Acupuncture for Dysphagia in Head and Neck Squamous Cell Carcinoma (ACP-HN)

Impact of Acupuncture on Acute Dysphagia in Patients Treated With Radio-chemotherapy for Head and Neck Squamous Cell Carcinoma: a Randomized Phase 2 Study

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

Study Overview

• Status: Recruiting
• Conditions: 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).

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Lorenzo Livi, Professor; Phone Number: 0557947192; Email: lorenzo.livi@unifi.it

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Azienda Ospedaliero Universitaria Careggi
    • Contact: Noela Gori, Study Coordinator; Phone Number: 0557947192; Email: datamanager.ng.rt@sbsc.unifi.it
  • Florence, Italy, 50134
    • Recruiting
    • AOU Careggi Radiation Oncology Unit
    • Contact: Pierluigi Bonomo; Phone Number: +390557947264; Email: bonomop@aou-careggi.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• histologically-confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with HNSCC of unknown primary or non-squamous histologies
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary objective	Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)	two weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary objective n.1	Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)	12 weeks after end of treatment
Secondary objective n.2	Swallowing function assessed with MDADI scale (MD Anderson Dysphagia Inventory)	24 weeks after end of treatment
Secondary objective n.3	Patients' quality of life assessed with the EORTC QLQ-C30 and QLC-HN 43	12 and 24 weeks after end of treatment
Secondary objective n.4	Feasibility of acupuncture (percentage of completed acupuncture sessions out of planned per protocol)	maximum of 11 weekly sessions
Secondary objective n.5	Incidence of moderate-severe dysphagia (>G2) assessed with CTCAE v. 5.0	2 weeks after end of treatment
Secondary objective n.6	Incidence of moderate-severe adverse events (G3-G4) assessed with CTCAE v.5	2 weeks after end of treatment
Secondary objective n.7	Relative dose intensity of systemic therapy	2 weeks after the end of treatment
Secondary objective n.8	Radiation interruptions	2 weeks after end of treatment
Secondary objective n.9	Relative weight loss (percentage of weight loss compared with baseline value at start of therapy)	2 weeks after end of treatment

Collaborators and Investigators

• Sponsor: Lorenzo Livi

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: ACP-HN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No