Acupuncture for Dysphagia in Head and Neck Squamous Cell Carcinoma

NCT05143268 | Unknown

• 1 other identifier: ACP-HN
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)

  two weeks after the end of treatment

Secondary Outcomes (9)

• Secondary objective n.1

  12 weeks after end of treatment

• Secondary objective n.2

  24 weeks after end of treatment

• Secondary objective n.3

  12 and 24 weeks after end of treatment

• Secondary objective n.4

  maximum of 11 weekly sessions

• Secondary objective n.5

  2 weeks after end of treatment

Study Arms (2)

A

In the experimental arm (arm A), a total of 11 sessions of acupuncture will be performed on a weekly basis, spanning from 2 weeks before Radiotherapy start throughout 7 weeks of treatment, to 2 weeks after its completion. Patients randomized to the experimental arm will receive acupuncture in addition to standard of care treatment, chosen by the treating multidisciplinary team in accordance with international guidelines.

B

In the standard arm (arm B), patients will be treated with standard of care treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients over 18 years old who have received a histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx

You may qualify if:

• histologically-confirmed diagnosis of squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx and larynx or histologically-confirmed diagnosis of undifferentiated carcinoma of the nasopharynx
• by judgement of the local investigator, indication for a DNST with curative intent, consisting of one of the 3 following options:
• radiotherapy alone
• cisplatin-based concomitant chemo-radiotherapy
• cetuximab-based concomitant bio-radiotherapy
• clinical stage of disease: II, III, IVA, IVB (according to TNM/AJCC 8th edition) for primary tumors of the larynx, hypopharynx and oropharynx (p16/HPV negative), provided that for stage II disease (cT2N0) the local investigator will prescribe an elective irradiation of regional lymph nodes
• clinical stage of disease: I, II, III (according to TNM/AJCC 8th edition) for primary tumors of the oropharynx (p16/HPV positive), provided that for stage I disease (cT1N0) the local investigator will prescribe an elective irradiation of regional lymph nodes

You may not qualify if:

• metastatic disease
• gross total excision of both primary and nodal disease before index treatment
• surgical manipulation including therapeutic tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease
• prior radiotherapy to the head and neck region
• induction chemotherapy prior to radiotherapy
• prior use of acupuncture for SCCHN or for different indications
• prior allergic reaction or history of hypersensitivity to inox austenitic steel (Cr18Ni9)
• active or prior documented neurologic or rheumatologic disorder with a potential impact on the swallowing function (i.e: multiple sclerosis, amyotrophic lateral sclerosis, scleroderma)
• active process of severe skin infection in the neck contraindicating the execution of acupuncture in the opinion of the investigator
• severe baseline dysphagia documented by a MDADI scale (MD Anderson Dysphagia Inventory) composite score below 60
• any condition that, in the opinion of the investigator, would not require to encompass at least ipsilateral neck lymph nodes in the irradiation field
• any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

Sponsors & Collaborators

• Lorenzo Livi: lead

Study Sites (2)

AOU Careggi Radiation Oncology Unit

Florence, 50134, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, 50134, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Lorenzo Livi, Professor

CONTACT

0557947192; lorenzo.livi@unifi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: June 3, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

IT (2)