Nutrition Impact on Immunotherapy of Cancer

Phase 3

Recruiting

• Conditions: Nutrition Disorders; Cancer; Survival, Prosthesis; Immunotherapy
• Interventions: Drug: Megestrol Acetate and olanzapine; Drug: Starch powder 50 mg

• Registration Number: NCT06500234
• Lead Sponsor: Qingdao Central Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
megestrol acetate-olanzapine	Megestrol Acetate and olanzapine	Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday
control	Starch powder 50 mg	Starch powder 50 mg, oral, everyday,

Primary Outcome Measures

Name	Time	Method
ORR	12 months	overall response rate

Secondary Outcome Measures

Name	Time	Method
PFS	12 months	profression-free survival

Trial Locations

Locations (1)

Qingdao Central Hospital; 🇨🇳 Qingdao, Shandong, China