Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC) Save

Date Added
October 16th, 2018
PRO Number
Pro00079274
Researcher
Terrence Day
Keywords
Cancer/Head & Neck
Summary

The purpose of this research study is to see if it is possible to collect tissue, saliva and blood samples from patients who are having surgery and send those samples to different labs across MUSC. The researchers in these labs will collect tissue, blood and saliva samples before surgery and during surgery to see if there are any changes in the samples. They will compare the changes in the samples to the clinical outcomes.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Knowledge and Delays in Diagnosis of Oropharyngeal Neoplasms Save

Date Added
June 19th, 2018
PRO Number
Pro00078856
Researcher
Amanda Barrett
Keywords
Cancer, Cancer/Head & Neck
Summary

The objective of this study is to determine potential factors that contribute to late-stage diagnosis and treatment of HPV-positive and HPV-negative oropharyngeal tumors. We have developed a voluntary survey that will be given to patients treated at the MUSC Head and Neck Tumor Center. The survey consists of subsections that identify general HPV knowledge, timeline to diagnosis and treatment, educational background, and sociodemographic characteristics. The participating patients will be given the Short Test of Functional Health Literacy (S-TOFHLA) with the survey. The survey and health literacy data will be used to assess correlations between these factors and the patients stage of cancer at diagnosis. This study will also compare a chart review of prospective patients with retrospective chart review of former oropharyngeal cancer patients. The chart review will include data such as: stage of cancer at diagnosis, treatment, sequence of intervention for diagnosis and treatment, type of biopsy, and types of doctors involved in diagnosis and treatment.

Institution
MUSC
Recruitment Contact
Amanda Barrett
(843) 446-2234
barretam@musc.edu

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination with Cetuximab in Patients with Advanced Head and Neck Squamous Cell Carcinoma Save

Date Added
June 12th, 2018
PRO Number
Pro00076144
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see whether an investigational drug called CDX-3379 combined with cetuximab, a monoclonal antibody that targets a protein called EGFR, will shrink tumors for subjects with head and neck squamous cell carcinoma (HNSCC). This study is for patients who have been diagnosed with HNSCC and who have previously received cetuximab but who have since experienced progression. Both the investigational drug, CDX-3379, and cetuximab are administered intravenously (into a vein). Subjects can expect to participate in the study for 2 years or longer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin Save

Date Added
May 18th, 2018
PRO Number
Pro00077581
Researcher
Anand Sharma
Keywords
Cancer, Cancer/Head & Neck, Stage II, Stage III
Summary

This study is for patients that have been diagnosed with stage III-IVB Head and Neck cancer. The investigational drug in this study is MEDI4736 (Durvalumab). The purpose of the safety lead-in portion of the study is to determine whether adding the study drug MEDI4736 to radiation is safe in patients with head and neck cancer who cannot take the drug cisplatin. The purpose of the phase II/III portion is to compare any good and bad effects of usual radiation plus the study treatment, MEDI4736 (durvalumab), to the usual therapy of radiation plus cetuximab in patients with head and neck cancer who cannot take the drug cisplatin. Participants in the safety lead-in portion can expect to be in this study for approximately 2.5 years. Participants in the Phase II/III portion can expect to be in the study for up to 32 weeks, and then followed by their study doctor to monitor for side effects every year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A randomized, double-blind Phase II study of pembrolizumab versus placebo in patients with head and neck cancers at high risk for recurrence or low-volume residual disease ? the PATHWay Study Save

Date Added
March 27th, 2018
PRO Number
Pro00076352
Researcher
John Kaczmar
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The investigational drug in this study is Pembrolizumab. The main purpose of this study is to attempt to reduce the risk of cancer recurrence using a drug called pembrolizumab. Participants can expect to be in this study for approximately 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Creation and validation of a head and neck cancer body image disturbance scale Save

Date Added
February 16th, 2018
PRO Number
Pro00074632
Researcher
Mark Ellis
Keywords
Cancer/Head & Neck
Summary

Body image disturbance (BID) is a self-perceived negative change in appearance and or function. Head and neck cancer is associated with BID since head and neck cancer (HNC) involves cosmetically and functionally important areas. BID in HNC patients is common and causes anxiety, depression, social isolation and decreased quality of life. Unfortunately, there is little information with regards to BID in HNC patients. Current research is limited by the lack of a HNC specific BID scale and instead relies on BID scales created for other cancer subsites. Thus, a measurement scale made specifically for BID in HNC patient is needed. The objective of this project is to create and validate a BID scale specific to HNC patients.

Institution
MUSC
Recruitment Contact
Mark Ellis
843-792-8299
ellismar@musc.edu

Cognitive Behavioral Therapy for Body Image Disturbance in Patients with Surgically-Treated Head and Neck Cancer Save

Date Added
January 10th, 2018
PRO Number
Pro00072856
Researcher
Evan Graboyes
Keywords
Cancer/Head & Neck
Summary

Arising in cosmetically and functionally critical areas, head and neck cancer and its treatments commonly cause life-altering changes in appearance, swallowing, and speaking. These changes affect body function and quality of life. Body image disturbance, a displeasing change in appearance or function noted by the patient, is common in head and neck cancer patients and causes stress, anxiety, and isolation in these patients. Unfortunately, there is not a lot of data on the topic. Treatments of body image disturbance for head and neck cancer patients remain unknown preventing us from providing patients with the best cancer care. This study will evaluate the effects of a type of therapy on body image disturbance in head and neck cancer patients undergoing surgery.

Institution
MUSC
Recruitment Contact
Courtney Marsh
843-792-0719
marshch@musc.edu

Identifying Barriers to Timely and Equitable Adjuvant Therapy Following Surgery for Head and Neck Cancer Save

Date Added
November 2nd, 2017
PRO Number
Pro00070798
Researcher
Evan Graboyes
Keywords
Cancer/Head & Neck, Minorities, Throat
Summary

Delays in starting radiation after surgery for head and neck cancer disproportionately affect minorities and those of low socioeconomic status, causing increased mortality. The barriers that prevent the delivery of timely, equitable postoperative radiation remain unknown. This study seeks to identify the barriers to timely, equitable postoperative radiation following surgery for head and neck cancer.

Institution
MUSC
Recruitment Contact
Evan Graboyes
843-792-0719
graboyes@musc.edu

A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer Save

Date Added
August 20th, 2017
PRO Number
Pro00066211
Researcher
Katherine Sterba
Keywords
Cancer/Head & Neck, Nutrition
Summary

This research will develop and test a nutrition-focused mobile-support program for head and neck cancer patients and their caregivers at the end of treatment.

Phase I: To guide system development, we will conduct interviews with 15 individuals with head and neck cancer and their caregivers to understand the nutritional challenges faced at the end of treatment. We will also recruit 128 oncology dietitians to complete online surveys to identify key caregiver nutritional support tasks and caregiver demands.
Phase II: After system development, we will recruit 33 head and neck cancer patients and their main supporters to pretest our nutrition support system. Participants will be asked to complete two surveys and a one-time clinic session. The clinic session will include information and resources about symptoms and concerns and after the visit, the program will provide follow-up resources and support online for one month. Lastly, we we will conduct individual/small group interviews with 10 head and neck health care providers to evaluate feasibility and recommendations for future system development.

The information from this study may help us to improve supportive care programs in the future to help others as they complete head and neck cancer treatment.

Institution
MUSC
Recruitment Contact
Megan Scallion
843-876-2438
scallion@musc.edu

Pembrolizumab In Combination With Anti-platelet Therapy For Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck Save

Date Added
August 15th, 2017
PRO Number
Pro00069442
Researcher
Carolyn Britten
Keywords
Cancer/Head & Neck
Summary

This is a study that looks at the use of anti-platelet therapy and chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). Anti-platelet therapy is the use of drugs that reduce the blood's ability to form clots. The overall goal of this study is to see if this therapy combination can increase the body's ability to fight the disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@musc.edu

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