title: A prospective, randomized trial of integrative medicine for women with ovarian cancer.
abstract: OBJECTIVE
  Despite increased use of integrative medicine in cancer therapy, little data exist on its efficacy. This prospective, randomized, pilot trial sought to evaluate the feasibility of combined modality integrative medicine (CM-IM) in women with ovarian cancer (OvCA) and evaluate its effects on quality of life (QoL), chemotherapy toxicity and immunologic profiles.
  
  
  METHODS
  Women with newly diagnosed OvCA requiring chemotherapy were offered enrollment. Those randomized to the experimental arm received hypnosis, therapeutic massage and healing touch with each cycle of chemotherapy. The control arm received chemotherapy without CM-IM. All patients completed QoL questionnaires prior to cycles 1, 3 and 6, and 6-months after chemotherapy. Immunologic profiles were measured. Statistical analysis was based on intent-to-treat. Student's t-test and Fischer's exact-test were used to determine differences.
  
  
  RESULTS
  Forty-three women enrolled. All women randomized to CM-IM were successfully treated. There were no statistical differences between the groups in age, stage, grade, histologic cell type, CA125 levels, or surgical cytoreductive status. There was no difference in overall QoL measurements. Re-hospitalization rates, treatment delays, anti-emetic use, and infection rates were similar. Immunologic profiles revealed no difference between arms for WBC or salivary IgA levels. Women receiving CM-IM had consistently higher levels of CD4, CD8 and NK cells, although this did not reach statistical significance.
  
  
  CONCLUSIONS
  Prospective clinical evaluation of integrative medicine for women with gynecologic malignancy is feasible. This first, pilot study of CM-IM in gynecologic oncology demonstrated no improvement in QoL or chemotherapy toxicity. Integrative medicine-associated improvements in immunologic profiles warrant further investigation.
authors.affiliation: H. Lee Moffitt Cancer Center & Research Institute, Department of Women's Oncology, USA. Patricia.Judson@moffitt.org
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Judson
authors.forename: Elizabeth L
authors.initials: EL
authors.lastname: Dickson
authors.forename: Peter A
authors.initials: PA
authors.lastname: Argenta
authors.forename: Yin
authors.initials: Y
authors.lastname: Xiong
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Geller
authors.forename: Linda F
authors.initials: LF
authors.lastname: Carson
authors.forename: Rahel
authors.initials: R
authors.lastname: Ghebre
authors.forename: Amy L
authors.initials: AL
authors.lastname: Jonson
authors.forename: Levi S
authors.initials: LS
authors.lastname: Downs
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects; D005260:Female; D006801:Humans; D055048:Integrative Medicine; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000523:psychology; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents