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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00719303
First received: July 18, 2008
Last updated: July 13, 2015
Last verified: July 2015

July 18, 2008
July 13, 2015
June 2012
December 2020   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Will be assessed by a log-rank test stratified by stage of disease (II and III vs. IV) and consolidation therapy (yes or no).
Progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00719303 on ClinicalTrials.gov Archive Site
  • Change in irritable bowel syndrome-specific symptoms measured using GSRS-IBS [ Time Frame: Baseline to up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Quality of life and physical function [ Designated as safety issue: No ]
  • Blood markers in predicting progression or death [ Designated as safety issue: No ]
  • Blood markers in predicting recurrence or survival [ Designated as safety issue: No ]
  • Plasma carotenoid levels [ Designated as safety issue: No ]
  • Patient compliance [ Designated as safety issue: No ]
  • Impact on other aspects of quality of life [ Designated as safety issue: No ]
  • Impact on bowel function [ Designated as safety issue: No ]
  • Change in sleep quality measured using Pittsburgh Sleep Quality Index [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in telomere length [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  • Mental health measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Will be used to estimate compliance to the dietary portion of the healthy lifestyle intervention.
  • Treatment compliance [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
  • Vitality measured using RAND-36 and GSRS-IBS [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    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.
Not Provided
 
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
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?

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.

PRIMARY OBJECTIVE:

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 OBJECTIVE:

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 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • 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
  • Malignant Ovarian Mixed Epithelial Tumor
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Stage IIA Fallopian Tube Cancer
  • Stage IIA Ovarian Cancer
  • Stage IIB Fallopian Tube Cancer
  • Stage IIB Ovarian Cancer
  • Stage IIC Fallopian Tube Cancer
  • Stage IIC Ovarian Cancer
  • Stage III Fallopian Tube Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Primary Peritoneal Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Primary Peritoneal Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IIIC Primary Peritoneal Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Primary Peritoneal Cancer
  • Undifferentiated Fallopian Tube Carcinoma
  • Undifferentiated Ovarian Carcinoma
  • 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 Names:
    • counseling
    • Counseling Intervention
  • Other: Educational Intervention
    Receive educational materials
    Other Names:
    • Education for Intervention
    • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1070
Not Provided
December 2020   (final data collection date for primary outcome measure)

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 Müllerian 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 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)
  • 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
Female
18 Years and older
No
United States
 
NCT00719303
GOG-0225, NCI-2009-00595, CDR0000594600, GOG-0225, GOG-0225, GOG-0225, U10CA101165, UG1CA189867
No
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Alberts NRG Oncology
Gynecologic Oncology Group
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP