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NCT00719303

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

Status unknown Phase 3 Last updated 19 February 2018
What this trial tests

Phase 3 trial testing Behavioral Dietary Intervention in Fallopian Tube Clear Cell Adenocarcinoma in 1,070 participants. Status unknown.

Timeline
18 June 2012
Primary endpoint
31 December 2020

Quick facts

Lead sponsorGynecologic Oncology Group
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,070
Start date18 June 2012
Primary completion31 December 2020
Sites687 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Gynecologic Oncology Group — full company profile →

Who can join

18 and older, female only, with Fallopian Tube Clear Cell Adenocarcinoma or Fallopian Tube Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management.
    Pati S, Irfan W, Jameel A, Ahmed S, et al · · 2023 · cited 393× · PMID 36672434 · DOI 10.3390/cancers15020485
  2. Physical Activity Reduces the Risk of Recurrence and Mortality in Cancer Patients.
    Brown JC, Gilmore LA. · · 2020 · cited 48× · PMID 31913187 · DOI 10.1249/jes.0000000000000214
  3. 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.
    Thomson CA, Crane TE, Miller A, Garcia DO, et al · · 2016 · cited 42× · PMID 27394382 · DOI 10.1016/j.cct.2016.07.005
  4. Targeting obesity-related dysfunction in hormonally driven cancers.
    Rubinstein MM, Brown KA, Iyengar NM. · · 2021 · cited 39× · PMID 33911195 · DOI 10.1038/s41416-021-01393-y
  5. Lifestyle intervention in ovarian cancer enhanced survival (LIVES) study (NRG/GOG0225): Recruitment, retention and baseline characteristics of a randomized trial of diet and physical activity in ovarian cancer survivors.
    Thomson CA, Crane TE, Miller A, Gold MA, et al · · 2023 · cited 17× · PMID 36608382 · DOI 10.1016/j.ygyno.2022.12.017
  6. Adipocyte Microenvironment in Ovarian Cancer: A Critical Contributor?
    Duarte Mendes A, Freitas AR, Vicente R, Vitorino M, et al · · 2023 · cited 11× · PMID 38068912 · DOI 10.3390/ijms242316589
  7. Translating energy balance research from the bench to the clinic to the community: Parallel animal-human studies in cancer.
    Garcia MB, Schadler KL, Chandra J, Clinton SK, et al · · 2023 · cited 11× · PMID 36825928 · DOI 10.3322/caac.21773
  8. Development and Evaluation of an Accelerometer-Based Protocol for Measuring Physical Activity Levels in Cancer Survivors: Development and Usability Study.
    Crane TE, Skiba MB, Miller A, Garcia DO, et al · · 2020 · cited 10× · PMID 32969828 · DOI 10.2196/18491

Verify or expand the search:

Other trials of Behavioral Dietary Intervention

Trials testing the same drug.

Other recruiting trials for Fallopian Tube Clear Cell Adenocarcinoma

Currently open trials in the same condition.

Other Gynecologic Oncology Group trials

Trials by the same sponsor.

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