Resistance Training During Radiation Therapy for Pharyngeal or Laryngeal Cancer

NCT ID: NCT00827164

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-04-30

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.

Detailed 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.

Conditions

Head and Neck Cancer; Pharyngeal Cancer; Laryngeal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance Training

Intervention Type: 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.

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.

Group Type: OTHER

Nutrition Counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

nutrition

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Institute for Cancer Research

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Laura Q. Rogers, MD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Q Rogers, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19360748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19340875 (View on PubMed)

Other Identifiers

UAB IRB X121218021

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ROG-SCCI 09-001-1

Identifier Type: -

Identifier Source: org_study_id