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Early IntraVenous Administration of Nutritional Support (IVANS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949907
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Riccardo Caccialanza, IRCCS Policlinico S. Matteo

Brief 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 metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

Condition or disease Intervention/treatment Phase
Cancer of Stomach GastroEsophageal Cancer Other: Nutritional counseling alone Other: Early supplemental parenteral nutrition plus nutritional counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Nutritional counseling alone
Nutritional 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.
Other: Nutritional counseling alone

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.


Experimental: Supplemental parenteral nutrition plus nutritional counseling
Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
Other: Early supplemental parenteral nutrition plus nutritional counseling

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.





Primary Outcome Measures :
  1. Combined endpoint - overall survival and weight maintenance [ Time Frame: 12 months ]
    A combined endpoint consisting of overall and/or absence of unintentional weight loss >10% of the weight recorded at enrollment


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    Overall survival

  2. Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0 [ Time Frame: 4 months ]
    Difference in the incidence of grade >=3 toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v4.0]

  3. Progression-Free Survival (PFS) [ Time Frame: 12 months ]
    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.

  4. Eligibility to second-line chemotherapy [ Time Frame: 12 months ]
    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.

  5. Total dose of chemotherapy administered [ Time Frame: 4 months ]
    To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan

  6. Objective response rate [ Time Frame: 4 months ]
    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.

  7. Change in body weight [ Time Frame: 12 months ]
    Change in body weight during the study (at 4 and 12 months)

  8. Change in handgrip strength [ Time Frame: 12 months ]
    Change in handgrip strength during the study (at 4 and 12 months)

  9. Change in muscle mass [ Time Frame: 12 months ]
    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

  10. Change in phase angle [ Time Frame: 12 months ]
    Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis

  11. Patients requiring unplanned hospitalization [ Time Frame: 12 months ]
    The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.

  12. Change in self-perceived quality of life [ Time Frame: 12 months ]
    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]

  13. Incidence of infections [ Time Frame: 12 months ]
    The rate of incident infections in each group and the related difference will be calculated

  14. Abnormal values in safety laboratory variables [ Time Frame: 12 months ]
    The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups


Other Outcome Measures:
  1. Serum levels of immunologic profiles [ Time Frame: 1 months ]
    Levels of soluble effectors and immunoregulatory cells at 1 week and 1 month from the start of chemotherapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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);
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
  • availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
  • signed informed consent.

Exclusion Criteria:

  • 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
  • unfeasible home parenteral nutrition for social/familial reasons
  • absence of caregivers
  • patients refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949907


Contacts
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Contact: Riccardo Caccialanza, MD +390382501615 r.caccialanza@smatteo.pv.it
Contact: Emanuele Cereda, MD, PhD +390382501615 e.cereda@smatteo.pv.it

Locations
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Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Contact: Riccardo Caccialanza, MD         
Principal Investigator: Riccardo Caccialanza, MD         
Sub-Investigator: Emanuele Cereda, MD, PhD         
Sub-Investigator: Paolo Pedrazzoli, MD         
Sub-Investigator: Silvia Brugnatelli, MD         
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
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Study Chair: Riccardo Caccialanza, MD Fondazione IRCCS Policlinico San Matteo
Principal Investigator: Emanuele Cereda, MD, PhD Fondazione IRCCS Policlinico San Matteo
Study Director: Paolo Pedrazzoli, MD Fondazione IRCCS Policlinico San Matteo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Riccardo Caccialanza, Director - Clinical Nutrition and Dietetics Unit, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT03949907    
Other Study ID Numbers: 20190028466
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Caccialanza, IRCCS Policlinico S. Matteo:
Parenteral Nutrition (PN)
Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases