Nutrition Impact on Immunotherapy of Cancer

Qingdao Central Hospital

Status and phase: Enrolling; Phase 3

Conditions: Survival, Prosthesis; Nutrition Disorders; Immunotherapy; Cancer

Treatments: Drug: Starch powder 50 mg; Drug: Megestrol Acetate and olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT06500234

KY202400918

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

megestrol acetate-olanzapine

Experimental group

Description:

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

Treatment:

Drug: Megestrol Acetate and olanzapine

control

Placebo Comparator group

Description:

Starch powder 50 mg, oral, everyday,

Treatment:

Drug: Starch powder 50 mg