The Feasibility and Effects of Acupuncture on Quality of Life Scores During Chemotherapy in Ovarian Cancer: Results from a Pilot, Randomized Sham-Controlled Trial.

BACKGROUND: Within a pilot trial regarding chemotherapy-induced neutropenia, the secondary aim of the main study was explored. This involved measuring the effects-as shown on two key measurement scales reflecting quality of life (QoL)-of verum versus sham acupuncture on patients with ovarian cancer during chemotherapy. OBJECTIVE: The aim of this substudy was to determine the feasibility of determining the effects of verum acupuncture versus sham acupuncture on QoL in patients with ovarian cancer during chemotherapy. DESIGN: This was a randomized, sham-controlled trial. SETTING: The trial was conducted at two cancer centers. PATIENTS: Patients with ovarian cancer (N=21) who were receiving chemotherapy-primarily intravenous carboplatin and paclitaxel-participated in this substudy. INTERVENTION: The participants were given either active or sham acupuncture 1 week prior to cycle 2 of chemotherapy. There were ten sessions of acupuncture, with manual and electro-stimulation over a 4-week period. MAIN OUTCOME MEASURES: The European Organization for Research and Treatment of Cancer-Quality-of-Life Questionnaire-Core 30 Item (EORTC-QLQ-C30) and the Quality of Life Questionnaire-Ovarian Cancer Module-28 Item (QLQ-OV28) were administered to the patients at baseline and at the end of their acupuncture sessions. RESULTS: Of the original 21, 15 patients (71%) completed the study, and 93% of them completed the questionnaires. The EORTC-QLQ-C30 subscores were improved in the acupuncture arm, including the mean scores of social function (SF), pain, and insomnia (p=0.05). However, after adjusting for baseline differences, only the SF score was significantly higher in the active acupuncture arm, compared with the sham acupuncture arm (p=0.03). CONCLUSIONS: It appears feasible to conduct a randomized sham-controlled acupuncture trial measuring QoL for patients with ovarian cancer who are undergoing chemotherapy. Acupuncture may have a role in improving QoL during chemotherapy.

Effects of complementary therapies on clinical outcomes in patients being treated with radiation therapy for prostate cancer.

BACKGROUND: This pilot randomized controlled trial (RCT) examined the clinical effects of 2 complementary (CAM) therapies, relaxation response therapy (RRT) and Reiki therapy, in men being treated with external beam radiotherapy (EBRx) for prostate cancer. METHODS: Study participants were randomly assigned to weekly RRT, Reiki therapy twice weekly, or wait-list control. Well-validated instruments measured anxiety (STAI), depression (CES-D), and quality of life in cancer patients (FACT-G) at randomization and 3 subsequent time points. RESULTS: Fifty-four men were randomized, and 16 of 18 (89%) of RRT and 15 of 18 (83%) of Reiki patients completed the intervention protocol. No statistically significant difference was found between the RRT, Reiki, and control groups on total scores for the STAI, CES-D, or FACT-G instruments at any time point. However, at the end of the intervention, significant improvement was found on the emotional well-being subscale of the FACT-G quality of life scale in the RRT group compared with the Reiki and control groups (P = .01). In participants who were classified as "anxious" at baseline, statistically significant improvement occurred in the RRT group (P = .02), and a positive trend was found in the Reiki group (P = .10). CONCLUSIONS: This pilot study documented the feasibility of conducting a RCT of CAM therapies in men undergoing EBRx for prostate cancer. Relaxation response therapy improved emotional well being and eased anxiety in participants. Reiki therapy also had a positive effect in anxious patients. A larger study to verify and better define the benefits of these therapies in men with prostate cancer is warranted.

Acupuncture as palliative therapy for physical symptoms and quality of life for advanced cancer patients.

BACKGROUND: Acupuncture is underutilized as an adjunct cancer therapy. The main study objectives were to determine the feasibility of administering acupuncture as palliative therapy to patients with advanced ovarian or breast cancer and to assess the effect on symptoms and quality of life (QOL). METHODS: This study was a pilot, single-armed prospective clinical trial for patients with advanced cancer to receive 12 acupuncture sessions over 8 weeks with follow-up at weeks 9 and 12. Ambulatory patients with advanced ovarian or breast cancer were enrolled to receive treatments at an outpatient academic oncology center. Symptom severity was measured before and after each acupuncture session.A composite QOL assessment tool, consisting of validated instruments, was completed at 5 time points. RESULTS: Forty patients enrolled in the study. Twenty-eight patients (70%; 95% confidence interval [CI] = 53%-83%) completed 4 weeks of treatment, and 26 patients (65%; 95% CI = 48%-79%) completed 8 weeks. Eight patients (20%) withdrew before receiving acupuncture, and 6 patients (15%) discontinued treatment early because of disease progression or scheduling demands. Among all 32 assessed patients, there was self-reported improvement immediately post-treatment in anxiety,fatigue, pain, and depression and significant improvement over time for patients with anxiety (P = .001) and depression(P = .02). Among patients experiencing baseline symptoms, there was improvement in anxiety (P = .001), fatigue (P = .0002),pain (P = .0002), and depression (P = .003). QOL measures of pain severity and interference, physical and psychological distress, life satisfaction, and mood states showed improved scores during treatment, with sustained benefit at 12 weeks. CONCLUSIONS: This pilot study demonstrates that an 8-week outpatient acupuncture course is feasible for advanced cancer patients and produces a measurable benefit that should be evaluated in controlled trials.

Integrative Tumor Board: a case report and discussion from Dana-Farber Cancer Institute.

A 34-year-old woman carrying a BRCA1 gene and a significant family history was diagnosed with T1c, N1 breast cancer. The tumor was estrogen receptor, progesterone receptor, and HER-2/Neu negative. The patient received dose-dense chemotherapy with Adriamycin and Cytoxan followed by Taxol, and left breast irradiation. Later, a bilateral S-GAP flap reconstruction with right prophylactic mastectomy and left mastectomy were performed. During her treatment, the patient had an integrative medicine consultation and was seen by a team of health care providers specializing in integrative therapies, including integrative nutrition, therapeutic massage, acupuncture, and yoga. Each modality contributed unique benefit in her care that led to a satisfactory outcome for the patient. A detailed discussion regarding her care from each modality is presented. The case elucidates the need for integrative approaches for cancer patients in a conventional medical setting.

Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: a pilot randomized, sham-controlled clinical trial.

OBJECTIVES: The objective of this study was to investigate the effect of acupuncture administered during myelosuppressive chemotherapy on white blood cell (WBC) count and absolute neutrophil count (ANC) in patients with ovarian cancer. DESIGN: This study is a pilot, randomized, sham-controlled clinical trial. Patients received active acupuncture versus sham acupuncture while undergoing chemotherapy. A standardized acupuncture protocol was employed with manual and electrostimulation. The frequency of treatment was 2-3 times per week for a total of 10 sessions, starting 1 week before the second cycle of chemotherapy. SETTING: The setting was two outpatient academic centers for patients with cancer. SUBJECTS: Twenty-one (21) newly diagnosed and recurrent ovarian cancer patients were the subjects. OUTCOME MEASURES: WBC count, ANC, and plasma granulocyte colony-stimulating factor (G-CSF ) were assessed weekly. RESULTS: The median leukocyte value in the acupuncture arm at the first day of the third cycle of chemotherapy was significantly higher than in the control arm after adjusting for baseline value (8600 cells/microL, range: 4800-12,000 versus 4400 cell/microL, range: 2300-10,000) (p = 0.046). The incidence of grade 2-4 leukopenia was less in the acupuncture arm than in the sham arm (30% versus 90%; p = 0.02). However, the median leukocyte nadir, neutrophil nadir, and recovering ANC were all higher but not statistically significantly different (p = 0.116-0.16), after adjusting for baseline differences. There were no statistically significant differences in plasma G-CSF between the two groups. CONCLUSIONS: We observed clinically relevant trends of higher WBC values during one cycle of chemotherapy in patients with ovarian cancer, which suggests a potential myeloprotective effect of acupuncture. A larger trial is warranted to more definitively determine the efficacy of acupuncture on clinically important outcomes of chemotherapy-induced neutropenia.

The value of acupuncture in cancer care.

Clinical research on acupuncture in cancer care is a new and challenging field in oncology. The results of clinical research will continue to provide clinically relevant answers for patients and oncologists. The evidence currently available has suggested that acupuncture is a safe and effective therapy to manage cancer and treatment related symptoms, while giving patients the ability to actively participate in their own care plan. The article explains the potential benefits of acupuncture and describes the difficulties in studying its effectiveness.

Acupuncture for chemotherapy-induced leukopenia: exploratory meta-analysis of randomized controlled trials.

Chemotherapy-induced leukopenia and neutropenia are common side effects during cancer treatment. Acupuncture has been reported as an adjunct therapy for this complication. The current study reviewed published randomized controlled trials of acupuncture's effect and explored the acupuncture parameters used in these trials. We searched biomedical databases in English and Chinese from 1979 to 2004. The study populations were cancer patients who were undergoing or had just completed chemotherapy or chemoradiotherapy, randomized to either acupuncture therapy or usual care. The methodologic quality of trials was assessed. From 33 reviewed articles, 682 patients from 11 eligible trials were included in analyses. All trials were published in non-PubMed journals from China. The methodologic quality of these trials was considerably poor. The median sample size of each comparison group was 45, and the median trial duration was 21 days. The frequency of acupuncture treatment was once a day, with a median of 16 sessions in each trial. In the seven trials in which white blood cell (WBC) counts were available, acupuncture use was associated with an increase in leukocytes in patients during chemotherapy or chemoradiotherapy, with a weighted mean difference of 1,221 WBC/muL on average (95% confidence interval 636-1,807; p < .0001). Acupuncture for chemotherapy-induced leukopenia is an intriguing clinical question. However, the inferior quality and publication bias present in these studies may lead to a false-positive estimation. Meta-analysis based on these published trials should be treated in an exploratory nature only.

Integrative medicine in hematology/oncology: benefits, ethical considerations, and controversies.

Integrative Medicine (IM), a newly emerging field, has evolved from Complementary and Alternative Medicine (CAM). CAM refers to diverse medical and health care systems, practices, and products that are not presently considered part of conventional medicine and generally have limited scientific evidence. In the US, CAM is a multi-billion dollar, unregulated industry with potential benefits and risks to consumers, including cancer patients, who are high utilizers of complementary therapies. Patients' CAM use often is unsupervised by physicians, yet patients need the advice and guidance of their hematologists/oncologists as part of total cancer care. Ethical and legal issues physicians need to address include inquiring about and educating patients regarding potential interactions (e.g., drug-herb, radiation-antioxidant) or product contaminants, while discussing other therapies that may alleviate symptoms and/or improve quality of life. Administratively, CAM offerings in medical settings require relevant policies and procedures, such as properly credentialing practitioners and providing financial assistance counseling for those who cannot afford fee-for-service. Unlike "Alternative Medicine," the goal of IM is to combine mainstream medical therapies and CAM therapies (e.g., acupuncture, meditation, music therapy) that have some high-quality scientific evidence of safety and effectiveness. The Society for Integrative Oncology (SIO), a new international organization of oncology professionals studying and integrating effective complementary therapies in cancer care, serves as a forum for presenting scientific data on these therapies while emphasizing the importance of developing infrastructure that promotes IM principles and practices. The ultimate goal is to develop multidisciplinary expertise and therapeutic synergy between conventional and complementary therapies.