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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01136824
First received: June 2, 2010
Last updated: July 26, 2016
Last verified: July 2016
  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:


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 ]

Enrollment: 11
Study Start Date: June 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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 assessments:

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   (Adult, Senior)
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
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: NCT01136824

Locations
United States, Pennsylvania
University of Pittsburgh, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
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

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: July 26, 2016
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
Ifosfamide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016