Last reviewed · How we verify
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
Phase 3 trial testing Behavioral Dietary Intervention in Fallopian Tube Clear Cell Adenocarcinoma in 1,070 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Gynecologic Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,070 |
| Start date | 18 June 2012 |
| Primary completion | 31 December 2020 |
| Sites | 687 locations across United States |
Drugs / interventions tested
- Behavioral Dietary Intervention
- Compliance Monitoring
- Counseling
- Educational Intervention
- Exercise Intervention
- Laboratory Biomarker Analysis — full drug profile →
- Quality-of-Life Assessment
- Questionnaire Administration
Conditions studied
- Fallopian Tube Clear Cell Adenocarcinoma — all drugs for Fallopian Tube Clear Cell Adenocarcinoma →
- Fallopian Tube Endometrioid Adenocarcinoma — all drugs for Fallopian Tube Endometrioid Adenocarcinoma →
- Fallopian Tube Mucinous Adenocarcinoma — all drugs for Fallopian Tube Mucinous Adenocarcinoma →
- Fallopian Tube Serous Adenocarcinoma — all drugs for Fallopian Tube Serous Adenocarcinoma →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT00719303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Behavioral Dietary Intervention
Trials testing the same drug.
- NCT06733363 — A Cruciferous Vegetable Eating Program for the Reduction of Cancer Recurrence and Progression in Patients With Non-muscl · Phase 2 · recruiting
- NCT06643455 — Mindfulness Intervention for Improving Nutrition in the Digital Kitchen Among Stage I-III Breast Cancer Survivors, MIND · NA · active not recruiting
- NCT06315296 — An Interactive Time-Restricted Diet Intervention (txt4fasting) for Reducing Neurocognitive Decline and Improving Surviva · NA · terminated
- NCT06030427 — Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors · NA · completed
- NCT04548193 — Behavioral Dietary Intervention for the Improvement of Bladder Cancer Survivorship · Phase 1 · completed
Other recruiting trials for Fallopian Tube Clear Cell Adenocarcinoma
Currently open trials in the same condition.
- NCT06639074 — Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fa · Phase 2 · recruiting
- NCT04919629 — APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurr · Phase 2 · recruiting
- NCT04575935 — Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal · Phase 3 · recruiting
- NCT04092270 — A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansi · Phase 1 · active not recruiting
- NCT02502266 — Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Pl · Phase 2, PHASE3 · active not recruiting
Other Gynecologic Oncology Group trials
Trials by the same sponsor.
- NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer · Phase 2 · active not recruiting
- NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer · Phase 2 · active not recruiting
- NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent · Phase 2, PHASE3 · unknown
- NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer · Phase 2 · completed
- NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00719303 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
- Last refreshed: 19 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00719303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing