Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05427032 |
| Other study ID # |
HRQoL PRRT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2009 |
| Est. completion date |
December 10, 2018 |
Study information
| Verified date |
June 2022 |
| Source |
Uppsala University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Neuroendocrine tumours (NETs) can arise in different locations in the body, and may give rise
to hormonal symptoms, which may affect the patients' health-related quality of life (HRQoL).
Up to four cycles of peptide receptor radionuclide therapy (PRRT) have been shown effective
for symptom alleviation and prolonging survival. The aim of this study is to assess the
patient's perspective, regarding changes in their HRQoL during, and at long-term follow-up
after, PRRT. Patients with NET will rate their HRQoL before PRRT cycles one and four, and 1-8
years after PRRT. The patients' HRQoL will be compared to a matched reference population. The
investigators hope that this study will reveal specific care needs for patients wiht NET and
may provide information that will make it possible to deliver a more person-centered care.
Description:
The inclusion criteria for PRRT were tumour somatostatin receptor expression higher than that
in the normal liver found on somatostatin receptor scintigraphy (Krenning score 3 and 4), or
on 68Ga-DOTATOC positron emission tomography (PET), and sufficient bone marrow, liver and
kidney function. DOTATATE was labelled in house with 177Lu (IDB Holland BV, Noord Brabant,
Netherlands). Up to nine cycles were given, yet a majority of patients received four cycles
of PRRT.
The patients' medical records were reviewed regarding functional status (functioning versus
non-functioning tumours), gender, age at diagnosis and at 1st PRRT, marital and employment
status, PRRT cycles received, previous treatments and body mass index (BMI).
HRQoL was assessed using the questionnaires for cancer in general, EORTC QLQ-C30, and the
gastrointestinal NET-specifically EORTC QLQ-GINET21 at every cycle.
From a large random sample (n=4,910) of the Swedish adult population, a reference population
was extracted. They all had chronical diseases (diabetes, cardiac, respiratory, renal or
other specified conditions) and were age and gender matched. The reference population
completed only the QLQ-C30 questionnaire.
In order to investigate how HRQoL developed during the eight years after PRRT, the
questionnaires were sent to 58 patients.
