Phase 2 Ovarian Cancer Trial, Recruiting NCT07050771 Sponsor: The Methodist Hospital Research Institute Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT07050771
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older at the time of signing the consent form.
  • People who have signed an informed consent form agreeing to take part.
  • People whose physical functioning is rated at a certain level (ECOG performance status 0–2), as assessed by their treating surgical oncologist, and in some cases also their medical or radiation oncologist (confirm with trial site).
  • People who are classified as "pre-frail" or "frail" based on a specific frailty assessment tool called the Fried Frailty Phenotype.
  • People with a probable or confirmed diagnosis of pancreatic cancer, bile duct cancer (cholangiocarcinoma), duodenal cancer, ampullary cancer, ovarian cancer, kidney cancer, or bladder cancer, confirmed through central review at Houston Methodist Hospital.
  • People whose cancer has not spread to other parts of the body (stage I–III) or whose cancer has spread (stage IV).
  • People whose cancer is considered surgically removable, with no major involvement of nearby blood vessels, nerves, or bone, and where the surgical team believes a complete removal may be safely achieved.
  • People who are tentatively scheduled for a specific major cancer surgery (such as removal of part of the pancreas, ovarian tumour reduction, kidney removal, or bladder removal) by one of the study surgeons, with the surgery planned more than 28 days after joining the trial.
  • People in the neoadjuvant therapy group: those who have completed their planned pre-surgery treatment (chemotherapy or radiation) at least 2 weeks before study registration.
  • People in the no-neoadjuvant therapy group: those who are medically suitable for and planned to receive pre-surgery treatment, as determined by their oncologist.
  • People who are able and willing to follow the study's exercise and nutrition programme and complete all required assessments, in the lead investigator's judgement.
  • People willing and able to consume a protein supplement (whey, marine-based, or pea protein, depending on any allergies or medical history).
  • People willing to provide blood and tissue samples as required by the study.
  • People on blood-thinning medication who are on a stable, unchanged treatment regimen.
  • People who have access to a smartphone — either their own or through a caregiver who lives with them.
  • People who understand, speak, and read English.

Who may not be able to join:

  • People who have significant difficulty hearing or understanding spoken words and sounds.
  • People who are unable to eat food by mouth (for example, those who rely on tube feeding or intravenous nutrition).
  • People who require supplemental oxygen, whether at rest or during activity.
  • People who have had a significant heart or cardiovascular event — such as a heart attack, stroke, unstable chest pain, or serious heart rhythm problems — within the 3 months before starting the trial programme.
  • People who rely on a mobility aid other than a single cane to walk (for example, a walker, crutches, or wheelchair).
  • People with active cancer that has spread to the brain or the lining around the brain and spinal cord.
  • People with active cancer spread to the bones, or a recent bone fracture.
  • People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month (note: people with a permanently placed drainage catheter may still be eligible — confirm with trial site).
  • People who are planned to receive another experimental treatment or therapy (outside of this trial's programme) during the study period.
  • People who have had a major surgery or procedure within 12 weeks before starting the trial programme, if this would prevent them from completing the study activities, in the lead investigator's judgement.
  • People with an active physical or mental health condition, or a personal or social situation, that would prevent them from completing the study programme and assessments, in the lead investigator's judgement.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Nestor Esnaola, M.D., Houston Methodist Neal Cancer Center

Phone: 713-441-6232

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
The Methodist Hospital Research Institute
Registry
ClinicalTrials.gov
Start date
14 August 2025
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of morbidity-free survival; Rates of adverse events and serious adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov