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OpenTrials
Completed

NCT Number: NCT01098669

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association between the severity of lymphedema with symptoms, functional status, and quality of life

    Time frame: Cross-sectional

  2. Factors contributing to the development of secondary lymphedema

    Time frame: Cross-sectional Study

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 5, 2010
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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