Nutrition DisordersPhase 3NCT06500234
Nutrition Impact on Immunotherapy of Cancer
A Phase 3 study testing Megestrol Acetate and olanzapine and Starch powder 50 mg in people with Nutrition Disorders and Immunotherapy, run by Qingdao Central Hospital at 1 site in China.
Trial summary
This study investigates nutritional status and outcomes of immuntherapy in cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Disorders, Immunotherapy, Cancer
- What is being tested?
- Megestrol Acetate and olanzapine and Starch powder 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
KEKE NIE, MD, 68665078, NIEKEKEQD@163.COM
Keke Nie, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Disorders, Immunotherapy, Cancer, Survival, Prosthesis
- Being tested
- Megestrol Acetate and olanzapine, Starch powder 50 mg
- Medical subject headings
- Nutrition Disorders, Neoplasms, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol Acetate and olanzapineDrug
megestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday
Starch powder 50 mgDrug
Starch powder 50 mg, oral, everyday
| Study group | Role | What they receive |
|---|---|---|
| megestrol acetate-olanzapine | Experimental | Megestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday Receives: Drug: Megestrol Acetate and olanzapine |
| control | Placebo comparator | Starch powder 50 mg, oral, everyday, Receives: Drug: Starch powder 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: 12 months
Secondary outcomes (1)
PFS
profression-free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Jun 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chunling zhang, MD, Study chair, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500234
- Sponsor's protocol ID
- KY202400918
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients
- ClinicalTrials.gov ID
- NCT06500234
- Acronym / sponsor ID
- KY202400918
- Conditions
- Nutrition Disorders, Immunotherapy, Cancer, Survival, Prosthesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Malnourished patients with megestrol acetate 160mg oral, olanzapine 2.5mg oral, everyday during the immunotherapy course or intolerable.
| Arm | Type | Receives |
|---|---|---|
| megestrol acetate-olanzapine | Experimental | Drug: Megestrol Acetate and olanzapineMegestrol acetate 160 mg, oral, everyday Olanzapine 2.5 mg, oral everyday |
| control | Placebo comparator | Drug: Starch powder 50 mgStarch powder 50 mg, oral, everyday, |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol Acetate and olanzapinemegestrol acetate, 160 mg, oral everyday; olanzapine 2.5 mg, oral everyday | Drug | megestrol acetate-olanzapine |
| Starch powder 50 mgStarch powder 50 mg, oral, everyday | Drug | control |
Primary outcome
ORR
Time frame: 12 months
overall response rate
1 secondary outcome
PFS
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
chunling zhang, MD study chair
Qingdao Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol Acetate and olanzapine and Starch powder 50 mg in people with Nutrition Disorders and Immunotherapy, run by Qingdao Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keke Nie, MD (53268665078, niekeke@uor.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.