Weidong Lu1, Ursula A Matulonis2, Julie E Dunn3, Hang Lee4, Anne Doherty-Gilman5, Elizabeth Dean-Clower5, Annekathryn Goodman6, Roger B Davis7, Julie Buring7, Peter Wayne7, David S Rosenthal5, Richard T Penson6. 1. Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute , Boston, MA. ; The New England School of Acupuncture , Newton, MA. 2. Department of Medical Oncology, Dana-Farber Cancer Institute , Boston, MA. 3. The New England School of Acupuncture , Newton, MA. 4. Biostatistics Center, Massachusetts General Hospital , Boston, MA. 5. Leonard P. Zakim Center for Integrative Therapies, Dana-Farber Cancer Institute , Boston, MA. 6. Department of Gynecologic Oncology & Medicine, Massachusetts General Hospital , Boston, MA. 7. Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital , Boston, MA.
Abstract
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 receivingchemotherapy-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.
RCT Entities:
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.
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