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Intensive Symptom Management for Head and Neck Cancer

N/A
Recruiting
Led By Anurag K Singh
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with biopsy-proven, non-metastatic squamous cell carcinoma of head and neck
Able to provide informed consent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 or 6 month
Awards & highlights

Study Summary

This trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer.

Who is the study for?
Adults diagnosed with non-metastatic head and neck cancer, who can consent in English and are starting curative-intent radiation therapy soon. They must have a caregiver able to provide informed consent in English without payment. Pregnant individuals, those with metastatic cancer or only eligible for palliative care, or unable to follow the trial protocol cannot participate.Check my eligibility
What is being tested?
The INSIGHT Trial is testing whether intensive symptom surveillance guided by machine learning improves patient outcomes compared to standard symptom management during and after radiation therapy for patients with non-metastatic head and neck cancers.See study design
What are the potential side effects?
Since this trial focuses on monitoring symptoms rather than administering drugs, there are no direct side effects from interventions like questionnaires or quality-of-life assessments. However, participants may experience discomfort discussing their symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of throat or mouth cancer that has not spread.
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I can understand and sign the consent form in English.
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I am 18 years old or older.
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My caregiver understands English and can make informed decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 or 6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 or 6 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first acute care visit
Secondary outcome measures
Change in Health-related quality of life EORTC QLQ-C30
Change in caregiver burden
Change in financial burden
+5 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181
73%
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%
Blurred vision
2%
Acute kidney injury
2%
Hemorrhoids
2%
Hypothyroidism
2%
Urticaria
2%
Palpitations
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%
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

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (quality of life questionnaire)Experimental Treatment2 Interventions
Patients complete a quality of life questionnaires over 10-15 minutes BIW during standard of care radiation therapy and QW for the first month after completing standard of care radiation therapy course, and then once monthly for 6 months.
Group II: Group B (standard symptom management)Active Control1 Intervention
Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course.

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,658 Total Patients Enrolled
Anurag K SinghPrincipal InvestigatorRoswell Park Cancer Institute
5 Previous Clinical Trials
1,714 Total Patients Enrolled

Media Library

Intensive Symptom Surveillance Clinical Trial Eligibility Overview. Trial Name: NCT05338905 — N/A
Head and Neck Squamous Cell Carcinoma Research Study Groups: Group B (standard symptom management), Group A (quality of life questionnaire)
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Intensive Symptom Surveillance Highlights & Side Effects. Trial Name: NCT05338905 — N/A
Intensive Symptom Surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338905 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still open for this research project?

"Affirmative. Clinicaltrials.gov shows that this medical research study is actively searching for participants, with the post date being September 26th 2022 and a most recent update on the same day. Subsequently, 200 people are required to join from one particular venue."

Answered by AI

How many individuals have signed up to take part in this scientific experiment?

"Indeed, the clinical trial is currently recruiting participants. The listing was first posted on September 26th of this year and has since been updated once again. 200 patients need to be recruited from a single centre for the study's success."

Answered by AI
~48 spots leftby Oct 2024