Clinical trial NCT00756795: Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
Official title: Increasing Physical Activity of Patients With Head and Neck Cancer (I-PAP Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Generally, patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Regular physical activity improves emotional well-being, increases immunological response, improves wound healing, lessens fatigue and improves general functionality and quality of life.

This study will determine effectiveness of the 12-week exercise intervention program, determine if physically active patients differ in quality of life, depression and fatigue during the course of the study, and determine if the change in physical activity levels is related to changes in immune responses.

Detailed description: The general hypothesis of this research is that patients who have undergone treatments for Head Neck Cancer have a decreased quality of life and experience depression and fatigue. Increasing and sustaining physical activity of these patients will improve their emotional well-beings, increase their immunological response, improve wound healing, lessen fatigue and improve their general functionality and quality of life.

The purposes of this study are to: (1) determine the effectiveness of the 12-week exercise intervention program in increasing physical activity in head and neck cancer patients; (2) determine if physically active patients differ in quality of life, depression and fatigue during the course of the study; and (3) determine if the change in physical activity levels is related to changes in the immune responses in human.

Eligibility criteria: Inclusion Criteria:

1. Patients 19 years of age or above (Nebraska legal age).
2. Patients diagnosed with HNC who are seen at the University of Nebraska Medical Center.
3. Patients who have undergone chemotherapy, radiation and/or surgery for their cancer.
4. Patients who have completed their cancer treatment at least 3 months prior.
5. Patients who have consented to participate in this study with approval by their physicians.
6. Patients who have no significant mental impairment.

Exclusion Criteria:

1. Patients who are on enteral feeding.
2. Patients who are not able to walk or whose surgeons report that walking is not advisable.
3. Patients diagnosed with Lymphoma, Thyroid cancer or Melanoma.
4. Patients who are on antidepressant medications.
5. Patients who are unwilling to return to the clinic at the end of the study - after 12 weeks of intervention.
6. Patients participating in another research study involving a therapeutic intervention.
7. Patients with chronic medical and orthopedic conditions that would preclude physical activity (e.g., congestive heart failure, recent knee or hip replacements).
8. Patients who are at 18 months or more after the start of cancer treatment.

Primary outcomes:
measure: Self-report of physical activity behavior (duration, intensity and frequency)
timeFrame: Baseline and Post Intervention
Secondary outcomes:
measure: Plasma IL-6 Concentration
timeFrame: Baseline and Post Intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Alvin G Wee
role: PRINCIPAL_INVESTIGATOR
References: