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

NCT00979329 | Completed

• 1 other identifier: UMCNONCO20082
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Renal Cell Cancer; Colorectal Cancer; GIST

Keywords

sunitinib; sorafenib; fatigue; depression; quality of life; metastatic RCC; colorectal cancer; GIST

Study Arms (1)

mRCC or GIST treated with sunitinib/sorafenib

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

mRCC or GIST treated with sunitinib/sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

University Medical Center Nijmegen st Radboud

Nijmegen, 6525 GH, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Colorectal Neoplasms; Fatigue; Depression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• C.M.L. van Herpen, MD, Phd

  UMCN st Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2015
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

NL (1)