Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Head and Neck Cancer Clinical Trial

Official title:

Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827164
• Other study ID #: ROG-SCCI 09-001-1
• Secondary ID: UAB IRB X1212180
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2009
• Last updated: May 9, 2015
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Head and neck cancer (HNCa) patients often lose significant body weight and lean mass which is associated with higher mortality, greater fatigue, poorer quality of life, and reduced physical functioning. Because nutritional supplementation may not consistently improve lean body mass, resistance training may be beneficial. HNCa patients experience unique side effects that impact nutritional status, limiting generalization of exercise intervention study results in other cancer types to HNCa patients. Therefore, 44 HNCa patients will be enrolled in a randomized controlled trial with the following study aims:

Primary study aim: Because this pilot proposal is among the first to attempt a randomized controlled exercise trial in HNCa patients, the primary study aim examines feasibility (e.g., study acceptance, recruitment, intervention process evaluation, adherence, adverse events, retention). The investigators hypothesize that study procedures will require minor alterations in future studies.

Secondary study aim #1: Because effect sizes are necessary for planning efficacy trials, the proposal will compare the effect of a 12-week resistance training plus nutritional counseling intervention versus nutritional counseling alone on muscle strength, lean body mass, physical functioning, fatigue, and quality of life in HNCa patients receiving radiation with or without chemotherapy. The investigators hypothesize that patients receiving resistance training with nutritional counseling will demonstrate greater improvements in the outcomes when compared with participants receiving nutritional counseling alone.

Secondary study aim #2: To enhance adherence in future intervention trials, this proposal will determine resistance training and nutritional adherence rates and associated factors among HNCa patients using attendance records, exercise logs, diet records, self-administered survey, and medical record review. The investigators hypothesize that adherence rates will be lower than that of other cancer populations with correlates including demographic, medical, and psychosocial factors.

Assessments will occur at baseline (first week of radiation), week 6 (mid-intervention), and week 12 (post-intervention). Qualitative and quantitative (e.g., rates, 95% confidence intervals) will assess feasibility and mixed model ANOVA will examine group differences. This information is critical for the design of future resistance training efficacy trials in HNCa patients to prevent lean body mass loss in HNCa patients, potentially reducing mortality, minimizing fatigue, and improving physical functioning and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion criteria:

• 1st 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Laryngeal Cancer
• Laryngeal Neoplasms
• Pharyngeal Cancer

Intervention

Behavioral:
• Nutrition Counseling
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.
• Resistance Training
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Institute for Cancer Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in muscle strength	dynamometer measurement	baseline, week 6, and week 12	No
Secondary	Number of patients who adhere to cohort activity schedule	completion of exercise or diet recommendations	baseline, week 6, and week 12	No
Secondary	change in lean body mass	bioelectrical impedence	baseline, week 6, week 12	No
Secondary	change in physical functioning	physical performance by doing a semi-tandem, tandem, or side by side stance with the feet, an 8 foot walk time, and 5 chair rise and sits	baseline, week 6, week 12	No
Secondary	change in fatigue level	13-item Functional Assessment of Cancer Therapy-Fatigue scale	baseline, week 6, week 12	No
Secondary	change in quality of life	37-item Functional Assessment of Cancer Therapy-Head and Neck scale	baseline, week 6, week 12	No