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GOG-0225 CAN DIET AND PHYSICAL ACTIVITY MODULATE OVARIAN, FALLOPIAN TUBE AND PRIMARY PERITONEAL CANCER PROGRESSION-FREE SURVIVAL?

Description

Ovarian cancer is diagnosed in approximately 22,430 women annually in the United States. The Gynecological Oncology Group affords a unique opportunity to test hypotheses relating dietary intake and increased physical activity to improved progression-free survival among women diagnosed with ovarian cancer.The lifestyle intervention, which consist of 20% total energy as dietary fat, greater than 6 colorful vegetables and fruit servings, plus 4,000+ additional steps daily, included in this protocol is consistent with national and international recommendations for cancer prevention and survival.Primay Objective:To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for Stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention will have significantly increased progressionfree survival compared to similar women who are randomized to a usual carecomparison group.Study Population:Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis.Study Arms:Women will be randomized 1:1 to intervention versus control and randomization will include stratification according to consolidation therapy (yes/no) as well as stage at diagnosis (II, III, or IV)Endpoints:Patients experiencing a recurrence of disease or a second primary cancer event will have reached the targeted study endpoint.Follow up:follow-up will be at 3 month intervals for the first 2 years, 6 month intervals for the next 3 years, and annually thereafter.Analysis:The overall effectiveness of the intervention will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no). Progression-free survival time for those who are still alive and have not been observed to fail by study end will be treated as censored observations.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria:
  • Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma
  • Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy (chemo) or biological therapy
  • Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution's upper limit of normal) and CT scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast)
  • Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2
  • Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen
  • Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.)
  • Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months)
  • Patients must complete all pre-entry assessments
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC Exclusion Criteria:
  • Patients with GOG performance grade of 3 or 4
  • Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometroid adenocarcinoma of the uterus
  • Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction)
  • Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
  • Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
  • Patients with a life expectancy of less than one year
  • Patients with body mass index (BMI) < 20 kg/m^2
  • Vegan vegetarians
  • Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue
  • Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
  • Patients who have had surgery for weight loss

Sites

  • California

    • University of Southern California/Norris Cancer Center, Los Angeles, California, 90033
    • Los Angeles County-USC Medical Center, Los Angeles, California, 90033
    • Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027
    • Cedars-Sinai Medical Center, Los Angeles, California, 90048
    • University of California at Los Angeles (UCLA ), Los Angeles, California, 90095
    • Saint Joseph Hospital - Orange, Orange, California, 92868
    • UC San Diego Moores Cancer Center, La Jolla, California, 92093
    • University of California at Davis Cancer Center, Sacramento, California, 95817
  • Arizona

    • Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
    • Gynecologic Oncology Group of Arizona, Phoenix, Arizona, 85012
    • Arizona Cancer Center at University Medical Center North, Tucson, Arizona, 85719
  • Nevada

    • Center of Hope at Renown Medical Center, Reno, Nevada, 89502
    • Renown Regional Medical Center, Reno, Nevada, 89502
  • Utah

    • Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112
  • New Mexico

    • Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106
    • University of New Mexico, Albuquerque, New Mexico, 87106
  • Colorado

    • University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, 80045
    • Poudre Valley Hospital, Fort Collins, Colorado, 80524
  • Washington

    • Virginia Mason Medical Center, Seattle, Washington, 98101
    • Virginia Mason CCOP, Seattle, Washington, 98101
  • Texas

    • Brooke Army Medical Center, Fort Sam Houston, Texas, 78234
    • Baylor All Saints Medical Center at Fort Worth, Fort Worth, Texas, 76104
    • Memorial Hermann Texas Medical Center, Houston, Texas, 77030
  • North Dakota

    • Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501
    • Sanford Clinic North-Fargo, Fargo, North Dakota, 58122
    • Sanford Medical Center-Fargo, Fargo, North Dakota, 58122
    • Roger Maris Cancer Center, Fargo, North Dakota, 58122
  • South Dakota

    • Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, 57104
  • Kansas

    • University of Kansas Medical Center, Kansas City, Kansas, 66160
  • Arkansas

    • University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
  • Minnesota

    • Park Nicollet Frauenshuh Cancer Center, Saint Louis Park, Minnesota, 55426
    • Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416
    • Sanford Clinic North-Bemidgi, Bemidji, Minnesota, 56601
  • Missouri

    • Washington University School of Medicine, Saint Louis, Missouri, 63110
  • Louisiana

    • Hematology/Oncology Clinic LLP, Baton Rouge, Louisiana, 70809
    • Woman's Hospital, Baton Rouge, Louisiana, 70817
  • Mississippi

    • Saint Dominic-Jackson Memorial Hospital, Jackson, Mississippi, 39216
  • Wisconsin

    • Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin, 54848
    • University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792
    • Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904
    • Aurora West Allis Medical Center, West Allis, Wisconsin, 53227
    • Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, 53215
    • Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, 54303
    • Saint Mary's Hospital, Green Bay, Wisconsin, 54303
    • Saint Vincent Hospital, Green Bay, Wisconsin, 54301
    • Holy Family Memorial Hospital, Manitowoc, Wisconsin, 54221
    • Bay Area Medical Center, Marinette, Wisconsin, 54143
  • Illinois

    • Carle Cancer Center, Urbana, Illinois, 61801
    • UC Comprehensive Cancer Center at Silver Cross, New Lennox, Illinois, 60451
    • Rush University Medical Center, Chicago, Illinois, 60612
    • University of Chicago, Chicago, Illinois, 60637
    • Northwestern University, Chicago, Illinois, 60611
  • Indiana

    • Michiana Hematology Oncology-PC Westville, Westville, Indiana, 46391
    • IU Health La Porte Hospital, La Porte, Indiana, 46350
    • Michiana Hematology Oncology PC-Plymouth, Plymouth, Indiana, 46563
    • Northern Indiana Cancer Research Consortium, South Bend, Indiana, 46628
    • Community Howard Regional Health, Kokomo, Indiana, 46904
    • Memorial Hospital of South Bend, South Bend, Indiana, 46601
    • Michiana Hematology Oncology PC-South Bend, South Bend, Indiana, 46601
    • South Bend Clinic, South Bend, Indiana, 46617
    • Michiana Hematology Oncology PC-Elkhart, Elkhart, Indiana, 46514
    • Elkhart General Hospital, Elkhart, Indiana, 46515
  • Alabama

    • University of Alabama at Birmingham, Birmingham, Alabama, 35294
    • Tennessee Valley Gynecologic Oncology, Huntsville, Alabama, 35805
  • Michigan

    • Lakeland Hospital, St. Joseph, Michigan, 49085
    • Marie Yeager Cancer Center, Saint Joseph, Michigan, 49085
    • Lakeland Community Hospital, Niles, Michigan, 49120
    • Gynecologic Oncology of West Michigan PLLC, Grand Rapids, Michigan, 49546
    • Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, 49307
  • Kentucky

    • Norton Health Care Pavilion - Downtown, Louisville, Kentucky, 40202
    • Saint Elizabeth Medical Center South, Edgewood, Kentucky, 41017
  • Tennessee

    • Chattanooga's Program in Women's Oncology, Chattanooga, Tennessee, 37403
  • Ohio

    • Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, 45220
  • Georgia

    • Piedmont Hospital, Atlanta, Georgia, 30309
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