Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Soft Tissue Sarcoma Clinical Trial

Official title:

Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136824
• Other study ID #: 10-046
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: July 26, 2016
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. There will be no change in the treatment plan for these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are receiving doxorubicin plus ifosfamide (AI)

Exclusion Criteria:

• There is no exclusion criteria

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• Questionnaires
Subjects will be given a series of questionnaires to assess the effect of AI chemotherapy, and the possible role of tumor load, on the amount of symptoms. The extent of nausea, vomiting, fatigue, anxiety, sleep disturbance, and cognitive changes will be measured. In adjuvant chemotherapy patients, we will also assess the relationship between tumor size and amount of chemotherapy-induced symptoms. These questionnaires will involve the following assessments: Demographic & health Trait anxiety Quality of life Nausea Expectations Anxiety & total mood disturbance Nausea & vomiting Multiple symptoms

Locations

Country	Name	City	State
United States	University of Pittsburgh, Hillman Cancer Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy.		2 years	No