Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 8:23 PM
Study NCT ID:
NCT05143268
Status:
UNKNOWN
Last Update Posted:
2022-11-10
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Dysphagia in Head and Neck Squamous Cell Carcinoma
Sponsor:
Lorenzo Livi
Organization:
Study Overview
Official Title:
Impact of Acupuncture on Acute Dysphagia in Patients Treated With Radio-chemotherapy for Head and Neck Squamous Cell Carcinoma: a Randomized Phase 2 Study
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACP-HN
Brief Summary:
This is a randomized phase 2 study on the impact of acupuncture on acute dysphagia in patients treated with radio-chemotherapy for head and neck squamous cell carcinoma
Detailed Description:
In order to attempt to reduce the impact of adverse effects produced by oncological treatments, cancer patients frequently turn to complementary integrative therapies.
Among them, acupuncture has been characterized by a growing role in cancer-related symptoms management in last 10 years.
After FDA approval for use as a medical device in 1996, the application of this technique in oncology has been on the rise in the Western countries.
By modulating brain regions involved in cognition and emotion, some degree of successful symptom management with acupuncture has been demonstrated in oncology In the context of head and neck cancer, the first application of acupuncture was related to chronic shoulder pain and dysfunction following neck dissection.
The primary objective of the study is to compare the effect of acupuncture and standard treatment on swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory) 2 weeks after the end of RT (end of treatment, EoT).
Among them, acupuncture has been characterized by a growing role in cancer-related symptoms management in last 10 years.
After FDA approval for use as a medical device in 1996, the application of this technique in oncology has been on the rise in the Western countries.
By modulating brain regions involved in cognition and emotion, some degree of successful symptom management with acupuncture has been demonstrated in oncology In the context of head and neck cancer, the first application of acupuncture was related to chronic shoulder pain and dysfunction following neck dissection.
The primary objective of the study is to compare the effect of acupuncture and standard treatment on swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory) 2 weeks after the end of RT (end of treatment, EoT).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: