Impact of Nutrition on Cancer Immunotherapy
Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients
PHASE3 · Qingdao Central Hospital · NCT06500234
This study tests if improving nutrition can help cancer patients who are malnourished do better with immunotherapy treatments.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qingdao Central Hospital (other) |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT06500234 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a cancer diagnosis and malnutrition, who can comply with the study protocol.
Not a fit: Patients who cannot swallow oral medications or have significant gastrointestinal impairments may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Qingdao, Shandong
- Qingdao Central Hospital — Qingdao, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Keke Nie, MD
- Email: niekeke@uor.edu.cn
- Phone: 53268665078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nutrition Disorders, Immunotherapy, Cancer, Survival, Prosthesis