Head and Neck NeoplasmsNCT03034603
The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
A study testing Nutri-jelly with PEITC and Nutri-jelly in people with Head and Neck Neoplasms and Quality of Life, run by Dental Innovation Foundation Under Royal Patronage at 5 sites in Thailand.
Trial summary
This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Neoplasms, Quality of Life, Nutrition Related Cancer
- What is being tested?
- Nutri-jelly with PEITC and Nutri-jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 5 sitesThailand
- Study dates
- Aug 2014to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
- Finished radiotherapy or/and chemotherapy for at least one month
- Has at least one measurable target lesion
- Baseline KPS ≥ 40% or ECOG 0-3
- Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
- Able to take the intervention (through mouth or NG tube) without aspiration
- Able to communicate and consent to the study
Who cannot join
- Cannot come back for the follow-up visits
- Receive or had received N-acetylcysteine during the intervention
- Has systemic diseases that might interfere with the results
- Chronic kidney disease that requires dialysis
- Increased risk of aspiration pneumonia
- Pregnancy or lactation
- Untreated infectious diseases
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Thailand5 sites
National cancer institute
Bangkok, Bangkok
Chonburi Cancer Hospital
Chon Buri, Changwat Chon Buri, 20000
Lopburi Cancer Hospital
Lopburi, 15000
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000
Maha Vajiralongkorn Thanyaburi Hospital
Pathum Thani, 12110
About this study
This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. The secondary outcome includes serum p53 and cytochrome C levels and functional status.
Read the detailed description
Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies. Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. The purpose of this study is to determine safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.
independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome C levels and functional status
- Being tested
- Nutri-jelly with PEITC, Nutri-jelly
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri-jelly with PEITCDietary supplement
Nutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly.
Nutri-jellyDietary supplement
Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.
| Study group | Role | What they receive |
|---|---|---|
| Nutri-jelly with PEITC | Experimental | Continuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months. Receives: Dietary Supplement: Nutri-jelly with PEITC |
| Nutri-jelly | Placebo comparator | Continuous intake of 200 g Nutri-jelly per day, five days per week for 3 months. Receives: Dietary Supplement: Nutri-jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
Measured: 1 month and 3 months after receiving intervention
Changes in Health-related quality of life score compared to baseline
Evaluation of Health-related quality of life by using questionnaire FACT-HN
Measured: Baseline, 1 month and 3 months after receiving intervention
Changes in Tumor response compared to baseline
Evaluation of tumor response following RECIST criteria at 1 month and 3 months
Measured: Baseline, 1 month, 3 months after receiving intervention
Progression-free survival time
The length of time during the intervention that the participant lives with stable disease
Measured: The time of the intervention until any signs or symptoms of progressive disease be recorded.
Secondary outcomes (3)
Serum p53 level
Level of both wild type and mutant p53 in serum
Measured: 1 month and 3 months after receiving intervention
Serum cytochrome C level
Level of cytochrome C in serum
Measured: 1 month and 3 months after receiving intervention
Changes in Functional status
Evaluation of functional status using KPS (Karnofsky Performance Score) score
Measured: Baseline, 1 month and 3 months after receiving intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startAug 2014
- Primary completionFeb 2021
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dental Innovation Foundation Under Royal Patronage
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Aroonwan Lam-ubol, DDS, PhD, Principal investigator, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034603
- Sponsor's protocol ID
- DIF-04
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Test of Nutri-PEITC Jelly in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT03034603
- Acronym / sponsor ID
- DIF-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dental Innovation Foundation Under Royal PatronageUniversity, hospital or other
- Collaborators
- Mahidol University, Srinakharinwirot University, Ministry of Health, Thailand
- Study start
- Aug 2014 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This triple-blinded randomized placebo control trial aims to investigate the safety and efficacy of Nutri-PEITC jelly, a functional food, in head and neck cancer patients. The primary outcome measure includes adverse events, health-related quality of life, tumor response and progression-free survival. The secondary outcome includes serum p53 and cytochrome C levels and functional status.
Detailed description
Previously, Nutri-jelly, a novel edible nutritious gel for patients with chewing and swallowing difficulties, was shown to be effective in improving the quality of life of head and neck cancer patients. Recently, Nutri-PEITC jelly is recently developed by addition of Phenethyl Isothiocyanate (PEITC), a phytochemical compound with chemopreventive action in animal bearing oral cancer. It intends to be a functional food for cancer survivor. The dose of PEITC in Nutri-jelly was based on safe and effective dose determined in animal studies. Furthermore, Nutri-PEITC jelly was proven safe in healthy volunteers who daily consumes for a consecutive month with no serious adverse events. The purpose of this study is to determine safety and efficacy of Nutri-jelly with PEITC in head and neck cancer patients.
independent variable: continuous Nutri -jelly with PEITC intake dependent variable (outcome): adverse effects, health-related quality of life score, tumor response, progression-free survival, serum p53 and cytochrome C levels and functional status
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutri-jelly with PEITC | Experimental | Dietary Supplement: Nutri-jelly with PEITCContinuous intake of 200 g Nutri-jelly with 20 mg PEITC per day, five days per week for 3 months. |
| Nutri-jelly | Placebo comparator | Dietary Supplement: Nutri-jellyContinuous intake of 200 g Nutri-jelly per day, five days per week for 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of squamous cell carcinoma in areas of lip, oral cavity, oropharynx and hypopharynx, who receive only palliative care or deny definitive treatment
- Finished radiotherapy or/and chemotherapy for at least one month
- Has at least one measurable target lesion
- Baseline KPS ≥ 40% or ECOG 0-3
- Blood tests are in acceptable ranges (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥50 mL/min) and hepatic function (SGOT , SGPT, serum bilirubin ≤ 1.5 of upper limits of normal
Key exclusion criteria (7 listed)
- Cannot come back for the follow-up visits
- Receive or had received N-acetylcysteine during the intervention
- Has systemic diseases that might interfere with the results
- Chronic kidney disease that requires dialysis
- Increased risk of aspiration pneumonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutri-jelly with PEITCNutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly. | Dietary supplement | Nutri-jelly with PEITC |
| Nutri-jellyNutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal. | Dietary supplement | Nutri-jelly |
Primary outcome
Adverse events
Time frame: 1 month and 3 months after receiving intervention
Evaluation of adverse events by physical examination, blood tests, and interviewing the subjects
Changes in Health-related quality of life score compared to baseline
Time frame: Baseline, 1 month and 3 months after receiving intervention
Evaluation of Health-related quality of life by using questionnaire FACT-HN
Changes in Tumor response compared to baseline
Time frame: Baseline, 1 month, 3 months after receiving intervention
Evaluation of tumor response following RECIST criteria at 1 month and 3 months
Progression-free survival time
Time frame: The time of the intervention until any signs or symptoms of progressive disease be recorded.
The length of time during the intervention that the participant lives with stable disease
3 secondary outcomes
Serum p53 level
Time frame: 1 month and 3 months after receiving intervention
Serum cytochrome C level
Time frame: 1 month and 3 months after receiving intervention
Changes in Functional status
Time frame: Baseline, 1 month and 3 months after receiving intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aroonwan Lam-ubol, DDS, PhD principal investigator
Srinakharinwirot University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri-jelly with PEITC and Nutri-jelly in people with Head and Neck Neoplasms and Quality of Life, run by Dental Innovation Foundation Under Royal Patronage at 5 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 1 month and 3 months after receiving intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.