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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 or 6 month

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

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Acute kidney injury

Blurred vision

Hemorrhoids

Hypothyroidism

Urticaria

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,607 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

Recent research and studies

clinicaltrials.govStudy

Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial

2022. "Intensive Symptom Surveillance Guided by Machine Learning-Directed Risk Stratification in Patients With Non-Metastatic Head and Neck Cancer, The INSIGHT Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05338905.