Acupuncture in Cancer Patients Undergoing Radiotherapy Treatment

NCT03433118 | Completed DMC

• 1 other identifier: 15/0357
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

fatigue; health-related quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• MFI

  Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)

• MSAS

  Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)

• EQ-5D-5L

  Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2)

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Standard care for patients attending the UCH radiotherapy department for radiotherapy intended to be curative of their cancer

Interventions

Acupuncture DEVICE

Acupuncture administered by specially-trained therapeutic radiographers

Acupuncture

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Royal London Hospital for Integrated Medicine: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospitals Cancer Clinical Trials Unit

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Fatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Peter A Fisher, MD

  Royal London Hospital for Integrated Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (RCT) comparing standard care against standard care with additional acupuncture

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: February 14, 2018
• Study Start: August 12, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)