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
NCT00719303 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1070
Last updated 2018-02-19
Summary
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.
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
- Ovarian Clear Cell Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Ovarian Seromucinous Carcinoma
- Ovarian Serous Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Stage IIA Fallopian Tube Cancer AJCC v6 and v7
- Stage IIA Ovarian Cancer AJCC V6 and v7
- Stage IIB Fallopian Tube Cancer AJCC v6 and v7
- Stage IIB Ovarian Cancer AJCC v6 and v7
- Stage IIC Fallopian Tube Cancer AJCC v6 and v7
- Stage IIC Ovarian Cancer AJCC v6 and v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IV Primary Peritoneal Cancer AJCC v7
- Undifferentiated Fallopian Tube Carcinoma
- Undifferentiated Ovarian Carcinoma
Interventions
- BEHAVIORAL
-
Behavioral Dietary Intervention
Receive dietary intervention
- BEHAVIORAL
-
Compliance Monitoring
Complete daily fat gram and step diaries
- OTHER
-
Counseling
Undergo face-to-face and telephone counseling
- OTHER
-
Educational Intervention
Receive educational materials
- BEHAVIORAL
-
Exercise Intervention
Undergo physical activity intervention
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Gynecologic Oncology Group
lead NETWORK
Principal Investigators
-
David Alberts · NRG Oncology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-18
- Primary Completion
- 2020-12-31
Countries
- United States
Study Locations
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