Effect of a mixed solution of sodium hyaluronate and carboxymethyl cellulose on upper limb dysfunction after total mastectomy: a double-blind, randomized clinical trial

Breast Cancer Res Treat. 2012 Nov;136(1):187-94. doi: 10.1007/s10549-012-2272-5. Epub 2012 Sep 29.

Abstract

Restricted shoulder mobility is a major upper limb dysfunction related to lower quality of life and disability after breast cancer surgery. We hypothesized that sodium hyaluronate-carboxymethyl cellulose (HA-CMC) applied to the surface of the pectoralis major muscle after mastectomy would significantly reduce pain and improve range of motion (ROM) of the shoulder in breast cancer patients. We conducted a double-blind, randomized controlled study to evaluate the clinical efficacy and safety of HA-CMC in the prevention of upper limb dysfunction after total mastectomy (TM). A total of 99 women with breast cancer were randomly assigned to one of two groups. In the HA-CMC group (n = 50), a mixed HA-CMC was applied to the surface of the pectoralis major and serratus anterior muscle after TM. In the control group (n = 49), TM was performed without the use of HA-CMC. The primary outcomes were ROM of the shoulder and motion-related pain assessed using a numeric rating scale measured before surgery (T0) and 3 (T1) and 6 months (T2) after surgery. Secondary outcomes included disabilities of the arm, shoulder, and hand (DASH) and the pectoralis minor length test. Compared with the control group, the HA-CMC group showed greater reductions in postoperative restriction of total shoulder ROM (sum of flexion and horizontal abduction) at 3 months (10.20°, P = 0.004). Mean pain levels related to flexion and horizontal abduction were significantly lower in the HA-CMC group (-1.32 and -0.93, respectively, P < 0.05). The DASH score was lower (-4.94; P = 0.057) in the HA-CMC group at T2. No adverse effect was observed in either group. These results provide evidence that HA-CMC may provide pain relief and improve ROM of the shoulder without causing adverse effects. The effect on pectoralis tightness should be investigated in further studies.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / physiopathology
  • Breast Neoplasms* / surgery
  • Carboxymethylcellulose Sodium / administration & dosage*
  • Double-Blind Method
  • Exercise Therapy
  • Female
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Mastectomy / adverse effects
  • Middle Aged
  • Range of Motion, Articular / drug effects
  • Treatment Outcome
  • Upper Extremity / physiopathology*

Substances

  • Hyaluronic Acid
  • Carboxymethylcellulose Sodium