Acupuncture in Cancer Patients Undergoing Radiotherapy Treatment (ART)

A Feasibility Study of Acupuncture to Improve Quality of Life and Fatigue in Cancer Patients Undergoing Radiotherapy Treatment

Feasibility randomized controlled trial of standard care v standard care + acupuncture administered by specially-trained therapy radiographers in patients undergoing radiotherapy. It is a feasibility study to investigate all aspects of a future definitive randomized controlled trial, including statistical power calculation, hence there is no primary outcome or time point.

Mixed methods: literature review, model validity, training and mentoring of radiographers, processes, resources, interventions, procedures, patient clinical outcomes, patient and stakeholder qualitative outcomes

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Acupuncture

Detailed Description

The aim of the 'Acupuncture to improve quality of life and fatigue in cancer patients undergoing Radiotherapy Treatment' (ART) project is to investigate all aspects of the feasibility of undertaking clinical research on acupuncture with patients having radiotherapy at the University College Hospital (UCH) Cancer division.

The program includes an exploratory feasibility randomized controlled trial to investigate all aspects of a future definitive randomized controlled trial, including: organizational and procedural issues, patient group (including cancer diagnosis and stage), statistical power calculation, primary outcome measure and time point. It is NOT intended to deliver definitive results in terms of clinical outcomes.

ART aims to establish a platform for the investigation of integrating complementary therapy into cancer care, between the Royal London Hospital for Integrated Medicine (RLHIM) and the UCH cancer division. The development of a research project to investigate the use of acupuncture, a therapy not currently provided by the cancer division, to address the key concerns of cancer patients was the starting point. The intention is to evaluate the feasibility of such research, not to produce definitive results.

The greatest concerns of people with cancer include anxiety, fatigue, sleep problems and pain as a consequence of their disease and its treatment. Many patients find complementary therapies beneficial for these problems. UCH and RLHIM are both part of the University College London Hospital NHS Trust. The RLHIM is a specialist provider of complementary therapies, and offers treatment to cancer patients attending for radiotherapy and chemotherapy at UCH.

ART uses multiple methods, including a systematic review of the literature, model validity expert consensus, a novel therapy (acupuncture) and mode of delivery (specially trained health professionals already working in the radiotherapy department), and standard measures of outcome, culminating in a feasibility randomized controlled clinical trial.

The research program will evaluate all involved processes, resources, interventions and procedures. Outcomes measured included patient clinical outcomes, and the views of patients and stakeholders.

The research team comprises the Royal London Hospital for Integrated Medicine (RLHIM) research team, UCH Cancer Clinical Trials Unit (CCTU), a Steering Group including representatives of all interested parties including patients, an International Scientific Advisory Committee, an Acupuncture Expert Panel, with support from Quality Health Ltd.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College London Hospitals Cancer Clinical Trials Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients due to receive radical (curative) radiotherapy
• Patients of either gender and older than 16 years old.
• Patients with any cancer diagnosis.
• Patients willing to participate in the study and be randomised to one of the two treatment arms.
• Patients willing to attend at least 3 acupuncture treatments if assigned to the acupuncture intervention.
• Palliative patients.
• Patients unwilling to participate (for instance due to needle phobia).
• Patients currently receiving acupuncture.
• Patients with a platelet count <20 000mm.
• Patients with a white blood cell count <1000mm.
• Patients with severe clotting dysfunction or who bruise spontaneously.
• Patients unable to complete the questionnaires as judged by the investigators.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture; Acupuncture administered by specially-trained therapeutic radiographers to patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer	Device: Acupuncture; Acupuncture administered by specially-trained therapeutic radiographers
NO_INTERVENTION: Standard care; Standard care for patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQC-30	EORTC QLQC-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. A well-validated quality of life questionnaire for cancer patients focusing on functional assessment. It consists of nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. High internal consistency and construct validity have been demonstrated.	Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MFI	Multidimensional Fatigue Inventory. A well-validated scale comprising 20 items measuring general fatigue including dimensions of physical and mental fatigue.	Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
MSAS	Memorial Symptom Assessment Scale. A multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment.	Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)
EQ-5D-5L	European Quality of Life 5 Dimensions 5 levels. A well-validated instrument which includes five indices to represent patients' Health Related Quality of Life: mobility; self-care; usual activities; pain/discomfort; anxiety/depression	Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)

Collaborators and Investigators

• Sponsor: Royal London Hospital for Integrated Medicine
• Collaborators: University College London Hospitals
• Investigators: Principal Investigator: Peter A Fisher, MD, Royal London Hospital for Integrated Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 12, 2015
• Primary Completion (ACTUAL): October 31, 2016
• Study Completion (ACTUAL): October 31, 2016

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 7, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: fatigue; health-related quality of life
• Other Study ID Numbers: 15/0357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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