Evaluating manual therapy to prevent fibrosis in head and neck cancer patients after radiation
The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
This study is testing if manual therapy can help prevent stiffness and improve movement in head and neck cancer patients after they finish radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Taipei City) |
| Trial ID | NCT04850170 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of manual therapy and rehabilitation in preventing radiation-induced fibrosis in patients who have completed radiotherapy for head and neck cancer. It consists of two parts: a pilot study with 10 subjects receiving manual therapy and rehabilitation over six months, and a randomized controlled study with 60 patients divided into two groups—one receiving manual therapy and rehabilitation, and the other receiving rehabilitation only. Evaluations will be conducted at baseline, and at 3, 6, and 12 months to assess various outcomes related to fibrosis and functional mobility.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old who have completed radiation therapy for head and neck cancer within the last 4 to 6 weeks.
Not a fit: Patients with recurrent or metastatic cancer, concurrent second cancers, or those with severe post-radiation dermatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to prevent or reduce the severity of radiation-induced fibrosis in head and neck cancer patients.
How similar studies have performed: While the approach of using manual therapy for this specific condition is novel, similar interventions have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : 1. Age \> 20 years 2. Head and neck cancer 3. After Completion of radiation therapy for 4 to 6 weeks 4. Be willing to accept manual therapy and long-term follow up Exclusion Criteria : 1. Recurrence, metastatic cancer, or concurrent second cancer 2. With post-radiation dermatitis at neck or shoulder 3. Current pregnancy or lactation 4. Life expectancy of \< 12 months.
Where this trial is running
New Taipei City
- New Taipei Municipal Tucheng Hospital — New Taipei City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Tsung-Hsien Yang, MD
- Email: cgupanda@gmail.com
- Phone: 886-975-362-728
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.