Identifying and treating vitamin deficiencies in patients after esophageal or gastric cancer surgery
Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
This study is testing if giving specific vitamin supplements to adults who have had surgery for esophageal or gastric cancer can help improve their nutrition and quality of life after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sittard, Limburg) |
| Trial ID | NCT05281380 on ClinicalTrials.gov |
What this trial studies
This study aims to address the nutritional deficiencies that often occur after surgery for esophageal and gastric cancers. It focuses on patients aged 18 and older who have undergone esophagectomy or subtotal gastrectomy, assessing their vitamin levels before and after tailored supplementation. The intervention includes two specific supplements designed for each type of surgery, with follow-up measurements at 6, 12, and 24 months to evaluate the effectiveness of the treatment. The goal is to improve the nutritional status and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have had esophagectomy or subtotal gastrectomy for cancer without signs of disease recurrence.
Not a fit: Patients who have undergone wedge resection, have recurrent malignancy, or are unable to take supplements due to mental or swallowing difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the nutritional recovery and overall quality of life for patients recovering from esophagogastric surgeries.
How similar studies have performed: While studies on postoperative nutritional status are limited, this approach to specifically target vitamin deficiencies in esophagogastric cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A potential subject who meets any of the following criteria will be included for participation in this study: * Patients ≥18 years of age who underwent an esophagectomy or (sub)total gastrectomy for malignancy with no signs of postoperative recurrence of disease. * Written voluntary informed consent (IC). Exclusion Criteria: - A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients that underwent a wedge resection of the stomach * Malignant disease recurrence * Metastases * Patients that are not capable to take supplementation due to altered mental status or swallow difficulties * No signed informed consent * Patients who are receiving chemotherapy * Patients with high vitamin status at baseline
Where this trial is running
Sittard, Limburg
- ZuyderlandMC — Sittard, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Guy Vijgen, MD,PhD — Zuyderland MC
- Study coordinator: Guy Vijgen, MD, PhD
- Email: g.vijgen@zuyderland.nl
- Phone: 0031884597777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.