Acupuncture for Lymphedema Secondary to Breast Cancer Treatment

NCT ID: NCT02158832

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-12-31

Brief Summary

This study is being conducted to determine if electro-acupuncture can reduce swelling of the arm due to breast cancer treatment (commonly referred to as 'lymphedema'). Research conducted on animals suggests that such treatment might be used to improve circulation leading to reductions in swelling. Previous research in humans with lymphedema suggests that treatment may be safe to use, although results regarding its efficacy in the reduction of swelling have not yet been established.

This research will use sophisticated, non-invasive assessment methods to determine if a single session of electro-acupuncture treatment can be effective for reducing lymphedema. Results may be used to further develop our understanding of how electro-acupuncture can be used in the management of this condition. Electro-acupuncture may provide a promising complement or alternative to conventional lymphedema treatments such as compression bandaging, massage therapy or surgery.

Detailed Description

Participants will be invited to attend a 30-60 minute screening visit to determine eligibility. This screening visit will be located at a laboratory at McMaster University's Institute of Applied Health Sciences. Eligibility will be determined using health questionnaires and non-invasive physical assessment of the upper limbs. Participants may not be eligible for further participation based on their health status and risks to health and safety.

Participants meeting eligibility criteria will be invited to 1 scheduled appointment (30-60 minutes in duration). The appointment time will be scheduled according to individual symptoms, such that it will coincide with the time of day that lymphedema symptoms are predicted to be at their highest. Upon arrival at the scheduled appointment, participants will be randomized to receive 20 minutes of acupuncture+applied electrical stimulation or no treatment. Participants in both groups will be asked to provide physical assessment data over a period of 30 minutes during the scheduled appointment. Differences between groups in tissue swelling of the affected upper-limb will be determined immediately following treatment, and at 10 minutes following treatment.

Participants will be asked to report any significant changes to their health state for a period of 2 weeks following treatment. A follow-up questionnaire will be made available at 2 weeks following attendance of the scheduled appointment.

Conditions

Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture + Electrical Stimulation

Acupuncture needles are inserted beneath the skin and electrical stimulation applied for 20 minutes.

Group Type: EXPERIMENTAL

Acupuncture + Electrical Stimulation

Intervention Type: DEVICE

2 acupuncture needles are inserted into the upper back. 10Hz, 0.5ms biphasic square wave electrical pulses are applied to needles x20 mins. Current >sensation threshold & maintained at a level that is comfortable/painless & does not elicit skeletal muscle contractions (~5mA, <10mA).

Needle locations are in the vicinity of nerves that supply the affected upper limb:

EX-B1': Affected hemisphere, 1.5cm lateral to C5 spinous process. Insertion angle: shallow, 'inferior-lateral', ~15⁰ perpendicular to the skin, ~15⁰ lateral to the midline. Depth: ~1.5 cm (secure anchorage).

EX-HN15': Affected hemisphere, 1.5cm lateral to the C7 spinous process. Insertion angle: shallow, 'inferior-medial' ~15⁰ perpendicular to the skin, ~15⁰ medial. Depth: ~1.5 cm (secure anchorage).

Control

Participants who are randomized to receive no intervention will still receive physical assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupuncture + Electrical Stimulation

2 acupuncture needles are inserted into the upper back. 10Hz, 0.5ms biphasic square wave electrical pulses are applied to needles x20 mins. Current >sensation threshold & maintained at a level that is comfortable/painless & does not elicit skeletal muscle contractions (~5mA, <10mA).

Needle locations are in the vicinity of nerves that supply the affected upper limb:

EX-B1': Affected hemisphere, 1.5cm lateral to C5 spinous process. Insertion angle: shallow, 'inferior-lateral', ~15⁰ perpendicular to the skin, ~15⁰ lateral to the midline. Depth: ~1.5 cm (secure anchorage).

EX-HN15': Affected hemisphere, 1.5cm lateral to the C7 spinous process. Insertion angle: shallow, 'inferior-medial' ~15⁰ perpendicular to the skin, ~15⁰ medial. Depth: ~1.5 cm (secure anchorage).

Intervention Type: DEVICE

Other Intervention Names

Acupuncture; Electrical Stimulation; Electro-Acupuncture

Eligibility Criteria

Inclusion Criteria

• >1yr following the conclusion of breast cancer treatment
• Lymphedema of the upper limb: unilateral (one-side)

Exclusion Criteria

• History or evidence of hormone-receptor positive cancer
• Previous nodal dissection or radiotherapy to other regions
• Contraindications for acupuncture or electrical stimulation
• Pre-cancer or bi-lateral lymphedema
• Evidence of active cancer
• History of contralateral cancer, radiation or surgery
• Edema of the neck/midline/torso
• Pregnancy
• Allergies to nickel, chromium, or silicon
• Seizures (epilepsy)
• Tremors (shakiness) that may interfere with treatment
• Infections, scarring, open wounds, or broken skin at needle sites
• Infections, open wounds, or broken skin on the upper limbs (electrode & landmark sites)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Interdisciplinary Network Complementary & Alternative Medicine Research

OTHER

Sponsor Role: collaborator

Holistic Health Research Foundation of Canada

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek Rosa, PhD(c)

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

HIREB 14-089

Identifier Type: -

Identifier Source: org_study_id