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Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00979329
First received: September 17, 2009
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to assess the influence of Sunitinib and Sorafenib on fatigue, quality of life and depression in patients with metastatic renal cell or colorectal cancer or GIST. In order to get more insight in the mechanism of vascular endothelial growth factor (VEGF) related fatigue and if possible to come to a resolution for this side effect.


Condition Intervention
Renal Cell Cancer
Colorectal Cancer
GIST
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study on the Influence of Sunitinib and Sorafenib on Fatigue, Quality of Life and Depression in Patients With Metastatic Renal Cell Cancer or GIST

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
mRCC or GIST treated with sunitinib/sorafenib Other: Questionnaires
During the study three questionnaires must repeatedly be completed in by the patients: the BDI (PC) a depression scale, the EORTC-QLQ a quality of life assessment and the CIS20r, a fatigue scale and patients must fill in their medication on a list.

Detailed Description:

When cure is not longer possible, cancer patients enter the palliative phase. For many types of cancer several treatment options are available. The goal of this treatment is to prolong survival, but maintenance or even improvement of quality of life is of equal importance. The currently available systemic treatment options consist of conventional cytotoxic therapy, hormonal therapy, immunotherapy and the so-called targeted therapies. Combinations of these therapies are also being used. Targeted therapy concerns the application of a new class of drugs that are specifically directed against one or more well-defined molecular targets that are relevant for carcinogenesis, cell cycle regulation, tumour progression, metastasis, tumour angiogenesis and/or apoptosis. Today, the most successful drugs in this class are directed against the vascular endothelial growth factor (VEGF) and the epidermal growth factor receptor (EGFR). There is an explosive development ongoing in this field and many new drugs become available that have new targets or inhibit a combinations of targets. Meanwhile, targeted therapy has shown efficacy in many types of cancer and is registered for several indications.

The toxicity profile of targeted therapies is still largely unknown, and the aetiology of many known side effects has not been clarified. This implies that the effective treatment of side effects is in an early phase of development. Given the impact of side effects on the quality of life of a patient, increased knowledge on this topic is urgently required. Currently only a few systematic studies are available that address this issue. At the moment, three targeted therapies that are directed against VEGF are registered and used in the Netherlands: Sunitinib (Sutent®) and Sorafenib (Nexavar ®) both oral drugs and Bevacizumab (Avastin®), an intravenously drug.

In this study we will focus on fatigue, quality of life and depression in patients with metastatic cancer, treated with Sunitinib and Sorafenib. Fatigue is one of the most frequent side effects of targeted therapy that are directed against VEGF and that can have a huge influence on the quality of life. The incidence of fatigue in patients using Sunitinib in phase I studies was 70% and the fatigue was often dose limiting. (1-4) In phase II-III studies the incidence was 27% - 51%. 5,6 In a phase III randomized, double-blind placebo-controlled trial of Sorafenib the incidence of fatigue in the Sorafenib group was 37% and in the placebo group 28%. (7) It is possible that fatigue is a symptom of depression or anxiety, alternatively, prolonged fatigue in itself can lead to depression or anxiety.8 There has been found a significant and positive correlation between anxiety and depressive symptoms and fatigue after treatment for cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with metastatic renal cell cancer or GIST who will be treated with Sunitinib or Sorafenib

Criteria

Inclusion Criteria:

  • patients with metastatic renal cell or GIST for whom treatment with Sunitinib or Sorafenib is planned
  • Karnofsky score > 70%
  • age > 18 year
  • written informed consent for questionnaires

Exclusion Criteria:

  • contra-indications for treatment with Sunitinib or Sorafenib
  • patients who do not speak or write the Dutch language adequately
  • previous systemic treatment within the last 7 days before start with the study, with Sunitinib, Sorafenib or Bevacizumab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979329

Contacts
Contact: C.M.L. van Herpen, Md, Phd 31 24 3610353 c.vanherpen@onco.umcn.nl
Contact: S. Mulder, Md 31 24 3610353 s.mulder@onco.umcn.nl

Locations
Netherlands
University Medical Center Nijmegen st Radboud Recruiting
Nijmegen, Netherlands, 6525 GH
Contact: C.M.L van Herpen       c.vanherpen@onco.umcn.nl   
Principal Investigator: C.M.L van Herpen, Md, Phd         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C.M.L. van Herpen, MD, Phd UMCN st Radboud
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00979329     History of Changes
Other Study ID Numbers: UMCNONCO20082
Study First Received: September 17, 2009
Last Updated: October 6, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
sunitinib
sorafenib
fatigue
depression
quality of life
metastatic RCC
colorectal cancer
GIST

Additional relevant MeSH terms:
Sorafenib
Carcinoma, Renal Cell
Colorectal Neoplasms
Depression
Depressive Disorder
Fatigue
Adenocarcinoma
Behavioral Symptoms
Carcinoma
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Kidney Diseases
Kidney Neoplasms
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Signs and Symptoms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib

ClinicalTrials.gov processed this record on November 20, 2014