Head and Neck CancerPhase 1NCT01332682
Resistance Training and Physical Functioning in Head and Neck Cancer Patients
A Phase 1 study testing Nutrition Counseling and Resistance Training and Nutrition Counseling in people with Head and Neck Cancer and Pharyngeal Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer
- What is being tested?
- Nutrition Counseling and Resistance Training and Nutrition Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- dementia or organic brain syndrome
- severe emotional distress
- active schizophrenia
- quadriplegia or loss of use of limbs or torso
- tendon rupture
- muscle tear
Show all 9Show fewer
- cancer recurrence
- another diagnoses of cancer in the past 5 years, and
- oncologist refuses to allow screening for possible study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
About this study
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.
Read the 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 safety and 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
- Being tested
- Nutrition Counseling, Resistance Training and Nutrition Counseling
- Keywords
- head and neck cancer, resistance training, nutrition counseling, pharyngeal or laryngeal cancer
- Medical subject headings
- Head and Neck Neoplasms, Pharyngeal Neoplasms, Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition CounselingBehavioural
Also called nutrition
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 and Nutrition CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training and Nutrition Counseling | Experimental | Not described Receives: Behavioral: Resistance Training and Nutrition Counseling |
| Nutrition Counseling | Other | Not described Receives: Behavioral: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of head and neck cancer patients
adverse events
Measured: daily (up to 12 weeks)
Secondary outcomes (7)
change in muscle strength
dynamometer measurement
Measured: baseline, week 6, and week 12
Number of patients who adhere to cohort activity schedule
completion of exercise or diet recommendations
Measured: baseline, week 6, and week 12
change in lean body mass
bioelectrical impedence
Measured: baseline, week 6, week 12
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
Measured: baseline, week 6, week 12
change in fatigue level
13-item Functional Assessment of Cancer Therapy-Fatigue scale
Measured: baseline, week 6, week 12
change in quality of life
37-item Functional Assessment of Cancer Therapy-Head and Neck scale
Measured: baseline, week 6, week 12
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
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
- Investigators
- Laura Q Rogers, MD, MPH, Principal investigator, Southern Illinois University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332682
- Sponsor's protocol ID
- SCCI-09-001-A
- Other IDs
- SCRIHS 07-164
- Status last verified
- Oct 2023
- First submitted
- 7 Apr 2011
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19360748Rogers 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.
PubMed 19340875Rogers 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.
PubMed 22847995
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training and Physical Functioning in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01332682
- Acronym / sponsor ID
- SCCI-09-001-A
- Conditions
- Head and Neck Cancer, Pharyngeal Cancer, Laryngeal Cancer
- Keywords
- head and neck cancer, resistance training, nutrition counseling, pharyngeal or laryngeal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 safety and 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training and Nutrition Counseling | Experimental | Behavioral: Resistance Training and Nutrition Counseling |
| Nutrition Counseling | Other | Behavioral: Nutrition Counseling |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- dementia or organic brain syndrome
- severe emotional distress
- active schizophrenia
- quadriplegia or loss of use of limbs or torso
- tendon rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition CounselingAlso: nutritionPatients 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. | Behavioural | Nutrition Counseling |
| Resistance Training and Nutrition CounselingPatient 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. | Behavioural | Resistance Training and Nutrition Counseling |
Primary outcome
safety of head and neck cancer patients
Time frame: daily (up to 12 weeks)
adverse events
7 secondary outcomes
change in muscle strength
Time frame: baseline, week 6, and week 12
Number of patients who adhere to cohort activity schedule
Time frame: baseline, week 6, and week 12
change in lean body mass
Time frame: baseline, week 6, week 12
change in physical functioning
Time frame: baseline, week 6, week 12
change in fatigue level
Time frame: baseline, week 6, week 12
change in quality of life
Time frame: baseline, week 6, week 12
Number of head and neck cancer patients recruited to participate
Time frame: up to 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 19360748Rogers 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.
- Background: PubMed 19340875Rogers 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.
- Results publication: PubMed 22847995Rogers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Q Rogers, MD, MPH principal investigator
Southern Illinois University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nutrition Counseling and Resistance Training and Nutrition Counseling in people with Head and Neck Cancer and Pharyngeal Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of head and neck cancer patients (time frame: daily (up to 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01332682, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.