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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Qingdao Central Hospital Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | May 31, 2025 |
| Study ends | May 31, 2027 |
| Registry record updated | July 15, 2024 |
| Trial ID | NCT06500234 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
- Study coordinator: Keke Nie, MD
- Email: niekeke@uor.edu.cn
- Phone: 53268665078
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.