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Optimal intervention scheme for non-drug therapy for cancer-related fatigue: a sequential multiple assignment randomized trial

Optimal intervention scheme for non-drug therapy for cancer-related fatigue: a sequential multiple assignment randomized trial (SMART)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073014
Enrollment
Unknown
Registered
2023-06-29
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer-related fatigue (CRF)

Interventions

Treatment group of the first stage:Acupuncture points selected are "Pi San Zhen" (Sishenzhen, bilateral Neiguan, bilateral Zusanli), once a day, five times a week (Monday to Friday morning).
Control group of the first stage:Psychotherapy interventions will be performed, including educational interventions (including CRF-related educational interventions, dietary guidance, sleep guidance),
Treatment group of the second stage:Acupuncture points selected are "Pi San Zhen" (Sishenzhen, bilateral Neiguan, bilateral Zusanli), once a day, three times a week (Monday, Wednesday and Friday morni
Control group of the second stage:No treatment.

Sponsors

Shanxi Province Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The tumor was confirmed by imaging, pathology or cytology, and the clinical stage was clear; (2) Patients with KPS score =60 and identified as CRF by Piper-R score; (3) Age, sex and tumor species are unlimited; (4) Expected survival =3 months; (5) The subject must be conscious and cognitively capable of subjectively evaluating his feelings; (6) Informed consent to participate in the project study, sign the informed consent and be able to cooperate with the scale assessment.

Exclusion criteria

Exclusion criteria: (1) Conditions that may prevent subjects from completing the clinical trial process, including but not limited to serious and difficult to control organic diseases or infections, heart failure, etc.; Severe abnormal liver and kidney function (serum creatinine =1.5 times the normal value; ALT or AST=5 times the normal value; Bilirubin =1.5 times the normal value); (2) Patients with hematopoietic system diseases, such as anemia, need to use anemia correction drugs; (3) Patients who are receiving or are about to receive treatment that may have an impact on CRF; (4) People who are using drugs that may have an improving effect on CRF; (5) Those who suffer from mental illness and are unable to complete the scale assessment; (6) Subjects assessed by the investigator as unable to cooperate with the completion of the clinical investigation. Those who meet 1 or more of the above requirements are excluded.

Design outcomes

Primary

MeasureTime frame
PFS-R;

Secondary

MeasureTime frame
KPS;Patient satisfaction score;Patient compliance score;

Countries

China

Contacts

Public ContactZhi-JieWang

Shanxi Province Hospital of Traditional Chinese Medicine

wang15244616809@126.com+86 136 2347 1342

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026