Nutrition Impact on Immunotherapy of Cancer

NCT06500234 | Recruiting Phase 3

• 1 other identifier: KY202400918
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nutrition Disorders; Immunotherapy; Cancer; Survival, Prosthesis

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  12 months

Secondary Outcomes (1)

• PFS

  12 months

Study Arms (2)

megestrol acetate-olanzapine

EXPERIMENTAL

Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday

Drug: Megestrol Acetate and olanzapine

control

PLACEBO COMPARATOR

Starch powder 50 mg, oral, everyday,

Drug: Starch powder 50 mg

Interventions

Megestrol Acetate and olanzapine DRUG

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

megestrol acetate-olanzapine

Starch powder 50 mg DRUG

Starch powder 50 mg, oral, everyday

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Nutrition Disorders; Neoplasms; Prosthesis Failure

Interventions

Megestrol Acetate; Olanzapine

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• chunling zhang, MD

  Qingdao Central Hospital

  STUDY CHAIR

Central Study Contacts

Keke Nie, MD

CONTACT

53268665078; niekeke@uor.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 15, 2024
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

CN (1)