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Use of acupuncture with acupressure in addition to standard-of-care cryotherapy to decrease chemotherapy-associated neuropathy in patients with gastrointestinal malignancies receiving oxaliplatin-based chemotherapy: Study protocol for a randomized, controlled pilot and feasibility study.
Cohen, Stacey A; Veleber, Susan; Siman, Jonathan; Guthrie, Katherine A; McMillen, Kerry; Heit, Madilyn; Wadhera, Sonia; Daniels, Jonathan; Hansen, Kjell; Jacoby, Madeline; Taromina, Katherine; Chin, Samantha; Romeo, Melissa; Langley, Blake O; Coveler, Andrew L; Hannan, Lindsay M; King, Gentry; Purcell, Tom; Safyan, Rachael A; Shankaran, Veena; Zhen, David B; Chiorean, E Gabriela; Greenlee, Heather.
Afiliación
  • Cohen SA; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA. Electronic address: shiovitz@uw.edu.
  • Veleber S; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA; Division of Public Health Sciences, Fred Hutchinson Cancer Center, USA.
  • Siman J; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA; Division of Public Health Sciences, Fred Hutchinson Cancer Center, USA.
  • Guthrie KA; Division of Public Health Sciences, Fred Hutchinson Cancer Center, USA.
  • McMillen K; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA.
  • Heit M; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Wadhera S; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Daniels J; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Hansen K; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Jacoby M; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Taromina K; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA.
  • Chin S; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA.
  • Romeo M; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA.
  • Langley BO; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA; Division of Public Health Sciences, Fred Hutchinson Cancer Center, USA; Department of Child, Family, and Population Health Nursing, University of Washington, Seattle, WA 98195, USA.
  • Coveler AL; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Hannan LM; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • King G; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Purcell T; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Safyan RA; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Shankaran V; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Zhen DB; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Chiorean EG; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA.
  • Greenlee H; Clinical Research Division, Fred Hutchinson Cancer Center, 825 Eastlake Ave E, Seattle, WA 98109, USA; Division of Medical Oncology, University of Washington School of Medicine, USA; Integrative Medicine Program, Division of Supportive Care, Fred Hutchinson Cancer Center, USA; Division of Public Hea
Contemp Clin Trials ; 131: 107273, 2023 08.
Article en En | MEDLINE | ID: mdl-37380021
BACKGROUND: Oxaliplatin is a key chemotherapeutic agent in the treatment of local and metastatic gastrointestinal (GI) malignancies. Dose density and treatment adherence can be limited by chemotherapy-induced peripheral neuropathy (CIPN). Early research suggests CIPN incidence and severity may be mitigated by acupuncture, but rigorous data in GI oncology patients is limited. Here, we describe the protocol of a randomized, waitlist-controlled pilot study testing the use of preemptive of acupuncture plus acupressure to decrease CIPN and chemotherapy-related toxicities. METHODS: Patients with a GI malignancy (n = 56) with planned 5-fluorouracil (5-FU) and oxaliplatin IV (FOLFOX, FOLFIRINOX) every 2 weeks are being recruited. Additional concurrent anti-neoplastic agents may be used. Enrolled patients are randomized 1:1 to a 3-month intervention of Arm A: acupuncture with acupressure and standard-of-care treatment, or Arm B: standard-of-care alone. In Arm A, on days 1 and 3 of each chemotherapy cycle a standardized acupuncture protocol is administered and patients are taught self-acupressure to perform daily between chemotherapy treatments. Patients in both arms are given standard-of-care oral and peripheral (hands/feet) ice chip cryotherapy during oxaliplatin administration. CIPN and other symptoms are assessed at baseline, 6 weeks, and 3 months from registration. The primary endpoint is CIPN severity at 3 months (EORTC-CIPN 20). Additional endpoints evaluate CIPN incidence (CTCAE, Neuropen, tuning fork); incidence of pain, fatigue, nausea, oral dysesthesia, and anxiety; and feasibility (recruitment, retention, adherence, acceptability). If warranted, trial results will inform the design of a multi-center trial to expand testing of the intervention to a larger patient cohort.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Terapia por Acupuntura / Enfermedades del Sistema Nervioso Periférico / Acupresión / Neoplasias Gastrointestinales / Antineoplásicos Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Límite: Humans Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Pancreáticas / Terapia por Acupuntura / Enfermedades del Sistema Nervioso Periférico / Acupresión / Neoplasias Gastrointestinales / Antineoplásicos Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Risk_factors_studies Límite: Humans Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos