Neoplasms

All Conditions

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Xerostomia

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

2 gram d-limonene orally, once daily delivered during chemoradiation

4 gram d-limonene orally, as 2 grams 2 times daily delivered during chemoradiation

6 gram d-limonene orally, as 3 grams 2 times daily delivered during chemoradiation

8 gram d-limonene orally, as 4 grams 2 times daily delivered during chemoradiation

Administered orally at 2 to 8 grams daily

D-Limonene Gelcaps

Standard of Care -All patients will receive standard radiation treatment of 66 to 70 Gy given in 33 to 35 fractions (2 to 2.12 Gy/fractions) over 6.5 to 7 weeks.

Intensity modulated radiotherapy (IMRT)

Standard of Care -Cisplatin as 100 mg/m2 IV

Xerostomia questionnaire consists of 4 items on dryness while eating/speaking and 4 on dryness at rest. Patients rate each symptom on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater xerostomia

Xerostomia questionnaire

Mahjabin Noroozi

Quynh-Thu Le, M.D.

Quynh-Thu Le

This study explores the safety of d-limonene, a commercially-available dietary supplement (food) as a potential therapeutic for the severe dry mouth (xerostomia) experienced by patients with head and neck cancer as a side effect of their anti-cancer treatment.

Primary Objective:To determine the maximum tolerated dose (MTD) of d limonene when combined with radiation and platinum based chemotherapy in subjects with loco regionally advanced head and neck squamous cell carcinoma (HNSCC) based upon dose limiting toxicity (DLT)

Secondary Objective:

* To evaluate the feasibility and subject compliance with adjuvant administration of d limonene daily up to a maximum of 4 months after completion of chemoradiation
* To correlate the level of d-limonene measured in the plasma to the dose levels(s) administered to the subject
* To correlate the level of d limonene measured in the plasma to saliva flow rate and xerostomia questionnaire scores in subjects enrolled in this trial

d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 1 Study of d Limonene With Concurrent Radiation and Platinum Based Chemotherapy for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Dose limiting toxicity is defined as d-limonene related toxicity causing:

* Greater than 1 week delay in completing the radiation course.
* Inability to receive ≥ 66 Gy of radiotherapy.
* Inability to receive at least 200 mg/m2 of total cisplatin equivalent dose or a total area under the curve (AUC) of 10 for carboplatin equivalent dose due to toxicity related to d-limonene Grade 3 or higher diarrhea that is attributable to the study drug.
* Grade 3 abdominal pain that is attributable to the study drug. The outcome will be reported as the number of participants per dose level who experience any DLT (a number without dispersion / variance).

Participant compliance with adjuvant administration of d-limonene will be assessed as completing at least 14 weeks of per protocol adjuvant d-limonene treatment. The outcome is reported as the number of participants per dose level that were compliant.

The degree of xerostomia will be assessed by the xerostomia survey. The survey consists of 8 items: 4 items regarding dryness or discomfort while eating or chewing and 4 items regarding dryness and discomfort while not eating or chewing. The participant will rate each item on a Likert scale from 0 to 10 (least effect to most severe effect) with higher scores implying greater dryness or discomfort. A summary score is calculated by summing the scores for each item and linearly transforming the score to produce a final score on a scale from 0 to 100. The outcome is reported as the mean and standard deviation of the final transformed scores from all subjects with survey results, by treatment level.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Stanford University

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Participants recruited between weeks 3-5 of radiotherapy. Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Participants also have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Questionnaires

Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

Acupuncture

Participants have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

Electroencephalogram (EEG)

Lorenzo Cohen, PHD

The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.

Dry mouth is a common problem in cancer patients who have received radiation treatment to the head and neck. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. You will have an equal chance of being in either group.

Group 1 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

Group 2 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

You will not know if you are assigned to Group 1 or Group 2.

Study Visits:

Your acupuncture treatments will be within 3 to 7 days of each other during Weeks 3-5 of your regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, you will complete 3 questionnaires before each session that ask about dry mouth, any other symptoms you may be having, and your treatment expectations. It should take about 5 minutes total to complete these questionnaires. You will also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

You will also have an EEG at each acupuncture treatment. The EEG will be recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

You will give a saliva sample before and after each acupuncture treatment to measure the amount of saliva produced.

Length of Study:

You will remain on study for about 1 week. Your participation in the study will be over after you complete the dry mouth questionnaire after your second acupuncture session.

This is an investigational study.

Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.

Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia

Primary outcome variables include percentage changes of EEG scores at the medial frontal gyrus, precuneus, and anterior cingulate regions from pre- to post-acupuncture at each acupuncture session. Repeated measures ANOVA used for the analysis, with fixed effects of sequence (order of acupuncture sessions), treatment (each acupuncture group), and period (1st vs 2nd session), and random patient (nested within sequence) effects included. Adjustments for multiple testing made according to the method of Westfall and Young.

Secondary outcomes are to determine between-acupuncture differences in radiation-induced xerostomia. Association examined between changes in neural outcomes and changes in salivary flow and self-report measures of xerostomia and other quality of life measures, controlling for the factors of acupuncture and period (1st vs 2nd) as appropriate.

M.D. Anderson Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Paranasal Sinus Neoplasms

Nose Neoplasms

Otorhinolaryngologic Neoplasms

Nose Diseases

Respiratory Tract Diseases

Paranasal Sinus Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire.

Roi Dagan, MD, MS

The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

The study is non interventional outcomes protocol designed to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma	NCT04392622	Xerostomia	D-Limonene Gelc... Intensity modul... Cisplatin Xerostomia ques...	18 Years -	Stanford University
d-Limonene +Radiation +Platinum Based Chemo for Xerostomia Prevention in Locally Advanced Head and Neck Squamous Cell Carcinoma	NCT04392622	Xerostomia	D-Limonene Gelc... Intensity modul... Cisplatin Xerostomia ques...	18 Years -	Stanford University
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center
Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses	NCT00797498	Cancers of Nasa... Cancers of Para...	Xerostomia ques...	18 Years -	University of Florida
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for xerostomia questionnaire