Study comparing diet and physical activity or usual care in improving length of survival without return of cancer

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"Will healthy diet and physical activity help ovarian, fallopian and peritoneal cancer from returning?"
Age:
18 to 100 years old
Gender:
Female
Healthy Volunteers:
No
Keywords:
ovarian cancer, fallopian tube cancer, peritoneal cancer, healthy diet, exercise, physical activity, cancer
Type:
Behavioral study, Phase 3
Investigator:
Description
This study looks at whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.
This study requires
Blood tests
MRI/CT
Physical exams (height, weigh, waist circumference)
Questionnaires
Phone interviews
Lifestyle intervention
Who can participate?
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
Resources
Schedule
Study duration and period
Active study participation: 2 years Follow up calls: Two years, every three months Three to five years, every six months Life, once a year
Recruitment period
From Nov. 5, 2012
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Malignant Ovarian Brenner Tumor
  • Malignant Ovarian Mixed Epithelial Tumor
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Stage IIA Fallopian Tube Cancer
  • Stage IIA Ovarian Cancer
  • Stage IIB Fallopian Tube Cancer
  • Stage IIB Ovarian Cancer
  • Stage IIC Fallopian Tube Cancer
  • Stage IIC Ovarian Cancer
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Primary Peritoneal Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer
  • Undifferentiated Fallopian Tube Carcinoma
  • Undifferentiated Ovarian Carcinoma

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