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

This study is currently recruiting participants.
Verified April 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01136824
First received: June 2, 2010
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Soft Tissue Sarcoma
 Other: Questionnaires

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Chemotherapy-induced Symptoms in Sarcoma Patients and the Impact of Tumor Burden

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To determine the extent of symptom burden and quality of life in sarcoma patients receiving AI chemotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sarcoma Subjects
Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI)
 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 assesments:

Demographic & health Trait anxiety Quality of life Nausea Expectations Anxiety & total mood disturbance Nausea & vomiting Multiple symptoms

  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

Soft tissue sarcoma patients treated with the adjuvant and neoadjuvant chemotherapy protocol of doxorubicin plus ifosfamide (AI)

Criteria

Inclusion Criteria:

  • Patients who are receiving doxorubicin plus ifosfamide (AI)

Exclusion Criteria:

  • There is no exclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136824

Contacts
Contact: Hussein Tawbi, MD 412-623-3483 tawbih@upmc.edu
Contact: Charles Horn, PhD 412-623-1417 hornc@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh, Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Hussein Tawbi, MD     412-623-3483     tawbih@upmc.edu    
Contact: Charles Horn, PhD     412-623-1417     hornc@upmc.edu    
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Hussein Tawbi, MD University of Pittsburgh
Principal Investigator: Charles Horn, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01136824     History of Changes
Other Study ID Numbers: 10-046
Study First Received: June 2, 2010
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Sarcoma
questionnaire
doxorubicin plus ifosfamide (AI)

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013