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出境医 / 临床实验 / Early IntraVenous Administration of Nutritional Support (IVANS)
Early IntraVenous Administration of Nutritional Support (IVANS)
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.
| 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.
Study Design
| 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 |
| Actual Study Start Date : | April 14, 2020 |
| Estimated Primary Completion Date : | October 30, 2023 |
| Estimated Study Completion Date : | October 30, 2023 |
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
Other Outcome Measures:
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Riccardo Caccialanza, MD | +390382501615 | r.caccialanza@smatteo.pv.it | |
| Contact: Emanuele Cereda, MD, PhD | +390382501615 | e.cereda@smatteo.pv.it |
Locations
| Italy | |
| Fondazione IRCCS Policlinico San Matteo | Recruiting |
| 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
| 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 |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 9, 2019 | |||||||||
| First Posted Date ICMJE | May 14, 2019 | |||||||||
| Last Update Posted Date | February 12, 2021 | |||||||||
| Actual Study Start Date ICMJE | April 14, 2020 | |||||||||
| Estimated Primary Completion Date | October 30, 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
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
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Recruiting | |||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Riccardo Caccialanza, IRCCS Policlinico S. Matteo | |||||||||
| Study Sponsor ICMJE | IRCCS Policlinico S. Matteo | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | IRCCS Policlinico S. Matteo | |||||||||
| Verification Date | February 2021 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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