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Recruiting

NCT Number: NCT06500234

Nutrition Impact on Immunotherapy of Cancer

This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

Location status: Recruiting

Location contact

KEKE NIE, MD

CONTACT

[email protected]

68665078

Keke Nie, MD

PRINCIPAL_INVESTIGATOR

About this study

Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cancer, malnutrition Age >18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.

For all oral medications patients must be able to comfortably swallow capsules;

Exclusion criteria

  • Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.

Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.

Treatment and study plan

Megestrol Acetate and olanzapine

Drug

megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday

Starch powder 50 mg

Drug

Starch powder 50 mg, oral, everyday

Primary outcomes

  1. ORR

    Time frame: 12 months

    overall response rate

Secondary outcomes

  1. PFS

    Time frame: 12 months

    profression-free survival

Study contacts

Contact information is provided by the study sponsor or research team.

Keke Nie, MD

CONTACT

[email protected]

53268665078

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Official study title

Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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