Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.

Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).



Original Primary Outcome: Progression-free survival

Current Secondary Outcome:

  • Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS [ Time Frame: Baseline to up to 24 months ]
    Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively.
  • Change in self-reported quality of life measured using RAND-36 [ Time Frame: Baseline to up to 24 months ]
    Linear mixed effects models for repeated measures will be fitted to general health subscale score, physical functioning subscale score of RAND-36, and to GSRS-IBS overall score respectively.


Original Secondary Outcome:

  • Quality of life and physical function
  • Blood markers in predicting progression or death
  • Blood markers in predicting recurrence or survival
  • Plasma carotenoid levels
  • Patient compliance
  • Impact on other aspects of quality of life
  • Impact on bowel function


Information By: Gynecologic Oncology Group

Dates:
Date Received: July 18, 2008
Date Started: June 2012
Date Completion: December 2020
Last Updated: February 9, 2016
Last Verified: February 2016