Resistance Training and Physical Functioning in Head and Neck Cancer Patients

NCT01332682 | Completed Phase 1

• 2 other identifiers: SCCI-09-001-ASCRIHS 07-164
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this feasibility study is to examine the safety and 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; pharyngeal or laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• safety of head and neck cancer patients

  adverse events

  daily (up to 12 weeks)

Secondary Outcomes (7)

• 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 and Nutrition Counseling

EXPERIMENTAL

Behavioral: Resistance Training and Nutrition Counseling

Nutrition Counseling

OTHER

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 and Nutrition Counseling BEHAVIORAL

Patient will meet with an exercise specialist once per week for the first 6 weeks. Patient 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. Also, patient 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.

Resistance Training and Nutrition Counseling

Eligibility Criteria

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

You may qualify if:

• cancer of the oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland
• ≥ 18 years of age
• English speaking
• radiation therapy planned or underway \< 1 week, 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
• cancer recurrence
• 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

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (3)

• 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

• Rogers LQ, Anton PM, Fogleman A, Hopkins-Price P, Verhulst S, Rao K, Malone J, Robbs R, Courneya KS, Nanavati P, Mansfield S, Robbins KT. Pilot, randomized trial of resistance exercise during radiation therapy for head and neck cancer. Head Neck. 2013 Aug;35(8):1178-88. doi: 10.1002/hed.23118. Epub 2012 Jul 30.

  PMID: 22847995 RESULT

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

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: April 7, 2011
• First Posted: April 11, 2011
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)