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
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ClinicalTrials.gov Identifier: NCT00719303 |
Recruitment Status : Unknown
Verified February 2018 by GOG Foundation ( Gynecologic Oncology Group ).
Recruitment status was: Recruiting
First Posted : July 21, 2008
Last Update Posted : February 19, 2018
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Tracking Information | ||||
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First Submitted Date ICMJE | July 18, 2008 | |||
First Posted Date ICMJE | July 21, 2008 | |||
Last Update Posted Date | February 19, 2018 | |||
Actual Study Start Date ICMJE | June 18, 2012 | |||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: From entry onto the protocol to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause, up to 9 years ] Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).
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Original Primary Outcome Measures ICMJE |
Progression-free survival | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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 | |||
Official Title ICMJE | Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? | |||
Brief 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. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine if women who are disease-free after successfully completing primary and potential consolidation/maintenance, therapy for stage II-IV ovarian, fallopian tube or primary peritoneal cancer and who are randomized to a healthy lifestyle intervention, will have significantly increased progression-free survival compared to similar women who are randomized to a usual care comparison group. SECONDARY OBJECTIVES: I. To determine if women who are randomized to the study intervention will have improved general quality of life as measured by the General Health subscale of Research and Development (RAND) 36-Item Health Survey (RAND-36). II. To determine if women who are randomized to the study intervention will have improved physical and bowel functioning as measured by the Physical Functioning subscale of RAND-36 and the Gastrointestinal Symptom Rating Scale (GSRS)-Irritable Bowel Syndrome (IBS), compared to women who are randomized to usual care. TERTIARY OBJECTIVES: I. To assess patient compliance with the healthy lifestyle intervention by analyzing biomarkers (e.g., total carotenoid) at baseline, 6, 12, and 24 months. II. To explore the relationship between carotenoid exposure and progression free survival from ovarian cancer. III. 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. IV. 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. V. To explore the impact of the intervention on bowel functioning as measured with the GSRS-IBS subscales. VI. To assess the association between subjectively measured sleep duration/quality (using the Pittsburgh Sleep Quality Scale), anthropometric measurements, and self-reported dietary energy intake among women previously treated for stage II-IV ovarian or primary peritoneal cancer. VII. To assess and compare telomere length and rate of telomere shortening between ovarian cancer survivors randomized to lifestyle intervention versus standard of care. VIII. To assess effects of the intervention on biomarkers of metabolic health as measured by changes in circulating insulin and related insulin resistance, lipids and inflammation. IX. To determine if the intervention effect on the biomarkers listed above is modified by baseline central adiposity. X. To determine if the intervention effect on biomarkers listed above is mediated by change in central adiposity. XI. To evaluate changes in central adiposity using computerized tomography (CT) scan data from regularly scheduled, routine surveillance CT scans to determine if change in CT-specific visceral adiposity is associated with changes in biomarkers of metabolic deregulation and inflammation in a random subsample. OUTLINE: 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 counseling, receive educational materials and counseling focused on how to read food labels to estimate grams of fat per serving and serving size, and undergo telephone counseling by a lifestyle intervention counselor twice a week for 4 weeks, then weekly for 2 weeks, twice a month for 5 months, monthly for the subsequent 6 months, and then once every other month for 12 months. Participants complete daily fat gram and step diaries at least three times per week. GROUP 2 (COMPARISON LIFESTYLE): Participants receive a study notebook containing general study-related information. Participants are not asked to record diet or physical activity but are provided a single sample diary in their study notebook. Participants receive telephone contact on a sliding scale similar to the intervention group, but at less frequent intervals (22 versus 33 calls over the course of the intervention). After completion of study, participants are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Thomson CA, Crane TE, Miller A, Garcia DO, Basen-Engquist K, Alberts DS. A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Contemp Clin Trials. 2016 Jul;49:181-9. doi: 10.1016/j.cct.2016.07.005. Epub 2016 Jul 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
1070 | |||
Original Enrollment ICMJE |
1428 | |||
Study Completion Date ICMJE | Not Provided | |||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00719303 | |||
Other Study ID Numbers ICMJE | GOG-0225 NCI-2009-00595 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000594600 GOG-0225 ( Other Identifier: NRG Oncology ) GOG-0225 ( Other Identifier: DCP ) GOG-0225 ( Other Identifier: CTEP ) U10CA101165 ( U.S. NIH Grant/Contract ) U10CA180830 ( U.S. NIH Grant/Contract ) UG1CA189867 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | GOG Foundation ( Gynecologic Oncology Group ) | |||
Study Sponsor ICMJE | Gynecologic Oncology Group | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | GOG Foundation | |||
Verification Date | February 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |