Trial Outcomes & Findings for The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia (NCT NCT02887586)

Last Updated: 2024-01-30

Results Overview

The Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess the patient's appetite.Possible scores range from 4（poor appetite) to20（good appetite）.The score lower than 14 predicts a risk of 5% weight loss.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

10 weeks

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Auricular Needling Group Patients will receive auricular needling for 4 weeks . auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Overall Study STARTED	30	30
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=28 Participants	0 Participants n=55 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=27 Participants	16 Participants n=28 Participants	26 Participants n=55 Participants
Age, Categorical >=65 years	17 Participants n=27 Participants	12 Participants n=28 Participants	29 Participants n=55 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7 • n=27 Participants	63 years STANDARD_DEVIATION 13 • n=28 Participants	65 years STANDARD_DEVIATION 11 • n=55 Participants
Sex: Female, Male Female	17 Participants n=27 Participants	13 Participants n=28 Participants	30 Participants n=55 Participants
Sex: Female, Male Male	10 Participants n=27 Participants	15 Participants n=28 Participants	25 Participants n=55 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=27 Participants	0 Participants n=28 Participants	0 Participants n=55 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=27 Participants	28 Participants n=28 Participants	55 Participants n=55 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=27 Participants	0 Participants n=28 Participants	0 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	27 participants n=27 Participants	28 participants n=28 Participants	55 participants n=55 Participants
Body weight	56.89 kg STANDARD_DEVIATION 10.04 • n=27 Participants	58.47 kg STANDARD_DEVIATION 6.85 • n=28 Participants	57.49 kg STANDARD_DEVIATION 8.55 • n=55 Participants

PRIMARY outcome

Timeframe: 10 weeks

Outcome measures

Outcome measures
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Simple Appetite Questionnaire Baseline	8.7 score on a scale Standard Deviation 1.996	9.57 score on a scale Standard Deviation 1.854
Simple Appetite Questionnaire Treatment for 2 weeks	11.26 score on a scale Standard Deviation 2.246	9.93 score on a scale Standard Deviation 1.654
Simple Appetite Questionnaire Treatment for 4 weeks	13.19 score on a scale Standard Deviation 2.058	9.50 score on a scale Standard Deviation 2.186
Simple Appetite Questionnaire Stop treatment for 4 weeks	13.00 score on a scale Standard Deviation 2.236	9.68 score on a scale Standard Deviation 2.161

PRIMARY outcome

Timeframe: 10 weeks

Symptom based anorexia assessment is used to evaluate whether and to what extent anorexia occurs in cancer patients.Possible scores range from 0(normal appetite) to 48(severe anorexia).After the patient answers all the questions in the table, the score is scored, and the final score is less than or equal to 24 points, which can be determined as anorexia.

Outcome measures

Outcome measures
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Symptom Based Anorexia Assessment Treatment for 2 weeks	11.26 score on a scale Standard Deviation 2.246	9.93 score on a scale Standard Deviation 1.654
Symptom Based Anorexia Assessment Baseline	8.70 score on a scale Standard Deviation 1.996	9.57 score on a scale Standard Deviation 1.854
Symptom Based Anorexia Assessment Treatment for 4 weeks	13.19 score on a scale Standard Deviation 2.058	9.5 score on a scale Standard Deviation 2.186
Symptom Based Anorexia Assessment Stop treatment for 4 weeks	13.00 score on a scale Standard Deviation 2.236	9.68 score on a scale Standard Deviation 2.161

SECONDARY outcome

Timeframe: 10 weeks

The appetite improvement is used to indicates the patient's appetite.Method: Use a moving ruler about 10cm long, with one side marked with 10 scales, the two ends are "0" and "10" respectively, 0 means normal appetite, 10 scores indicate extreme aversion to food. When in use, the side with the scale should face away from the patient, and let the patient mark on the ruler.The corresponding position that can represent one's own desire for food, the position marked by the doctor according to the patient is its score, clinical evaluation is divided into "normal appetite/basically normal eaters", "3-5" with "0-2". Divided into "mild anorexia", "6-8" into "moderate anorexia", \>8 into "severe anorexia"

Outcome measures

Outcome measures
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Appetite Improvement Baseline	6.56 score on a scale Standard Deviation 1.717	5.39 score on a scale Standard Deviation 1.548
Appetite Improvement Treatment for 2 weeks	4.56 score on a scale Standard Deviation 2.172	5.36 score on a scale Standard Deviation 1.496
Appetite Improvement Treatment for 4 weeks	3.59 score on a scale Standard Deviation 1.845	5.29 score on a scale Standard Deviation 1.823
Appetite Improvement Stop treatment for 4 weeks	3.30 score on a scale Standard Deviation 1.918	5.75 score on a scale Standard Deviation 1.818

SECONDARY outcome

Timeframe: 10 weeks

Weight used to assess the appetite of patient.Body weight changes caused by factors such as body cavity effusion and edema were excluded. Improvement: weight gain \> 2kg,and maintained for more than 4 weeks. Stable: Weight gain or loss ≤ 2kg. Exacerbation: Weight loss \> 2kg.

Outcome measures

Outcome measures
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Weight Baseline	56.89 kg Standard Deviation 10.040	58.47 kg Standard Deviation 6.851
Weight Treatment for 2 weeks	57.32 kg Standard Deviation 9.741	58.30 kg Standard Deviation 6.922
Weight Treatment for 4 weeks	58.05 kg Standard Deviation 9.998	57.86 kg Standard Deviation 6.751
Weight Stop treatment for 4 weeks	58.08 kg Standard Deviation 9.753	57.54 kg Standard Deviation 6.964

SECONDARY outcome

Timeframe: 10 weeks

Acupuncture treating expectation questionnaire used to assess patients' expectation for auricular needling.Higher scores indicate higher expectations.Possible scores range from 4（low expectations） to 20（high expectations).

Outcome measures

Outcome measures
Measure	Auricular Needling Group n=27 Participants Patients will receive auricular needling for 4 weeks . Auricular needling: Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Small intestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.	Control Group n=28 Participants This group will receive no treatment. Subjects will be assessed at baseline and the 2th, 4th and 8th week.
Acupuncture Treating Expectation Questionnaire baseline	12.26 score on a scale Standard Deviation 3.68	10.00 score on a scale Standard Deviation 4.42
Acupuncture Treating Expectation Questionnaire Treatment for 2 weeks	13.74 score on a scale Standard Deviation 3.25	9.64 score on a scale Standard Deviation 3.73
Acupuncture Treating Expectation Questionnaire Treatment for 4 weeks	14.30 score on a scale Standard Deviation 3.30	9.04 score on a scale Standard Deviation 4.38
Acupuncture Treating Expectation Questionnaire Stop treatment for 4 weeks	11.04 score on a scale Standard Deviation 5.09	7.57 score on a scale Standard Deviation 4.02

Adverse Events

Auricular Needling Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Hebin

Clinical Cancer Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences

Phone: 13520253895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place