.
Irradiated skin of inpatients was treated with 3% urea lotion (Eucerin® 3%, Beiersdorf).
Outpatients were treated with either urea lotion or powder, depending randomly on the date when they started RT (Azulon®, Baxter Oncology GmbH, formerly ASTA Medical AWD).
They were instructed to avoid mechanical, chemical, or thermal irritations of the skin, to wear light clothes, and to omit jewelry. Men were told to use an electric shaver.
Starting with the first day of irradiation, irradiated skin was treated with lotion or powder twice daily. At the occurrence of a skin reaction grade I or II, the lotion or powder was given at least five times per day. If skin lesions grade III or IV occurred, treatment with lotion or powder was stopped and the patient received appropriate wound care programs (povidone-iodine and zinc ointments). Findings were compared to those of historical controls.
Multiple sites in Germany
The study was a single-arm clinical trial with a historical control comparison.
Patients were evaluated weekly for acute skin reactions according to the Radiation Therapy Oncology Group (RTOG) score.
To exclude sampling errors and scoring differences between different observers, all skin evaluations were performed by the same physician.
Results showed that controls had a higher prevalence of skin toxicities at all grades, at lower radiation doses (p < 0.05).
Moist skin care with 3% urea lotion may delay the occurrence of acute RT-induced skin reactions.
Molpus, K.L., Anderson, L.B., Craig, C.L., & Puleo, J.G. (2004). The effect of regional cooling on toxicity associated with intravenous infusion of pegylated liposomal doxorubicin in recurrent ovarian carcinoma. Gynecologic Oncology, 93, 513–516.
To evaluate the effectiveness of regional cooling on palmar-plantar erythrodysesthesia (PPE).
Patients received pegylated liposomal doxorubicin (PLD) every 28 days, with dosages ranging from 30 mg/m2 to 50 mg/m2.
Group 1 (n = 17) used regional cooling. The regional cooling protocol (RCP) included administration of ice packs to the wrists and ankles, and iced liquids were available for consumption during PLD infusion. In addition, patients were encouraged to use the ice packs for up to 24 hours after completion of the PLD infusion.
Group 2 (n = 3) did not use RCP. Patients were instructed to avoid ingestion of hot foods or liquids, avoid contact with hot water and direct sunlight, and minimize friction to the hands and feet for 72 hours post-PLD treatment.
University of Nebraska Medical Center in Omaha
This was a retrospective analysis of 20 patients’ records.
PPE was graded from 1 to 4; however, the authors did not specify what grading system was used.
The frequency and severity of PPE was reduced in 17 women who used the RCP, compared to three women who did not use those measures (p = 0.047).
Regional cooling around the wrists and ankles was well tolerated and had a high degree of compliance during chemotherapy administration.
Moller, T., Moser, C., Adamsen, L., Rugaard, G., Jarden, M., Botcher, T.S., . . . Kjeldsen, L. (2016). Early warning and prevention of pneumonia in acute leukemia by patient education, spirometry, and positive expiratory pressure: A randomized controlled trial. American Journal of Hematology, 91, 271–276.
To evaluate the feasibility and effectiveness of a patient-performed daily spirometry as an early warning tool and the use of a positive expiratory pressure (PEP) flute device to prevent pneumonia among outpatients undergoing treatment for acute myeloid leukemia (AML)
All patients received a 45-minute face-to-face educational session about pneumonia prevention and assessing for early signs, plus instructions on how to use a spirometer and record findings daily. The intervention group received PEP flutes and instructions for use. All patients received instructions for contacting a healthcare provider if symptoms occurred. The primary outcome was occurrences of pneumonia.
The use of FEV1 to monitor for early onset pneumonia can be effective. The use of the PEP flute significantly decreases the occurrence of pneumonia.
Direct patient education on the use of spirometry to evaluate FEV1 and PEP flutes is effective. FEV1 findings can potentially aid with early pneumonia diagnosis, and the use of the PEP flutes can help prevent pneumonia.
Molinari, E., De Quatrebarbes, J., Andre, T., & Aractingi, S. (2005). Cetuximab-induced acne. Dermatology, 211, 330–333.
To evaluate the effectiveness of systemic antibiotic treatments (oral doxycycline) and local treatment for skin rash in patients receiving cetuximab.
Patients were prospectively evaluated by dermatologists from two phase 2 trials between October 2003 and May 2004. Dermatologists determined they would treat four patients with oral doxycycline; in three of those patients, a topical treatment (retinoid) was given as well. Other patients were treated with benzoyl peroxide (n = 1) or fusidic acid (n = 1).
Service de Dermatologie et Service d’Oncologie, Hôpital Tenon, in Paris, France
This was a prospective trial.
Rash intensity was graded as mild, moderate, or severe.
Antibiotic treatments (oral doxycycline) and local treatments given to six patients receiving cetuximab were effective in resolving skin lesions.
Molinari, E., De Quatrebarbes, J., Andre, T., & Aractingi, S. (2005). Cetuximab-induced acne. Dermatology, 211, 330–333.
To evaluate the effectiveness of systemic antibiotic treatments (oral doxycycline) and local treatment for skin rash in patients receiving cetuximab.
Patients were prospectively evaluated by dermatologists from two phase 2 trials between October 2003 and May 2004. Dermatologists determined they would treat four patients with oral doxycycline; in three of those patients, a topical treatment (retinoid) was given as well. Other patients were treated with benzoyl peroxide (n = 1) or fusidic acid (n = 1).
Service de Dermatologie et Service d’Oncologie, Hôpital Tenon, in Paris, France
This was a prospective trial.
Rash intensity was graded as mild, moderate, or severe.
Antibiotic treatments (oral doxycycline) and local treatments given to six patients receiving cetuximab were effective in resolving skin lesions.
Molassiotis, A., Charalambous, A., Taylor, P., Stamataki, Z., & Summers, Y. (2015). The effect of resistance inspiratory muscle training in the management of breathlessness in patients with thoracic malignancies: A feasibility randomised trial. Supportive Care in Cancer, 23, 1637–1645.
To assess the feasibility of inspiratory muscle training (IMT) in the lung cancer population and to explore changes in outcomes
Patients were randomized to either the standard care group or the intervention group, which received standard care and intervention of IMT, consisting of two supervised sessions, then home self-delivery of IMT with provided device (pressure threshold device) in five sessions weekly for 12 weeks of 30 minutes per day divided over two sessions. Assessments were completed at 4, 8, and 12 weeks.
This trial showed that IMT is feasible and acceptable for patients with lung cancer. In comparison of IMT group and control group, several outcomes, including worst breathlessness, average breathlessness, distress from breathlessness, ability to cope with breathlessness, satisfaction with management of breathlessness, fatigue, and depression and anxiety had improved for the IMT group over the control group. No differences were seen in spirometry and breathlessness between groups.
IMT is feasible and acceptable for patients with lung cancer and improved outcomes were seen for patients receiving IMT. However, this trial had a small sample size, so it cannot adequately draw solid conclusions regarding outcomes for patients with lung cancer undergoing IMT for breathlessness. Larger trials should be conducted to evaluate this.
IMT may be of benefit for the treatment of breathlessness, but data are too weak due to the small sample size to strongly recommend IMT. In addition, the study included only patients with lung cancer. This study is inadequately powered to draw conclusions about outcomes and does not address any patients experiencing breathlessness from nonthoracic malignancies.
Molassiotis, A., Bardy, J., Finnegan-John, J., Mackereth, P., Ryder, W. D., Filshie, J., . . . Richardson, A. (2013). A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture. Annals of Oncology, 24, 1645–1652.
To determine if maintenance acupuncture is beneficial in sustaining improvements in fatigue after a course of acupuncture.
Patients in a previous six-week acupuncture trial were rerandomized to three groups: maintenance self-acupuncture, therapist-delivered maintenance acupuncture, or a control group receiving usual care. Maintenance therapy lasted for four weeks. Standard acupuncture points were used, and sessions were weekly. Data were collected at the end of four weeks and at 12 weeks after rerandomization.
Patients were undergoing the transition phase of care after active treatment.
The study was a randomized, controlled trial.
Results showed a trend of fatigue improvement in the combined acupuncture groups compared to the control; the trend was not significant. In regard to results reflecting anxiety or depression, the study showed no differences between groups. Patients' logs indicated that patients performed self-needling as planned.
Findings suggested that it is feasible for patients to maintain acupuncture treatment through self-needling. Compared to symptom improvement in patients in the control group, symptom improvement in patients undergoing maintenance acupuncture through self-needling or through delivery by a therapist was not significant.
The study showed that patients can be taught to deliver their own acupuncture treatments effectively by self-needling. The study did not demonstrate that ongoing acupuncture, or maintenance acupuncture, had any effect on fatigue, anxiety, or depression.
Molassiotis, A., Bardy, J., Finnegan-John, J., Mackereth, P., Ryder, D. W., Filshie, J., . . . Richardson, A. (2012). Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. Journal of Clinical Oncology, 30, 4470–4476.
To assess the effectiveness of acupuncture for cancer-related fatigue (CRF) in women with breast cancer.
Women were randomly assigned to acupuncture or enhanced usual care groups. Usual care enhancement consisted of providing a booklet about CRF, diet, exercise, and sleep. The intervention group was offered six acupuncture treatments over six weeks. Sessions lasted 20 minutes each and involved unilateral or bilateral needles at three points. No rotation or flicking of needles was performed. Patients were followed for 18 weeks. Outcome measures were recorded at six weeks.
The study has clinical applicability for late effects and survivorship.
The study was a randomized, controlled trial.
The difference score between the control and acupuncture groups for fatigue was –3.11 (95% confidence interval [CI] [–3.97, –2.25]; p < 0.001). Intention-to-treat (ITT) analysis, using an assumption of no improvement for patients whose week six outcome data were missing, continued to show a significant difference (–2.49; p < 0.001). Week six outcomes, as reflected in HADS and FACT-B scores, were significantly improved from baseline in patients who received acupuncture (p < 0.001).
Findings showed that acupuncture as provided was effective in reducing fatigue over a six-week period among survivors of breast cancer.
Findings showed that acupuncture was helpful in reducing fatigue in patients with breast cancer who had completed antitumor treatment. The study supports the effectiveness of acupuncture for the treatment of fatigue.
Molassiotis, A., Sylt, P., & Diggins, H. (2007). The management of cancer-related fatigue after chemotherapy with acupuncture and acupressure: a randomised controlled trial. Complementary Therapies in Medicine, 15, 228–237.
The study was a randomized, controlled trial of acupuncture (n = 15); acupressure (n = 16); and sham acupressure (n = 16). Acupuncture included six 20-minute sessions over two weeks. Acupressure involved self-applying pressure to the same points daily. Sham acupressure involved self-applying pressure to nonenergy points. The selected acupuncture points were energy points that have been used for more than 2,000 years.
Patients were recruited from an outpatient clinic, an acupuncture treatment setting in a hospital in the United Kingdom, or in their own homes.
The study was a small randomized, controlled trial with blinding between two acupressure conditions.
The study included an intention-to-treat (ITT) analysis. Significant improvements existed in general fatigue (p < 0.001), physical fatigue (p = 0.016), activity (p = 0.004), and motivation (p = 0.024). Patients showed 36% improvement in acupuncture, 19% in acupressure, and 0.6% in sham acupressure. The effect was not sustained at the same level after two weeks.
Spot bleeding was observed in two cases. Trained acupuncturists are necessary. A detailed description of acupuncture was given using Standards of Reporting Interventons of Controlled Trials of Acupuncture (STRICTA) guidelines.