GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube And Primary Peritoneal Cancer Progression-Free Survival?

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GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube And Primary Peritoneal Cancer Progression-Free Survival?

Primary Objective
1.11 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.
1.2 Secondary Objectives
1.21 To determine if women who are randomized to the study intervention will have:
1.211 Improved general quality of life as measured by the General Health
subscale of RAND-36.
1.212 Improved physical and bowel functioning as measured by the Physical
Functioning subscale of RAND-36 and the GSRS-IBS, compared to
women who are randomized to usual care.
1.3 Exploratory Objectives:
1.31 To perform a pilot assessment at baseline, 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.
1.32 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.
1.33 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.
1.34 To explore the impact of the intervention on bowel functioning as measured
with the GSRS-IBS subscales.

Protocol Number101302
Principal InvestigatorDarlene Gibbon
PhasePhase III
ScopeNational
Applicable Disease SitesOvary
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.