Trial Outcomes & Findings for Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema (NCT NCT00828516)

Results Overview

MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

Before 7th acupuncture treatment

Results posted on

2013-01-17

Participant Flow

Recruitment: June 2008 though May 2009. Participants recruited via the Mount Vernon Hospital Lymphoedema Service.

Participant milestones

Participant milestones
Measure	Clinical Phase Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
Clinical Phase: Series 1 STARTED	35
Clinical Phase: Series 1 COMPLETED	33
Clinical Phase: Series 1 NOT COMPLETED	2
Clinical Phase: Series 2 STARTED	30
Clinical Phase: Series 2 COMPLETED	30
Clinical Phase: Series 2 NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Clinical Phase Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
Clinical Phase: Series 1 Withdrawal by Subject	2

Baseline Characteristics

Using Traditional Acupuncture in the Management of Cancer Treatment Related Lymphoedema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinical Phase n=35 Participants Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	57.5 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United Kingdom	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Before 7th acupuncture treatment

Population: All participants completing 6 acupuncture treatments were analysed

MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.

Outcome measures

Outcome measures
Measure	Usual Care Plus Traditional Acupuncture n=32 Participants All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile (MYMOP)	1.51 units on a scale Standard Deviation 0.96

PRIMARY outcome

Timeframe: Before the 13th acupuncture treatment

Population: This was the number of participants who continued to, and completed, Series 2 of the treatments

MYMOP is a questionnaire widely used for evaluating interventions based on holistic and participative principles. It enables respondants to specify and measure the treatment outcomes that are important to them.

Outcome measures

Outcome measures
Measure	Usual Care Plus Traditional Acupuncture n=30 Participants All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
Change From Baseline in Patient-specified and Reported Symptoms on the Measure Yourself Medical Outcome Profile	1.32 units on a scale Standard Deviation 0.94

Adverse Events

Usual Care Plus Traditional Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Beverley de Valois

Lynda Jackson Macmillan Centre

Phone: +44(0)1923-844456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place