Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This randomized phase III trial studies 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.

Eligibility 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, endometrioid 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 or biological therapy

- Patients must have achieved a documented complete response to treatment based on
normal cancer antigen (CA)-125 and computed tomography (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 endometrioid
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

Principal Investigator

Julia Chapman

Study Contact

ctnursenav@kumc.edu, 913-945-7553

Estimated Completion Date

Tuesday, December 1, 2020

ClinicalTrials.gov #

NCT00719303
05/17/2015