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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

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ClinicalTrials.gov Identifier: NCT00719303
Recruitment Status : Recruiting
First Posted : July 21, 2008
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 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 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1070 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival?
Actual Study Start Date : June 18, 2012
Estimated Primary Completion Date : December 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
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).
 Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Change in sleep quality measured using Pittsburgh Sleep Quality Index [ Time Frame: Baseline to 24 months ]
  2. Change in telomere length [ Time Frame: Baseline to 24 months ]
  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Total carotenoid level [ Time Frame: Up to 24 months ]
    Will be used to estimate compliance to the dietary portion of the healthy lifestyle intervention.

  9. Treatment compliance [ Time Frame: Up to 9 years ]
  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719303


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David Alberts NRG Oncology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00719303    
Other Study ID Numbers: 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 )
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carcinoma, Transitional Cell
Cystadenocarcinoma, Serous
Carcinoma, Endometrioid
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Adenocarcinoma, Clear Cell
Brenner Tumor
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms, Cystic, Mucinous, and Serous