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Cognitive Behavioral Resistance Exercise for Head and Neck Cancer
N/A
Waitlist Available
Led By Brian C Focht, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All participants must be free of severe heart or systemic disease or medical contraindications that would make supervised RE participation unsafe
Patients with locally advanced human papillomavirus (HPV)+ stage III-IV head and neck (HN) squamous cell carcinomas undergoing concurrent chemotherapy and radiation therapy. Patients with prior cancers or post-surgical patients needing adjuvant therapy will not be allowed to participate in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6-month
Awards & highlights
Study Summary
This trialwill look at how exercise and nutrition can help head and neck cancer patients undergoing chemoradiation treatment improve their muscle mass, physical function, and quality of life.
Who is the study for?
This trial is for adults over 18 with head and neck cancer, specifically HPV+ stage III-IV squamous cell carcinomas, who are undergoing chemoradiation. They must be cleared by their doctor to do resistance exercises and have no severe heart conditions or other medical issues that make exercise unsafe. Pregnant or nursing women and those with prior cancers not eligible.Check my eligibility
What is being tested?
The study tests a cognitive-behavioral program combined with resistance training during standard chemoradiation treatment for head and neck cancer patients. It aims to see if this approach helps maintain muscle mass, physical function, and quality of life.See study design
What are the potential side effects?
While the trial itself focuses on exercise intervention which typically has minimal side effects such as muscle soreness or fatigue, participants will also undergo standard chemoradiation which can cause nausea, fatigue, skin reactions among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have severe heart disease or other conditions that make exercise unsafe.
Select...
I have HPV+ stage III-IV head and neck cancer and am undergoing chemotherapy and radiation.
Select...
I am over 18 and have approval to do resistance exercises during treatment.
Select...
I am willing and able to join in physical activities.
Select...
I am scheduled for a specific radiation therapy course lasting about 6.5 to 7 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence of Intervention
Anthropometric measurements
Body composition
+6 moreSide effects data
From 2022 Phase 3 trial • 87 Patients • NCT0206618173%
Fatigue
71%
Palmar-plantar erythrodysesthesia syndrome
63%
Hypertension
61%
Papulopustular rash
55%
Diarrhea
51%
Nausea
39%
Myalgia
37%
Alopecia
35%
Arthralgia
33%
Abdominal pain
31%
Anorexia
27%
Vomiting
22%
Mucositis oral
22%
Constipation
18%
Anemia
18%
Alanine aminotransferase increased
16%
Platelet count decreased
14%
Pruritus
14%
Hyperglycemia
14%
Rash maculo-papular
14%
Skin and subcutaneous tissue disorders - Other, specify
12%
Aspartate aminotransferase increased
12%
Rash acneiform
12%
Peripheral sensory neuropathy
10%
Investigations - Other, specify
10%
Dry skin
10%
Neutrophil count decreased
10%
Blood bilirubin increased
8%
Back pain
8%
Headache
8%
Nervous system disorders - Other, specify
8%
Pain in extremity
6%
General disorders and administration site conditions - Other, specify
6%
Skin infection
6%
White blood cell decreased
6%
Hypercalcemia
6%
Hypokalemia
6%
Musculoskeletal and connective tissue disorder - Other, specify
6%
Dizziness
6%
Respiratory, thoracic and mediastinal disorders - Other, specify
6%
Eye disorders - Other, specify
6%
Hyperkalemia
6%
Pain
6%
Alkaline phosphatase increased
6%
Hypocalcemia
6%
Cough
4%
Flushing
4%
Tinnitus
4%
Dental caries
4%
Gastrointestinal disorders - Other, specify
4%
Hemoglobin increased
4%
Weight loss
4%
Metabolism and nutrition disorders - Other, specify
4%
Dysgeusia
4%
Anxiety
4%
Irregular menstruation
4%
Menorrhagia
4%
Sore throat
4%
Lymphocyte count decreased
4%
Hyperuricemia
4%
Non-cardiac chest pain
4%
Infections and infestations - Other, specify
4%
Hypernatremia
4%
Hypoglycemia
4%
Scalp pain
4%
Dry mouth
2%
Hypothyroidism
2%
Hemorrhoids
2%
Blurred vision
2%
Palpitations
2%
Acute kidney injury
2%
Leukocytosis
2%
Myocardial infarction
2%
Vertigo
2%
Anal hemorrhage
2%
Dysphagia
2%
Esophageal pain
2%
Periodontal disease
2%
Fever
2%
Sinusitis
2%
Urinary tract infection
2%
Bruising
2%
Dermatitis radiation
2%
Cholesterol high
2%
Creatinine increased
2%
Neck pain
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Concentration impairment
2%
Memory impairment
2%
Spasticity
2%
Depression
2%
Insomnia
2%
Allergic rhinitis
2%
Productive cough
2%
Sleep apnea
2%
Pregnancy, puerperium and perinatal conditions - Other, specify
2%
Dry eye
2%
Lymphedema
2%
Chest pain - cardiac
2%
Heart failure
2%
Gastric perforation
2%
Hypertriglyceridemia
2%
Dyspnea
2%
Cardiac disorders - Other, specify
2%
Gastroesophageal reflux disease
2%
Oral dysesthesia
2%
Chills
2%
Hypophosphatemia
2%
Chest wall pain
2%
Psychiatric disorders - Other, specify
2%
Hematuria
2%
Urinary tract obstruction
2%
Dysmenorrhea
2%
Skin hypopigmentation
2%
Urticaria
2%
Unintended pregnancy
2%
Flu like symptoms
2%
Nail infection
2%
Pancreatitis
2%
Blood and lymphatic system disorders - Other, specify
2%
Oral pain
2%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Sorafenib Tosylate)
Arm II (Placebo)
Crossover Group
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (resistance exercise, counseling)Experimental Treatment5 Interventions
Patients undergo personalized resistance exercises over 1 hour daily. Patients receive dietary counseling over 60 minutes at week 1 and then over 15-30 minutes weekly for up to 6 weeks. Patients also receive group-based behavioral counseling BIW in weeks 1-8, QW in weeks 9-12, and then twice a month in weeks 13-24.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,666 Total Patients Enrolled
Brian C Focht, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
3 Previous Clinical Trials
570 Total Patients Enrolled
Dukagjin Blakaj, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that makes it unsafe for me to exercise.I don't have severe heart disease or other conditions that make exercise unsafe.I have a severe heart condition or other serious illness that prevents me from exercising.I have HPV+ stage III-IV head and neck cancer and am undergoing chemotherapy and radiation.I am over 18 and have approval to do resistance exercises during treatment.I am willing and able to join in physical activities.My cancer diagnosis is not head and neck cancer.I am unable to understand and give consent for treatment.I am scheduled for a specific radiation therapy course lasting about 6.5 to 7 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (resistance exercise, counseling)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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