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Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?

Phase 3
Open (Enrolling)
Cognitive/Functional Effects, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer, Weight Changes

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Trial Information

Can Diet and Physical Activity Modulate Ovarian and Primary Peritoneal Cancer Progression-Free Survival?



- To determine if patients who are disease-free after successfully completing primary and
potential consolidation/maintenance therapy for stage II, III, or IV ovarian
epithelial, fallopian tube, or primary peritoneal cancer and who are randomized to a
healthy lifestyle intervention, will have significantly increased progression-free
survival when compared with similar patients who are randomized to usual care.


- To determine if patients who are randomized to the study intervention will have
improved general quality of life as measured by the General Health subscale of RAND-36
and physical functioning as measured by the Physical Functioning subscale of RAND-36
and the GSRS-IBS when compared with women who are randomized to usual care.

Tertiary (Exploratory)

- To perform a pilot assessment at baseline and at 6-, 12-, and 24-month dietary
biomarkers in a sub-sample of the study population to estimate compliance with the
healthy lifestyle intervention and to explore the relationship between carotenoid
exposure and progression-free survival from ovarian cancer.

- To examine patient compliance with the healthy lifestyle intervention and to assess
which types of patients are more likely to be compliant with the healthy lifestyle
intervention and whether progression-free survival is better among compliant

- To explore the impact of the intervention on other aspects of quality of life such as:
pain, role limitations due to physical health and emotional problems, mental health,
vitality, and social functioning as measured by the corresponding subscales of the

- To explore the impact of the intervention on bowel functioning as measured with the
GSRS-IBS subscales.

OUTLINE: This is a multicenter study. Participants are stratified according to stage of
disease at diagnosis (II vs III vs IV) and presence or absence of maintenance/consolidation
therapy following primary treatment. Participants are randomized to 1 of 2 groups.

- Group 1 (lifestyle intervention): Participants receive a dietary intervention designed
to promote increased levels of plasma carotenoids, control weight, and to ensure
adequacy of micronutrient intake. Participants also undergo a physical activity
intervention comprising a moderately low aerobic regimen to raise the usual activity
level. Participants also undergo face-to-face coaching, receive educational materials
and coaching focused on how to read food labels to estimate grams of fat per serving
and serving size, and undergo telephone coaching by a lifestyle-intervention coach once
a week for 4 weeks, then twice a month for 6 months, monthly for the subsequent 6
months, and then once every other month for 11 months. Participants complete a daily
Lifestyle Journal: fat gram and step diary at least three times per week.

- Group 2 (comparison lifestyle): Participants receive a blue study notebook containing
general study-related information. Participants receive telephone contact every six
months focusing on general health status.

All participants complete baseline questionnaires including demographic and lifestyle
information, medical history, and a comprehensive assessment of risk factors for ovarian
cancer. The Arizona Food Frequency Questionnaire and repeat 24-hour recalls are used to
measure dietary intake. Participants also complete physical activity assessments using the
Arizona Physical Activity Questionnaire and quality-of-life assessments using the RAND-36
and GSRS-IBS. Height, weight, body mass index, and waist circumference are measured
periodically during study. Participants undergo blood collection at baseline and at 6, 12,
and 24 months. Plasma samples are assessed for total carotenoid, alpha and beta-carotene,
lutein, lycopene, and beta-cryptoxanthin concentrations.

Inclusion Criteria


- Histologically confirmed ovarian epithelial cancer, fallopian tube cancer, or primary
peritoneal carcinoma, including any of the following subtypes*:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner's tumor

- Adenocarcinoma not otherwise specified

- NOTE: *However, the histologic features of the tumor must be compatible with a
primary Müllerian epithelial adenocarcinoma.

- Stage II, III, or IV disease

- No prior histological diagnosis of or treatment for clinical stage I epithelial
ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma

- Patients must have completed all primary chemotherapy and consolidation therapy (if
administered) at least 6 weeks, and no more than 4 months, 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 CA-125 and CT scan (i.e., there must be no clinical evidence of persistent or
recurrent disease based on CA-125 and CT scan)


- GOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 times upper limit normal (ULN)

- Bilirubin ≤ 1.5 times ULN

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Willing to provide names and appropriate telephone contact information and to be
contacted periodically via telephone by Arizona Diet, Behavior and Quality of Life
Shared Service staff for completion of individualized lifestyle intervention

- Life expectancy ≥ 1 year

- Body Mass Index ≥ 20 kg/m^2

- No history of other invasive malignancies within the past 5 years, except for
nonmelanoma skin cancer

- No patients enrolled in a weight-loss program or who are taking weight-loss
medications or dietary supplements and are unwilling to discontinue

- More than 24 months since prior marathon, triathlon, or other endurance-related
physical activity

- No other chronic disease that would preclude randomization into a lifestyle
intervention trial including, but not limited to, any of the following:

- Recent myocardial infarction or unstable angina (within the past 6 months)

- Chronic hepatitis

- Rheumatoid disease

- Renal or hepatic disease or dysfunction

- Diabetics receiving insulin

- Other clinical condition limiting ability to walk (e.g., recent leg fracture,
significant osteoarthritis, related orthopedic conditions, or degenerative
neurological conditions)

- No vegans

- No ongoing medically prescribed diet or physical activity regimen that has lasted for
6 months or longer

- Patients must not have a serious psychiatric illness (e.g., lifetime bipolar
disorder, schizophrenia or other psychosis, serious personality disorder, severe
major depressive disorder, recent suicide attempt, or psychiatric hospitalization
(previous 12 months)


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

David S. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona



Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • Weight Changes
  • weight changes
  • cognitive/functional effects
  • stage IV ovarian epithelial cancer
  • stage IV primary peritoneal cavity cancer
  • ovarian serous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • ovarian mixed epithelial carcinoma
  • Brenner tumor
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIA primary peritoneal cavity cancer
  • stage IIB primary peritoneal cavity cancer
  • stage IIC primary peritoneal cavity cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIA fallopian tube cancer
  • stage IIB fallopian tube cancer
  • stage IIC fallopian tube cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • Body Weight Changes
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial



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