Head and Neck Squamous Cell CarcinomaTGP-OCSNCT07682285
Taiwanese Green Propolis for Lipid Profiles, Fatigue, and Quality of Life in Oral Cavity Cancer Survivors
A study testing Taiwanese Green Propolis in people with Head and Neck Squamous Cell Carcinoma and Cancer-related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study examined whether Taiwanese Green Propolis (TGP), a natural bee-derived supplement, can improve blood fat levels, reduce tiredness (fatigue), and improve quality of life in people who have completed treatment for oral cavity (mouth) cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Cancer-related Fatigue, Dyslipidemias
- What is being tested?
- Taiwanese Green Propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2024to 26 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Histologically confirmed diagnosis of oral cavity squamous cell carcinoma (OSCC)
- Post-primary treatment follow-up phase (surgery with or without adjuvant radiotherapy and/or chemotherapy completed)
- Alert and oriented; able to complete study assessments independently or with research staff assistance
- Able to communicate in Mandarin or Taiwanese
- Not chewing betel quid during the study period
- Willing to provide written informed consent
Who cannot join
- Known allergy to propolis, honey, multiple pollens, or alcohol
- Psychiatric disorder or cognitive impairment preventing study participation
- Neuromuscular or joint disorders preventing performance of grip strength or sit-to-stand assessments
- Pain at testing limb sites preventing physical assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Taiwanese Green Propolis (2,000 mg/Day) on Lipid Profiles, Cancer-Related Fatigue, and Quality of Life in Post-Treatment Oral Cavity Squamous Cell Carcinoma Survivors: A Double-Blind, Randomized Controlled Trial
This study examined whether Taiwanese Green Propolis (TGP), a natural bee-derived supplement, can improve blood fat levels, reduce tiredness (fatigue), and improve quality of life in people who have completed treatment for oral cavity (mouth) cancer.
People who had finished treatment for oral cavity squamous cell carcinoma (a type of mouth cancer) and were in the follow-up period were invited to participate. Participants were randomly assigned to take either 4 TGP capsules per day (2,000 mg/day total) or 4 identical-looking placebo capsules for 12 weeks. Neither participants nor the study team knew who received which capsules until after the study ended (double-blind). All participants were followed for a further 12 weeks after stopping the capsules.
Read more
At the start and at Weeks 4, 8, 12, and 24, participants had blood tests to measure cholesterol, triglycerides, liver enzymes, and inflammation markers. They also completed questionnaires about fatigue (BFI-T), symptoms (ESAS-r), and quality of life (FACT-H\&N), and performed physical tests including grip strength and a 30-second sit-to-stand test.
The study aimed to determine whether TGP can help manage the metabolic and fatigue-related problems common after oral cancer treatment, and to provide data for planning larger future trials. 25 participants were enrolled at a regional teaching hospital in northern Taiwan. Stool and saliva samples were also collected at each timepoint to assess gut and oral microbiota composition (16S rRNA sequencing) and salivary inflammatory markers. Heart rate variability was monitored via smart wristband (minimum 24 hours per timepoint).
Read the detailed description
Background:
Oral cavity squamous cell carcinoma (OSCC) survivors frequently experience persistent metabolic complications after treatment, including dyslipidemia, chronic low-grade inflammation, cancer-related fatigue (CRF), muscle weakness, and impaired quality of life. The prevalence of metabolic syndrome in this population substantially exceeds that of the general Taiwanese adult population.
Taiwanese green propolis (TGP), derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae), has a phytochemical profile distinct from Brazilian or Mediterranean propolis, comprising prenylated flavanones-principally propolin C, D, F, G, and H. These compounds have demonstrated hepatoprotective effects (TGF-β/Smad2/3 pathway), anti-inflammatory activity (NLRP3 inflammasome suppression), and lipid-metabolic regulatory properties in preclinical studies. No prior clinical trial has evaluated TGP in OSCC survivors.
Study Design:
Pilot double-blind, placebo-controlled, parallel-group randomized controlled trial (RCT). Intervention period: 12 weeks. Post-intervention follow-up: 12 weeks (total 24 weeks). Assessment timepoints: Week 0 (T0/baseline), Week 4 (T4), Week 8 (T8), Week 12 (T12), Week 24 (T24).
Intervention:
- Experimental: TGP capsules (500 mg/capsule), 4 capsules/day (2 capsules BID), providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds/day; 12 weeks.
- Control: Identical-appearing placebo capsules, 4 capsules/day, 12 weeks. Both capsules were identical in appearance, size, color, and smell.
Randomization and Blinding:
Computer-generated random number sequence with allocation concealment. Participants, care providers, investigators, and outcome assessors were blinded throughout the 24-week study period (quadruple blinding).
Primary Outcomes (T0, T8, T12, T24):
Total cholesterol (TC, mg/dL); Triglycerides (TG, mg/dL); High-density lipoprotein cholesterol (HDL-C, mg/dL); Low-density lipoprotein cholesterol (LDL-C, mg/dL).
Secondary Outcomes:
- Cancer-related fatigue: BFI-T mean score (0-10); T0,T8,T12,T24
- Symptom distress: ESAS-r total score (0-90); T0,T4,T8,T12,T24
- Quality of life: FACT-H\&N total score; T0,T8,T12,T24
- Grip strength (kg), dominant hand, mean of 3 trials; T0,T4,T8,T12,T24
- 30-second sit-to-stand test (repetitions); T0,T4,T8,T12,T24
- C-reactive protein (CRP, mg/dL); T0,T8,T12,T24
- Alanine aminotransferase (ALT/GPT, U/L); T0,T8,T12,T24
- Aspartate aminotransferase (AST/GOT, U/L); T0,T8,T12,T24
- Gamma-glutamyl transferase (γ-GT, U/L); T0,T8,T12,T24
Exploratory Outcomes:
Body weight, BMI, waist circumference, hip circumference, body fat %, hemoglobin, albumin, fasting glucose, HbA1c, BUN, creatinine, uric acid, WBC count, TSH, T3, T4. Serum interleukin-6 (IL-6, pg/mL); T0,T8,T12,T24. Gut microbiota alpha diversity (Shannon index) and beta diversity (Bray-Curtis dissimilarity) via stool 16S rRNA amplicon sequencing; T0,T8,T12,T24. Gut microbiota relative abundance of key bacterial taxa; T0,T8,T12,T24. Oral microbiota composition via saliva 16S rRNA amplicon sequencing; T0,T8,T12,T24. Salivary inflammatory markers including IL-6 (pg/mL); T0,T8,T12,T24. Heart rate variability: RMSSD and SDNN via smart wristband (minimum 24 hours per timepoint); T0,T4,T8,T12,T24.
Statistical Analysis:
Generalized Estimating Equations (GEE) with exchangeable working correlation structure; independent variables: group, time, and group × time interaction; adjusted for baseline values. Cohen's d calculated for significant interaction terms. Intent-to-treat (ITT) principle; N=25.
Sample Size:
Target: 62 participants (G*Power v3.1; repeated-measures ANOVA; f²=0.30; α=0.05; power=0.80; 10% dropout). Actual enrollment (pilot phase): 25.
Ethics:
Enrolment commenced in April 2024 under the original approved protocol N202305017 (approved 2023-05-22, Taipei Medical University Joint Institutional Review Board). A protocol amendment (N202407011, approved 2024-08-15) refined the inclusion criteria to focus on post-treatment oral cavity cancer survivors, designated lipid profiles as the primary outcome, and repositioned fatigue and quality of life as secondary outcomes. The amendment applied prospectively to all subsequently enrolled participants. Written informed consent was obtained from all participants prior to enrolment.
- Being tested
- Taiwanese Green Propolis, Placebo
- Keywords
- Taiwanese green propolis, propolis, oral cavity cancer survivors, cancer-related fatigue, lipid profiles, quality of life, dietary supplement, randomized controlled trial
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiwanese Green PropolisDietary supplement
Taiwanese Green Propolis (TGP) capsules derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae). Each capsule contains 500 mg TGP with approximately 50 mg propolin compounds. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks; total daily dose 2,000 mg TGP containing approximately 200 mg propolin compounds/day.
PlaceboOther
Placebo capsules identical to TGP capsules in appearance, size, color, and smell, but containing inert excipients with no active propolis constituents. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Taiwanese Green Propolis (TGP) | Experimental | Participants receive Taiwanese Green Propolis capsules (500 mg/capsule, 4 capsules/day divided as 2 capsules in the morning and 2 in the evening) for 12 weeks, providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds (propolin C, D, F, G, H)/day. Receives: Dietary Supplement: Taiwanese Green Propolis |
| Placebo | Placebo comparator | Participants receive identical-appearing placebo capsules (4 capsules/day, divided as 2 capsules in the morning and 2 in the evening) for 12 weeks. Capsules are identical to TGP capsules in appearance, size, color, and smell but contain no active propolis constituents. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Triglycerides (TG)
Fasting serum triglycerides (mg/dL)
Measured: Baseline (Week 0), Week 8, Week 12, Week 24
Total Cholesterol (TC)
Fasting serum total cholesterol (mg/dL)
Measured: Baseline (Week 0), Week 8, Week 12, Week 24
High-Density Lipoprotein Cholesterol (HDL-C)
Fasting serum HDL-C (mg/dL)
Measured: Baseline (Week 0), Week 8, Week 12, Week 24
Low-Density Lipoprotein Cholesterol (LDL-C)
Fasting serum LDL-C (mg/dL)
Measured: Baseline (Week 0), Week 8, Week 12, Week 24
Secondary outcomes (9)
Cancer-Related Fatigue - BFI-T Mean Score
Brief Fatigue Inventory-Taiwanese version; 9-item; mean score 0-10; higher = greater fatigue
Measured: Week 0, 8, 12, 24
Symptom Distress - ESAS-r Total Score
Edmonton Symptom Assessment Scale-Revised; total score 0-90; higher = greater symptom burden
Measured: Week 0, 4, 8, 12, 24
Quality of Life - FACT-H&N Total Score
Functional Assessment of Cancer Therapy-Head and Neck; higher score = better quality of life
Measured: Week 0, 8, 12, 24
Grip Strength
Dominant hand; mean of 3 trials with handheld dynamometer (kg)
Measured: Week 0, 4, 8, 12, 24
30-Second Sit-to-Stand Test
Number of complete sit-to-stand repetitions in 30 seconds
Measured: Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Serum CRP (mg/dL); systemic inflammatory marker
Measured: Week 0, 8, 12, 24
Alanine Aminotransferase (ALT/GPT)
Serum ALT (U/L); hepatic injury marker
Measured: Week 0, 8, 12, 24
Aspartate Aminotransferase (AST/GOT)
Serum AST (U/L)
Measured: Week 0, 8, 12, 24
Gamma-Glutamyl Transferase (γ-GT)
Serum γ-GT (U/L); hepatic function marker
Measured: Week 0, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start22 May 2024
- Primary completion26 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two-arm parallel-group design. Participants were randomized 1:1 to receive either Taiwanese Green Propolis or identical placebo capsules for 12 weeks, with follow-up to Week 24.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai-Wei Huang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682285
- Sponsor's protocol ID
- TMU-N202305017oralcancer
- Other IDs
- N202407011, N202305017
- Acronym
- TGP-OCS
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin CC, Chang AP, Chen ML, Cleeland CS, Mendoza TR, Wang XS. Validation of the Taiwanese version of the Brief Fatigue Inventory. J Pain Symptom Manage. 2006 Jul;32(1):52-9. doi: 10.1016/j.jpainsymman.2005.12.019.
PubMed 16824985
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Taiwanese Green Propolis (2,000 mg/Day) on Lipid Profiles, Cancer-Related Fatigue, and Quality of Life in Post-Treatment Oral Cavity Squamous Cell Carcinoma Survivors: A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07682285
- Acronym / sponsor ID
- TGP-OCS / TMU-N202305017oralcancer
- Keywords
- Taiwanese green propolis, propolis, oral cavity cancer survivors, cancer-related fatigue, lipid profiles, quality of life, dietary supplement, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- 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 study examined whether Taiwanese Green Propolis (TGP), a natural bee-derived supplement, can improve blood fat levels, reduce tiredness (fatigue), and improve quality of life in people who have completed treatment for oral cavity (mouth) cancer.
People who had finished treatment for oral cavity squamous cell carcinoma (a type of mouth cancer) and were in the follow-up period were invited to participate. Participants were randomly assigned to take either 4 TGP capsules per day (2,000 mg/day total) or 4 identical-looking placebo capsules for 12 weeks. Neither participants nor the study team knew who received which capsules until after the study ended (double-blind). All participants were followed for a further 12 weeks after stopping the capsules.
At the start and at Weeks 4, 8, 12, and 24, participants had blood tests to measure cholesterol, triglycerides, liver enzymes, and inflammation markers. They also completed questionnaires about fatigue (BFI-T), symptoms (ESAS-r), and quality of life (FACT-H\&N), and performed physical tests including grip strength and a 30-second sit-to-stand test.
The study aimed to determine whether TGP can help manage the metabolic and fatigue-related problems common after oral cancer treatment, and to provide data for planning larger future trials. 25 participants were enrolled at a regional teaching hospital in northern Taiwan. Stool and saliva samples were also collected at each timepoint to assess gut and oral microbiota composition (16S rRNA sequencing) and salivary inflammatory markers. Heart rate variability was monitored via smart wristband (minimum 24 hours per timepoint).
Detailed description
Background:
Oral cavity squamous cell carcinoma (OSCC) survivors frequently experience persistent metabolic complications after treatment, including dyslipidemia, chronic low-grade inflammation, cancer-related fatigue (CRF), muscle weakness, and impaired quality of life. The prevalence of metabolic syndrome in this population substantially exceeds that of the general Taiwanese adult population.
Taiwanese green propolis (TGP), derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae), has a phytochemical profile distinct from Brazilian or Mediterranean propolis, comprising prenylated flavanones-principally propolin C, D, F, G, and H. These compounds have demonstrated hepatoprotective effects (TGF-β/Smad2/3 pathway), anti-inflammatory activity (NLRP3 inflammasome suppression), and lipid-metabolic regulatory properties in preclinical studies. No prior clinical trial has evaluated TGP in OSCC survivors.
Study Design:
Pilot double-blind, placebo-controlled, parallel-group randomized controlled trial (RCT). Intervention period: 12 weeks. Post-intervention follow-up: 12 weeks (total 24 weeks). Assessment timepoints: Week 0 (T0/baseline), Week 4 (T4), Week 8 (T8), Week 12 (T12), Week 24 (T24).
Intervention:
- Experimental: TGP capsules (500 mg/capsule), 4 capsules/day (2 capsules BID), providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds/day; 12 weeks.
- Control: Identical-appearing placebo capsules, 4 capsules/day, 12 weeks. Both capsules were identical in appearance, size, color, and smell.
Randomization and Blinding:
Computer-generated random number sequence with allocation concealment. Participants, care providers, investigators, and outcome assessors were blinded throughout the 24-week study period (quadruple blinding).
Primary Outcomes (T0, T8, T12, T24):
Total cholesterol (TC, mg/dL); Triglycerides (TG, mg/dL); High-density lipoprotein cholesterol (HDL-C, mg/dL); Low-density lipoprotein cholesterol (LDL-C, mg/dL).
Secondary Outcomes:
- Cancer-related fatigue: BFI-T mean score (0-10); T0,T8,T12,T24
- Symptom distress: ESAS-r total score (0-90); T0,T4,T8,T12,T24
- Quality of life: FACT-H\&N total score; T0,T8,T12,T24
- Grip strength (kg), dominant hand, mean of 3 trials; T0,T4,T8,T12,T24
- 30-second sit-to-stand test (repetitions); T0,T4,T8,T12,T24
- C-reactive protein (CRP, mg/dL); T0,T8,T12,T24
- Alanine aminotransferase (ALT/GPT, U/L); T0,T8,T12,T24
- Aspartate aminotransferase (AST/GOT, U/L); T0,T8,T12,T24
- Gamma-glutamyl transferase (γ-GT, U/L); T0,T8,T12,T24
Exploratory Outcomes:
Body weight, BMI, waist circumference, hip circumference, body fat %, hemoglobin, albumin, fasting glucose, HbA1c, BUN, creatinine, uric acid, WBC count, TSH, T3, T4. Serum interleukin-6 (IL-6, pg/mL); T0,T8,T12,T24. Gut microbiota alpha diversity (Shannon index) and beta diversity (Bray-Curtis dissimilarity) via stool 16S rRNA amplicon sequencing; T0,T8,T12,T24. Gut microbiota relative abundance of key bacterial taxa; T0,T8,T12,T24. Oral microbiota composition via saliva 16S rRNA amplicon sequencing; T0,T8,T12,T24. Salivary inflammatory markers including IL-6 (pg/mL); T0,T8,T12,T24. Heart rate variability: RMSSD and SDNN via smart wristband (minimum 24 hours per timepoint); T0,T4,T8,T12,T24.
Statistical Analysis:
Generalized Estimating Equations (GEE) with exchangeable working correlation structure; independent variables: group, time, and group × time interaction; adjusted for baseline values. Cohen's d calculated for significant interaction terms. Intent-to-treat (ITT) principle; N=25.
Sample Size:
Target: 62 participants (G*Power v3.1; repeated-measures ANOVA; f²=0.30; α=0.05; power=0.80; 10% dropout). Actual enrollment (pilot phase): 25.
Ethics:
Enrolment commenced in April 2024 under the original approved protocol N202305017 (approved 2023-05-22, Taipei Medical University Joint Institutional Review Board). A protocol amendment (N202407011, approved 2024-08-15) refined the inclusion criteria to focus on post-treatment oral cavity cancer survivors, designated lipid profiles as the primary outcome, and repositioned fatigue and quality of life as secondary outcomes. The amendment applied prospectively to all subsequently enrolled participants. Written informed consent was obtained from all participants prior to enrolment.
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
- Model description
- Two-arm parallel-group design. Participants were randomized 1:1 to receive either Taiwanese Green Propolis or identical placebo capsules for 12 weeks, with follow-up to Week 24.
| Arm | Type | Receives |
|---|---|---|
| Taiwanese Green Propolis (TGP) | Experimental | Dietary Supplement: Taiwanese Green PropolisParticipants receive Taiwanese Green Propolis capsules (500 mg/capsule, 4 capsules/day divided as 2 capsules in the morning and 2 in the evening) for 12 weeks, providing 2,000 mg TGP/day containing approximately 200 mg propolin compounds (propolin C, D, F, G, H)/day. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive identical-appearing placebo capsules (4 capsules/day, divided as 2 capsules in the morning and 2 in the evening) for 12 weeks. Capsules are identical to TGP capsules in appearance, size, color, and smell but contain no active propolis constituents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Histologically confirmed diagnosis of oral cavity squamous cell carcinoma (OSCC)
- Post-primary treatment follow-up phase (surgery with or without adjuvant radiotherapy and/or chemotherapy completed)
- Alert and oriented; able to complete study assessments independently or with research staff assistance
- Able to communicate in Mandarin or Taiwanese
Key exclusion criteria (4 listed)
- Known allergy to propolis, honey, multiple pollens, or alcohol
- Psychiatric disorder or cognitive impairment preventing study participation
- Neuromuscular or joint disorders preventing performance of grip strength or sit-to-stand assessments
- Pain at testing limb sites preventing physical assessments
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 |
|---|---|---|
| Taiwanese Green PropolisTaiwanese Green Propolis (TGP) capsules derived from Macaranga tanarius (L.) Müll.Arg. (Euphorbiaceae). Each capsule contains 500 mg TGP with approximately 50 mg propolin compounds. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks; total daily dose 2,000 mg TGP containing approximately 200 mg propolin compounds/day. | Dietary supplement | Taiwanese Green Propolis (TGP) |
| PlaceboPlacebo capsules identical to TGP capsules in appearance, size, color, and smell, but containing inert excipients with no active propolis constituents. Administered as 4 capsules/day (2 capsules BID, orally) for 12 weeks. | Other | Placebo |
Primary outcome
Serum Triglycerides (TG)
Time frame: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum triglycerides (mg/dL)
Total Cholesterol (TC)
Time frame: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum total cholesterol (mg/dL)
High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum HDL-C (mg/dL)
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline (Week 0), Week 8, Week 12, Week 24
Fasting serum LDL-C (mg/dL)
9 secondary outcomes
Cancer-Related Fatigue - BFI-T Mean Score
Time frame: Week 0, 8, 12, 24
Symptom Distress - ESAS-r Total Score
Time frame: Week 0, 4, 8, 12, 24
Quality of Life - FACT-H&N Total Score
Time frame: Week 0, 8, 12, 24
Grip Strength
Time frame: Week 0, 4, 8, 12, 24
30-Second Sit-to-Stand Test
Time frame: Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Time frame: Week 0, 8, 12, 24
Alanine Aminotransferase (ALT/GPT)
Time frame: Week 0, 8, 12, 24
Aspartate Aminotransferase (AST/GOT)
Time frame: Week 0, 8, 12, 24
Gamma-Glutamyl Transferase (γ-GT)
Time frame: Week 0, 8, 12, 24
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 2 Jul 2026.
- Results publication: PubMed 16824985Lin CC, Chang AP, Chen ML, Cleeland CS, Mendoza TR, Wang XS. Validation of the Taiwanese version of the Brief Fatigue Inventory. J Pain Symptom Manage. 2006 Jul;32(1):52-9. doi: 10.1016/j.jpainsymman.2005.12.019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taiwanese Green Propolis in people with Head and Neck Squamous Cell Carcinoma and Cancer-related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
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 4 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Serum Triglycerides (TG) (time frame: Baseline (Week 0), Week 8, Week 12, Week 24). 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?
On the ClinicalTrials.gov record for NCT07682285, which also lists 1 linked publication.
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 2 Jul 2026.