NCT04418115

Brief Summary

The success of treatment of breast cancer has improved, hence the prevalence of survivors have increased. However, experienced late effects from the cancer itself or from cancer treatment is substantial. Anti-cancer treatment can have a number of side effects including nausea, fatigue, vomiting, anorexia and alopecia. Late effects such as cancer related fatigue (CRF) are very persistent. CRF is a common side effect of cancer therapy, and affects the quality of life of patients and their families. It is important to point out that CRF is a form of fatigue that are different from normal fatigue which everyone can experience every now and then. Acupuncture is increasingly used in cancer centers both in the US and Europe, and that patients are positive to using acupuncture. Albeit the emerging evidence for acupuncture and CRF, acupuncture has neither been offered as a treatment for CRF within a Norwegian hospital nor in general practice. Hence the investigators think there is a need for a large randomized controlled trial (RCT) in a Norwegian health care setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 10, 2025

Status Verified

June 1, 2024

Enrollment Period

2.8 years

First QC Date

November 9, 2019

Last Update Submit

March 6, 2025

Conditions

FatigueDepression, AnxietyInsomniaHot FlashesQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Fatigue

    Chalders Fatigue questionnaire (FQ)

    12 weeks (treatment completion), Change from baseline registration at 3 and 6 month

  • Fatigue 2

    Fatigue Severity Scale (FSS)

    Change from baseline registration at 3 and 6 month

Secondary Outcomes (6)

  • Anxiety and depression

    12 weeks (treatment completion), Change from baseline registration at 3 and 6 months

  • Bergen Insomnia Scale

    12 weeks (treatment completion), Change from baseline registration

  • The Epworth Sleepiness Scale

    12 weeks (treatment completion), Change from baseline registration

  • Hot flashes

    12 weeks (treatment completion), Change from baseline registration

  • Quality of Life (QLQ) questionnaire

    12 weeks (treatment completion), Change from baseline registration

  • +1 more secondary outcomes

Study Arms (2)

Acupuncture + usual care

EXPERIMENTAL

Participants randomized to acupuncture treatment will receive 12 acupuncture treatments during 8-12 weeks.

Other: Acupuncture; based on Tradidtional Chinese Medicine

Usual care

NO INTERVENTION

Our control group will receive "business as usual". Hence, they will continue with their usual care for their CRF. By inclusion in the study and by the end of it, the participants in the control group will fill in the requested and similar instruments as the participants in the acupuncture group. Further, we will document any medical care they have received during the study period. This includes also life styles advice, and to which point they have followed such advices.

Interventions

Acupuncture; based on Tradidtional Chinese MedicineOTHER

Acupuncture is a form of treatment that involves inserting very thin needles through a person's skin at specific points on the body, to various depths. Research suggests that it can help relieve pain, and it is used for a wide range of other complaints.

Acupuncture + usual care

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast cancer survivors, aged 18 or older, not receiving any curative cancer treatment
  • Fatigue score on a VAS scale ≥4 will be eligible
  • Sufficient knowledge of Norwegian is necessary for communicating with the acupuncturist and for filling in and understanding all the Norwegian questionnaires within the study.
  • Participants who have freely agreed to take part in the study and have signed an informed consent form.

You may not qualify if:

  • Any causal pathology related to fatigue or receiving ongoing acupuncture treatment for fatigue.
  • Participants who are pregnant at baseline or planning to get pregnant within the treatment period will be excluded. Reason is that several acupuncture points should be avoided during pregnancy and several of those are related to the treatment of fatigue.
  • Potential participants who are unable to understand, speak, or who find it difficult to communicate in Norwegian will be excluded from the study.
  • Individuals presenting with clinically diagnosed conditions or pathologies known to contribute to fatigue and persons whose fatigue could be attributed to pre-existing conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristiania University College

Oslo, 0107, Norway

Location

Related Publications (1)

  • Alraek T, Skjerve H, Sorensen A, Lie SA, Presterud Odegard H, Lu W, Mao J, Deng G, Lee MS, Birch S, Lamu AN, Kim TH, MacPherson H. Acupuncture for fatigue in breast cancer survivors: a study protocol for a pragmatic, mixed method, randomised controlled trial. BMJ Open. 2024 Jul 30;14(7):e077514. doi: 10.1136/bmjopen-2023-077514.

    PMID: 39079925DERIVED

MeSH Terms

Conditions

FatigueDepressionAnxiety DisordersSleep Initiation and Maintenance DisordersHot Flashes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Terje Alraek, PhD

    School of Health Sciences, Kristiania University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician is not involved in any other aspect of the study, hence we can secure that the evaluation of the outcomes are done blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a pragmatic, mixed-method, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2019

First Posted

June 5, 2020

Study Start

September 1, 2021

Primary Completion

June 15, 2024

Study Completion

December 31, 2024

Last Updated

March 10, 2025

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Baseline data, primary and secondary outcomes may be shared. This is applicable since all data sheets are rendered anonymous by removing participant names and addresses. Trial number alone identifies all computerized data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
December 2024 and for 3 years
Access Criteria
Application to the sent to the Principle Investigator

Locations

NO(1)