Trial Outcomes & Findings for Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232) (NCT NCT01881932)
NCT ID: NCT01881932
Last Updated: 2019-11-07
Results Overview
The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Week 12
Results posted on
2019-11-07
Participant Flow
University Medical Centers and Hospital Based Oncology Programs recruited participants from February 2013 until June 2014.
Nineteen patients were enrolled and randomly assigned to one of three arms: a) real acupuncture, b) sham acupuncture or c) standard of care. Two patients received standard of care, 4 real and 13 sham.
Participant milestones
| Measure |
Standard Care
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
|
Acupuncture
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.
Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.
Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and
|
Sham Acupuncture
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.
Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.
Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
13
|
|
Overall Study
COMPLETED
|
2
|
4
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (GCC1232)
Baseline characteristics by cohort
| Measure |
Standard Care
n=2 Participants
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
|
Acupuncture
n=4 Participants
Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points \& immediately affix a pair of needles to the surface of the same points with adhesive tape, w
|
Sham Acupuncture
n=13 Participants
Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.
Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.
Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
44 years
n=5 Participants
|
50 years
n=7 Participants
|
49 years
n=5 Participants
|
49 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Zero participants analyzed due to early termination of study.
The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acupuncture
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham 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
| Measure |
Standard Care
n=2 participants at risk
Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
|
Acupuncture
n=4 participants at risk
Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.
Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.
Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points \& affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion.
|
Sham Acupuncture
n=13 participants at risk
Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week \& all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle \& adhesive tube into the sham points, \& then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm \& leg to produce sensation \& apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
rash, bruising & scabs
|
0.00%
0/2
|
50.0%
2/4 • Number of events 2
|
0.00%
0/13
|
|
General disorders
swelling
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/13
|
|
General disorders
visual impairment, numbness, trouble writing, loss of balance
|
0.00%
0/2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/13
|
Additional Information
Michelle Medeiros
University of Maryland Baltimore Greenebaum Cancer Center
Phone: 410-328-1160
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place