Benefits of Exercise Training in Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
Benefits of Resistance Exercise Training in Locally Advanced Head and Neck Cancer Patients Undergoing Organ-Preserving Definitive Therapy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- The University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48105
- Veterans Affairs (VA) Ann Arbor Healthcare System
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with American Joint Committee on Cancer (AJCC) stage II-IV head and neck squamous cell carcinoma who are beginning first-line non-surgical treatment with radiotherapy (with or without chemotherapy or targeted agents), and who are capable of understanding and adhering to the protocol requirements.
- Patients must be willing to comply with the study procedures and visits
Exclusion Criteria:
- Active cardiopulmonary disease
- Substantial dementia (based on Folstein Mini Mental State Examination <24 out of 30)
- Acute medical conditions, such as acute flare-up of joint condition or infection
- Participants must not be actively receiving physical therapy, at time of enrollment, or actively exercising 2 or more hours a day, with the intent to continue that regimen
- Patients refusing a percutaneous endoscopic gastrotomy (PEG) Tube needed for nutrition, as determined necessary by treating physician
- Patients are actively being treated for another cancer at the time of enrollment.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Usual Care
Participants allocated to usual care will receive their usual treatment program which will include dietician counseling as needed.
As part of standardized care, participants will not be encouraged to begin a new exercise program(patients needing physical therapy at time of enrollment will be excluded.
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Experimentell: Resistance Exercise Training
If you are randomized to the resistance exercise training (RET) program, you will undergo up to three 1-hour training sessions per week for 7 weeks during radiation therapy. There will be up to 3 sessions per week lasting up to one hour, and will generally include a 10- minute warm-up, rest periods and 10 minute cool-down. The goal is to perform the exercises as tolerated in week 1 and increase intensity as the weeks progress. Weights will be added each week depending on your tolerance to them. Rest periods will be incorporated into the exercises as needed. The intensity and weights used will be customized to the individual. During the home program portion, you will be asked to keep a weekly log of your exercises and the trainer will call you weekly to go over the log and provide support. At week 11 the trainer will meet with you to go over your individualized program and review your technique. |
If you are randomized to the resistance exercise training (RET) program, you will undergo up to three 1-hour training sessions per week for 7 weeks during radiation therapy. There will be up to 3 sessions per week lasting up to one hour, and will generally include a 10- minute warm-up, rest periods and 10 minute cool-down. The goal is to perform the exercises as tolerated in week 1 and increase intensity as the weeks progress. Weights will be added each week depending on your tolerance to them. Rest periods will be incorporated into the exercises as needed. The intensity and weights used will be customized to the individual. During the home program portion, you will be asked to keep a weekly log of your exercises and the trainer will call you weekly to go over the log and provide support. At week 11 the trainer will meet with you to go over your individualized program and review your technique. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of lean body mass.
Tidsram: 14 weeks
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Lean body mass will be analyzed at baseline, 3, 5, and 7-weeks (representing the last week of cancer treatment and end of on-site RET), 11-weeks (first clinic follow-up) and 14-weeks (second clinic follow-up and end of home-based RET program) for patients on both arms of the study.
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14 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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The effect of resistance exercise training (RET) versus usual care (UC) on the preservation of muscle strength.
Tidsram: 14 weeks
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Upper and lower body strength will be analyzed at baseline, 3, 5, and 7-weeks (representing the last week of cancer treatment and end of on-site RET), 11-weeks (first clinic follow-up) and 14-weeks (second clinic follow-up and end of home-based RET program) for patients on both arms of the study.
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14 weeks
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The effect of resistance exercise training (RET) versus usual care (UC) on six minute walk distance
Tidsram: 14 weeks
|
The distance walked in six minutes at baseline will be compared to the distance walked at 14 weeks for both groups.
These finding will then be compared between the groups.
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14 weeks
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Shruti Jolly, MD, University of Michigan Rogel Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011.070
- HUM 33897 (Annan identifierare: University of Michigan IRBMED)
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