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Completed NCT07682285

Taiwanese Green Propolis for Lipid Profiles, Fatigue, and Quality of Life in Oral Cavity Cancer Survivors

Conditions: Head and Neck Squamous Cell Carcinoma, Cancer-related Fatigue, Dyslipidemias

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Taipei Medical University

Location: Taipei Medical University Hospital Taipei

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. 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).

Eligibility Criteria

Inclusion Criteria: 1. Age 18 years or older 2. Histologically confirmed diagnosis of oral cavity squamous cell carcinoma (OSCC) 3. Post-primary treatment follow-up phase (surgery with or without adjuvant radiotherapy and/or chemotherapy completed) 4. Alert and oriented; able to complete study assessments independently or with research staff assistance 5. Able to communicate in Mandarin or Taiwanese 6. Not chewing betel quid during the study period 7. Willing to provide written informed consent Exclusion Criteria: 1. Known allergy to propolis, honey, multiple pollens, or alcohol 2. Psychiatric disorder or cognitive impairment preventing study participation 3. Neuromuscular or joint disorders preventing performance of grip strength or sit-to-stand assessments 4. Pain at testing limb sites preventing physical assessments

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07682285). StuddyBuddy aggregates publicly available trial information.