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

Tracking Information
First Submitted Date ICMJE	July 18, 2008
First Posted Date ICMJE	July 21, 2008
Last Update Posted Date	February 16, 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; (submitted: February 26, 2014)	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).
Original Primary Outcome Measures ICMJE; (submitted: July 18, 2008)	Progression-free survival
Change History	Complete list of historical versions of study NCT00719303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 13, 2015)	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 Measures ICMJE; (submitted: July 18, 2008)	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
Current Other Outcome Measures ICMJE; (submitted: February 9, 2016)	Change in sleep quality measured using Pittsburgh Sleep Quality Index [ Time Frame: Baseline to 24 months ]; Change in telomere length [ Time Frame: Baseline to 24 months ]; Changes in visceral adiposity using CT scan [ Time Frame: Baseline to up to 14 months ]Changes in visceral adiposity will be associated with changes in biomarkers of metabolic deregulation and inflammation in a random subsample. The association between (continuous) change in visceral adipose and progression free survival will be quantified using Cox proportional hazards regression.; Mental health measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ]Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.; Pain measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ]Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.; Role limitations due to physical health and emotional problems measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ]Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.; Social functioning measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ]Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.; Total carotenoid level [ Time Frame: Up to 24 months ]Will be used to estimate compliance to the dietary portion of the healthy lifestyle intervention.; Treatment compliance [ Time Frame: Up to 9 years ]; Vitality measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ]Will be examined in exploratory manner and summarized with descriptive statistics such as the mean score accompanied with standardized deviation for each group at each assessment time points. No hypotheses testing will be conducted.
Original Other Outcome Measures ICMJE	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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	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
Intervention ICMJE	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 Name: Counseling Intervention; Other: Educational Intervention Receive educational materials Other Names: Education for Intervention Intervention by Education Intervention through Education Intervention, Educational; Behavioral: Exercise Intervention Undergo physical activity intervention; Other: Laboratory Biomarker Analysis Correlative studies; Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment; Other: Questionnaire Administration Ancillary studies
Study Arms	Experimental: Group I (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. Interventions: Behavioral: Behavioral Dietary Intervention Behavioral: Compliance Monitoring Other: Counseling Other: Educational Intervention Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration; Active Comparator: Group II (observation) 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). Interventions: Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration
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.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: June 25, 2012)	1070
Original Enrollment ICMJE; (submitted: July 18, 2008)	1428
Study Completion Date	Not Provided
Estimated Primary Completion Date	December 31, 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis; Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner?s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary M?llerian epithelial adenocarcinoma; Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, 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 (chemo) or biological therapy; Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution?s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast); Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2; Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen; Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases include recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.); Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa); Patients must complete all pre-entry assessments; Patients must have signed an approved informed consent and authorization permitting release of personal health information; Patients must be willing to provide name and appropriate telephone contact information and be willing to be contacted periodically via telephone by The University of Arizona Cancer Center (AZCC) staff for completion of individualized lifestyle intervention coaching, completion of the Pittsburgh Sleep Quality Index, and for clarification of patient-completed responses if necessary; patient must be willing to have Arizona Food Frequency Questionnaire (AFFQ), Arizona Physical Activity Questionnaire (APAQ), baseline questionnaire, and personal contact information sent to AZCC Exclusion Criteria: Patients with GOG performance grade of 3 or 4; Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus; Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction); Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma; Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago; Patients with a life expectancy of less than one year; Patients with body mass index (BMI) < 20 kg/m^2; Vegan vegetarians; Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue; Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months; Patients who have had surgery for weight loss Note: women will not be excluded if their baseline lifestyle assessment indicates a healthy eating and moderate physical activity with the exception of the exclusion criteria above
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE
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 )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gynecologic Oncology Group
Study Sponsor ICMJE	Gynecologic Oncology Group
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: David Alberts NRG Oncology
PRS Account	Gynecologic Oncology Group
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP