Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 80

Impact of Nutrition on Cancer Immunotherapy

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

Run by Qingdao Central Hospital · NCT06500234 · Data updated 2026-11-12

This study tests if improving nutrition can help cancer patients who are malnourished do better with immunotherapy treatments.

More Immunotherapy trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment300 (estimated)
SponsorQingdao Central Hospital
Academic / other
Locations1 site (Qingdao, Shandong)
StatusRecruiting
StartedJune 1, 2024
Main results expectedMay 31, 2025
Study endsMay 31, 2027
Registry record updatedJuly 15, 2024
Trial IDNCT06500234 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 years old with a cancer diagnosis and malnutrition, who can comply with the study protocol.

Probably not a fit

Patients who cannot swallow oral medications or have significant gastrointestinal impairments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how nutritional status affects the outcomes of immunotherapy in cancer patients. It focuses on patients who are malnourished at the time of their cancer diagnosis, as this condition can lead to increased complications and lower survival rates. The study will administer treatments including Megestrol Acetate and olanzapine, along with starch powder, to evaluate their effects on patient outcomes. Participants will be monitored for their performance status and measurable lesions as defined by standard imaging criteria.

Why it matters

Potential benefit: If successful, this study could improve survival rates and treatment outcomes for cancer patients who are malnourished.

How similar studies have gone: While there is evidence suggesting the importance of nutrition in cancer care, this specific approach is relatively novel and has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Qingdao Central Hospital
    Qingdao, Shandong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.