Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients (GALENOS 2)

March 31, 2026 updated by: Fondazione del Piemonte per l'Oncologia

Use of an Immunonutrition Galenic Formulation in Head and Neck, Lung and Rectal Cancer Patients During Antineoplastic Treatments: A Prospective Study

GALENOS 2 is a single-arm, single-center, phase II interventional study designed to evaluate the effects of a galenic immunonutrition dietary supplement in patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment. The study aims to assess whether the formula may reduce treatment-related toxicity and improve treatment compliance, using patients from the GALENOS 1 observational study as the control group for comparison

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective interventional study will enroll adult patients with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer who are candidates for standard chemoradiotherapy, chemotherapy, radiotherapy, or immunotherapy according to clinical practice. All enrolled participants will receive a galenic immunonutrition formula twice daily starting on the first day of antineoplastic treatment and continuing for up to 45 days, in addition to standard nutritional counseling and routine oncologic care. The study will prospectively assess treatment-related toxicity, nutritional status, body composition, muscle function, cytokine profiles, quality of life, physical activity, treatment adherence/tolerance, and compliance with the galenic formula. Outcomes in GALENOS 2 will be compared with matched or pooled control patients from the GALENOS 1 observational study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Torino (TO)
      • Candiolo, Torino (TO), Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo, Candiolo, Turin 10060
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent to study procedures
  • Male or female, age greater than 18 years
  • Histological or cytological documentation of head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer candidate for immunotherapy, chemotherapy, and/or radiotherapy according to standard clinical practice
  • ECOG Performance Status score less than 2
  • Adequate kidney, liver, and bone marrow function
  • Ability to understand, sign informed consent, and comply with study procedures

Exclusion Criteria:

  • Incomplete recovery from surgery before starting antineoplastic treatment
  • Other progressing malignancy or malignancy requiring active treatment within the last 3 years, except localized basal cell carcinoma, localized squamous cell carcinoma of the skin, or cervical carcinoma in situ
  • Active infection requiring systemic antibiotic therapy
  • Serious or unstable medical conditions, psychiatric disorders, or substance abuse interfering with study compliance
  • Receipt of any live vaccine within 30 days before study treatment
  • Active cardiac pacing/pacing implants/neurostimulators/hearing system not compatible with bioimpedance analysis
  • Edema and/or ascites not compatible with body weight evaluation and bioimpedance analysis
  • Enteral or parenteral nutritional support at baseline

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Galenic Immunonutrition Formula
Participants with head and neck squamous cell carcinoma, locally advanced rectal cancer, or lung cancer undergoing standard antineoplastic treatment will receive the galenic immunonutrition formula twice daily from treatment start for a maximum of 45 days, alongside routine nutritional counseling and standard clinical management
Dietary supplement: Galenic Immunonutrition Formula
The investigational galenic immunonutrition formula is a jelly-based oral supplement formulated with arginine, brewer's yeast, omega-3 powder, olive oil, soy lecithin, glycerol, animal gelatine, purified water, citrate components, and flavoring, with sugar-containing or sweetener-containing versions and peach or lemon flavor options. Participants will receive two servings per day starting on the first day of antineoplastic treatment and continuing for up to 45 days. The product will be prepared and supplied free of charge by the Hospital Pharmacy of FPO-IRCCS Candiolo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants with at least 1 Grade 3 or higher treatment-related adverse event
Time Frame: From the first day of antineoplastic treatment to end of trial, assessed up to 63 days
Number of participants with at least 1 treatment-related adverse event of Grade 3 or higher, assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
From the first day of antineoplastic treatment to end of trial, assessed up to 63 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body weight measured in kilograms (kg)
From baseline (T0) to end of trial (T3), assessed up to 63 days
Body mass index
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²)
From baseline (T0) to end of trial (T3), assessed up to 63 days
Daily oral energy intake
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Average daily oral energy intake assessed from food record and expressed in kilocalories per day (kcal/day).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Nutritional Risk Screening 2002 score
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Nutritional risk assessed using the Nutritional Risk Screening 2002 (NRS-2002). Total score ranges from 0 to 7, with higher scores indicating greater nutritional risk and worse nutritional status
From baseline (T0) to end of trial (T3), assessed up to 63 days
Prognostic Nutritional Index
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Prognostic Nutritional Index (PNI). Higher values indicate better nutritional and immunologic status
From baseline (T0) to end of trial (T3), assessed up to 63 days
Participants requiring additional nutritional support
Time Frame: From the first day of treatment to end of trial, assessed up to 63 days
Number of participants requiring additional oral, enteral, or parenteral nutritional support during the study period
From the first day of treatment to end of trial, assessed up to 63 days
Skeletal muscle mass
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle mass measured by bioimpedance analysis and expressed in kilograms (kg)
From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat-free mass
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat-free mass measured by bioimpedance analysis and expressed in kilograms (kg).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Body cell mass
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Body cell mass measured by bioimpedance analysis and expressed in kilograms (kg).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat mass
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Fat mass measured by bioimpedance analysis and expressed in kilograms (kg).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Total body water
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Total body water measured by bioimpedance analysis and expressed in liters (L)
From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle index
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Skeletal muscle index measured by bioimpedance analysis and expressed in kg/m²
From baseline (T0) to end of trial (T3), assessed up to 63 days
Phase angle
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Phase angle measured by bioimpedance analysis and expressed in degrees. Higher values generally indicate better cellular integrity
From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip strength
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Maximum handgrip strength measured using a handgrip dynamometer and expressed in kilograms (kg).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Handgrip endurance measured using a handgrip dynamometer.
From baseline (T0) to end of trial (T3), assessed up to 63 days
ECOG Performance Status score
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Performance status assessed using the Eastern Cooperative Oncology Group (ECOG) Performance Status scale. Scores range from 0 to 5, with higher scores indicating worse functional impairment
From baseline (T0) to end of trial (T3), assessed up to 63 days
Toxicity-free survival
Time Frame: From the first day of treatment to first toxicity or end of trial, assessed up to 63 days
Time from the first day of antineoplastic treatment to the first documented treatment-related adverse event, assessed according to CTCAE v5.0, expressed in days
From the first day of treatment to first toxicity or end of trial, assessed up to 63 days
Relative chemotherapy dose delivered
Time Frame: From treatment start to end of treatment, assessed up to 63 days
Total chemotherapy dose administered expressed as the percentage of the planned chemotherapy dose
From treatment start to end of treatment, assessed up to 63 days
Relative radiotherapy dose delivered
Time Frame: From treatment start to end of treatment, assessed up to 63 days
Total radiotherapy dose administered expressed as the percentage of the planned radiotherapy dose.
From treatment start to end of treatment, assessed up to 63 days
Relative immunotherapy dose delivered
Time Frame: From treatment start to end of treatment, assessed up to 63 days
Total immunotherapy dose administered expressed as the percentage of the planned immunotherapy dose.
From treatment start to end of treatment, assessed up to 63 days
Relative variation in treatment duration
Time Frame: From treatment start to end of treatment, assessed up to 63 days
Variation in actual treatment duration compared with planned treatment duration, expressed as a percentage
From treatment start to end of treatment, assessed up to 63 days
Participants completing the planned treatment schedule
Time Frame: From treatment start to end of treatment, assessed up to 63 days
Number of participants who complete the planned treatment schedule.
From treatment start to end of treatment, assessed up to 63 days
Participants requiring unplanned hospitalization
Time Frame: From treatment start to end of trial, assessed up to 63 days
Number of participants requiring at least 1 unplanned hospitalization during the study period.
From treatment start to end of trial, assessed up to 63 days
EORTC QLQ-C30 Global Health Status / Quality of Life score
Time Frame: At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days
Self-perceived quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 version 3.0 (EORTC QLQ-C30 v3.0), Global Health Status / Quality of Life scale. Scores range from 0 to 100, with higher scores indicating better quality of life.
At baseline (T0), during treatment, and at end of trial (T3), assessed up to 63 days
International Physical Activity Questionnaire score
Time Frame: From baseline (T0) to end of trial (T3), assessed up to 63 days
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ).
From baseline (T0) to end of trial (T3), assessed up to 63 days
Formula compliance
Time Frame: From the first day of treatment to Day 45, assessed up to 45 days
Compliance with the galenic immunonutrition formula, expressed as the percentage of prescribed daily servings recorded as consumed in the daily intake diary.
From the first day of treatment to Day 45, assessed up to 45 days
Change in circulating CCL2 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma CCL2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL4 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma CCL4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CCL22 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma CCL22 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating CXCL10 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma CXCL10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IFN-γ concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IFN-γ concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-2 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-2 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-4 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-4 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-5 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-5 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-6 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-6 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-8 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-8 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-10 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-10 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-12 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-12 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-13 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-13 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating IL-15 concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma IL-15 concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TGF-β concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma TGF-β concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in circulating TNF-α concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Plasma TNF-α concentration measured using the Simple Plex system and expressed in picograms per milliliter (pg/mL).
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
Change in C-reactive protein concentration
Time Frame: From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort
C-reactive protein concentration measured in peripheral blood
From baseline (T0) to end of treatment blood sampling, assessed up to 42 days for HNSCC and lung cohorts and up to 31 days for LARC cohort

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione del Piemonte per l'Oncologia

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 006-FPO25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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