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Trial · NCT07883161

Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Cancer

NCT07883161, Not applicable, Not yet recruiting, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Cancer. Trials, record NCT07883161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883161

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Targeted Nutritional Intervention (HMB, Arginine, Glutamine) in Patients With Pancreatic Cancer
NCT number
NCT07883161
Status
Not yet recruiting
Phases
Not applicable
Enrollment
24 participants, estimated
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
PDAC, Pancreas Adenocarcinoma (MSI-H)
Interventions
HMB / L-Arginine / L-Glutamine oral nutritional mixture, Standard Dietary Counseling
First posted
2026-10-20
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange from Baseline in Skeletal Muscle Index (SMI) at Day 60Baseline (Day 0) and Day 60
Skeletal Muscle Index (SMI) is calculated from cross-sectional abdominal computed tomography (CT) images at the third lumbar vertebra (L3) level using densitometric muscle area segmentation normalized for height squared (cm²/m²). The primary outcome measure evaluates the difference in SMI between baseline (T0, prior to intervention initiation) and Day 60 (T60).
SecondaryChange from Baseline in Muscle Radiation Attenuation and Adipose Depots at Day 60Baseline (Day 0) and Day 60Radiologic assessment via abdominal CT scan at the L3 level to quantify myosteatosis measured as Mean Muscle Attenuation in Hounsfield Units (HU).
SecondaryChange from Baseline in Isometric Handgrip Strength at Day 60Baseline (Day 0) and Day 60Handgrip strength assessed using a calibrated digital dynamometer, measured in kilograms (kg), recording the average/maximum across dominant-hand trials.
SecondaryChange from Baseline in Short Physical Performance Battery (SPPB) Total Score at Day 60Baseline (Day 0) and Day 60
Physical capacity will be measured via the SPPB composite score combining gait speed, balance testing, and chair-rise test. Total score ranges from 0 to 12 points, with higher scores reflecting better functional status and performance.
SecondaryChange from Baseline in Prognostic Nutritional Index at Day 60Baseline (Day 0) and Day 60Prognostic Nutritional Index (PNI) will be calculated using albumin and lymphocyte levels
SecondaryOverall Survival (OS) Rate at 6 and 12 MonthsAssessed at 6 and 12 months from enrollmentOS: Percentage of participants alive from the date of enrollment to the designated follow-up timepoints.
SecondaryProgression-Free Survival (PFS) Rate at 6 and 12 MonthsAssessed at 6 and 12 months from enrollmentPFS: Percentage of participants without objective radiological disease progression (according to standard RECIST criteria) or death from any cause.
SecondaryChange from Baseline in Patient-Reported Quality of Life (EORTC QLQ-C30) at Day 60Baseline (Day 0) and Day 60
Multidimensional assessment evaluated through validated instruments: EORTC QLQ-C30 (core oncology questionnaire; scores 0-100). Higher functional scores indicate better function; higher symptom scores indicate worse symptom severity.
SecondaryChange from Baseline in Disease-Specific Symptoms (EORTC QLQ-PAN26) at Day 60Baseline (Day 0) and Day 60
Pancreatic cancer-specific symptoms and side effects assessed using the EORTC QLQ-PAN26 module, comprising 26 items covering disease-specific symptoms (e.g., pain, digestive issues, cachexia-related signs). Scores are linearly converted to a 0 to 100 scale, where higher scores represent greater symptom severity/burden.
SecondaryChange from Baseline in Patient-Change from Baseline in Cachexia-Related Quality of Life (EORTC QLQ-CAX24) at Day 60Baseline (Day 0) and Day 60
Cancer cachexia-specific symptom burden and psychosocial impact assessed using the EORTC QLQ-CAX24 module, consisting of 24 items evaluating cachexia-related eating difficulties, food worries, and physical decline. Scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting worse cachexia-related symptoms and impact.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
34621468BACKGROUNDPubMed
36771433BACKGROUNDPubMed
38836800BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07883161

GET https://conductscience.org/api/trials/v1/NCT07883161/registered