Olanzapine Anorexia Cachexia

NCT05243251 | Completed Phase 3 DMC

• 1 other identifier: OlanCA
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

164 patients will be recruited..Adult patients diagnosed with incurable solid tumors and CCAA who presented to Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK) - Kasr Al-Ainy School of Medicine - Cairo University will be randomly distributed into 1:1..82 will receive Olanzapine 5 mg daily at night and 82 patients will receive placebo for 4 weeks. Primary outcome is Change in loss of appetite score from day 0 to day 7 of treatment and secondary outcomes change in body weight, change in loss of appetite score..and change in quality of life

Conditions

Anorexia

Outcome Measures

Primary Outcomes (1)

• appetite score

  Change in loss of appetite score from day 0 to day 7 of treatment with olanzapine 5 mg orally once daily at night: on the loss of appetite item of the ESAS-r. Where 0 is no loss of appetite and 10 worst appetite ever.

  1 week

Secondary Outcomes (9)

• appetite score

  weekly till week 4

• Change in quality-of-life

  day 28

• body weight

  day 28

• body mass index

  day 28

• handgrip strength

  day 28

Study Arms (2)

Olanzapine

ACTIVE COMPARATOR

82 patients will receive olanzapine 5 mg daily at night for 4 weeks

Drug: Olanzapine 5 MG

Placebo

PLACEBO COMPARATOR

82 patients will receive placebo for 4 weeks

Drug: Placebo

Interventions

Olanzapine 5 MG DRUG

, Olanzapine (OLZ) is an atypical antipsychotic agent that blocks multiple neurotransmitters: dopamine at D1, D2, D3 and D4 brain receptors, serotonin at 5-HT2a , 5-HT2c, 5-HT3, and 5-HT6receptors, catecholamines at alpha 1 adrenergic receptors, acetylcholine at muscarinic receptors, and histamine at H1 receptors is suggested to have a valuable role in CAC

Also known as: Zyprexa

Olanzapine

Placebo DRUG

Tablets containing 300 mg of microcrystalline cellulose. It will be identical to the active drug

Placebo

Eligibility Criteria

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

You may qualify if:

• o Age ≥ 18 years old at time of informed consent
• Confirmed diagnosis of incurable solid tumor (cancer patients with incurable disease receiving anti-cancer therapy with palliative intent or best supportive care).
• Loss of appetite score ≥ 4 on a 0 to 10 loss of appetite scale where 10 = worst possible lack of appetite as assessed by the Arabic version of Edmonton Symptom Assessment Scale (R/ESAS r) (ESAS-r, 2021).
• Cachexia defined as "loss \> 5% of body weight over the last 6 months" or "any degree of weight loss \> 2 % associated with a body mass index (BMI) \< 20" (Fearon et al, 2011).
• Ability to take pills orally and not dependent on tube feeding (no oral mucosal inflammation, active dysphagia or gastrointestinal tract obstruction).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Ability to understand and communicate in Arabic and willingness to sign a written informed consent.
• Patients were allowed to receive three-weekly regimens of anti-cancer treatment with palliative intent except those containing highly emetogenic chemotherapeutic (HEC) agents/regimens according to the American Society of Clinical Oncology (Hesketh et al, 2020).
• Clinically-predicted survival of \> 3 months.
• Normal organ function (creatinine ≤2× upper limit of normal, bilirubin ≤2; upper limit of normal).

You may not qualify if:

• o Weight gain for known cause, e.g. oedema or ascites.
• Treatment with other antipsychotic agents during the past 30 days.
• Hypersensitivity to olanzapine.
• Premenopausal women with childbearing potential with a positive serum B-HCG pregnancy test.
• Inability to maintain oral intake.
• Central nervous system disease (e.g., brain metastases, seizure disorder, schizophrenia, bipolar disorder, dementia or delirium).
• Patients on supplements or medications with potential appetite-stimulating activity, such as megestrol acetate, corticosteroids, or thalidomide.
• Patients unwilling or unable to comply with the protocol.
• Nausea and/or vomiting score \>3 on a 0 to 10 scale where 10 = extreme nausea/vomiting.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al-Ainy Center of Clinical Oncology & Nuclear Medicine

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Anorexia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• S Al Sirafy, Professor

  Kasr el einy school of medicine Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: We will prepare 82 jars containing the oral olanzapine tablets and similar 82 jars containing the placebo tablets. Each jar will have a unique number from 1 to 164. The jars will be prepared by Dr. Noha Abdel Razek, The Oncology Pharmacy Director at the department. The codes of the jars will be safeguarded till the end of the study at a closed cupboard at our clinic. The jars will be uncoded only at the end of the study by only one investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator (Dr)

Model Details: This is a placebo-controlled double-blinded phase III randomized clinical trial. One hundred and sixty-four adult incurable cancer patients under treatment at Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK) - Kasr Al-Ainy School of Medicine - Cairo University during the period from December 2021 to September 2022. A written informed consent is to be obtained from all patients before entering the study. Then the investigators will give them dietary advice at baseline. Routine labs as complete blood count, liver, kidney function tests and CRP will be obtained to assess safety to start the drug and to assess its dose adjustment. Participants will be 1:1 randomized to the intervention (olanzapine) arm or the control (placebo) arm. Olanzapine will be given as oral 5 mg tablets (Zyprexa) and the placebo will be given in the form of tablets containing 300 mg of microcrystalline cellulose.

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: February 17, 2022
• Study Start: December 25, 2021
• Primary Completion: November 21, 2022
• Study Completion: December 14, 2022
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)