Nutrition Impact on Immunotherapy of Cancer

July 12, 2024 updated by: Qingdao Central Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Recruiting
        • Qingdao Central Hospital
        • Contact:
        • Principal Investigator:
          • Keke Nie, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: megestrol acetate-olanzapine
Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday
Drug: Megestrol Acetate and olanzapine
megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday
Placebo Comparator: control
Starch powder 50 mg, oral, everyday,
Drug: Starch powder 50 mg
Starch powder 50 mg, oral, everyday

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 12 months
overall response rate
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 12 months
profression-free survival
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Investigators

  • Study Chair: chunling zhang, md, Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY202400918

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe