Fatigue and Quality of Life in Patients With Neuroendocrine Neoplasia

NCT04557137 | Unknown

• 1 other identifier: 1-10-72-1-20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous studies describe HRQoL in other cancer types, whereas only sparse research has been done in NEN patients. We wish to investigate HRQol in NEN patients. Using a validated generic tool with normative values derived from a background population, allows us to compare the values healthy controls. Methods Study A: A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC). Study B: A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Conditions

Neuroendocrine Tumors (NET) Health Related Qualito of Life (HRQoL)

Outcome Measures

Primary Outcomes (1)

• NET and NEC

  HRQoL

  12 months

Study Arms (2)

NET

Study A: A cross-sectional study that investigates 250 patients (Cohort A) with neuroendocrine neoplasia, encompassing both patients with neuroendocrine tumors (NET) and neuroendocrine carcinomas (NEC). Study B:

Newly diagnosed NET

A prospective study that investigates 30 newly diagnosed NET patients over three months (Cohort B) who are offered palliative treatment with somatostatin analogues.

Drug: Somatostatin analog

Interventions

Somatostatin analog DRUG

120 mg ipstyl every 28 days

Newly diagnosed NET

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All newly diagnosed NET and NEC patients All patients will be recruited from the department of Hepatology and Gastroenterology and at the Department of Oncology, at Aarhus University Hospital. Inclusion will happen at standard follow-up visits for patients in Cohort A and at first visit/time of diagnosis and at three-month follow-up for patients in Cohort B. Inclusion time is expected to be 9-10 months.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Gitte Dam

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Gitte Dam

CONTACT

31562547; gitdam@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 21, 2020

Record last verified: 2020-09

Locations

DK (1)