Quality of LifeFOODPANCNCT05360745
Quality of Life With Nutritional Supplementation in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
A study testing ARACOMPLEX® in people with Quality of Life and Locally Advanced Pancreatic Carcinoma, run by Fundacion para la Excelencia y la Calidad de la Oncologia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life, Locally Advanced Pancreatic Carcinoma, Metastatic Pancreatic Cancer
- What is being tested?
- ARACOMPLEX®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 Jun 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Significant medical history of heart disease.
- Pregnancy or lactation.
- Impossibility of the patient, due to medical condition, to follow the study.
About this study
Official title: Study of the Impact on Quality of Life of Nutritional Supplementation With a Food Supplement Versus Placebo in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
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.
Read the detailed description
This study is composed of two phases: pilot phase and experimental phase. The pilot phase is also composed of two stages: first stage of pilot phase and second stage of pilot phase.
There are 22 patients recruited within the first stage of the pilot phase. 11 patients will be treated with ARACOMPLEX® and 11 patients will be treated with placebo. If the results are positive, a second stage of the pilot phase will take place until 43 patients are recruited in each treatment group, that is, 32 more patients in each group. The placebo group in the pilot phase is not analyzed.
In the experimental phase, a total of 234 patients are required, that is, 117 patients in each of the two study groups (ARACOMPLEX® and placebo). This phase will include the patients who participated in the pilot phase (86 patients, 43 randomized patients in each group) and 148 additional patients (74 patients in each group) up to a total of 234 patients (117 patients in each group).
If the results obtained from the analysis of the data from the first stage of the pilot phase are satisfactory, according to the protocol, the sponsor will present these results to the ethics committee, at the same time that also an addition of investigational sites, to move on to the second stage of the pilot phase. The approval or authorization of the ethics committee is required to progress to the second stage of the pilot phase.
The criteria for moving to the second stage is that more than 7 responders patients are achieved, after 6 months of treatment, out of the 11 patients in the experimental group. The responder patient is the one who meets an improvement in quality of life (difference of at least 10 points of quality improvement on the EORTC QLQ-C30 scale) between baseline and final time.
If the expected successful results are not obtained, the study will be closed and a new study will be proposed based on the data provided at this stage.
If the results obtained from the data analysis from the second stage of the pilot phase are satisfactory, according to the protocol, the sponsor will present these results to the ethics committee, at the same time as also an addition of investigational sites, if applicable. The ethics committee will be responsible for authorizing or approving the transition from the second stage of the pilot phase to the experimental phase.
The criteria for moving on to the experimental phase is that more than 30 responders patients are achieved, after 6 months of treatment, out of the 43 patients in the experimental group. The responder patient is the one who meets an improvement in quality of life (difference of at least 10 points of quality improvement on the EORTC QLQ-C30 scale) between baseline and final time.
In this study, the data of the patients included in the pilot phase will be counted, that is, the data of the 86 patients (ARACOMPLEX® and placebo), for which 148 additional patients are required in this phase (74 more patients in the ARACOMPLEX® group and 74 more in the placebo group) to reach a total of 234 patients.
- Being tested
- ARACOMPLEX®, placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
placeboDietary supplement
Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | ARACOMPLEX® (food supplement). 2 tablets per day, during 6 months. Receives: Dietary Supplement: ARACOMPLEX® |
| Control arm | Placebo comparator | Placebo. 2 tablets per day, during 6 months. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (6)
Nutritional status assessment
Measured by the Malnutrition Screening Tool (MST)
Measured: Baseline, 1 month, 3 months and 6 months.
Functional status assessment
Measured by the Eastern Cooperative Oncology Group (ECOG) scale. The score is from 0 (better) to 5 (worse outcome, death)
Measured: Baseline, 1 month, 3 months and 6 months.
Functional status assessment
Measured by the Karnofsky scale.The score is from 100 %, normal activity and no evidence of disease, to 0 %, dead. Values ≤ 40% mean that patient is unable to care for self and requires equivalent of institutional or hospital care; diseases may be progressing rapidly.
Measured: Baseline, 1 month, 3 months and 6 months.
Tumor response assessment
Measured by the RECIST criteria v.1.1
Measured: Assessment at the end of the third and sixth chemotherapy cycles, as per normal clinical practice.
Compliance treatment
Measured as the percentage of tablets taken from the previous visit: (number of tablets taken since the last visit (n) / number of days since the last visit (N) ) x 100.
Measured: 1 month, 3 months and 6 months.
Adverse events due to chemotherapy
The assessment of adverse events due to chemotherapy is performed according to the CTCAE criteria, and are those reported as per usual clinical practice.
Measured: 1 month, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start29 Jun 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Why it stopped: Few months later the site initiation visit, the principal investigator decided not to continue with the study. He explained that his investigational team was not able to combine the study procedures with their usual clinical practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Excelencia y la Calidad de la Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Sandiego, Doctor, Principal investigator, Fundación Instituto Valenciano de Oncología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360745
- Sponsor's protocol ID
- fe-2021-001
- Acronym
- FOODPANC
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact on Quality of Life of Nutritional Supplementation With a Food Supplement Versus Placebo in Patients With Locally Advanced/Metastatic Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT05360745
- Acronym / sponsor ID
- FOODPANC / fe-2021-001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Few months later the site initiation visit, the principal investigator decided not to continue with the study. He explained that his investigational team was not able to combine the study procedures with their usual clinical practice.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion para la Excelencia y la Calidad de la OncologiaUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 4 May 2022 (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.
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.
Detailed description
This study is composed of two phases: pilot phase and experimental phase. The pilot phase is also composed of two stages: first stage of pilot phase and second stage of pilot phase.
There are 22 patients recruited within the first stage of the pilot phase. 11 patients will be treated with ARACOMPLEX® and 11 patients will be treated with placebo. If the results are positive, a second stage of the pilot phase will take place until 43 patients are recruited in each treatment group, that is, 32 more patients in each group. The placebo group in the pilot phase is not analyzed.
In the experimental phase, a total of 234 patients are required, that is, 117 patients in each of the two study groups (ARACOMPLEX® and placebo). This phase will include the patients who participated in the pilot phase (86 patients, 43 randomized patients in each group) and 148 additional patients (74 patients in each group) up to a total of 234 patients (117 patients in each group).
If the results obtained from the analysis of the data from the first stage of the pilot phase are satisfactory, according to the protocol, the sponsor will present these results to the ethics committee, at the same time that also an addition of investigational sites, to move on to the second stage of the pilot phase. The approval or authorization of the ethics committee is required to progress to the second stage of the pilot phase.
The criteria for moving to the second stage is that more than 7 responders patients are achieved, after 6 months of treatment, out of the 11 patients in the experimental group. The responder patient is the one who meets an improvement in quality of life (difference of at least 10 points of quality improvement on the EORTC QLQ-C30 scale) between baseline and final time.
If the expected successful results are not obtained, the study will be closed and a new study will be proposed based on the data provided at this stage.
If the results obtained from the data analysis from the second stage of the pilot phase are satisfactory, according to the protocol, the sponsor will present these results to the ethics committee, at the same time as also an addition of investigational sites, if applicable. The ethics committee will be responsible for authorizing or approving the transition from the second stage of the pilot phase to the experimental phase.
The criteria for moving on to the experimental phase is that more than 30 responders patients are achieved, after 6 months of treatment, out of the 43 patients in the experimental group. The responder patient is the one who meets an improvement in quality of life (difference of at least 10 points of quality improvement on the EORTC QLQ-C30 scale) between baseline and final time.
In this study, the data of the patients included in the pilot phase will be counted, that is, the data of the 86 patients (ARACOMPLEX® and placebo), for which 148 additional patients are required in this phase (74 more patients in the ARACOMPLEX® group and 74 more in the placebo group) to reach a total of 234 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Dietary Supplement: ARACOMPLEX®ARACOMPLEX® (food supplement). 2 tablets per day, during 6 months. |
| Control arm | Placebo comparator | Dietary Supplement: placeboPlacebo. 2 tablets per day, during 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| ARACOMPLEX®ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient. | Dietary supplement | Experimental arm |
| placeboPlacebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®. | Dietary supplement | Control arm |
Primary outcome
Change in quality of life
Time frame: 6 months
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 secondary outcomes
Nutritional status assessment
Time frame: Baseline, 1 month, 3 months and 6 months.
Functional status assessment
Time frame: Baseline, 1 month, 3 months and 6 months.
Functional status assessment
Time frame: Baseline, 1 month, 3 months and 6 months.
Tumor response assessment
Time frame: Assessment at the end of the third and sixth chemotherapy cycles, as per normal clinical practice.
Compliance treatment
Time frame: 1 month, 3 months and 6 months.
Adverse events due to chemotherapy
Time frame: 1 month, 3 months and 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sergio Sandiego, Doctor principal investigator
Fundación Instituto Valenciano de Oncología
Questions about this trial
What is this clinical trial studying?
A study testing ARACOMPLEX® in people with Quality of Life and Locally Advanced Pancreatic Carcinoma, run by Fundacion para la Excelencia y la Calidad de la Oncologia.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: 6 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 11 Feb 2026.