Back to resultsEarly IntraVenous Administration of Nutritional Support (IVANS)
Primary Purpose
Cancer of Stomach, GastroEsophageal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nutritional counseling alone
Early supplemental parenteral nutrition plus nutritional counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Stomach focused on measuring Parenteral Nutrition (PN), Cancer
Eligibility 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
Sites / Locations
- Fondazione IRCCS Policlinico San MatteoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Nutritional counseling alone
Supplemental parenteral nutrition plus nutritional counseling
Arm Description
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.
Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall survival
Overall survival
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]
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.
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.
Total dose of chemotherapy administered
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
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.
Change in body weight
Change in body weight during the study (at 4 and 12 months)
Change in handgrip strength
Change in handgrip strength during the study (at 4 and 12 months)
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
Change in phase angle
Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis
Patients requiring unplanned hospitalization
The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.
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]
Incidence of infections
The rate of incident infections in each group and the related difference will be calculated
Abnormal values in safety laboratory variables
The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949907
Brief Title
Early IntraVenous Administration of Nutritional Support
Acronym
IVANS
Official Title
Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Stomach, GastroEsophageal Cancer
Keywords
Parenteral Nutrition (PN), Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional counseling alone
Arm Type
Other
Arm Description
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.
Arm Title
Supplemental parenteral nutrition plus nutritional counseling
Arm Type
Experimental
Arm Description
Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
Intervention Type
Other
Intervention Name(s)
Nutritional counseling alone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Early supplemental parenteral nutrition plus nutritional counseling
Intervention Description
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 Measure Information:
Title
Combined endpoint - overall survival and weight maintenance
Description
A combined endpoint consisting of overall and/or absence of unintentional weight loss >10% of the weight recorded at enrollment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival
Time Frame
12 months
Title
Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0
Description
Difference in the incidence of grade >=3 toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v4.0]
Time Frame
4 months
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
12 months
Title
Eligibility to second-line chemotherapy
Description
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.
Time Frame
12 months
Title
Total dose of chemotherapy administered
Description
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Time Frame
4 months
Title
Objective response rate
Description
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.
Time Frame
4 months
Title
Change in body weight
Description
Change in body weight during the study (at 4 and 12 months)
Time Frame
12 months
Title
Change in handgrip strength
Description
Change in handgrip strength during the study (at 4 and 12 months)
Time Frame
12 months
Title
Change in muscle mass
Description
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
Time Frame
12 months
Title
Change in phase angle
Description
Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis
Time Frame
12 months
Title
Patients requiring unplanned hospitalization
Description
The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.
Time Frame
12 months
Title
Change in self-perceived quality of life
Description
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]
Time Frame
12 months
Title
Incidence of infections
Description
The rate of incident infections in each group and the related difference will be calculated
Time Frame
12 months
Title
Abnormal values in safety laboratory variables
Description
The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Serum levels of immunologic profiles
Description
Levels of soluble effectors and immunoregulatory cells at 1 week and 1 month from the start of chemotherapy
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Caccialanza, MD
Phone
+390382501615
Email
r.caccialanza@smatteo.pv.it
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuele Cereda, MD, PhD
Phone
+390382501615
Email
e.cereda@smatteo.pv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emanuele Cereda, MD, PhD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Pedrazzoli, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
First Name & Middle Initial & Last Name & Degree
Emanuele Cereda, MD, PhD
First Name & Middle Initial & Last Name & Degree
Paolo Pedrazzoli, MD
First Name & Middle Initial & Last Name & Degree
Silvia Brugnatelli, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32127922
Citation
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.
Results Reference
derived
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Early IntraVenous Administration of Nutritional Support
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