Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

The Impact of Secondary Lymphedema After Head and Neck Cancer Treatment on Symptoms, Functional Status, and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098669
• Other study ID #: CDR0000669342
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: April 2, 2010
• Last updated: April 6, 2017
• Start date: December 2009
• Est. completion date: February 2012

Study information

• Verified date: April 2017
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

Description:

OBJECTIVES:

• To examine the association of secondary lymphedema, symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

• To examine the possible factors contributing to the development of secondary lymphedema in these patients.

OUTLINE: Participants undergo a physical and external (e.g., submental area) and internal (e.g., larynx, pharynx, and oral cavity) lymphedema examination. Demographics, background, and lymphedema treatment information are also collected. Participants' medical records with head and neck cancer information and treatment are reviewed.

Participants complete surveys on Vanderbilt Head and Neck Symptom (VHNSS), Lymphedema Symptom Intensity and Distress Survey Head and Neck (LSIDS-HN), Functional Assessment Cancer Therapy-Head Neck (FACT-HN), Quality of Life Scale, Hospital Anxiety and Depression Scale (HADS), and Body Image Scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosed with head and neck cancer

• At least 3 months since completion of head and neck cancer treatment

• Participating in the Pain and Symptom Management Program at the Vanderbilt-Ingram Cancer Center

• No current evidence of cancer

• No metastatic disease

PATIENT CHARACTERISTICS:

• No other active cancer

• Able to understand informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent chemotherapy or radiotherapy

Related Conditions & MeSH terms

• Cancer Survivor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphedema

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the severity of lymphedema with symptoms, functional status, and quality of life		Cross-sectional
Primary	Factors contributing to the development of secondary lymphedema		Cross-sectional Study