Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

NCT00827164 | Completed Phase 2

• 2 other identifiers: ROG-SCCI 09-001-1UAB IRB X121218021
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to examine the effect of resistance training on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in head and neck cancer patients receiving radiation therapy.

Conditions

Head and Neck Cancer; Pharyngeal Cancer; Laryngeal Cancer

Keywords

head and neck cancer; resistance training; nutrition counseling; radiation therapy; pharyngeal or laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• Number of head and neck cancer patients recruited to participate

  to test the feasibility of a randomized controlled exercise trial in head and neck cancer patients receiving radiation therapy

  up to 24 months

Secondary Outcomes (6)

• change in muscle strength

  baseline, week 6, and week 12

• Number of patients who adhere to cohort activity schedule

  baseline, week 6, and week 12

• change in lean body mass

  baseline, week 6, week 12

• change in physical functioning

  baseline, week 6, week 12

• change in fatigue level

  baseline, week 6, week 12

Study Arms (2)

Resistance Training

EXPERIMENTAL

Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients will receive guidance in a safe and appropriate exercise regimen based on specific medical history and preference. An exercise specialist will telephone weekly for consultation and support once per week for the final 6 weeks.

Behavioral: Resistance Training

Nutrition Counseling

OTHER

Patients will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.

Behavioral: Nutrition Counseling

Interventions

Nutrition Counseling BEHAVIORAL

Patients will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.

Also known as: nutrition

Nutrition Counseling

Resistance Training BEHAVIORAL

Patient will meet with an exercise specialist once per week for the first 6 weeks. Patients will receive guidance in a safe and appropriate exercise regimen based on specific medical history and preference. An exercise specialist will telephone weekly for consultation and support once per week for the final 6 weeks.

Resistance Training

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st time diagnosis of head and neck cancer (stage I, II, III, or IV; pharyngeal, laryngeal, nasopharyngeal, oral, floor of mouth, tongue, palate, maxillary, or mandibular)
• age 19 to 90 years old
• English speaking
• radiation therapy planned or underway \< 1 week
• Karnofsky performance status ≥ 60%, and
• able to stand

You may not qualify if:

• dementia or organic brain syndrome
• severe emotional distress
• active schizophrenia
• quadriplegia or loss of use of limbs or torso
• tendon rupture
• muscle tear
• another diagnoses of cancer in the past 5 years, and
• oncologist refuses to allow screening for possible study participation

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Institute for Cancer Research: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Rogers LQ, Rao K, Malone J, Kandula P, Ronen O, Markwell SJ, Courneya KS, Robbins KT. Factors associated with quality of life in outpatients with head and neck cancer 6 months after diagnosis. Head Neck. 2009 Sep;31(9):1207-14. doi: 10.1002/hed.21084.

  PMID: 19360748 BACKGROUND

• Rogers LQ, Malone J, Rao K, Courneya KS, Fogleman A, Tippey A, Markwell SJ, Robbins KT. Exercise preferences among patients with head and neck cancer: prevalence and associations with quality of life, symptom severity, depression, and rural residence. Head Neck. 2009 Aug;31(8):994-1005. doi: 10.1002/hed.21053.

  PMID: 19340875 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Pharyngeal Neoplasms; Laryngeal Neoplasms

Interventions

Nutritional Status; Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura Q Rogers, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)