Acupuncture to treat acute radiotherapy side effects in head and neck cancer
Acupuncture as the Therapeutic Modalities of Acute Toxicity in the Radiotherapy of Head and Neck Tumors
This trial will test whether adding acupuncture to standard supportive care reduces acute side effects in people receiving curative or adjuvant radiotherapy for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masaryk Memorial Cancer Institute Academic / other |
| Locations | 1 site (Brno) |
| Trial ID | NCT03751566 on ClinicalTrials.gov |
What this trial studies
The trial will enroll 100 patients undergoing curative or adjuvant radiotherapy for head and neck tumors who have at least grade 1 acute radiotoxic symptoms and randomize them 1:1 to standard supportive care alone or standard care plus individualized acupuncture. Acupuncture points and treatments will be documented, patients will keep symptom diaries, and skin toxicity will be photographed. Randomization is by ticket and enrollment is managed to balance arms so that after one arm reaches 50 patients subsequent enrollment favors the other arm until the target is met. Outcomes focus on changes in acute radiotherapy toxicity, symptom burden, and supportive medication use during treatment and follow-up.
Who should consider this trial
Good fit: Ideal candidates are patients with head and neck cancer receiving curative or adjuvant radiotherapy, with performance status 1–2, at least grade 1 acute radiotoxic symptoms, and who can comply with acupuncture visits and keep a symptom diary.
Not a fit: Patients receiving palliative radiotherapy, those with performance status of 3, or patients unwilling or unable to comply with acupuncture sessions and diary keeping are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, acupuncture could reduce acute radiotherapy symptoms such as mucositis, pain, or skin toxicity and improve treatment tolerability and quality of life.
How similar studies have performed: Previous small trials and pilot studies have reported symptomatic benefits of acupuncture for some radiation-related problems like xerostomia and mucositis, but high-quality randomized evidence is limited and results are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Curative and adjuvant radiotherapy for head and neck tumors; * PS 1-2; * Patient collaboration in evaluation of the toxicity diary. Exclusion Criteria: * Palliative radiotherapy in the head and neck tumor; * PS 3; * Non-compliance of the patient.
Where this trial is running
Brno
- Masaryk Memorial Cancer Institute — Brno, Czechia (Recruiting)
Study contacts
- Study coordinator: Renata Hejnová, Msc
- Email: renata.hejnova@mou.cz
- Phone: +42054313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.