NCT05360745

Brief Summary

Metastatic pancreatic cancer has a poor prognosis, with approximately one-third of patients experiencing poor quality of life at six months. ARACOMPLEX® is a food supplement that contains maca extract, vitamin complexes and ions, and this nutritional contribution seems to favor the improvement of the patient's quality of life. To verify this statement, this experimental study is carried out in patients with locally advanced/metastatic pancreatic cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

April 20, 2022

Last Update Submit

February 9, 2026

Conditions

Metastatic Pancreatic CancerQuality of LifeLocally Advanced Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life

    To assess the degradation of quality of life at 6 months using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale in patients with locally advanced/metastatic pancreatic cancer receiving chemotherapy and supplementation with ARACOMPLEX® (PILOT PHASE) and compared with patients that are treated with chemotherapy and placebo (EXPERIMENTAL PHASE). The EORTC QLQ-C30 includes the "Global Health Status/Quality of life" scales, which are composed by items 29 and 30, and they are scored from 0 (worse) to 100 (better).

    6 months

Secondary Outcomes (6)

  • Nutritional status assessment

    Baseline, 1 month, 3 months and 6 months.

  • Functional status assessment

    Baseline, 1 month, 3 months and 6 months.

  • Functional status assessment

    Baseline, 1 month, 3 months and 6 months.

  • Tumor response assessment

    Assessment at the end of the third and sixth chemotherapy cycles, as per normal clinical practice.

  • Compliance treatment

    1 month, 3 months and 6 months.

  • +1 more secondary outcomes

Study Arms (2)

Experimental arm

EXPERIMENTAL

ARACOMPLEX® (food supplement). 2 tablets per day, during 6 months.

Dietary Supplement: ARACOMPLEX®

Control arm

PLACEBO COMPARATOR

Placebo. 2 tablets per day, during 6 months.

Dietary Supplement: placebo

Interventions

ARACOMPLEX®DIETARY_SUPPLEMENT

ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.

Experimental arm
placeboDIETARY_SUPPLEMENT

Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.

Control arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with locally advanced or metastatic pancreatic cancer without previous chemotherapy treatment.
  • Patients for whom chemotherapy treatment has been indicated.
  • Adequate bone marrow function (neutrophils ≥1500 mm3, platelets ≥100,000 mm3), adequate liver function (bilirubin ≤1.5 times the upper limit of the normal range)
  • Adequate renal function (glomerular filtration rate greater than or equal to 90 ml/min/1.73).
  • ECOG functional stage 0-1 (Karnofsky ≥ 80).
  • Patients must agree to carry out study visits and procedures with precise instructions.

You may not qualify if:

  • Age ≥76 years.
  • Endocrine or acinar pancreatic cancer.
  • Serious systemic diseases such as: sepsis, heart failure, severe COPD, liver failure and chronic kidney disease.
  • Prior radiation to areas of measurable disease.
  • Chronic diarrhea.
  • Active infection.
  • Significant medical history of heart disease.
  • Pregnancy or lactation.
  • Impossibility of the patient, due to medical condition, to follow the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Sergio Sandiego, Doctor

    Fundación Instituto Valenciano de Oncología

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 4, 2022

Study Start

June 29, 2022

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share