Renal Cell CancerNCT00979329
Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST
An observational study of Renal Cell Cancer and Colorectal Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer, Colorectal Cancer, GIST
- What is being tested?
- Questionnaires
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with metastatic renal cell cancer or GIST who will be treated with Sunitinib or Sorafenib
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Nijmegen st Radboud
Nijmegen, 6525 GH
About this study
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
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.
Read the 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.
- Conditions
- Renal Cell Cancer, Colorectal Cancer, GIST
- Being tested
- Questionnaires
- Keywords
- sunitinib, sorafenib, fatigue, depression, quality of life, metastatic RCC, colorectal cancer, GIST
- Medical subject headings
- Carcinoma, Renal Cell, Colorectal Neoplasms, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| mRCC or GIST treated with sunitinib/sorafenib | Not described Receives: Other: Questionnaires |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.M.L. van Herpen, MD, Phd, Principal investigator, UMCN st Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979329
- Sponsor's protocol ID
- UMCNONCO20082
- Status last verified
- Nov 2017
- First submitted
- 17 Sep 2009
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00979329
- Acronym / sponsor ID
- UMCNONCO20082
- Conditions
- Renal Cell Cancer, Colorectal Cancer, GIST
- Keywords
- sunitinib, sorafenib, fatigue, depression, quality of life, metastatic RCC, colorectal cancer, GIST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRCC or GIST treated with sunitinib/sorafenib | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with metastatic renal cell cancer or GIST who will be treated with Sunitinib or Sorafenib
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesDuring 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. | Other | mRCC or GIST treated with sunitinib/sorafenib |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.M.L. van Herpen, MD, Phd principal investigator
UMCN st Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Cancer and Colorectal Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.