Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients

Trial Title: Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients

NCT ID: NCT05929690

Condition: Cancer

Conditions: Keywords:
cancer
acupuncture
feasibility trial

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Self-acupuncture
Description: Participants be taught to safely apply acupuncture bilaterally using traditional acupuncture needles to the acupuncture point Stomach 36. If deemed to be clinically appropriate by the acupuncturists, and if patients are willing and able, they will also be taught how to safely needle the acupuncture points Spleen 6 and/or Liver 3 (maximum of six points in total).
Arm group label: Standard care plus self-acupuncture

Summary: The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients due to receive radical (curative) intravenous chemotherapy (any chemotherapy regime). - 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 the self-acupuncture workshop, and self-administer acupuncture, if assigned to the intervention. Exclusion Criteria: - 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.

Gender: All

Minimum age: 16 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UCH Macmillan Cancer Centre

Address:
City: London
Country: United Kingdom

Status: Recruiting

Contact:
Last name: John Hughes

Phone: 02034488883
Email: john.hughes8@nhs.net

Start date: November 16, 2023

Completion date: December 2024

Lead sponsor:
Agency: University College London Hospitals
Agency class: Other

Source: University College London Hospitals

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05929690