Intensive Symptom Management for Head and Neck Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Metastatic cancer, Palliative therapy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares intensive symptom evaluation with supportive care to standard symptom management in patients with head and neck cancer that has not spread to other places in the body (non-metastatic). Standard symptom management involves symptom management during and after radiation therapy, using problem-focused history and physical examination followed by appropriate symptomatic management as appropriate per treating physician's discretion. Intensive symptom management with monitoring patient reported outcomes is performed among patients with metastatic cancers receiving systemic therapies and with various cancers receiving radiation therapy. This trial may help researchers determine the impact of intensive symptom surveillance in patients with non-metastatic head and neck cancers.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Intensive Symptom Management for Head and Neck Cancer is an effective treatment?

The available research shows that Intensive Symptom Management for Head and Neck Cancer can effectively support clinical and symptom research. For example, one study highlights the use of a system that helps predict and manage symptoms during and after treatment, which can improve the quality of life for patients. This system uses advanced methods to analyze large amounts of data, helping doctors make better decisions about patient care. While the research does not directly compare this treatment to others, it suggests that managing symptoms effectively can lead to better patient outcomes. ^{1 2 3 4 5}

What safety data exists for Intensive Symptom Management in head and neck cancer treatment?

The available research highlights the use of patient-reported outcomes (PROs) and electronic patient-reported outcomes (ePROs) to assess symptoms and quality of life during radiotherapy for head and neck cancer. These studies focus on documenting symptom acuity, adverse events, and supportive care. Additionally, machine learning methods like sequential rule mining are being used to predict post-treatment symptoms based on during-treatment data. However, there is a noted lack of reliable data specifically describing the impact of therapy on symptom burden and quality of life, especially in recurrent or metastatic cases. Tools like the Vanderbilt Head and Neck Symptom Survey-Recurrent/Metastatic (VHNSS-RM) are being developed to better assess these factors. ^{2 5 6 7 8}

Is Intensive Symptom Surveillance, Machine Learning-Directed Risk Stratification a promising treatment for head and neck cancer?

Yes, Intensive Symptom Surveillance, Machine Learning-Directed Risk Stratification is a promising treatment for head and neck cancer. It uses advanced computer techniques to predict and manage symptoms, helping improve the quality of life for patients. ^{1 2 4 9 10}

Research Team

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

Informed caregiver not receiving any payment to provide care for patients

I have been diagnosed with a specific type of throat or mouth cancer that has not spread.

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related assessment

Exclusion Criteria

Unwilling or unable to follow protocol requirements

Any condition which in the Investigator's opinion deems the participant an unsuitable candidate

I have been diagnosed with cancer that has spread from my head or neck.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants receive standard of care radiation therapy with symptom management

6 months

Weekly visits

Intensive Symptom Surveillance

Participants complete quality of life questionnaires twice weekly during radiation therapy and once weekly for the first month after completing radiation therapy

1 month

Twice weekly visits during radiation, weekly visits post-radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly visits

Treatment Details

Interventions

• Intensive Symptom Surveillance
• Machine Learning-Directed Risk Stratification
• Supportive Care

Trial Overview 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.

Participant Groups

Group I: Group A (quality of life questionnaire) Experimental Treatment 2 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 Control 1 Intervention

Patients receive standard symptom management QW during standard of care radiation therapy and for 6 months after completing radiation therapy course.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

The study involving 30 head and neck cancer patients demonstrated that semi-automatic Quality of Life (QOL)-weighted NTCP-guided VMAT treatment plans effectively prioritized the sparing of organs at risk, leading to a significant reduction in complications like dysphagia and fatigue, while maintaining adequate target coverage.

Compared to conventional treatment plans, the QOL-weighted approach resulted in a systematic improvement in predicted QOL scores over 24 months, with an average increase of 1.1 points on a 0-100 scale, indicating enhanced patient well-being post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and toxicity guided treatment plan optimisation for head and neck cancer. van der Laan, HP., van der Schaaf, A., Van den Bosch, L., et al.[2021]

The development of a data-driven visual system using sequential rule mining (SRM) allows for better prediction of long-term symptoms in head and neck cancer patients based on their treatment experiences, enhancing personalized care.

This system not only aids in understanding complex symptom patterns but also supports clinical decision-making by explaining predictions in the context of therapeutic choices, ultimately improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roses Have Thorns: Understanding the Downside of Oncological Care Delivery Through Visual Analytics and Sequential Rule Mining. Floricel, C., Wentzel, A., Mohamed, A., et al.[2023]

In a study of 48 patients with head and neck cancer undergoing chemoradiotherapy, significant reductions in tumor volume were observed, with median changes of 26.8% for primary tumors and 43.0% for nodal tumors, indicating effective treatment response.

Two decision trees were developed to predict tumor volume reduction based on clinical and pathological parameters, achieving an accuracy of 88%, which can help radiation oncologists identify patients who may benefit most from adaptive radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Trees Predicting Tumor Shrinkage for Head and Neck Cancer: Implications for Adaptive Radiotherapy. Surucu, M., Shah, KK., Mescioglu, I., et al.[2017]

A study of oropharyngeal cancer patients identified four distinct clusters based on their symptom severity over six months, which correlated with their overall survival rates.

Patients in different clusters exhibited significant differences in factors such as HPV status, performance status, and treatment modalities, suggesting that tracking symptom severity can provide valuable prognostic information beyond traditional clinical characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of post-treatment longitudinal symptom severity clusters with subsequent survival in oropharyngeal cancer. Haddad, G., Hueniken, K., Xu, MC., et al.[2022]

The study successfully collected patient-reported outcomes electronically from 318 head and neck cancer patients undergoing radiotherapy, demonstrating that this method is feasible for tracking symptoms during treatment.

Patients reported significant symptoms during radiotherapy, with the most severe being dysgeusia (taste changes), pain, and mucositis, particularly among those with oropharynx cancer, highlighting the need for targeted symptom management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. Hamilton, SN., Tran, E., Ho, C., et al.[2021]

In a study of 65 patients undergoing head-and-neck radiotherapy, significant declines in quality of life (QOL) were observed, particularly in fatigue, social activity, and overall QOL, with 70.8% of patients reporting these issues during treatment.

The study highlighted that concurrent chemoradiotherapy (CCRT) led to more severe adverse events, including grade 3 complications in 35.4% of patients, significant weight loss averaging 5.5 kg, and a high need for supportive care interventions like intravenous hydration and feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. Niska, JR., Halyard, MY., Tan, AD., et al.[2023]

Patients with metastatic or locally recurrent head and neck cancer face significant challenges, including limited treatment options and high symptom burden, which complicates disease management and requires careful consideration of individual patient factors.

Recent phase III trials have shown that incorporating patient-reported outcome measures can help assess symptoms and quality of life, but there is still a need for better tools to evaluate treatment impact on symptom burden and functional impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To treat or not to treat: balancing therapeutic outcomes, toxicity and quality of life in patients with recurrent and/or metastatic head and neck cancer. Murphy, BA.[2019]

The Vanderbilt Head and Neck Symptom Survey-Recurrent/Metastatic (VHNSS-RM) was developed to assess a wide range of symptoms and psychosocial issues in 50 patients with recurrent/metastatic head and neck cancer, identifying 12 physical symptoms and 7 psychosocial issues that significantly impact patients' quality of life.

The survey is designed to be feasible and not overly burdensome, suggesting it could effectively improve symptom management and palliative care for patients with recurrent/metastatic head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Testing of a Patient-Reported Outcome Measure for Recurrent or Metastatic Head and Neck Cancer. Jackson, LK., Deng, J., Ridner, SH., et al.[2017]

The study identified two main symptom clusters in head and neck cancer patients undergoing chemoradiotherapy: one specific to head and neck symptoms (including radiodermatitis, dysphagia, and dry mouth) and another gastrointestinal cluster (including nausea and vomiting), based on data from 684 patients.

These symptom clusters were generally applicable across various patient subgroups, suggesting that understanding these clusters can enhance symptom management in clinical practice and highlight the need for further research into their biological mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom clusters in patients with head and neck cancer receiving concurrent chemoradiotherapy. Xiao, C., Hanlon, A., Zhang, Q., et al.[2021]

In a study of 1589 head and neck cancer patients followed for over 10 years, those presenting with fewer symptoms had significantly better survival rates; median survival was 5.3 years for one symptom compared to just 1.1 years for three symptoms.

Specific symptoms also impacted survival: patients with weight loss had a median survival of only 0.8 years, while those with hoarseness had a median survival of 5.9 years, indicating that certain symptoms can serve as important indicators for prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Presenting symptoms and long-term survival in head and neck cancer. Douglas, CM., Ingarfield, K., McMahon, AD., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Quality of life and toxicity guided treatment plan optimisation for head and neck cancer. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Roses Have Thorns: Understanding the Downside of Oncological Care Delivery Through Visual Analytics and Sequential Rule Mining. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Decision Trees Predicting Tumor Shrinkage for Head and Neck Cancer: Implications for Adaptive Radiotherapy. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Association of post-treatment longitudinal symptom severity clusters with subsequent survival in oropharyngeal cancer. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

To treat or not to treat: balancing therapeutic outcomes, toxicity and quality of life in patients with recurrent and/or metastatic head and neck cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Preliminary Testing of a Patient-Reported Outcome Measure for Recurrent or Metastatic Head and Neck Cancer. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Symptom clusters in patients with head and neck cancer receiving concurrent chemoradiotherapy. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Presenting symptoms and long-term survival in head and neck cancer. [2019]