AzTrials
AzTrials

Cancer of StomachIVANSNCT03949907

Early IntraVenous Administration of Nutritional Support

A study testing Nutritional counseling alone and Early supplemental parenteral nutrition plus nutritional counseling in people with Cancer of Stomach and GastroEsophageal Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Stomach, GastroEsophageal Cancer
What is being tested?
Nutritional counseling alone and Early supplemental parenteral nutrition plus nutritional counseling
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteItaly
Study dates
14 Apr 2020to 30 Jul 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer;
  • no previous chemotherapy for metastatic disease;
  • indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
  • measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
  • presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3);
  • availability of permanent venous access (Port, Groshong, PICC);
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
  • signed informed consent.

Who cannot join

  • age <18 years
  • ECOG performance status >2
  • indication to complete artificial nutrition support (totally compromised spontaneous food-intake)
  • contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention)
  • availability of jejunostomy for nutritional purposes
  • ongoing home artificial nutrition
Show all 9Show fewer
  • unfeasible home parenteral nutrition for social/familial reasons
  • absence of caregivers
  • patients refusal

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

About this study

Official title: Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy

The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

Read the detailed description

Although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. It is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. International guidelines suggest that parenteral nutrition (PN) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. Although recent trials suggest that supplemental PN (SPN) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early SPN in cancer patients at nutritional risk receiving first-line chemotherapy.

Being tested
Nutritional counseling alone, Early supplemental parenteral nutrition plus nutritional counseling
Keywords
Parenteral Nutrition (PN), Cancer
Medical subject headings
Stomach Neoplasms, Hyperphagia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional counseling aloneOther

    Nutritional counseling consists of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences, in order to achieve estimated protein-calorie requirements and to take into account chewing and swallowing abilities. Regular consultation by a registered dietitian will be also provided every 10 days by means of face-to-face interviews (at scheduled follow-up visits - chemotherapy cycle) and telephone interviews (planned between chemotherapy cycles and as required by the patient). In the presence of significant reduction of normal food intake, the use of oral nutritional supplements will be also considered.

    In the presence of body weight loss >10% of the weight recorded at enrollment, patients allocated to this group group will be censored and treated according to current supportive care guidelines, including home parenteral nutrition.

  • Early supplemental parenteral nutrition plus nutritional counselingOther

    Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.

    Supplemental home parenteral nutrition will be prescribed, provided daily and adjusted throughout the study (approximately every 10 days, until the end of the scheduled first-line chemotherapy) according to estimated protein-calorie oral intakes, in order to satisfy estimated requirements. Home parenteral nutrition will be infused mainly during night hours, using multi-chamber bags containing olive oil-based lipid emulsions, when not contraindicated.

Study groups in NCT03949907
Study groupRoleWhat they receive
Nutritional counseling aloneOtherNutritional counseling consists of a personalized dietary prescription with regular consultation by a registered dietitian and telephone interviews, as well as of the use of oral nutritional supplements, when necessary.
Receives: Other: Nutritional counseling alone
Supplemental parenteral nutrition plus nutritional counselingExperimentalPatients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
Receives: Other: Early supplemental parenteral nutrition plus nutritional counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined endpoint - overall survival and weight maintenance

    A combined endpoint consisting of overall and/or absence of unintentional weight loss >10% of the weight recorded at enrollment

    Measured: 12 months

Secondary outcomes (14)

  1. Overall survival

    Overall survival

    Measured: 12 months

  2. Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0

    Difference in the incidence of grade >=3 toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v4.0]

    Measured: 4 months

  3. Progression-Free Survival (PFS)

    A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months.

    Measured: 12 months

  4. Eligibility to second-line chemotherapy

    The rate of patients eligible for second-line chemotherapy at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and eligible or not eligible or dead at 12 months.

    Measured: 12 months

  5. Total dose of chemotherapy administered

    To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan

    Measured: 4 months

  6. Objective response rate

    Defined as a complete response or partial response that has been confirmed by a subsequent assessment no earlier than 2 months after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

    Measured: 4 months

  7. Change in body weight

    Change in body weight during the study (at 4 and 12 months)

    Measured: 12 months

  8. Change in handgrip strength

    Change in handgrip strength during the study (at 4 and 12 months)

    Measured: 12 months

  9. Change in muscle mass

    Change in muscle mass during the study (at 4 and 12 months) evaluated with computed tomography scan at the level of the third lumbar vertebra

    Measured: 12 months

  10. Change in phase angle

    Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis

    Measured: 12 months

  11. Patients requiring unplanned hospitalization

    The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.

    Measured: 12 months

  12. Change in self-perceived quality of life

    Change in self-perceived quality of life during the study (at 4 and 12 months) as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 [EORTC QLQ-C30]

    Measured: 12 months

  13. Incidence of infections

    The rate of incident infections in each group and the related difference will be calculated

    Measured: 12 months

  14. Abnormal values in safety laboratory variables

    The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2019
  2. Study start14 Apr 2020
  3. Primary completion30 Jul 2024
  4. Study completion30 Jul 2024

Why it stopped: Changes in anticancer treatment protocols which limit recruitment

Resources

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
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03949907
Sponsor's protocol ID
20190028466
Acronym
IVANS
Status last verified
May 2025
First submitted
9 May 2019
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Caccialanza R, Cereda E, Klersy C, Brugnatelli S, Borioli V, Ferrari A, Caraccia M, Lobascio F, Pagani A, Delfanti S, Aprile G, Reni M, Rimassa L, Melisi D, Cascinu S, Battistini L, Candiloro F, Pedrazzoli P. Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial. Ther Adv Med Oncol. 2020 Feb 22;12:1758835919890281. doi: 10.1177/1758835919890281. eCollection 2020.

    PubMed 32127922

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional counseling alone and Early supplemental parenteral nutrition plus nutritional counseling in people with Cancer of Stomach and GastroEsophageal Cancer, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.

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 9 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: stopped early, as of the sponsor's last update on 7 May 2025. 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 Italy. 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. 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 stopped early (reason given: Changes in anticancer treatment protocols which limit recruitment). Results are not available in the source record.

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?

Combined endpoint - overall survival and weight maintenance (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949907, which also lists 1 linked publication.

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 7 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in