|Phase III||Behavioral study, Biomarker/Laboratory analysis||Active||Not specified||NCI, Other||GOG-0225|
CDR0000594600, NCI-2009-00595, NCT00719303
RATIONALE: A healthy lifestyle and counseling (coaching) after treatment may improve progression-free survival in patients with previously treated cancer.
PURPOSE: This randomized phase III trial is studying diet and physical activity changes to see how well they work compared with usual care in improving progression-free survival of patients with previously treated stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Further Study Information
- 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.
- 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 individuals.
- 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 RAND-36.
- 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.
- 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 counseling
- 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)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|David Samuel Alberts||Study Chair|
|Philip J. DiSaia||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00719303
ClinicalTrials.gov processed this data on October 17, 2013
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