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Early IntraVenous Administration of Nutritional Support (IVANS)

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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

Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date February 12, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Overall survival [ Time Frame: 12 months ]
    Overall survival
  • 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]
  • 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.
  • 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.
  • 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
  • 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.
  • Change in body weight [ Time Frame: 12 months ]
    Change in body weight during the study (at 4 and 12 months)
  • Change in handgrip strength [ Time Frame: 12 months ]
    Change in handgrip strength during the study (at 4 and 12 months)
  • 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
  • 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
  • Patients requiring unplanned hospitalization [ Time Frame: 12 months ]
    The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.
  • 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]
  • Incidence of infections [ Time Frame: 12 months ]
    The rate of incident infections in each group and the related difference will be calculated
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 13, 2019)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Early IntraVenous Administration of Nutritional Support
Official Title  ICMJE Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer of Stomach
  • GastroEsophageal Cancer
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Other: Nutritional counseling alone
  • Experimental: Supplemental parenteral nutrition plus nutritional counseling
    Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
    Intervention: Other: Early supplemental parenteral nutrition plus nutritional counseling
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2023
Estimated Primary Completion Date October 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Riccardo Caccialanza, MD +390382501615 r.caccialanza@smatteo.pv.it
Contact: Emanuele Cereda, MD, PhD +390382501615 e.cereda@smatteo.pv.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949907
Other Study ID Numbers  ICMJE 20190028466
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Riccardo Caccialanza, IRCCS Policlinico S. Matteo
Study Sponsor  ICMJE IRCCS Policlinico S. Matteo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account IRCCS Policlinico S. Matteo
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP